Pocket Drug Guide

Archive for the ‘Antineoplastic agents’ Category

Vincristine Sulphate 1 mg/ml Injection

(1 mg/1 ml and 2 mg/2 ml vials)

1. WHAT VINCRISTINE SULPHATE INJECTION IS AND WHAT IT IS USED FOR

Vincristine sulphate is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.

Vincristine Sulphate Injection is used in the treatment of cancers of the blood (eg. leukaemia or lymphomas), breast, head and neck or lung. It may be used to treat multiple myeloma (a cancer of plasma cells) and it may also be used in the treatment of some cancers in children. It may be used in a blood disorder known as idiopathic thrombocytopenic purpura (ITP) after other treatments have not been successful.

Vincristine Sulphate Injection may be given alone or in combination with other anti-cancer medicines.

2. BEFORE YOU USE VINCRISTINE SULPHATE INJECTION

Vincristine Sulphate Injection must never be injected intrathecally (into the spine).

Do not use Vincristine Sulphate Injection

•    if you have shown signs of hypersensitivity (severe allergy) to vincristine or mannitol in the past

•    if you have Charcot-Marie-Tooth syndrome (disease which causes weakness in the leg muscles)

Tell your doctor if any of the above applies to you before this medicine is used.

Take special care with Vincristine Sulphate Injection

•    if you have a mental or nervous system disorder

•    if you have liver trouble

•    if you are having radiotherapy

•    if you have breathing problems

Tell your doctor if any of the above applies to you before this medicine is used. Special care is also needed if you are elderly.

Taking/using other medicines

Special care is needed if you are taking/using other medicines as some could interact with vincristine sulphate.

Use of the following medicines may make the side effects of vincristine sulphate worse:

•     allopurinol (medicine used to treat gout)

•    pyridoxine (vitamin B6)

•    isoniazid (medicine used to treat tuberculosis)

•    mitomycin-C (anti-cancer medicine)

•    itraconazole (a medicine used to treat fungal infections)

•    L-asparaginase (used for treating some types of cancer)

•     some anti-cancer drugs (eg containing platinum) that may cause problems with hearing or balance

•    medicines which cause problems with passing water (urine). These should be stopped before you start treatment with vincristine

•    medicines which cause problems with your nervous system e.g. walking difficulties, pins and needle or numbness

Phenytoin (medicine used to control fits) may not work as well when vincristine sulphate is used, so blood levels of phenytoin will need to be monitored.

Methotrexate used in the treatment of cancer may work better when used with vincristine.

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

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine.

Women of childbearing potential should use appropriate contraception methods during treatment with vincristine sulphate.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Do not drive or use machines if you experience any side effect which may lessen your ability to do so.

3. HOW TO USE VINCRISTINE SULPHATE INJECTION

This medicine is given by injection (using a syringe) or infusion (drip) into a vein.

Vincristine sulphate is an irritant, if it accidentally gets into your eye tell your doctor or nurse immediately so that it may be washed out.

You may be given medicines to prevent constipation during treatment with vincristine sulphate.

Dosage

Your doctor will work out the correct dose of vincristine sulphate for you and how often it must be given.

The dose will depend on your medical condition, your size and how well your liver is working. Your doctor will tell how well your liver is working using a blood sample.

Vincristine sulphate is usually given once a week.

If you are given too much or too little Vincristine Sulphate Injection

This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS

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

If any of the following happen, tell your doctor immediately:

•     severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.

•    pain or swelling at the injection site during or immediately after the injection

•     severe chest pains possibly radiating to the jaw or arm, sweating, breathlessness and nausea

•     severe breathing problems

These are serious side effects. You may need urgent medical attention. All of these serious side effects are rare.

If any of the following happen, tell your doctor as soon as possible:

•     convulsions (fits)

•     deafness or hearing loss

•    worsening eyesight

•    pain (may involve the jaw, throat, neck, bones or muscles)

•     dizziness

•    fever, sore throat, skin rashes, or sores on your body and in your mouth (may indicate a drop in white blood cells)

•     significant weight loss

•    numbness or pins and needles

•     difficulty in walking

•    muscle weakness or muscle wasting

•     difficulty with speech

•    unusual eye movements

•    problems with passing water (more or less urine than normal, or pain when passing urine)

•    mild breathing problems

•    raised or lowered blood pressure

•    headache

•    tiredness

•    unexpected bruises

•     stomach cramps, constipation or diarrhoea

•    being sick or feeling sick

•    hair loss

•    missed periods

•     soreness around the injection site after the injection

Vincristine sulphate may lead to changes in your blood cells. Your doctor may take blood samples to monitor for these and also to check how well your liver is working.

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

Effects on fertility

Treatment with vincristine sulphate may permanently reduce fertility in men and women. Tell your doctor if you have concerns.

5. HOW TO STORE VINCRISTINE SULPHATE INJECTION

Keep out of the reach and sight of children

Expiry

This medicine must not be used after the expiry date which is stated on the vial label and carton after ‘EXP’. Where only a month and year is stated, the expiry date refers to the last day of that month.

Storage

The vials should be kept in the outer carton, in order to protect from light, and stored in a refrigerator.

6. FURTHER INFORMATION

What Vincristine Sulphate Injection contains

The active substance is vincristine sulphate. Each millilitre (ml) of solution contains 1 milligram (mg) of vincristine sulphate.

The other ingredients are mannitol and Water for Injections.

 

Vinblastine Sulphate 1 mg per ml Injection

-    The active substance is vinblastine sulphate

-    The other ingredients are sodium chloride and Water for Injections

-    Sodium hydroxide and sulphuric acid are used as pH adjusters

1. What Vinblastine Sulphate Injection is and what it is used for

Vinblastine Sulphate Injection is an anti-cancer medicine. The medicine is presented in the form of a solution for injection in glass containers called vials.

Each millilitre (ml) of Vinblastine Sulphate Injection contains 1 milligram (mg) of Vinblastine Sulphate. Each 10 ml vial contains 10 mg of vinblastine sulphate.

It is available in packs of 5 x 10 ml vials.

Vinblastine Sulphate Injection is used on its own or in a combination with other medicines to treat cancer.

2.  Before Vinblastine Sulphate Injection is used

Vinblastine Sulphate Injection should not be used:

-     If you are pregnant, trying for a baby or are breast-feeding

-     If your blood cells show that you do not have enough white blood cells (which fight infection) you will not be given vinblastine until the levels increase

-     If you have a bacterial infection you will not be given vinblastine until this is controlled.

-     If being given an injection of furosemide at the same time.

Tell your doctor if:

-    You are trying for a baby. Vinblastine can cause birth defects if either the male or female is taking it at the time of conception. Vinblastine may also interfere with the production of sperm.

-    You notice any pain, during or soon after the injection is given

-    You have had liver disease (or hepatitis)

-    You are taking any of the following medicines:

Other anti-cancer medicines e.g. mitomycin (with or without progesterone), cisplatin, bleomycin.

Erythromycin (an anti-biotic)

Anti-epilepsy medicines

Special care will be taken by the doctor and medical staff to watch for signs of infection after your injection if your white blood cells fall below a certain level.

