Pocket Drug Guide

Posts Tagged ‘EXP’

ZIMBACOL XL TABLETS

WHAT IS IN ZIMBACOL XL TABLETS?

The name of your medicine is Zimbacol XL tablets.

Zimbacol XL tablets contain bezafibrate 400mg as the active ingredient. They also contain maize starch, sodium starch glycolate, lactose, poly(ethyl aery late-methyl methacrylate), magnesium stearate, polysorbate 80, hypromellose (E464), talc, calcium carbonate (E170), povidone, arabic gum, titanium dioxide (E171), glucose, sucrose, purified water and macrogol 6000.

WHEN SHOULD YOU NOT TAKE ZIMBACOL XL TABLETS?

You should not take Zimbacol XL tablets:

•    if you have received bezafibrate previously and had a bad reaction such as an allergy or wheezing,

•    if you have a severe liver disease (except that caused by increased fat in the liver),

•    if you have a gall bladder disease,

•    if you have poor kidney function or kidney disease.

BEFORE TAKING YOUR MEDICINE

Tell your doctor or pharmacist if any of the following apply:

•    if you are being treated for diabetes or depression,

•    if you are being treated with any other lipid-regulating drugs,

•    if you are taking medicine to ‘thin’ your blood,

•    if you are currently taking any other medicines,

•    if you are pregnant or trying to become pregnant,

•    if you are breast-feeding.

HOW TO TAKE YOUR MEDICINE

It is important that you take your medicine as directed by your doctor.

Normally your doctor will tell you to take one tablet a day, and the tablet should be swallowed whole with a little fluid after a meal, either in the morning or the evening.

Keep taking the medicine until your doctor tells you to stop. If you forget to take a dose take another as soon as you remember and then carry on as before.

The length of time needed for the medicine to work can vary from person to person and your doctor will check from time to time how well it is working.

In the event of an accidental overdose, consult your nearest hospital casualty department or doctor immediately.

DO ZIMBACOL XL TABLETS HAVE ANY SIDE EFFECTS?

As well as benefits, all medicines may occasionally have unwanted effects in some patients. These are called side effects.

Zimbacol XL tablets may cause side effects. These may include nausea and vomiting, loss of appetite, diarrhoea, indigestion, flatulence (wind) and stomach discomfort, particularly when you first start taking your medicine. These effects should not last for long, if they do consult your doctor.

Other effects which occur less frequently include weight gain, headache, dizziness, tiredness or drowsiness, skin rashes, itching or hair loss. Rarely, muscle cramps or weakness may occur.

If you notice any of these side effects or any other changes in your health whilst taking this medicine tell your doctor immediately.

Do not be alarmed by this list of possible events. Most people take Zimbacol XL tablets without any problems.

EXPIRY DATE

You must not take these tablets after the expiry date. This is given on the carton and the blister as ‘EXP’ followed by the month and year. Tablets should not be used after the end of that month. If you are not sure when this is check with your doctor or pharmacist.

STORAGE OF YOUR ZIMBACOL XL TABLETS

Keep your medicine in a safe place where children cannot reach it. These tablets are not prescribed for children and could be dangerous for them.

Do not store your medicine above 25°C.

When your doctor tells you to stop taking the tablets return any left over to your pharmacist.

REMEMBER: This medicine is only for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are similar to yours.

 

Taxotere 160 mg/8 ml concentrate for solution for infusion

Docetaxel

1.   What Taxotere is and what it is used for

The name of this medicine is Taxotere. Its common name is Docetaxel. Docetaxel is a substance derived from the needles of yew trees.

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

Taxotere has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:

-     For the treatment of advanced breast cancer, Taxotere could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.

-     For the treatment of early breast cancer with or without lymph node involvement, Taxotere could be administered in combination with doxorubicin and cyclophosphamide.

-     For the treatment of lung cancer, Taxotere could be administered either alone or in combination with cisplatin.

-     For the treatment of prostate cancer, Taxotere is administered in combination with prednisone or prednisolone.

-     For the treatment of metastatic gastric cancer, Taxotere is administered in combination with cisplatin and 5-fluorouracil.

-     For the treatment of head and neck cancer, Taxotere is administered in combination with cisplatin and 5-fluorouracil.

2.    Before you use Taxotere

You must not be given Taxotere

•    if you are allergic (hypersensitive) to Docetaxel or any of the other ingredients of Taxotere.

•    if the number of white blood cells is too low.

•    if you have a severe liver disease.

Take special care with Taxotere

Before each treatment with Taxotere, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Taxotere. In case of white blood cells disturbances, you may experience associated fever or infections.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Taxotere administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Taxotere in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

During treatment, you may be given other medicines to maintain the number of your blood cells.

Taxotere contains alcohol. Discuss with your doctor if you suffer from alcohol dependency or liver impairment. See also section “Important information about some of the ingredients of Taxotere” below.

Taking other medicines

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription. This is because Taxotere or the other medicine may not work as well as expected and you may be more likely to get a side effect.

Pregnancy

Ask your doctor for advice before being given any medicine.

Taxotere must NOT be administered if you are pregnant unless clearly indicated by your doctor.

You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Taxotere may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

If you are a man being treated with Taxotere you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because Docetaxel may alter male fertility.

Breast-feeding

You must not breast-feed while you are treated with Taxotere.

Driving and using machines

There is no reason why you cannot drive between courses of Taxotere except if you feel dizzy or are unsure of yourself.

Important information about some of the ingredients of Taxotere.

This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 3.16 g (4 ml) per vial, equivalent to 80 ml of beer or 33 ml wine per vial.

Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are breast-feeding women, in children and high-risk groups such as patients with liver disease, or epilepsy.

The amount of alcohol in this medicinal product may alter the effects of other medicines.

The amount of alcohol in this medicine may impair your ability to drive or use machines.

3.   How to use Taxotere

Taxotere will be administered to you by a healthcare professional.

• Usual dose

The dose will depend on your weight and your general condition. Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.

• Method and route of administration

Taxotere will be given by infusion into one of your veins (intravenous use). The infusion will last approximately one hour during which you will be in the hospital.

• Frequency of administration

You should usually receive your infusion once every 3 weeks.

Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Taxotere. In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him results of your blood tests. Such information will allow her/him to decide whether a dose reduction is needed. If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.

4.   Possible side effects

Like all medicines, Taxotere can cause side effects, although not everybody gets them.

Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10); common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in 10,000); very rare (affects less than 1 user in 10,000); not known (frequency cannot be estimated from the available data).

The most commonly reported adverse reactions of Taxotere alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of Taxotere may be increased when Taxotere is given in combination with other chemotherapeutic agents.

During the infusion at the hospital the following allergic reactions (experienced in more than 1 person in 10) may occur:

•    flushing, skin reactions, itching

•    chest tightness; difficulty in breathing

•    fever or chills

•    back pain

•    low blood pressure.

More severe reactions may occur.

The hospital staff will monitoryour condition closely during treatment. Tell them immediately if you notice any of these effects.

Between infusions of Taxotere the following may occur, and the frequency may vary with the combinations of medicines that are received

Very common (affects more than 1 user in 10):

•    infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets

•    fever: if this happens you must tell your doctor immediately

•    allergic reactions as described above

•    loss of appetite (anorexia)

•    insomnia

•    feeling of numbness or pins and needles or pain in the joints or muscles

•    headache

•    alteration in sense of taste

•    inflammation of the eye or increased tearing of the eyes

•    swelling caused by faulty lymphatic drainage

•    shortness of breath

•    nasal drainage; inflammation of the throat and nose; cough

•    bleeding from the nose

•    sores in the mouth

•    stomach upsets including nausea, vomiting and diarrhoea, constipation

•    abdominal pain

•    indigestion

•    short term hair loss (in most cases normal hair growth should return)

•    redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)

•    change in the color of your nails, which may detach

•    muscle aches and pains; back pain or bone pain

•    change or absence of menstrual period

•    swelling of the hands, feet, legs

•    tiredness; or flu-like symptoms

•    weight gain or loss.