If you have lost a lot of weight, or have ulcerated skin vinblastine may have a greater effect on your white blood cells. This may be more of a problem in older patients, your doctor will decide if you can have vinblastine in these circumstances.

If your cancer has spread to your bone marrow vinblastine can cause a sudden fall in your number of white blood cells (which fight infection) and platelets (blood cells which help with blood clotting). In these circumstances your doctor may decide that you can no longer be given vinblastine.

If vinblastine is accidentally spilt into your eye, tell your doctor or nurse at once.

3.  How Vinblastine Sulphate Injection is used

During treatment you will undergo blood tests to look for signs of changes in blood cells.

The dose of medicine given to you depends on the condition being treated and the results of your blood test. The medicine will be given as an injection to the vein. Vinblastine is usually given at weekly intervals. This will continue depending on the results of your blood tests and your response to the treatment.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or your pharmacist if you have any concerns.

4.  Possible side effects

Like all medicines Vinblastine Sulphate can have side effects. If any of the following happen, tell the doctor immediately:

Feeling hot or cold – this may be a sign of infection

If you experience any of the following tell your doctor as soon as possible:

•    Feeling or being sick

•    Constipation or diarrhoea

•    Mouth ulcers

•    Loss of appetite

•    Stomach pain

•    Black tarry stools

•    Sore throat

•    Numbness or tingling in fingers and toes

•    Depression

•    Loss of reflexes

•    Headaches

•    Fits

•    Tiredness

•    Weakness

•    Dizziness

•    Pain at tumour site

•    Blisters

•    Hair loss

•    Severe pain and ulceration if the medicine leaks into skin during injection

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5.  Storing Vinblastine Sulphate Injection

Keep out of the reach and sight of children.

Store between 2°C – 8°C in a fridge.

Keep vial in the outer carton to protect from light.

Do not use after the expiry date printed on the label and carton.

 

Vidaza 25 mg/ml powder for suspension for injection

Azacitidine

1. WHAT VIDAZA IS AND WHAT IT IS USED FOR

Vidaza contains the active substance azacitidine. It works by preventing the growth of cancer cells.

Vidaza is used in adults who are not eligible for stem cell transplantation to treat:

•  higher-risk myelodysplastic syndromes (MDS) a group of illnesses of the bone marrow resulting in the production of too few blood cells.

•  chronic myelomonocytic leukaemia (CMML).

•  acute myeloid leukaemia (AML).

Talk to your doctor if you have any questions about how Vidaza works or why this medicine has been prescribed for you.

2. BEFORE YOU USE VIDAZA

Do not use Vidaza

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

•  if you have advanced liver cancer.

•  if you are breast-feeding.

Take special care with Vidaza

Check with your doctor or nurse before using this medicine if you have:

•  decreased counts of platelets, red or white blood cells.

•  kidney disease.

•  liver disease.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before having Vidaza.

Vidaza is not recommended for use in children and adolescents below the age of 18.

You will have blood tests before you begin treatment with Vidaza and at the start of each period of treatment (called a ‘cycle’). This is to check that you have enough blood cells and that your liver and kidneys are working properly.

For men having Vidaza, please see the section “Pregnancy and breast feeding” below.

Taking other medicines

Please tell your doctor or nurse if you are using or have recently used any other medicines including medicines obtained without a prescription and herbal preparations. This is because Vidaza may affect the way some other medicines work. Also, some other medicines may affect the way Vidaza works.

Pregnancy and breast-feeding

You should not use Vidaza during pregnancy as it may be harmful to the baby.

Use an effective method of contraception during and up to 3 months after treatment with Vidaza.

Tell your doctor straight away if you become pregnant during treatment with Vidaza.

You must not use Vidaza if you are breast-feeding. It is not known if Vidaza passes into the mother’s milk and therefore you must not breast-feed your baby during treatment.

Men should not father a child while receiving treatment with Vidaza. Use an effective method of contraception during and up to 3 months after treatment with Vidaza.

Talk to your doctor if you wish to conserve your sperm before starting this treatment.

Driving and using machines

No studies of the effects on the ability to drive and use machines have been performed. Some people may feel tired after being given Vidaza. If this happens to you, do not drive or use any tools or machines.

3. HOW TO USE VIDAZA

Your doctor will give you another medicine to prevent nausea and vomiting at the start of each treatment cycle, before giving you Vidaza.

•  The usual dose is 75 mg per m² body surface area. Your doctor will chose your dose of Vidaza, depending on your general condition, height and weight. Your doctor will check your progress and may change your dose if necessary.

•  Vidaza is given every day for one week, followed by a rest period of 3 weeks. This “treatment cycle” will be repeated every 4 weeks. You will usually receive at least  6 treatment cycles.

Vidaza will be given to you as an injection under the skin (subcutaneously) by a doctor or nurse. It may be given under the skin on your thigh, tummy or upper arm.

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

4. POSSIBLE SIDE EFFECTS

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

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

•  A fever. This may be due to an infection as a result of having low levels of white blood cells.

•  Chest pain or shortness of breath which may be accompanied with a fever. This may be due to an infection of the lung called “pneumonia”.

•  Bleeding. Such as blood in the stools due to bleeding in the stomach or gut.

•  Difficulty breathing, swelling of the lips, itching or rash. This may be due to an allergic (hypersensitivity) reaction.

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

•  Reduced red blood count (anaemia). You may feel tired and pale.

•  Reduced white blood cell count. This may be accompanied by a fever. You are also more likely to get infections.

•  A low blood platelet count (thrombocytopenia). You are more prone to bleeding and bruising.

•  Constipation, diarrhoea, nausea, vomiting.

•  Pneumonia.

•  Chest pain, being short of breath.

•  Tiredness (fatigue).

•  Injection site reaction including redness, pain or a skin reaction.

•  Loss of appetite.

•  Joint aches.

•  Bruising.

•  Rash.

•  Red or purple spots under your skin.

•  Pain in your belly (abdominal pain).

•  Itching.

•  Fever.

•  Sore nose and throat.

•  Dizziness.

•  Headache.

Common side effects

•  Bleeding inside your head.

•  An infection of the blood caused by bacteria (sepsis). This may be due to low levels of white cells in your blood.

•  Bone marrow failure. This can cause low levels of red and white blood cells and platelets.

•  A type of anaemia where your red and white blood cells and platelets are reduced.

•  An infection in your urine.

•  A viral infection causing cold sores (herpes).

•  Bleeding gums, bleeding in the stomach or gut, bleeding from around your back passage due to piles (haemorrhoidal haemorrhage), bleeding in your eye, bleeding under your skin, or into your skin (haematoma).

•  Blood in your urine.

•  Ulcers of your mouth or tongue.

•  Changes to your skin at the injection site. These include swelling, a hard lump, bruising, bleeding into your skin (haematoma), rash, itching and changes in the skin colour.

•  Redness of your skin.

•  An infection of the nose and throat, or sore throat.

•  Sore or runny nose or sinuses (sinusitis).

•  Low levels of potassium in your blood.

•  High or low blood pressure (hypertension or hypotension).

•  Being short of breath when you move.

•  Pain in your throat and voicebox.

•  Indigestion.

•  Weight loss.

•  Lethargy.

•  Feeling generally unwell.

•  Muscle aches.

•  Anxiety or having trouble sleeping (insomnia).

•  Being confused.

•  Hair loss.

Uncommon side effects

•  Allergic (hypersensitivity) reaction.

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 nurse.

5. HOW TO STORE VIDAZA

Keep out of the reach and sight of children.

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

This medicine does not require any special storage conditions.

The reconstituted suspension may be stored at 25 °C for 45 minutes or at 2°C to 8°C for 8 hours.

Your doctor or pharmacist are responsible for storing Vidaza. They are also responsible for disposing of any unused Vidaza correctly.

6. FURTHER INFORMATION

What Vidaza contains

•  The active substance is azacitidine. 1 vial contains 100 mg azacitidine. After reconstitution with 4 ml of water for injections, the reconstituted suspension contains 25 mg/ml azacitidine.

•  The other ingredient is mannitol (E421).

What Vidaza looks like and contents of the pack

Vidaza is a white powder for suspension for injection and is supplied in a glass vial containing 100 mg of azacitidine.

 

Vesanoid 10 mg soft capsules

Tretinoin

1. WHAT VESANOID IS

Vesanoid contains a medicine called tretinoin. This belongs to a group of medicines called ‘retinoids’. These medicines are similar to vitamin A.

Vesanoid is used to treat a type of blood problem called ‘acute promyelocytic leukaemia’. It works by slowing the growth of certain types of diseased blood cells.

2. BEFORE YOU TAKE VESANOID

Do not take Vesanoid if you are allergic (hypersensitive) to:

•  Tretinoin or any of the other ingredients of Vesanoid.

•  Other ‘retinoid’ medicines. These include acitretin and tazarotene.

•  Peanuts or soya. This is because Vesanoid contains soya-bean oil.

Do not take Vesanoid if:

•  You are taking a tetracycline (a type of antibiotic).

•  You are taking vitamin A.

•  You are pregnant, planning to become pregnant or breast-feeding.

In case of any doubts, you should obtain advice from your doctor or pharmacist.

Take special care with Vesanoid

Before starting treatment, make sure your doctor knows if you:

•  have any other illness

•  have allergies.

In case of any doubts, you should obtain advice from your doctor or pharmacist.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines. Therefore you should not take Vesanoid with any other drug unless you have told your doctor and he has agreed.

You must not take a tetracycline (a type of antibiotic) or vitamin A while taking Vesanoid.

Medicines which may require particular care when taken with Vesanoid include:

•  Rifampicin and erythromycin (antibiotics)

•  Glucocorticoids (for allergies and inflammation)

•  Phenobarbital (for epilepsy)

•  Pentobarbital (for insomnia)

•  Ketoconazole (an antifungal)

•  Cimetidine (for stomach ulcers)

•  Verapamil and diltiazem (for heart conditions or high blood pressure)

•  Ciclosporin (used following organ or bone marrow transplants)

•  Tranexamic acid, aminocaproic acid and aprotinin (used to reduce bleeding).

If you are taking low-dose progestogens (mini-pill) for birth control, your doctor will tell you to stop and prescribe a different oral contraceptive for you.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Before starting treatment with Vesanoid

You must tell your doctor immediately if

• you are pregnant
• you think you are pregnant
• you intend to become pregnant.

You should not become pregnant during and within one month (four weeks) after stopping treatment with Vesanoid. If you do become pregnant while taking Vesanoid, it is very likely that your baby will be born deformed.

During treatment with Vesanoid

During treatment with Vesanoid and for four weeks after stopping you and your partner should

• practise effective and continued contraception (birth control). Your doctor will tell you what methods of contraception you can use. If you are taking low-dose progestogens (mini-pill) for birth control, your doctor will tell you to stop and prescribe a different oral contraceptive for you.
• women taking Vesanoid should take a pregnancy test every month while during treatment with Vesanoid.

You must tell your doctor immediately if you become pregnant while taking Vesanoid. You and

your doctor will discuss the right treatment for you if you are pregnant and have acute promyelocytic leukaemia.

You must not breast-feed your baby while taking Vesanoid. Vesanoid enters the breast milk, and could therefore harm your baby.

Driving and using machines

Your ability to drive or operate machinery might be affected while you are taking Vesanoid, especially if you are experiencing dizziness or severe headaches.

Important information about some of the ingredients of Vesanoid

Vesanoid contains soya-bean oil. If you are allergic to peanut or soya, do not take this medicinal product.

Vesanoid contains sorbitol. 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 VESANOID

Always take Vesanoid exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Depending on the nature of your illness, your reaction to Vesanoid, your body weight and body height, your doctor will prescribe an adequate dose for you.

Swallow the capsules whole with water, preferably with a meal or shortly thereafter. Do not chew the capsules.

• Adults

The daily dose will be 45 mg/m² and will be about 8 capsules a day divided into two equal doses.

• Children

The daily dose will be 45 mg/m² divided into two equal doses. Children who suffer from bad headaches during treatment might receive a lower dose.

• Adults with kidney or liver disease

The daily dose will be 25 mg/m² divided into two equal doses.

You will take Vesanoid for up to a maximum of 90 days. During therapy with Vesanoid or immediately after, your doctor will start treatment with other medicines.

Do not change the prescribed dose yourself. If you feel that the effect of Vesanoid is too strong or too weak, talk to your doctor or pharmacist.

• If you take more Vesanoid than you should

If you or another person have taken an overdose of Vesanoid, you must contact your doctor, pharmacist or the nearest hospital immediately.

• If you forget to take Vesanoid

If you forget to take one dose, take your capsules as soon as you remember and tell your doctor immediately. Do not take a double dose to make up for a forgotten dose.

• If you stop taking Vesanoid

Do not change the prescribed dose yourself. If you feel that the effect of Vesanoid is too strong or too weak, talk to your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Vesanoid can cause side effects although not everybody will get them. In addition to the beneficial effects of Vesanoid, virtually all patients experience some undesirable effects during treatment, even when it is used as directed.

Tell your doctor immediately if you experience fever, especially together with difficulty in breathing, coughing, dizziness, chest pain and abdominal pain.

The most common effects include:

•    dry skin and mouth

•    rash

•    nausea and vomiting

•    bone pain.

You may also experience:

•    dryness and cracking of your lips

•    itching, peeling or inflammation of the skin

•    dryness of your eyes or conjunctivitis which may be a problem if you wear contact lenses

•    hair loss (of temporary nature)

•    increased sweating

•    genital ulcers

•    muscle pain

•   joint pain

•    abdominal pain

•    stomach upset

•    diarrhoea

•    constipation

•   vision disturbances (eyesight changes)

•    headache

•    fatigue (tiredness)

•    reactions of the skin (skin problems).

Rarely you may develop a fever with plaque-like skin lesions (raised areas of skin), typically on the head, neck or arms, or fever together with nodular lesions (lumpy areas of skin) on the thighs.