Common (affects 1 to 10 users in 100):

•    oral candidiasis

•    dehydration

•    dizziness

•    hearing impaired

•    decrease in blood pressure; irregular or rapid heart beat

•    heart failure

•    oesophagitis

•    dry mouth

•    difficulty or painful swallowing

•    haemorrhage

•    raised liver enzymes (hence the need for regular blood tests).

Uncommon (affects 1 to 10 users in 1,000):

•    fainting

•    at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling

•    inflammation of the colon, small intestine; intestinal perforation

•    blood clots.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist.

5.    How to store Taxotere

Keep out of the reach and sight of children.

Do not use Taxotere after the expiry date which is stated on outer carton and on the label of the vial after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Store in the original package in order to protect from light.

Use the vial immediately after its opening. If not used immediately, in-use storage times and conditions are the responsibility of the user.

From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions.

Use immediately the medicine once added into the infusion bag. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.

Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.

Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

Dispose any unused product or waste material in accordance with local requirements.

6.    Further information

What Taxotere contains

-    The active substance is Docetaxel. Each ml of concentrate for solution for infusion contains 20 mg Docetaxel as trihydrate.

-    The other ingredients are polysorbate 80, ethanol anhydrous and citric acid.

What Taxotere looks like and contents of the pack

Taxotere concentrate for solution for infusion is a pale yellow to brownish-yellow solution.

The concentrate is supplied in a 15 ml clear colourless glass vial with a blue aluminium seal and a blue plastic flip-off cap.

Each box contains one vial of 8 ml concentrate (160 mg Docetaxel).

 

Otomize

Dexamethasone, Neomycin Sulphate, Acetic Acid

1. What Otomize does

Otomize is used to treat infection and inflammation of the outer ear.

Otomize contains three active ingredients. Dexamethasone is a topical corticosteroid medicine which is used to control inflammation. Neomycin sulphate is a broad spectrum antibiotic to fight infections and acetic acid is an antibacterial agent that also helps to clear infections.

2. Check before you use Otomize

Do not use Otomize:

• if you have ever had an allergic reaction to dexamethasone, neomycin sulphate, acetic acid or to any of the other ingredients.

• anywhere other than in the ear. Do not inhale in the mouth or nose or spray near the eyes.

• if you have a perforated ear drum or have a grommet fitted in the affected ear.

• in children under 2 years of age

Take special care with Otomize

• Excessive use (high doses or prolonged use) of this product on open wounds or damaged skin may cause deafness. This is particularly important to consider when used on children.

• Do not swallow any of the spray. If swallowed (especially by a child) contact your doctor or casualty department immediately.

Pregnancy and breast feeding

Talk to your doctor before using Otomize if you are pregnant, trying to become pregnant, or breast feeding.

3.  How to use Otomize

Before using a new bottle of Otomize:

• Shake well before use.

• Press the pump down several times until you get a fine spray.

• Make sure you do not point the nozzle at yourself or someone else.

• Each time the pump is pressed down one measured dose will be delivered.

• If you have not used Otomize for more than a week, press the pump a few times until you get a fine spray again, and then follow the instructions above.

For external use only.

Using Otomize: Adults and children over the age of 2 years.

• Shake well before use.

• Place the nozzle tip gently into your ear.

• Press the pump once to deliver the correct dose.

• Spray one measured dose into each affected ear three times a day, or as directed by your doctor

• If you forget to use Otomize do not worry. Use it as soon as you remember then go on as before.

• The nozzle tip must always be in place when you use the spray. You can remove it for cleaning but always click it back into place afterwards.

Continue using Otomize until two days after symptoms have gone. • Stop using the product and consult a doctor if your condition worsens or does not improve after 7 days treatment. • Do not use more than the recommended dose.

4. Possible side effects

Like all medicines, Otomize can have side effects, but not everyone gets them.

Stop using the medicine and tell your doctor if you experience:

• Sensitivity or allergic reactions (irritation or a rash).

The following side effects may also occur, but usually go away after the first few days of treatment:

• Temporary stinging or a burning sensation.

If you do get any side effects, even those not mentioned in this leaflet, tell your doctor or pharmacist.

5.  How to store Otomize

Keep out of the reach and sight of children.

Do not use this medicine after the ‘EXP’ date shown on the pack.

Do not store above 25°C.

Do not freeze.

Keep container upright in the outer carton.

Use within one month of first use.

6.  Further information

Active ingredients Dexamethasone 0.1 % w/w, Neomycin Sulphate 0.5% w/w (3250 lU/ml), Acetic Acid (glacial) 2.0% w/w. Other ingredients Macrogol (2) stearyl ether, macrogol (20) stearyl ether, stearyl alcohol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216) and purified water.

Otomize is supplied in packs containing 5ml as an aqueous suspension. The spray is non-pressurised and does not contain CFCs.

 

Lysodren 500 mg tablets

Mitotane

1. WHAT LYSODREN IS AND WHAT IT IS USED FOR

Lysodren is an antitumoral medicine.

This medicine is used for the treatment of symptoms of advanced non operable, metastatic or recurrent malignant tumours of the adrenal glands.

2.BEFORE YOU TAKE LYSODREN

Do not take Lysodren

• if you are allergic (hypersensitive) to mitotane or any of the other ingredients of Lysodren
• if you are breast-feeding. You must not breast-feed while taking Lysodren.
• if you are being treated with medicines containing spironolactone.

Take special care with Lysodren

You should tell your doctor if any of the following applies to you:

• if you have an injury (shock, severe trauma), an infection or if you have any illness while you are taking Lysodren. Tell your doctor immediately, who may decide to temporarily stop treatment.
• if you have severe liver or kidney problems.
• if you are using any medicines mentioned below.

This medicine should not be handled by persons other than the patient and his/her caregivers, and especially not by pregnant women. Caregivers should wear disposable gloves when handling the tablets.

Your doctor may prescribe you some hormonal treatment (steroids) while you are taking Lysodren.

Always keep with you the Lysodren Patient Card included at the end of this leaflet.

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

You must not use Lysodren with medicines containing spironolactone, often used as a diuretic for heart, liver or kidney diseases.

Lysodren may interfere with several medicines. Therefore, you should tell your doctor if you are using medicines containing any of the following active substances:

• warfarin or other anticoagulants (blood thinners), used to prevent blood clots. The dose of your
• anticoagulant may need adjustment.
• antiepileptics
• rifabutin or rifampicin, used to treat tuberculosis
• griseofulvin, used in the treatment of fungal infections
• herbal preparations containing St. John’s wort (Hypericumperforation)

Taking Lysodren with food and drink

Lysodren should preferably be taken during meals containing fat-rich food such as milk, chocolate, oil.

Pregnancy and breast-feeding

Lysodren may harm the foetus. If you are pregnant or planning to become pregnant, tell your doctor. If you may become pregnant, you should use effective contraception during treatment with Lysodren and even after stopping it. Ask your doctor for advice.

You must not breast-feed while taking Lysodren and even after stopping it. Ask your doctor for advice.

Driving and using machines

Lysodren has a major influence on your ability to drive and use machines. Ask your doctor for advice.

3. HOW TO TAKE LYSODREN

Always take Lysodren exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dose and schedule

The usual starting dose for adults is 2 to 3 g (4 to 6 tablets) per day.

Your doctor may start treatment at higher doses such as 4 to 6 g (8 to 12 tablets).

In order to find the optimal dose for you, your doctor will monitor regularly the levels of Lysodren in your blood. Your doctor may decide to stop treatment with Lysodren temporarily or to lower the dose if you experience certain side effects.

Children and adolescents

The starting daily dose of Lysodren is 1.5 to 3.5 g/m² body surface (this will be calculated by your doctor according to the weight and the size of the child). The experience in patients in this age group is very limited.

• Method of administration

You should swallow the tablets with water during meals containing fat-rich food. You can divide the total daily dose in two or three intakes.