In rare cases, Vesanoid may increase your blood calcium levels (seen in blood tests), so your doctor might monitor this during your treatment. Other blood disorders may develop.

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

5. HOW TO STORE VESANOID

Keep out of the reach and sight of children.

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

Glass bottles:

•Do not store above 30°C.

•Keep the bottle tightly closed in order to protect from moisture.

•Keep the bottle in the outer carton in order to protect from light.

Blister packs:

•Do not store above 30°C.

•Keep the blisters in the outer carton in order to protect from light.

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 Vesanoid contains

•The active substance is tretinoin. Vesanoid capsules contain 10 mg of tretinoin.

•The other ingredients in the capsule contents are yellow beeswax, hydrogenated soya-bean oil, partially hydrogenated soya-bean oil and soya-bean oil.

•The other ingredients in the capsule shell are gelatin, glycerol (E 422), karion 83 containing sorbitol (E 420), mannitol (E 421) and starch (maize), and the colorants titanium dioxide (E 171), iron oxide yellow (E 172) and iron oxide red (E 172).

What Vesanoid looks like and contents of the pack

Vesanoid soft capsules are bi-coloured, orange-yellow and reddish-brown. They are packed in blister strips and glass bottles containing 100 capsules.

 

VEPESID SOFT CAPSULES 50 MG AND 100 MG

(ETOPOSIDE)

1. WHAT VEPESID IS AND WHAT IT IS USED FOR

The name of this medicine is Vepesid. Each capsule contains etoposide (either 50 or 100mg) as the active ingredient.

Etoposide belongs to the group of medicines called anti-neoplastic agents which are used in the treatment of cancer.

Vepesid is used in the treatment of certain types of cancer, in particular small cell lung cancer and testicular cancer.

The exact reason why you have been prescribed Vepesid Capsules is best discussed with your doctor.

2.  BEFORE TAKING YOUR MEDICINE

DO NOT take Vepesid if:

• you suffer from severe liver problems

• you have had an allergic reaction to a similar medicine or any of the ingredients in this medicine

• you are pregnant or planning to become pregnant or there is any possibility that you could become pregnant

• you are breast feeding

• you have any infections in any area of your body that your doctor does not know about

If any of the above affects you, or if you are unsure if they do, tell your doctor who will be able to advise you.

• Important Information

Effective anti-cancer treatment can destroy cancer cells rapidly in large numbers. On very rare occasions this may cause harmful amounts of substances from these cancer cells to be released into the blood. If this happens it can cause problems with the liver, kidney, heart or blood, which may result in death if not treated.

In order to prevent this, your doctor will need to do regular blood tests to monitor the level of these substances during treatment with this medicine.

This product contains propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

• Taking Vepesid with other medicines

Always tell your doctor about other medicines you are taking, or have recently taken, including those obtained without a prescription. This is especially important if you are taking;

• A medicine called ciclosporin, as it may affect your treatment with etoposide.

• Pregnancy and breastfeeding

If you are pregnant, planning to become pregnant or are breast feeding, you should speak to your doctor before using this product.

• Driving or operating machinery

Vepesid capsules should not affect your ability to drive or operate machinery, however, if you feel dizzy or light-headed you should not do so until you have discussed it with your doctor.

• Taking with food or drink

Vespid is not known to react with alcohol, however, you should speak to your doctor to find out if it is advisable for you to drink alcohol.

3. TAKING YOUR MEDICINE

Take Vepesid as your doctor has instructed. Your pharmacist may also help if you are not sure.

The dose you receive will be specific to you, which the doctor will calculate. The usual dose = is 120-240mg/m² body surface area, daily for 5 days in a row.

The doctor may sometimes prescribe a different dose.

The capsules should be taken with a glass of water on an empty stomach.

This course of treatment may then be repeated, depending on the results of blood tests, but this will not be for at least 21 days after the first course of treatment.

• If you take more Vepesid than you should

If you take too many tablets, go to your nearest hospital emergency department or tell your doctor immediately. Take the empty container and any remaining capsules with you.

• If you forget to take Vepesid

If you miss or forget to take a dose of this medicine, DO NOT WORRY -just take the next dose when it is due. DO NOT take a double dose to make up for the forgotten dose.

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

4.  POSSIBLE SIDE EFFECTS

As with all medicines, Vepesid can cause unwanted side effects, although not everybody gets them.

Stop taking the medicine and tell your doctor immediately if you get any of the following symptoms: swelling of your tongue or throat, breathing difficulties, fast heartbeat, flushing of the skin or a rash. These may be signs of an allergic reaction.

Possible side effects experienced with Vepesid are;

• blood disorders (this is why you will be having blood tests between courses of treatment)

• temporary hair loss

• nausea and vomiting

• abdominal pain

• loss of appetite

• diarrhoea

• acid reflux

• difficulty swallowing

• high or low blood pressure

• skin problems such as itching, rash and pigmentation •flushing

• sore mouth

• after taste

• fever

• sleepiness or tiredness

• tingling or numbness in hands and feet

• breathing problems

• temporary blindness

Rare Side Effects

Leukaemia has been reported in patients treated with Vepesid together with other anti-neoplastic drugs.

Very Rare Side Effects

Severe liver, kidney or heart damage from a condition called Tumour Lysis Syndrome, caused by harmful amounts of substances from the cancer cells getting into the blood stream.

If you notice any of these or any other side effects, during or after your treatment has finished, tell your doctor or pharmacist.

5. HOW TO STORE YOUR MEDICINE

Keep your medicines out of the reach and sight of children.

Do not store Vepesid capsules above 25°C

Vepesid capsules should not get too hot or damp; so do not leave your capsules near a radiator, on a window sill or in the bathroom.

Please check the expiry date of the product, shown on the blister strip and the outer packaging after EXP. The expiry date refers to the last day of that month. Do not use after the month stated.

Do not open any blister in which there is evidence of capsule leakage.

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 Vepesid contains

Each soft capsule contains etoposide (either 50mg or 100mg) as the active ingredient. In addition, Vepesid capsules contain the following ingredients: citric acid, glycerol, macrogol 400 and water; capsules containing gelatin, glycerol, iron oxide (E172), sodium hydroxybenzoic acid ethyl ester, sodium propyl parahydroxybenzoate (E217), titanium dioxide (E171) and water.

• What Vepesid looks like and contents of the pack

Vepesid capsules are opaque pink, soft gelatin capsules.

The 50mg capsules are packed in cartons of 20 capsules and the 100mg capsules are packed in cartons of 10 capsules.

 

Velcade 1 mg powder for solution for injection Velcade 3.5 mg powder for solution for injection

Bortezomib

1.What Velcade is and what it is used for

Velcade contains the active substance bortezomib, a so-called ‘proteasome inhibitor’. Proteasomes play an important role in controlling cell function and growth. By interfering with their function, bortezomib can kill cancer cells.

Velcade is used for the treatment multiple myeloma (a cancer of the bone marrow) in adults:

in combination with other medicines containing melphalan and prednisone, for patients who have not been previously treated for multiple myeloma and are unsuitable for high-dose chemotherapy with bone marrow transplant.

alone (monotherapy) for patients whose disease is worsening ( progressive) after receiving at least one prior treatment and for whom, bone marrow transplantation was not successful or is unsuitable.