• If you take more Lysodren than you should

Tell your doctor immediately if you have accidentally taken more Lysodren than you should or if a child has accidentally swallowed some.

• If you forget to take Lysodren

If you accidentally miss a dose, just take the next dose as scheduled. Do not take a double dose to make up for the forgotten one.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lysodren can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following side effects:

• Adrenal insufficiency: fatigue, abdominal pain, nausea, vomiting, diarrhoea, confusion
• Anaemia: cutaneous pallor, muscular fatigability, feeling breathless, vertigo especially when standing up
• Liver damage: yellowing of the skin and eyes, itching, nausea, diarrhoea, fatigue, dark coloured urine
• Neurological disorders: movement and coordination disorders, abnormal sensations like pins and needles, memory loss, concentration difficulty, difficulty to talk, vertigo

These symptoms may reveal complications for which specific medication could be appropriate.

Side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data

Very common side effects

• vomiting, nausea (feeling sick), diarrhoea, belly pain
• lack of appetite
• abnormal sensations like pins and needles
• movement and coordination disorders, vertigo, confusion
• feeling sleepy, fatigue, muscle weakness (fatigue of muscle during effort)
• inflammation (swelling, heat, pain) of mucosa, skin rash
• blood disorders (bleeding time prolonged)
• increase of cholesterol, triglycerides (fats) and liver enzymes (in blood tests)
• decrease in white blood cells count
• breast overdevelopment in men
• adrenal insufficiency

Common side effects

• dizziness, headache
• peripheral nervous system disorders (association of sensory disorders, muscular weakness and
• atrophy, decrease of tendon reflex and vasomotor symptoms such as hot flushes, sweat and sleep disorders)
• mental impairment (such as memory loss, concentration difficulty)
• movement disorder
• decrease of red blood cells (anaemia, with symptoms such as skin pallor and fatigue), decrease in blood platelets (may make you more prone to bruising and bleeding)
• hepatitis (auto-immune) (may cause yellowing of the skin and eyes, dark coloured urine)

Frequency Not Known

• fever
• general aching
• flushing, high or low blood pressure, feeling of dizziness/vertigo when you suddenly stand up increased production of saliva
• eye disorders : visual impairment, vision blurred, double vision
• fungal infection
• liver damage (may cause yellowing of the skin and eyes, dark coloured urine)
• decreased uric acid in blood tests
• bladder inflammation with bleeding
• presence of blood in urine, presence of proteins in urine,

In children and adolescents, thyroid problems, neuro-psychological and growth retardation have been observed.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or your pharmacist.

5. HOW TO STORE LYSODREN

Keep out of the reach and sight of children.

Store in the original container.

Do not use after the expiry date which is stated on the carton and the bottle after EXP.

Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicines.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

• What Lysodren contains

The active substance is mitotane. Each tablet contains 500 mg of mitotane.

The other ingredients are maize starch, microcrystalline cellulose (E 460), macrogol 3350 and silica colloidal anhydrous.

• What Lysodren looks like and contents of the pack

Lysodren tablets are white, biconvex, round and scored. Lysodren is available in plastic bottles of 100 tablets.

 

Litak 2 mg/ml solution for injection

Cladribine

1. What Litak is and what it is used for

Litak contains the active substance cladribine. Cladribine is a cytostatic agent. It affects the growth of malignant (cancerous) white blood cells which play a role in hairy cell leukaemia. Litak is used to treat this disease.

2. Before you use Litak

Do not use Litak

• if you are allergic (hypersensitive) to cladribine or any of the other ingredients of Litak
• if you are pregnant or breast-feeding
• if you are less than 18 years of age
• if you have moderate to severe kidney or liver impairment
• if you are using other medicines which affect the production of blood cells in the bone marrow (myelosuppression).

Take special care with Litak

Tell your doctor if you have or have had: liver or kidney problems infections

• if you suffer from an infection, this will be treated before you start using Litak.
• if you notice any signs of infections (such as flu-like symptoms or fever) during or after treatment with Litak, inform your doctor immediately.
• fever

Before and during treatment with Litak, you will have regular blood tests to check whether it is safe for you to continue with your treatment. Your doctor may decide that you should receive blood transfusions to improve your level of blood cells. In addition, the proper function of your liver and your kidneys will be checked.

If you want to father a child, please tell your doctor before treatment with Litak is started. You should not father a child during treatment and up to 6 months after treatment with Litak. Your doctor may advise you about the possibility to store deep-frozen sperm (cryoconservation).

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are using any medicines containing:

• corticosteroids, commonly used to treat inflammation
• antiviral agents, used to treat viral infections

You must not use Litak with other medicines that affect the production of blood cells in the bone marrow (myelosuppression).

Pregnancy and breast-feeding

Your must not use Litak if you are pregnant. You must take adequate contraceptive precautions during therapy and for at least six months after your last Litak dose. If pregnancy occurs during your treatment, you must immediately inform your doctor.

You must not breast-feed while you are treated with Litak and for at least six months after your last Litak dose.

Driving and using machines

Litak has a major effect on the ability to drive and use machines. If you feel drowsy, which may occur due to a low number of red blood cells caused by Litak treatment, or dizzy, you should not drive or use machines.

3. How to use Litak

Always use Litak as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will calculate your dose according to your body weight and explain the treatment schedule in detail. The recommended daily dose is 0.14 mg per kg body weight for five consecutive days (single treatment course).

Litak has to be injected under your skin (subcutaneous injection), at about the same time each day. If you are injecting Litak yourself, first you must receive adequate training by your doctor or nurse. You will find detailed instructions for injection at the end of this leaflet.

You may also receive an additional medicine containing the active substance allopurinol in order to reduce excess of uric acid.

• If you use more Litak than you should

In case you inject an incorrect dose, tell your doctor immediately.

• If you forget to use Litak

Do not inject a double dose to make up for a forgotten dose. In case you miss an injection of a dose, tell your doctor immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Litak can have side effects, although not everybody gets them.

Tell your doctor immediately if you have any of the following during or after treatment with Litak: any signs of infections (such as flu-like symptoms) fever

Repeated occurrence of malignant (cancerous) disease cannot be excluded. This means that the risk that you develop a malignant disease in the future is slightly higher than for healthy people. This slightly increased risk can be due to hairy cell leukaemia or to therapies used to treat the disease including Litak.

Side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.

Very common side effects

• Infections.
• Fever.
• Low numbers of certain white blood cells (neutrophils and lymphocytes) and platelets in blood tests.
• Low number of red blood cells, which may result in anaemia, with symptoms such as tiredness and drowsiness.
• Reduced function of your body’ s immune system.
• Headache, dizziness.
• Abnormal breath sounds, abnormal chest sounds, cough.
• Feeling sick, vomiting, constipation and diarrhoea.
• Skin eruption (rash), swelling, redness as well as soreness around the site of injection, sweating. Skin reactions are mostly mild to moderate and usually resolve within a few days.
• Tiredness, chills, decreased appetite.
• Weakness.

Common side effects

• Repeated occurrence of malignant (cancerous) disease.
• Low number of platelets, which can cause unusual bleeding (for example nose or skin bleeds).
• Sleeplessness, anxiety.
• Increased heart rate, abnormal heart sound, low blood pressure, decreased blood supply to the heart muscle.
• Shortness of breath, swelling in lung tissue due to infection, inflammation of mouth and tongue.
• Abdominal pain and presence of excessive amount of gas in the stomach or bowels, mostly mild increases in liver laboratory values (bilirubin, transaminases) which will return to normal values once treatment is over.
• Itching, itching skin eruption (urticaria), redness of the skin and skin pain.
• Swelling in tissues (oedema), not feeling well, pain (muscle pain, joint pain, and bone pain).

Uncommon side effects

• Anaemia caused by destruction of red blood cells.
• Sleepiness, numbness and tingling of the skin, feebleness, inactivity, disorder of peripheral nerves, confusion, impaired ability to coordinate movements.
• Eye inflammation.
• Sore throat.
• Inflammation of a vein.
• Severe weight loss.
• Rare side effects
• Reduced liver function.
• Reduced kidney function.
• Complications caused by cancer treatment due to break-down of cancer cells.
• Rejection response to blood transfusions.
• Increased number of certain white blood cells (eosinophils). Stroke.
• Disturbances in speech and swallowing.
• Heart failure.
• Abnormal heart rhythm.
• Inability of the heart to maintain adequate blood circulation.
• Obstruction of the bowels.
• Serious allergic skin reaction (Stevens-Johnson syndrome or Lyell syndrome).

Very rare side effects

• Depression, epileptic attack.
• Swelling of the eyelid.
• Blood clot in the lung.
• Inflammation of the gallbladder.

Reduced function of organs due to high amounts of a specific substance produced by the body (a glycoprotein).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Litak

Keep out of the reach and sight of children.

Store in a refrigerator (2°C-8°C). Do not freeze.

Do not use Litak after the expiry date which is stated on the vial label and the outer carton after EXP. The expiry date refers to the last day of that month.

From a microbiological point of view, unless the opening precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not use Litak if you notice that the vial is damaged or that the solution is not clear or contains any particles.

Any unused product or waste material should be disposed of in accordance with local requirements.

6. Further information

• What Litak contains

The active substance is cladribine. Each ml solution contains 2 mg cladribine. Each vial contains 10 mg cladribine in 5 ml solution.

The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.

• Instructions for injection

This section contains information on how to give an injection of Litak. It is important that you do not try to give yourself the injection unless you have been instructed by your doctor or nurse. Your doctor will tell you how much Litak you need and how often and when you have to inject yourself. Litak should be injected into the tissue just under the skin (subcutaneous injection). If you have any question with regard to giving the injection, please ask your doctor or nurse for help.

Litak is a cytotoxic and should therefore be handled with caution. When Litak is not self-administered by the patient, the use of disposable gloves and protective garments is recommended when handling and administering Litak. If Litak contacts the skin or eyes, rinse the involved surface immediately with copious amounts of water. Pregnant women must avoid contact with Litak.

What do I need for the injection?

To give yourself a subcutaneous injection, you will need:

• one vial of Litak (or two vials if you need to inject more than 5 ml). Do not use vials which are damaged, or if the solution is not clear or if it contains any particles.
• one sterile syringe (e.g. 10 ml LUER syringe),
• one sterile injection needle (e.g. 0.5 x 19 mm, 25 G x %”),
• alcohol wipes,
• a puncture-proof container for safe disposal of the used syringe.

What should I do before I give myself a subcutaneous injection of Litak?

1. Before injection, allow Litak to warm up to room temperature.

2. Wash your hands thoroughly.

3. Find a comfortable, well-lit place and put everything you need where you can reach it. How do I prepare the injection?

Before you inject Litak, you must do the following:

1. Remove the red protective cap from the Litak vial. Do not remove the rubber stopper of the vial. Clean the rubber top of the vial with an alcohol wipe. Remove the syringe from the wrapping without touching the tip of the syringe. Remove the injection needle from the wrapping and place it firmly on the tip of the syringe. Remove the needle guard without touching the needle.

2. Push the needle through the rubber stopper of the vial and turn the vial and the syringe upside down. Be sure that the tip of the needle is in the solution.

3. Draw the correct volume of Litak into the syringe by pulling back the plunger (your doctor will inform you how many ml of Litak you need to inject).

4. Pull the needle out of the vial.

5. Make sure there is no air left in the syringe: point the needle upwards and push the air out.

6. Check you have the right volume.

7. Inject straight away. Where should I give my injection?

The most suitable places to inject yourself are shown here: the top of your thighs and the abdomen, except for the area around the navel. If someone else is injecting you, they can also use the outer surface of the upper arms or the buttocks.

How do I give my injection?

1. Disinfect your skin by using an alcohol wipe, wait for the area to dry and pinch the skin between your thumb and forefinger, without squeezing it.

2. Put the needle fully into the skin at an angle of about 45°, as shown in the picture.

3. Pull slightly on the plunger to check that no blood vessel has been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.

4. Inject the liquid slowly and evenly for approximately one minute, always keeping the skin pinched.

5. After injecting the liquid, remove the needle.

6. Put the used syringe in the puncture-proof container. Use a new syringe and injection needle for each injection. The vials are for single use only. Return any portion of the contents remaining after use to your doctor or pharmacist for proper disposal.

Disposing of used syringes

Put used syringes into a puncture-proof container and keep it out of the reach and sight of children.

Dispose the puncture-proof container as instructed by your doctor, nurse or pharmacist. Do not put used syringes into the normal household garbage bin.

 

Iressa 250 mg film-coated tablets

Gefitinib

1. What Iressa is and what it is used for

Iressa contains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor’ (EGFR). This protein is involved in the growth and spread of cancer cells.

Iressa is used to treat adults with non-small cell lung cancer. This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.

2. Before you take Iressa

Do not take Iressa

• If you are allergic (hypersensitive) to gefitinib or any of the other ingredients of Iressa.

• If you are breast-feeding.

Take special care with Iressa

Check with your doctor or pharmacist before taking Iressa.

• If you have ever had any other lung problems. Some lung problems may get worse during treatment with Iressa.

• If you have ever had problems with your liver.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Phenytoin or carbamazepine (for epilepsy).

• Rifampicin (for tuberculosis).

• Itraconazole (for fungal infections).

• Barbiturates (a type of medicine used for sleeping problems).

• Herbal remedies containing St John’s wort {Hypericumperforation, used for depression and anxiety).

• Proton-pump inhibitors, H₂-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).

These medicines may affect the way Iressa works.

• Warfarin (a so-called oral anticoagulant, to prevent blood clots). If you are taking a medicine containing this active substance, your doctor may need to do blood tests more often.

If any of the above applies to you, or if you are not sure, check with your doctor or pharmacist before taking Iressa.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, may become pregnant or are breast-feeding.

It is recommended that you avoid becoming pregnant during treatment with Iressa because Iressa could harm your baby.

Do not take Iressa if you are breast-feeding.

Driving and using machines

Iressa has no or negligible influence on your ability to drive or use any tools or machines. However, if you feel weak whilst taking this medicine, take care driving or using tools or machines.

Important information about some of the ingredients of Iressa

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Iressa

Always take Iressa exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

•    The usual dose is one 250 mg tablet per day.

•    Take the tablet at about the same time each day.

•    You can take the tablet with or without food.

•    Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking Iressa.

If you have trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water. Do not use any other liquids. Do not crush the tablet. Swirl the water until the tablet has dissolved. This may take up to 20 minutes. Drink the liquid straight away. To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it.

• If you take more Iressa than you should

If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.

• If you forget to take Iressa

What to do if you forget to take a tablet, depends on how long it is until your next dose.

• If it is 12 hours or more until your next dose: take the missed tablet as soon as you remember. Then take the next dose as usual.

•    If it is less than 12 hours until your next dose: skip the missed tablet. Then take the next

tablet at the usual time. Do not take a double dose (two tablets at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects

Like all medicines, Iressa can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows:

• Very common: affects more than 1 user in 10.

• Common: affects 1 to 10 users in 100.

• Uncommon: affects 1 to 10 users in 1,000.

• Rare: affects 1 to 10 users in 10,000.

• Very rare: affects less than 1 user in 10,000.

• Not known: frequency cannot be estimated from the available data.

Tell your doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:

• Allergic reaction (uncommon), particularly if symptoms include swollen face, tongue or throat, difficulty to swallow, hives and difficulties to breathe.

•  Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever. This may mean that you have an inflammation of the lungs called ‘interstitial lung disease’. This may affect about 1 in 100 patients taking Iressa and can be life-threatening.

•  Severe skin reactions (rare) affecting large areas of your body. The signs may include redness, pain, ulcers, blisters, and shedding of the skin. The lips, nose, eyes and genitals may also be affected.

• Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.

• Eye problems (uncommon), such as pain, redness changes in vision or ingrowing eyelashes. This may mean that you have an ulcer on the surface of the eye (cornea).