2. Before you use Velcade

Do not use Velcade

• if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of Velcade
• if you have severe liver problems
• if you have certain severe pulmonary or heart problems.

Take special care with Velcade

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

• low numbers of red or white blood cells

• bleeding problems and/or low number of platelets in your blood

• diarrhoea, constipation, nausea or vomiting

• fainting, dizziness or light-headedness in the past.

• kidney problems

• liver problems.

• numbness, tingling, or pain in the hands or feet (neuropathy) in the past.

• heart or blood pressure problems.

• shortness of breath or cough

You will have to take regular blood tests before and during your treatment with Velcade, to check your blood cell counts regularly.

Velcade should not be used in children and adolescents, due to limited experience.

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.

In particular, tell you doctor if you are using medicines containing any of the following active substances:

• ketoconazole, used to treat fungal infections
• rifampicin, and antibiotic used to treat bacterial infections
• oral antidiabetics

Pregnancy and breast-feeding

You should not use Velcade if you are pregnant, unless clearly necessary.

Both men and women receiving Velcade must use effective contraception during and for up to 3 months after treatment. If, despite these measures, pregnancy occurs, tell your doctor immediately.

You should not breast-feed while using Velcade. Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.

Driving and using machines

Velcade might cause tiredness, dizziness, fainting, or blurred vision. Do not drive or operate any dangerous tools or machines if you experience such side effects; even if you do not, you should still be cautious.

3. How to use Velcade

Your doctor will work out your dose of Velcade according to your height and weight (body surface area). The usual starting dose is 1.3 mg/m² body surface area.

Your doctor may change the dose and total number of cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions.

Monotherapy

When Velcade is given alone, one cycle of treatment with Velcade consists of a total of 4 doses. Doses are given on days 1, 4, 8 and 11, followed by a 10-day ‘rest period’ without treatment. Therefore, the duration of a treatment cycle is 21 days (3 weeks).

Combination therapy

If you have not been treated before for multiple myeloma, you will receive Velcade together with two other medicines containing melphalan and prednisone.

In this case, the duration of a cycle is 6 weeks. The treatment consists of a total of 9 cycles (54 weeks).

In Cycles 1-4, Velcade is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32).

In Cycles 5-9, Velcade is administered once weekly (days 1, 8, 22 and 29).

Melphalan and prednisone are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.

How Velcade is given

You will receive Velcade in a specialised medical unit, under the supervision of a health care professional experienced in the use of cytotoxic medicinal products.

Velcade powder has to be dissolved before administration. This will be done by a healthcare professional. The resulting solution is then injected into a vein rapidly, over 3 to 5 seconds.

4. Possible side effects

Like all medicines, Velcade can cause side effects, although not everybody gets them. Some of these effects may be serious.

Treatment with Velcade can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood. Therefore, you will have to take regular blood tests before and during your treatment with Velcade, to check your blood cell counts regularly. You may experience a reduction in the number of platelets, which may make you be more prone to bruising, or to bleeding without obvious injury (e.g. bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver).

red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness white blood cells may make you more prone to infections or flu-like symptoms.

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

• Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage.

• Reduction in the number of red blood cells and or white blood cells (see above)

• Fever, shivering fits

• Shortness of breath without exercise

• Feeling sick (nausea) or vomiting, loss of appetite

• Constipation with or without bloating (can be severe),

• Diarrhoea: if this happens, it is important that you drink more water than usual. Your doctor may give you another medicine to control diarrhoea .

• Muscle pain

• Tiredness

• Headache

• Herpes zoster infection (including disseminated)

Common side effects

• Sudden fall of blood pressure on standing which may lead to fainting

• Depression which may be severe, confusion

• Swelling around the eyes or face (which may rarely be due to a serious allergic reaction), or swelling in the ankles, wrists, arms or legs.

• General ill feeling, dizziness, light-headedness, or a feeling of weakness

• Changes in potassium in your blood, too much sugar in your blood

• Chest pains or coughing with phlegm, shortness of breath with exercise

• Different types of rash and/or itching, lumps on the skin or dry skin

• Redness of the skin or redness and pain at the injection site

• Dehydration

• Heartburn, bloating, belching, wind or stomach pain

• A sore mouth or lip, dry mouth, mouth ulcers or throat pain

• Weight loss, loss of taste

• Muscle cramps, bone pain, pain in your limbs or back

• Blurred vision

• Nose bleeds

• Difficulty in sleeping, sweating, anxiety

• Overtiredness (fatigue)

Uncommon side effects

• Palpitations (sensation of rapid or irregular heart beat), changes in heart beat, heart failure, heart attack, chest pain, chest discomfort or decreased ability of the heart to work

• Bleeding from your bowels or stomach, bloody stools, bleeding in the brain, bleeding from the liver or bleeding from mucosal membranes e.g. mouth

• Paralysis, seizures

• Breathing becomes shallow, difficult or stops, wheezing, difficulty in breathing, cough that produces frothy sputum that may be tinged with blood or coughing blood

• Increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine

• Yellow discolouration of eyes and skin (jaundice)

• Loss of attention, restlessness or agitation, changes in your mental status, mood swings

• Facial blushing or tiny broken capillaries

• Hearing loss, deafness or ringing in the ears

• Changes in calcium, sodium, magnesium, and phosphates in your blood, too little sugar in your blood

• Hormone abnormality affecting salt and water absorption

• Irritated eyes, excessively wet or dry eyes, discharge from the eyes, abnormal vision, eye infections (including herpes zoster), bleeding of the eye or sensitivity to light

• Swelling of your lymph nodes

• Joint or muscle stiffness, muscle spasms or twitching, pain in your bottom

• Hair loss

• Allergic reactions

• Mouth pain, retching

• Abdominal pain

• Weight increase

• Severe skin reactions, which may have blisters and involve the mouth, throat, eyes and genitals, that can be life-threatening (Stevens Johnson Syndrome and toxic epidermal necrolysis).

• Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a severe reversible brain condition which includes seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems.

Rare

• Inflammation of the lining around your heart

• Inflammation of the blood vessels that can appear as small red or purple dots (usually on the legs) to bruise-like patches on the skin.

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 immediately.

5. How to store Velcade

Keep out of the reach and sight of children.

Do not store above 30°C. Keep the vial in the outer carton in order to protect from light.

Do not use after the expiry date stated on the vial and the carton after EXP.

The reconstituted solution should be used immediately after preparation. If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. However, the reconstituted solution is stable for 8 hours at 25 °C in the original vial and/or a syringe prior to administration, with a maximum of 8 hours in the syringe.

6. Further information

What Velcade contains

The active substance is bortezomib. Each vial contains 1 mg or 3.5 mg of bortezomib (as a mannitol boronic ester). After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.

The other ingredients are mannitol (E421) and nitrogen.

What Velcade looks like and contents of the pack

Velcade powder for solution for injection is a white to off-white cake or powder.