Tell your doctor if you notice any of the following side effects:

Very common side effects

• Diarrhoea.

• Vomiting.

• Nausea.

•  Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin.

• Loss of appetite.

• Weakness.

• Dry, red or sore mouth.

• Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, your doctor may tell you to stop taking Iressa.

Common side effects

•  Dry, red or itchy eyes.

•  Red and sore eyelids.

•  Nail problems.

•  Hair loss.

•  Fever.

•  Bleeding (such as nose bleed or blood in your urine).

•  Protein in your urine (shown in a urine test).

•  Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking Iressa.

•  Increase of creatinine levels in a blood test (related to kidney function).

•  Cystitis (burning sensations during urination and frequent, urgent need to urinate).

Uncommon side effects

•  Inflammation of the pancreas. The signs include very severe pain in the upper part of the stomach area and severe nausea and vomiting.

•  Inflammation of the liver. Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes). This side effect is uncommon; however, some patients have died from this.

•  Gastrointestinal perforation.

Rare side effects

•  Inflammation of the blood vessels in the skin. This may give the appearance of bruising or patches of non-blanching rash on the skin.

•  Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.  How to store Iressa

Keep out of the reach and sight of children.

Do not use Iressa after the expiry date which is stated on the carton, blister and overwrap foil after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.   Further information

What Iressa contains

•    The active substance is gefitinib. Each tablet contains 250 mg of gefitinib.

•    The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, povidone (K29-32) (E1201), sodium laurilsulfate, magnesium stearate, hypromellose (E464), macrogol 300, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

What Iressa looks like and contents of the pack

Iressa is a round brown tablet marked with ‘IRESSA 250′ on one side and plain on the other. Iressa comes in blister packs of 30 tablets.

 

Herceptin 150 mg powder for concentrate for solution for infusion

Trastuzumab

1. WHAT HERCEPTIN IS AND WHAT IT IS USED FOR

Herceptin contains the active substance trastuzumab, which is a monoclonal antibody. Monoclonal antibodies attach to specific proteins or antigens. Trastuzumab is designed to bind selectively to an antigen called human epidermal growth factor 2 (HER2). HER2 is found in large amounts on the surface of some cancer cells where it stimulates their growth. When Herceptin binds to HER2 it stops the growth of such cells and causes them to die.

Your doctor may prescribe Herceptin for the treatment of breast and gastric cancer when:

You have early breast cancer, with high levels of HER2 and your chemotherapy treatment is finished.

You have metastatic breast cancer (i.e. breast cancer that has spread beyond the original tumour) with high levels of HER2. Herceptin may be prescribed in combination with the chemotherapy agents paclitaxel or docetaxel as first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful. It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone receptor-positive metastatic breast cancer (i.e. cancer that is sensitive to the presence of female sex hormones)

You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-flououracil and cisplatin.

If you receive Herceptin with paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the package leaflets for these products.

2. BEFORE YOU USE HERCEPTIN

• Do not use Herceptin

If you are allergic to trastuzumab, to murine (mouse) proteins, or to any of the other ingredients. If you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.

• Tell your doctor before you use Herceptin

If you have had heart failure, coronary artery disease, heart valve disease (heart murmurs) or high blood pressure. Talk to your doctor about this because Herceptin can cause heart failure.

If you have ever had chemotherapy with a medicine called doxorubicin or a medicine related to doxorubicin (your doctor can advise you here). These medicinal products can damage heart muscle and increase the risk of heart problems with Herceptin.

If you are breathless. Herceptin can cause breathing difficulties, especially when it is first given. This could be more serious if you are already breathless. Very rarely, patients with severe breathing difficulties before treatment have died when they were given Herceptin.

Your doctor will closely supervise your therapy with Herceptin

Apart from breathing difficulties, Herceptin can cause fever, chills, flu-like symptoms, swelling of the face and lips, rash, wheezing, heart rhythm disturbances and blood pressure changes. These effects mainly occur with the first infusion (“drip” into your vein) and during the first few hours after the start of the infusion. Occasionally, symptoms start later than six hours after the infusion begins. Sometimes, symptoms may improve and then get worse later. If this happens to you, contact your doctor immediately. You will be observed by a health care professional during the infusion and for at least six hours after the start of the first infusion and for two hours after the start of other infusions. If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects.

Treatment with Herceptin may affect the heart. Therefore, your heart function will be checked before and during the treatment with Herceptin. If you develop any signs of heart failure (i.e., inadequate pumping of blood by the heart), you may have to stop Herceptin.

• Taking other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It may take up to 6 months for Herceptin to be removed from the body. Therefore you should tell your doctor or pharmacist that you have had Herceptin if you start any new medication in the 6 months after stopping treatment

• Use in children and adolescents

At present, Herceptin is not recommended for anyone under the age of 18 years because there is not enough information in this age group.

• Pregnancy and breast-feeding

Before starting treatment, you must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. You should use effective contraception during treatment with Herceptin and for at least 6 months after treatment has concluded. In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing baby within the womb has been observed in pregnant women receiving Herceptin. Your doctor will advise you of the risks and benefits of taking Herceptin during pregnancy.

Do not breast-feed your baby during Herceptin therapy and for 6 months after the last dose of Herceptin.

Ask your doctor or pharmacist for advice before taking any medicine

• Driving and using machines

We do not know whether Herceptin could affect your ability to drive a car or operate machines. However, if you experience symptoms, such as chills or fever, during an infusion of Herceptin, you should not drive or use machines until these symptoms disappear.

3. HOW TO USE HERCEPTIN

Herceptin is given as an intravenous infusion (“drip”) directly into your veins. The first dose of your treatment is given over 90 minutes and you will be observed by a health professional while it is being given in case you have any side effects. If the first dose is well tolerated the next doses may be given over 30 minutes.

Before starting the treatment your doctor will determine the amount of HER2 in your tumour. Only patients with a large amount of HER2 will be treated with Herceptin. Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Herceptin depends on your body weight. The number of infusions you receive will depend on how you respond to the treatment. Your doctor will discuss this with you.

For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Herceptin is given every 3 weeks. Herceptin may also be given once a week for metastatic breast cancer.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Herceptin can cause side effects, although not everybody gets them. Some of these side effects may be serious and may lead to hospitalisation.

During a Herceptin infusion, chills, fever and other flu like symptoms may occur. These are very common (affects more than 1 user in 10). They mainly occur with the first infusion and are temporary. Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired. These symptoms can be serious and some patients have died. You will be observed by a health professional during and after each infusion. If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects. The infusion may be continued after the symptoms improve.

Other side effects can occur at any time during treatment with Herceptin, not just related to an infusion. Heart problems can sometimes occur and can be serious. They include weakening of the heart muscle possibly leading to heart failure, inflammation (i.e. swollen, red, hot, and in pain) of the lining around the heart and heart rhythm disturbances. Your doctor will monitor your heart regularly during treatment but you should tell your doctor immediately if you notice:

• breathlessness (including breathlessness at night),
• cough,
• fluid retention (swelling) in the legs or arms,
• palpitations (heart fluttering or irregular heart beat).
• Very common side effects of Herceptin (affects more than 1 user in 10) :
• diarrhoea, weakness, skin rashes, chest pain, abdominal pain, joint pain, febrile neutropenia and muscle pain.
• Other common side effects of Herceptin (affects 1 to 10 users in 100):
• allergic reactions
• abnormal blood counts (anaemia, low
• platelet count and low white blood count)
• constipation
• heartburn (dyspepsia)
• infections including bladder and skin
• infections
• shingles
• inflammation of the breast
• inflammation of the pancreas or liver
• kidney disorders
• increased muscle tone /tension (hypertonia)
• tremor
• numbness or tingling of the fingers and toes
• nail disorders
• hair loss
• inability to sleep (insomnia)
• sleepiness (somnolence)
• nose bleeds
• bruising
• haemorrhoids
• itchiness
• dry mouth and skin
• dry or watery eyes
• sweating
• feeling weak and unwell
• anxiety
• depression
• abnormal thinking
• dizziness
• loss of appetite
• weight loss
• altered taste
• asthma
• lung disorders
• back pain
• neck pain
• bone pain
• acne
• leg cramps

Other rare side effects of Herceptin, (affects 1 to 10 users in 10,000) are:

• Weakness
• Inflammation/scarring of the lungs
• Jaundice

Other side effects that have been reported with Herceptin use (frequency cannot be estimated from the available data):

-Abnormally low clotting factor

-Anaphylactic reactions

-High potassium levels

-Swelling of the brain

-Swelling /bleeding at the back of the eyes

-Shock

-Swelling of the lining of the heart

-Slow heart rate

-Abnormal heart rhythm

-Respiratory distress

-Respiratory Failure

-Acute accumulation of fluid in the lungs

-Acute narrowing of the airways

-Abnormally low oxygen levels in the blood

-Swelling of the throat

-Difficulty in breathing when lying flat

-Liver damage/failure

-Swelling of the face, lips and throat

-rash (itchy, bumpy)

-Kidney damage/ failure

-Abnormally low levels of fluid around baby in womb

Some of the side effects you experience may be due to your underlying breast cancer. If you receive Herceptin in combination with chemotherapy, some of them may also be due to the chemotherapy.

If you experience any of the side effects mentioned in this leaflet or notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. HOW TO STORE HERCEPTIN

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP.

Store in a refrigerator (2°C – 8°C).

Infusion solutions should be used immediately after dilution. Do not use Herceptin if you notice any particulate matter or discoloration prior to administration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

• What Herceptin contains

The active substance is trastuzumab. Each vial contains 150 mg trastuzumab that has to be dissolved in 7.2 ml of water for injection. The resulting solution contains approximately 21 mg/ml trastuzumab.

The other ingredient(s) are L-histidine hydrochloride, L-histidine, a,a-trehalose dihydrate, polysorbate 20.

• What Herceptin looks like and contents of the pack

Herceptin is a powder for concentrate for solution for infusion, that is supplied in a glass vial with a rubber stopper containing 150 mg of trastuzumab. The powder is a white to pale yellow pellet. Each carton contains 1 vial of powder..

• The following information is intended for medical or healthcare professionals only

Always keep this medicine in the closed original pack at a temperature of 2°C – 8 °C in a refrigerator. A vial of Herceptin reconstituted with water for injections (not supplied) is stable for 48 hours at 2°C -8 °C after reconstitution and must not be frozen.

Appropriate aseptic technique should be used. Each vial of Herceptin is reconstituted with 7.2 ml of water for injections (not supplied). Use of other reconstitution solvents should be avoided. This yields a 7.4 ml solution for single-dose use, containing approximately 21 mg/ml trastuzumab. A volume overage of 4 % ensures that the labelled dose of 150 mg can be withdrawn from each vial.

Herceptin should be carefully handled during reconstitution. Causing excessive foaming during reconstitution or shaking the reconstituted Herceptin may result in problems with the amount of Herceptin that can be withdrawn from the vial.

Instructions for Reconstitution:

1)  Using a sterile syringe, slowly inject 7.2 ml of water for injections in the vial containing the lyophilised Herceptin, directing the stream into the lyophilised cake.

2)  Swirl vial gently to aid reconstitution. DO NOT SHAKE!

Slight foaming of the product upon reconstitution is not unusual. Allow the vial to stand undisturbed for approximately 5 minutes. The reconstituted Herceptin results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.

Determine the volume of the solution required:

•      based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight

 

•      based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight:

 

The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 ml of 0.9 % sodium chloride solution. Do not use with glucose-containing solutions. The bag should be gently inverted to mix the solution in order to avoid foaming. Parenteral solutions should be inspected visually for particulates and discoloration prior to administration. Once the infusion is prepared it should be administered immediately. If diluted aseptically, it may be stored for 24 hours (do not store above 30°C).

 

Gemzar 200 mg powder for solution for infusion

Gemzar 1000 mg powder for solution for infusion

Gemcitabine

1. WHAT GEMZAR IS AND WHAT IT IS USED FOR

Gemzar belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells.

Gemzar may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.

Gemzar is used in the treatment of the following types of cancer:

•     non-small cell lung cancer (NSCLC), alone or together with cisplatin.

•     pancreatic cancer.

•     breast cancer, together with paclitaxel.

•     ovarian cancer, together with carboplatin.

•     bladder cancer, together with cisplatin.

2. BEFORE YOU ARE GIVEN GEMZAR

You should not be given Gemzar:

if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemzar if you are breast-feeding

Take special care with Gemzar:

Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function. Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Gemzar. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. Periodically you will have samples of your blood taken to evaluate your kidney and liver function.

Please tell your doctor if:

•     you have, or have previously had liver disease, heart disease or vascular disease.

•     you have recently had, or are going to have radiotherapy,

•     you have been vaccinated recently,

•     you develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney failure).

Men are advised not to father a child during and up to 6 months following treatment with Gemzar. If you would like to father a child during the treatment or in the 6 months following treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy.

• Taking other medicines

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription.

• Pregnancy and breast-feeding

If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Gemzar should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemzar during pregnancy.

If you are breast-feeding, tell your doctor.

You must discontinue breast-feeding during Gemzar treatment.

• Driving and using machines

Gemzar may make you feel sleepy, particularly if you have consumed any alcohol. Do not drive a car or use machinery until you are sure that Gemzar treatment has not made you feel sleepy.

Important information about some of the ingredients of Gemzar

Gemzar contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial and 17.5 mg (< 1 mmol) sodium in each 1000 mg vial. To be taken into consideration by patients on a controlled sodium diet.

3. HOW GEMZAR IS GIVEN

The usual dose of Gemzar is 1000-1250 mg for every square metre of your body’s surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dosage may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.

How frequently you receive your Gemzar infusion depends on the type of cancer that you are being treated for.

A hospital pharmacist or doctor will have dissolved the Gemzar powder before it is given to you.

You will always receive Gemzar by infusion into one of your veins. The infusion will last approximately 30 minutes.

If you have further questions on the use of this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gemzar can cause side effects, although not everybody gets them.

Frequencies of the observed side effects are defined as:

•     very common: affects more than 1 user in 10

•     common: affects 1 to 10 users in 100

•     uncommon: affects 1 to 10 users in 1,000

•     rare: affects 1 to 10 users in 10,000

•     very rare: affects less than 1 user in 10,000

•    not known: frequency can’t be estimated from the available data

You must contact your doctor immediately if you notice any of the following:

• Fever or infection (common): if you have a temperature of 38°C or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
• Irregular heart rate (arrhythmia) (frequency not known).
• Pain, redness, swelling or sores in your mouth (common).
• Allergic reactions: if you develop skin rash (very common) / itching (common), or fever (very common).
• Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
• Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).
• Difficulty breathing (it is very common to have mild breathing difficulty soon after the Gemzar infusion which soon passes, however uncommonly or rarely there can be more severe lung problems).

Side effects with Gemzar may include:

Very common side effects

• Low haemoglobin level (anaemia)
• Low white blood cells
• Low platelet count
• Difficulty breathing
• Vomiting
• Nausea
• Skin rash- allergic skin rash, frequently itchy
• Hair loss
• Liver problems: found through abnormal blood test results
• Blood in urine
• Abnormal urine tests: protein in urine
• Flu like symptoms including fever
• Oedema (swelling of ankles, fingers, feet, face)

Common side effects

• Fever accompanied by low white blood cell count (febrile neutropenia)
• Anorexia (poor appetite)
• Headache
• Insomnia
• Sleepiness
• Cough
• Runny nose
• Constipation
• Diarrhoea
• Pain, redness, swelling or sores in the mouth
• Itching
• Sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills

Uncommon side effects

• Interstitial pneumonitis (scarring of the air sacs of the lung)
• Spasm of the airways (wheeze)
• Abnormal chest X ray/scan (scarring of the lungs)

Rare side effects

• Heart attack (myocardial infarction) Low blood pressure
• Skin scaling, ulceration or blister formation Injection site reactions

Very rare side effects

Increased platelet count

• Anaphylactic reaction (severe hypersensitivity/ allergic reaction)
• Sloughing of skin and severe skin blistering
• Side effects with frequency not known
• Irregular heart beat (arrhythmia)
• Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)
• Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy.
• Fluid in the lungs
• Radiation toxicity- scarring of the air sacs of the lung associated with radiation therapy
• Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)
• Heart failure
• Kidney failure
• Gangrene of fingers or toes
• Serious liver damage, including liver failure
• Stroke

You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.