Each carton of Velcade 1 mg powder for solution for injection contains a glass vial with a green cap, in a transparent blister pack.

Each carton of Velcade 3.5 mg powder for solution for injection contains a glass vial with a royal blue cap, in a transparent blister pack.

This medicinal product has been authorised under “Exceptional Circumstances”. This means that for scientific reasons it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency (EMA) will review any new information which may become available every year and this leaflet will be updated as necessary.

INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:

1.RECONSTITUTION

Note: Velcade is a cytotoxic agent. Therefore, caution should be used during handling and preparation. Use of gloves and other protective clothing to prevent skin contact is recommended.

ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF Velcade SINCE NO PRESERVATIVE IS PRESENT.

1.1.     a) Preparation of the 1 mg vial: add 1.0 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Velcade powder.

b) Preparation of the 3.5 mg vial: add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Velcade powder.

The concentration of the resulting solution will be 1 mg/ml. The solution will be clear and colourless, with a final pH of 4 to 7. You do not need to check the pH of the solution.

1.2.     Before administration, visually inspect the solution for particulate matter and discolouration. If any discolouration or particulate matter is observed, the reconstituted product should be discarded.

1.3.     The reconstituted product is preservative free and should be used immediately after preparation. However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25 °C stored in the original vial and/or a syringe prior to administration, with a maximum of 8 hours in the syringe. If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

It is not necessary to protect the reconstituted medicinal product from light.

2.ADMINISTRATION

•     Check the dose in the syringe.

•     Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.

•     Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.

3.       DISPOSAL

A vial is for single use only and remaining solution must be discarded.

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

 

 

Tyverb 250 mg film-coated tablets

Lapatinib

1. WHAT TYVERB IS AND WHAT IT IS USED FOR

Tyverb is used to treat certain types of breast cancer (HER2-overexpressing) which have spread beyond the original tumour {advanced or metastatic breast cancer). It may slow or stop cancer cells from growing, or may kill them.

Tyverb is prescribed to be taken in combination with another anti-cancer medicine.

Tyverb is prescribed in combination with capecitabine, for patients who have had other treatment for advanced or metastatic breast cancer before.

Tyverb is prescribed in combination with an aromatase inhibitor, for patients with hormone sensitive metastatic breast cancer (breast cancer that is more likely to grow in the presence of hormones), who are not currently intended for chemotherapy.

Information about these medicines is described in separate patient information leaflets. Ask your doctor to give you information about these other medicines.

2. BEFORE YOU TAKE TYVERB

Do not take Tyverb

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

Take special care with Tyverb

Your doctor will run tests to check that your heart is working properly before and during your treatment with Tyverb.

Tell your doctor if you have any heart problems before you take Tyverb.

Your doctor also needs to know before you take Tyverb:

•  if you have any liver problems.

•  if you have any kidney problems.

Your doctor will run tests to check that your liver is working properly before and during your treatment with Tyverb.

Tell your doctor if any of these apply to you.

Taking other medicines

Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines.

This includes any medicines you bought without a prescription.

It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines. Some medicines may affect the way Tyverb works or Tyverb may affect how other medicines work. These medicines include some medicines in the following groups:

•  St John’s Wort – a herb extract used to treat depression

•  erythromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin, telithromycin – medicines used to treat infections

•  cyclosporine – a medicine used to suppress the immune system for example after organ transplantations

•  ritonavir, saquinavir – medicines used to treat HIV

•  phenytoin, carbamazepine – medicines used to treat seizures

•  cisapride – a medicine used to treat certain digestive system problems

•  pimozide – a medicine used to treat certain mental health problems

•  quinidine, digoxin – medicines used to treat certain heart problems

•  repaglinide – a medicine used to treat diabetes

•  verapamil – a medicine used to treat high blood pressure or heart problems (angina)

•  nefazodone – a medicine used to treat depression

•  topotecan, paclitaxel, irinotecan, docetaxel – medicines used to treat certain types of cancer

•  rosuvastatin – a medicine used to treat high cholesterol

•  medicines that decrease stomach acidity – used to treat stomach ulcers or indigestion

Tell your doctor if you’re taking, or have recently taken, any of these.

Your doctor will review the medicines you are currently taking to make sure you are not taking something that can’t be taken with the Tyverb. Your doctor will advise you whether an alternative is available.

Taking Tyverb with food and drink

Take Tyverb either at least one hour before or at least one hour after food.

Tyverb is affected by food intake. It is important that you take your tablets at the same time in relation to food each day – for example, you could always take your tablet one hour before breakfast.

Don’t drink grapefruit juice while you are being treated with Tyverb.

Pregnancy and breast-feeding

The effect of Tyverb during pregnancy is not known. You should not use Tyverb if you are pregnant unless your doctor specifically recommends it.

•  If you are pregnant or planning to become pregnant tell your doctor.

•  Use a reliable method of contraception to avoid becoming pregnant while you’re taking Tyverb.

•  If you become pregnant during treatment with Tyverb, tell your doctor.

It is not known whether Tyverb passes into breast-milk. Do not breast-feed while taking Tyverb.

•  If you are breast-feeding or planning to breast-feed, tell your doctor.

Ask your doctor or pharmacist for advice before taking Tyverb if you are unsure. Driving and using machines

No studies have been performed on the effects of Tyverb on your ability to drive or use machines.

You are responsible to decide if you are able to drive a motor vehicle or perform other tasks that require increased concentration. Because of the possible side effects of Tyverb, your ability to drive or operate machinery could be affected.

Read all the information in this leaflet for guidance. Discuss with your doctor, nurse or pharmacist if you are unsure about anything.

3. HOW TO TAKE TYVERB

Always take Tyverb exactly as your doctor has told you. Check with your doctor or pharmacist if you’re not sure.

Your doctor will decide on the correct dose of Tyverb depending on the type of breast cancer being treated.

If you are prescribed Tyverb in combination with capecitabine, the usual dose is 5 Tyverb tablets a day, as a single dose.

If you are prescribed Tyverb in combination with an aromatase inhibitor, the usual dose is 6 Tyverb tablets a day, as a single dose.

Take the prescribed dose every day for as long as your doctor tells you to.

Your doctor will advise you about the dose of your other anti-cancer medicine, and how to take it.

Taking your tablets

•     Swallow the tablets whole with water, one after the other, at the same time each day.

•     Take Tyverb either at least one hour before or at least one hour after food. Take Tyverb at the same time in relation to food each day.

While you are taking Tyverb

•  Depending on your response to treatment, your doctor may recommend lowering your dose or temporarily stopping your treatment.

•  Your doctor will also carry out tests to check your heart and liver function before and during treatment with Tyverb.

If you take too much Tyverb

Contact a doctor or pharmacist immediately. If possible show them the pack.

If you forget to take Tyverb

Don’t take a double dose to make up for a missed dose. Just take the next dose at the scheduled time.

4. POSSIBLE SIDE EFFECTS

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

Severe allergic reaction

This rare side effect may affect up to 1 in 1000 people and develop rapidly. Symptoms may include:

•  skin rash (including itchy, bumpy rash)

•  unusual wheezing, or difficulty in breathing

•  swollen eyelids, lips or tongue

•  pains in muscles or joints

•  collapse or blackout.