If you are concerned about any side effects, talk to your doctor.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor.

5. HOW TO STORE GEMZAR

Keep out of the reach and sight of children.

Do not use after the expiry date (EXP) which is stated on the carton.

Unopened vial: Store below 30°C.

Reconstituted solution: The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted solutions of gemcitabine were demonstrated for 24 hours at 30°C. Further dilution by a healthcare provider may be done. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur.

This medicine is for single use only; any unused solution should be discarded under the local requirements.

6. FURTHER INFORMATION

• What Gemzar contains

The active substance is gemcitabine. Each vial contains 200 or 1000 mg of gemcitabine (as gemcitabine hydrochloride).

The other ingredients are mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.

• What Gemzar looks like and contents of the pack

Gemzar is a white to off-white powder, for solution for infusion in a vial. Each vial contains 200 or 1000 mg of gemcitabine. Each pack of Gemzar contains 1 vial.

Marketing Authorisation Holder and Manufacturer

[See Annex I - To be completed nationally]

The following information is intended for medical or healthcare professionals only: Instructions for use, handling and disposal.

1. Use aseptic techniques during the reconstitution and any further dilution of gemcitabine for intravenous infusion administration.

2. Calculate the dose and the number of Gemzar vials needed.

3. Reconstitute 200 mg vials with 5 ml of 9 mg/ml (0.9 %) sterile sodium chloride solution for injection, without preservative, or 25 ml sterile sodium chloride solution for injection, without preservative to the 1000 mg vial. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1000 mg vial) respectively. This dilution yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder. Further dilution with sterile sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative may be done. The resulting solution is clear and ranges in colour from colourless to light straw-coloured.

4. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.

5. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur. Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

6. Gemcitabine solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

Preparation and administration precautions

The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. Handling of the solution for infusion should be done in a safety box and protective coats and gloves should be used. If no safety box is available, the equipment should be supplemented with a mask and protective glasses.

If the preparation comes into contact with the eyes, this may cause serious irritation. The eyes should be rinsed immediately and thoroughly with water. If there is lasting irritation, a doctor should be consulted. If the solution is spilled on the skin, rinse thoroughly with water.

Disposal

Any unused product should be disposed of in accordance with local requirements.

 

 

Faslodex 250 mg solution for injection

Fulvestrant

1.What Faslodex is and what it is used for

Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer.

Faslodex is used to treat advanced or metastatic breast cancer in postmenopausal women.

2.Before you use Faslodex

Do not use Faslodex

if you are allergic (hypersensitive) to fulvestrant or to any of the other ingredients of Faslodex  if you are pregnant or breast-feeding if you have severe liver problems.

Take special care with Faslodex

Tell your doctor if any of these apply to you: kidney or liver problems

low numbers of platelets (which help blood clotting) or bleeding disorders previous problems with blood clots osteoporosis (loss of bone density) alcoholism.

Children

Faslodex is not indicated in children and adolescents under 18 years.

Using other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).

Pregnancy and breast-feeding

You must not use Faslodex if you are pregnant. If you can become pregnant, you should use effective contraception while being treated with Faslodex.

You must not breast-feed while on treatment with Faslodex.

Driving and using machines

Faslodex is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment do not drive or use machines.

Important information about some of the ingredients of Faslodex

This medicinal product contains 10 % w/v ethanol (alcohol), i.e. up to 1000 mg per dose, equivalent to 20 ml beer or 8 ml wine per dose.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

3. How to use Faslodex

The usual dose is 500 mg fulvestrant (two 250 mg/5 ml injections) given once a month with an additional 500 mg dose given 2 weeks after the initial dose.

Your doctor or nurse will give you Faslodex as a slow intramuscular injection, one into each of your buttocks.

4. Possible side effects

Like all medicines, Faslodex can cause side effects, although not everybody gets them.

•   These side effects may occur with certain frequencies, which are defined as follows:

•   Very common: affects more than 1 user in 10.

•   Common: affects 1 to 10 users in 100.

•   Uncommon: affects 1 to 10 users in 1,000.

•   Rare: affects 1 to 10 users in 10,000.

•   Very rare: affects less than 1 user in 10,000.

•   Not known: frequency cannot be estimated from the available data.

Very common side effects

•   Injection site reactions, such as pain and/or inflammation.

•   Abnormal levels of liver enzymes (in blood tests).

•   Nausea (feeling sick).

•   Weakness, tiredness.

Common side effects

•   Headache.

•   Hot flushes.

•   Vomiting, diarrhoea, or loss of appetite.

•   Rash.

•   Urinary tract infections.

•   Back pain.

•   Thromboembolism (Increased risk of blood clots).

•   Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat.

Uncommon side effects

•Vaginal bleeding, thick, whitish discharge and candidiasis (infection).

•Bruising and bleeding at the site of injection.

• Includes side effects for which the exact role of Faslodex cannot be assessed due to the underlying disease.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

5. How to store Faslodex

Store in a refrigerator (2°C – 8°C)

Keep the pre-filled syringe in the original package, in order to protect from light.

Keep out of the reach and sight of children.

Do not use Faslodex after the expiry date which is stated on the carton or syringe labels after the abbreviation EXP. The expiry date refers to the last day of that month.

Your health care professional will be responsible for the correct storage, use and disposal of Faslodex.

6.  Further Information

What Faslodex contains

The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.

The other ingredients are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil.

What Faslodex looks like and contents of the pack

Faslodex is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamper-evident closure, containing 5 ml solution for injection. Two syringes must be administered to receive the 500 mg recommended monthly dose.

Faslodex has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes. Safety needles (BD SafetyGlide™) for connection to each barrel are also provided.

The following information is intended for healthcare professionals only:

Faslodex 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3

BD SafetyGlide is a trademark of Becton Dickinson and Company and is CE-marked: CE 0050.

Instructions for administration

Warning – Do not autoclave safety needle (BD SafetyGlide™ Shielding Hypodermic Needle) before use. Hands must remain behind the needle at all times during use and disposal.

For each of the two syringes:

•   Remove glass syringe barrel from tray and check that it is not damaged.

•   Break the seal of the white plastic cover on the syringe Luer connector Luer-Lok to remove the cover with the attached rubber tip cap .

•   Peel open the safety needle (BD SafetyGlide) outer packaging. Attach the safety needle to the Luer-Lok

•   Twist until firmly seated.

•   Twist to lock the needle to the Luer connector.

•   Pull shield straight off needle to avoid damaging needle point.

•   Transport filled syringe to point of administration.

•   Remove needle sheath.

•   Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.

•   Expel excess gas from the syringe.

•   Administer intramuscularly slowly (1-2 minutes/injection) into the buttock. For user convenience, the needle bevel- up position is oriented to the lever arm.

•   After injection, immediately apply a single-finger stroke to the activation assisted lever arm to activate the shielding mechanism.

NOTE: Activate away from self and others. Listen for click and visually confirm needle tip is fully covered.

Disposal

Pre-filled syringes are for single use only.

Any unused product or waste material should be disposed of in accordance with local requirements.

 

Calcichew-D₃ Forte Chewable Tablets

Calcium Carbonate / Colecalciferol Equivalent to 500mg Calcium / 400IU Colecalciferol

1. WHAT CALCICHEW- D₃ FORTE ARE AND WHAT THEY ARE USED FOR

Calcichew- D₃ Forte are lemon flavoured chewable tablets. They contain the active ingredients:

•     Calcium (1250g calcium carbonate: equivalent to 500mg calcium)

•    vitamin D₃ (400IU colecalciferol: equivalent to 10 micrograms vitamin D₃)

Both calcium and vitamin D are found in the diet and vitamin D is also produced in the skin after exposure to the sun.