Tell your doctor immediately if you get any of these symptoms. Don’t take any more tablets. Very common side effects

These may affect more than 1 in 10 people:

•  diarrhoea (which may make you dehydrated and lead to more severe complications)

Tell your doctor if you get diarrhoea.

•  rash, dry skin, itching

Tell your doctor if you get a skin rash.

Other very common side effects

•  loss of appetite

•  feeling sick (nausea)

•  being sick (vomiting)

•  tiredness, feeling weak

•  indigestion

•  constipation

•  sore mouth/mouth ulcers

•  stomach pain

•  trouble sleeping

•  back pain

•  pain in hands and feet

• joint or back pain

•  a skin reaction on the palms of the hands or soles of the feet (including tingling, numbness, pain, swelling or reddening)

•  cough, shortness of breath

•  headache

•  nose bleed

•  hot flush

•  unusual hair loss or thinning

Tell your doctor if any of these side effects get severe or troublesome. Common side effects

These may affect up to 1 in 10 people:

•  an effect on how your heart works

In most cases, the effect on your heart will not have any symptoms. If you do experience symptoms associated with this side effect, these are likely to include an irregular heartbeat and shortness of breath.

•  liver problems, which may cause itching, yellow eyes or skin {jaundice), or dark urine or pain or discomfort in the right upper area of the stomach.

Tell your doctor if you get any of these symptoms.

Other common side effects

•  nail disorders – such as a tender infection and swelling of the cuticles Tell your doctor or pharmacist if this side effect gets severe or troublesome. Uncommon side effects

These may affect up to 1 in 100 people:

•  treatment-induced lung inflammation, which may cause shortness of breath or cough Tell your doctor immediately if you get either of these symptoms.

Other uncommon side effects include:

•  blood tests results that show changes in liver function (usually mild and temporary)

Rare side effects

This may affect up to 1 in 1000 people:

•   severe allergic reactions

If you get other side effects

If you notice any side effects not listed in this leaflet: Tell your doctor or pharmacist.

Reducing the risk of diarrhoea and skin rash

Tyverb can cause severe diarrhoea

If you suffer from diarrhoea while taking Tyverb:

•     drink plenty of fluids (8 to 10 glasses a day), such as water, sports drinks or other clear liquids

•     eat low-fat, high protein foods instead of fatty or spicy foods

•     eat cooked vegetables instead of raw vegetables and remove the skin from fruits before eating

•     avoid milk and milk products (including ice cream)

•     avoid herbal supplements (some may cause diarrhoea).

Tell your doctor if your diarrhoea continues.

Tyverb can cause skin rash

Your doctor will check your skin before and during treatment. To care for sensitive skin:

•     wash with a soap-free cleanser

•     use fragrance free, hypoallergenic beauty products

•     use sunscreen (Sun Protection Factor [SPF] 30 or higher).

Tell your doctor if you get a skin rash.

5. HOW TO STORE TYVERB

Keep out of the reach and sight of children.

Do not use Tyverb after the expiry date which is stated on the blister and the carton.

Do not store above 30°C

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 Tyverb contains

The active substance in Tyverb is lapatinib. Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.

The other ingredients are:

Microcrystalline cellulose, povidone (K30), sodium starch glycolate (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80, iron oxide yellow (E172), iron oxide red (El72).

• What Tyverb looks like and contents of the pack

Tyverb film-coated tablets are oval, biconvex, yellow film-coated, with ‘GS XJG’ marked on one side.

Each pack of Tyverb contains 70 or 84 tablets in aluminium foil blisters of 10 or 12 tablets each. Each foil has a perforation down the middle and can be divided into two blisters with 5 or 6 tablets in each, depending on the pack size. Always take the number of Tyverb tablets each day exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Tyverb is also available in multipacks containing 140 tablets that comprise 2 packs, each containing 70 tablets.

Not all pack sizes may be marketed.

 

Torisel 30 mg concentrate and diluent for solution for infusion

Temsirolimus

1. What Torisel is and what it is used for

Your doctor has prescribed Torisel because you have one of the following types of cancer:

Advanced cancer of the kidney (renal cancer).

Previously treated mantle cell lymphoma, a type of cancer affecting the lymph nodes

Torisel is a selective inhibitor of mTOR (mammalian target of rapamycin) that blocks tumour cell growth and division.

2. Before you receive Torisel

Do not use Torisel

• If you are allergic (hypersensitive) to temsirolimus, to polysorbate 80 or any of the other ingredients of Torisel
• If you are allergic (hypersensitive) to sirolimus (used to prevent the body from rejecting transplanted kidneys) since sirolimus is released from temsirolimus in the body.
• If you have mantle cell lymphoma and liver problems please tell your doctor.

Take special care with Torisel

• If you are allergic (hypersensitive) to antihistamines or cannot take antihistamines for other medical reasons.
• If you have high cholesterol, Torisel may elevate triglycerides and/or cholesterol.

This may require treatment with lipid-lowering agents (medicine used to reduce cholesterol in the blood).

• If you are going to have an operation, if you have had recent major surgery, or if you still have an unhealed wound following surgery, you should tell your doctor before receiving this medicine, as Torisel may increase the risk of problems with wound healing.
• If you are planning to have a vaccination during treatment with Torisel, the vaccination may be less effective. The use of certain vaccinations should be avoided during treatment with Torisel.
• If you have a history of kidney failure or kidney problems.
• If you have a history of liver problems.
• If you are a child or adolescent under 18 years of age, your doctor will consider the potential benefit to you in relation to any risk.
• If you are over 65 years of age, you may be more likely to have certain side effects,including swelling of your face, diarrhoea, pneumonia, anxiety, depression, shortness of breath, decreased number of white cells in the blood, muscle pain, change in the sense of taste, upper respiratory infection, fluid around the lungs, sores and inflammation in the mouth and/or the digestive tract and runny nose, dizziness and infections.
• If you have tumours in your brain or spinal cord, or are taking medicines to prevent your blood from clotting (such as warfarin), you may be more likely to have bleeding into your brain.

Torisel may also increase blood glucose levels and worsen diabetes mellitus. This may result in the need for insulin and/or oral antidiabetic agent therapy. Tell your doctor if you experience any excessive thirst or increased frequency and quantity of urination.

weaken your immune system; therefore, you may be at risk of getting an infection while you are taking Torisel.

cause shortness of breath, cough, and fever. Tell your doctor if you experience new or worsening symptoms.

increase the risk of cerebral haemorrhage (bleeding in the brain).

cause cataracts when taken with interferon-a (a medicine used in the treatment of hepatitis and cancer).

cause serious allergic reactions. Tell your doctor if you experience difficulty in breathing and/or swelling of the face.

cause a decrease in the number of cells that help blood to clot, which may increase the risk of bleeding.