Calcichew- D₃ Forte Chewable Tablets may be prescribed by doctors or recommended by pharmacists to treat and prevent vitamin D/calcium deficiency, or when the diet or lifestyle does not provide enough, or when body requirements are increased. This medicine may also be prescribed or recommended for certain bone conditions, for example osteoporosis, or in pregnancy.

2. BEFORE YOU TAKE CALCICHEW- D₃ FORTE

Do not take Calcichew- D₃ Forte if you:

•     are allergic (hypersensitive) to any of the ingredients

•     are allergic (hypersensitive) to soya or peanuts

•    have a condition causing high levels of calcium in your blood or urine (hypercalcaemia or hypercalciuria) e.g.

renal (kidney failure)

cancer that has affected your bones

•    have high levels of vitamin D in your blood

•    have kidney stones.

Take special care with Calcichew- D₃ Forte :

If any of the following applies to you, please tell your doctor:

•     phenylketonuria (a deficiency in the enzyme which breaks down phenylalanine) as these tablets contain aspartame, a source of phenylalanine

•     brittle bones (osteoporosis) as a result of being immobile

•    taking medicines for your heart, or diuretics

•     a high tendency to kidney stone (calculus) formation

•     cancer or any other condtions that may have affected your bones.

If you have any of the following conditions your serum calcium or phosphate levels, or urinary calcium excretion must be monitored. Calcichew should be taken under close medical supervision.

•     sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes)

•     kidney problems

•    you are on long-term treatment with Calcichew

•    you are already taking additional doses of calcium or vitamin D. Calcichew should be taken under close medical supervision

If you have increased calcium levels in the blood or develop signs of kidney problems, the dose of Calcichew-D₃ Forte should be reduced or the treatment discontinued.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, the following medicines may interact with Calcichew-D₃ Forte tablets:

•     diuretics (water tablets); your serum calcium levels should be monitored regularly.

•     heart medicines (cardiac glycosides); you should be monitored by electrocardiogram and your serum calcium levels measured.

•     corticosteroids (e.g. prednisolone, dexamethasone);   your dose of Calcichew- D₃ Forte may need to be increased

•    laxatives (such as paraffin oil) or a cholesterol-lowering drug called colestyramine.

•    tetracycline antibiotics; these should be taken at least two hours before, or four to six hours afterwards.

•    Hormones (levothyroxine); these should be taken at least four hours before, or afterwards.

•    Anti-infectives      (Quinolones:      Ciprofloxacin,     lomefloxacin,      norfloxacin, sparfloxacin): please speak with your doctor.

•    fluoride, or bisphosphonates; Calcichew- D₃ Forte   should be taken at least three hours afterwards.

Taking Calcichew- D₃ Forte with food and drink

Calcichew- D₃ Forte should not be taken within 2 hours of eating foods rich in oxalic acid (found in spinach and rhubarb) or phytic acid (found in whole cereals).

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding before taking Calcichew- D₃ Forte.

Driving and using machines

Calcichew- D₃ Forte has no known effect on your ability to drive or use machines.

Important information about some of the ingredients of Calcichew- D₃ Forte

The following are ingredients in this product:

•     Sorbitol, isomalt and sucrose: if you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

•    Aspartame contains a source of phenylalanine and may be harmful to people with phenylketonuria (a deficiency in the enzyme which breaks down phenylalanine).

•    Hydrogenated soya bean oil: if you are allergic to peanut or soya, do not use this medicinal product

3. HOW TO TAKE CALCICHEW- D₃ FORTE

Always take Calcichew- D₃ Forte Chewable Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults and elderly:

Chew or suck the two tablets a day, preferably one tablet in the morning and one in the evening.

Children:

Calcichew- D₃ Forte Chewable Tablets are not recommended for use in children

If you take more than you should

If you accidentally take more Calcichew- D₃ Forte Chewable Tablets than you should, you may have an increase in your blood calcium levels.

Symptoms of this are: excessive thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, tiredness, mental disturbances, lack of appetite, bone pain, having to pass more water than usual, kidney problems and, in severe cases, irregular heartbeat.

Very rarely in addition: irritability, continuing headache, lightheadedness, muscle spasms, twitches and tingling sensation.

Do not take any more Calcichew-D3 Forte and contact your doctor or emergency department as soon as possible. Take the packet and any remaining tablets with you.

If you forget to take Calcichew- D₃ Forte

If you forget to take a dose, leave out that dose completely. Take your next dose when it is due. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE-EFFECTS

Like all medicines, Calcichew- D₃ Forte can cause side-effects, although not everybody gets them.

Side effects with Calcichew- D₃ Forte may include:

Uncommon side-effects (affecting less than 1 in 100 people):

•    too much calcium in your blood (hypercalcaemia) – the symptoms include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, a need to pass more water than usual, muscle weakness, drowsiness and confusion.

•    too much calcium in your urine (hypercalciuria)

Rare side-effects (affecting less than 1 in 1000 people):

• nausea
• stomach ache
• constipation
• diarrhoea
• wind (flatulence)
• rash
• hives
• itching

Very rare side-effects (affecting less than 1 in 10000 people):

• Milk alkali syndrome

If any of these side-effects become serious, or if you notice any side-effect(s) not listed in this post, please talk to your doctor or pharmacist.

5. HOW TO STORE CALCICHEW-D3 FORTE

Keep out of the reach and sight of children.

Store in the original package and protect from moisture. Do not store above 30°C

Do not use Calcichew- D₃ Forte Chewable Tablets after the expiry date which is stated on the label after EXP. The expiry date refers to the last date of that month. If the tablets have changed shape or colour do not use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Calcichew-D₃ Forte Chewable Tablets contain The active ingredients in each tablet are:

•     1250g calcium carbonate (equivalent to 500mg calcium)

•    400IU colecalciferol (equivalent to 10 micrograms vitamin D₃)

The other ingredients are: sorbitol (E420), povidone, isomalt (E953), fatty acid mono- and di-glycerides, magnesium stearate, lemon flavour, aspartame (E951), sucrose, gelatin, hydrogenated soya bean oil, tocopherol and maize starch.

This product is gluten and lactose free.

What Calcichew-D₃ Forte look like and contents of the pack

The tablets are round, white, uncoated convex and lemon flavoured; they may have small specks.

The tablets are packed in white, plastic bottles of 60 or 100 tablets.

Additional Information

Calcichew-D₃ Forte are a combination of calcium and vitamin D designed to keep bones healthy. Calcium is an essential component of bones while vitamin D plays an important role in the absorption of calcium from food.

Requirements for calcium increase with age and, although many people obtain enough calcium from their diet, some people may require a supplement in order that their body has all the calcium it needs to maintain healthy bones. Vitamin D is produced largely from the action of sunlight. Certain foodstuffs do contain vitamin D in reasonable amounts but it is not always possible to obtain all the vitamin D you need from your diet. People who do not get out and about, for instance those who are housebound or people living in nursing and residential homes, may not receive all the vitamin D they need.

People with diets and lifestyles that mean they will obtain less than the recommended intake of calcium and vitamin D are at risk of weakened bones. Prolonged lack of adequate calcium and vitamin D intake can lead to the development of osteoporosis, a condition where bones become weak to a level that minimal trauma (for example, a fall) can result in a fracture, most typically at the hip, spine or wrist.

Calcichew-D₃ Forte have been designed to give people whose intakes of calcium and vitamin D are low a boost to the recommended amounts.

Maintaining healthy bones and helping to avoid osteoporosis is an important issue for many people. There are many ways that people can help themselves: regular exercise, a balanced diet with an adequate intake of calcium and vitamin D and, for some people, advice on how to prevent falls which may lead to fracture.