Using Torisel with other medicines

Some medicines can interfere with the breakdown or metabolism of Torisel. In particular,

you should inform your doctor if you are taking any of the following: protease inhibitors used in the treatment of HIV

antibiotics (including rifampicin) or antifungal medicines (including ketoconazole) used to treat infections

nefazodone or selective serotonin re-uptake inhibitors used to treat depression anti-epileptic medicines, including carbamazepine, phenytoin and phenobarbital rifabutin used to treat infection in people with HIV and other diseases herbal medicines or natural remedies containing St. John’s Wort (Hypericum perforatum) used to treat mild depression

Angiotensin converting enzyme (ACE) inhibitors used to treat high blood pressure or other cardiovascular problems (such as enalapril, ramipril, lisinopril), amphiphilic medicines used to treat heart arrhythmias (such as amiodarone), or statins used to treat high cholesterol

Using Torisel with food and drink

Grapefruit juice may increase blood concentrations of Torisel and should be avoided.

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

Pregnancy and breast-feeding

Torisel has not been studied in pregnant women, and it must not be used during pregnancy. It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving Torisel.

Women of childbearing potential must avoid pregnancy by using an effective method of birth control during treatment with Torisel. Men with partners of childbearing potential should use medically acceptable contraception while receiving Torisel.

Women should not breast-feed during treatment with Torisel, as this medicine may interfere with the growth and development of the baby. Ask your doctor for advice before breast-feeding your baby, as it is not known if Torisel passes into breast milk.

Driving and using machines

No studies on the ability to drive and use machines have been performed. However, the very common side effects include feeling or being sick (nausea and vomiting) and difficulty falling or staying asleep. It is recommended you do not drive immediately after treatment.

For patients receiving the higher dose of Torisel for the treatment of mantle cell lymphoma, the amount of alcohol in this medicinal product may impair your ability to drive or use machines.

Important information about some of the ingredients of Torisel

This medicine contains ethanol (alcohol), equivalent to 17.6 ml beer, 7.3 ml wine per 25 mg dose. Patients receiving the higher dose of 175 mg of Torisel for the initial treatment of mantle cell lymphoma may receive a dose of ethanol equivalent to up to 123 ml beer or 51 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. The amount of alcohol in this medicinal product may alter the effects of other medicines.

Children and adolescents

Insufficient data are available in patients under the age of 18 years. The treatment with this medicine is not recommended in children and adolescents.

3.How Torisel is given

Torisel will always be prepared and given to you by a doctor or another healthcare professional as an intravenous infusion (into your vein).

Torisel 30 mg concentrate must first be diluted with 1.8 ml of withdrawn diluent to achieve a concentration of 10 mg/ml before administration in sodium chloride 9 mg/ml (0.9%) solution for injection (see dilution instructions at the end of the package leaflet).

For renal cancer, the recommended dose is 25 mg infused (as a drip) over a 30- to 60-minute period once weekly.

For mantle cell lymphoma, the recommended dosing is 175 mg infused (as a drip) over a 30- to 60-minute period once weekly for 3 weeks followed by single weekly doses of 75 mg infused (as a drip) over a 30- to 60-minute period.

You should receive an injection of antihistamine (to try to prevent allergic reaction to Torisel) directly into your vein approximately 30 minutes before your dose of Torisel.

Treatment with Torisel should continue until you are no longer benefiting from therapy or until unacceptable side effects occur.

If too much Torisel is given or you miss a dose

As this medicine is prepared and given by a healthcare professional, it is unlikely you will be given too much.

If you are concerned about this, or think you may have missed a dose, tell your doctor immediately.

4. Possible side effects

Like all medicines, Torisel can cause side effects, although not everybody gets them. Side effects may be more pronounced during the higher dose of 175 mg / week during initial treatment for mantle cell lymphoma.

Very common serious side effects observed in more than 1 in 10 patients treated with Torisel are:

• Decreased number of white cells in the blood, which may increase your risk of infection.
• Increased blood glucose levels in diabetic and non-diabetic patients.
• Increased blood levels of cholesterol and triglycerides.
• Decreased number of cells in the blood that help the blood to clot, which may increase the risk of bleeding.

Common serious side effects observed in more than 1 in 100 patients treated with Torisel are:

• Blood clots in the veins.
• Allergic (hypersensitivity)/infusion reactions (including some life-threatening and rare fatal reactions [rare is less than 1 in 1,000 patients]). You should inform your doctor immediately if you have symptoms of angioedema, such as swollen face, tongue or pharynx, and difficulty in breathing.
• Perforation of the gut (mantle cell lymphoma).
• Inflammation of the lungs.
• Kidney failure or kidney problems.
• Problems with wound healing.
• Pleural effusion (fluid around the lungs).

The following side effects and frequencies are those that have been seen in patients treated with Torisel:

Very Common side effects occurring in more than 1 in 10 patients are:

General feeling of weakness, chills**, swelling due to fluid retention, pain (including abdominal, back, chest and joint pain), feeling or being sick (nausea and vomiting), diarrhoea, fever, sore throat, sores and inflammation in the mouth and/or the digestive tract, cough, upper respiratory infections**, pneumonia**, nose bleed, runny nose, rash, itching, nail disorder, acne, dry skin, anorexia, shortness of breath, low levels of potassium in the blood (which may cause muscle weakness), low red blood cell count, decreased number of white blood cells**, decreased number of lymphocytes**, high blood sugar, high cholesterol and other blood fats, abscess, infections, urinary tract infections, abnormal kidney function (including kidney failure), change in the sense of taste, difficulty falling or staying asleep, anxiety**, muscle pain**.

Common side effects occurring in less than 1 out of 10 patients, but more than 1 per 100 patients, are:

Gum redness and swelling, mouth pain (including sores inside the mouth), stomach bloating, high blood pressure, redness and swelling of the tissues around the eye, including watery eye disorder, taste loss, redness and swelling of the follicles in the skin, allergic (hypersensitivity) reactions, severe scaling of the skin, and problems with healing after surgery, increased blood clotting (including thrombosis of the veins, embolism in the lung), inflammation of the lung, infection in the blood, dehydration, depression, sleepiness, numbness and tingling of the skin, dizziness, perforation of the gut*, bleeding from the stomach or intestines, inflammation of the lining of the stomach, trouble with swallowing, eye or skin bleeding (bruising), yeast infection, fungal infection of the skin, and blood tests that show changes in the way the liver or kidney are working, low levels of phosphate in the blood, low levels of calcium in the blood.

* occurred as uncommon for renal cell carcinoma ** occurred as common for renal cell carcinoma

Uncommon side effects occurring in less than 1 out of 100 patients, but more than 1 per 1,000 patients are:

• Pericardial effusion (fluid around the heart that may require drainage and can affect the pumping of blood).
• Bleeding into the brain in patients with brain tumours or who are on blood thinners
• Side effects for which frequency has not been determined are:
• Swelling of the face, lips, tongue, and throat, possibly causing difficulty breathing.
• Serious reactions of the skin and/or mucous membranes which may include painful blisters and fever {Stevens-Johnson syndrome).
• Unexplained muscle pain, tenderness or weakness which could indicate muscle damage (rhabdomyolysis)

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 Torisel

Keep out of the reach and sight of children.

Do not use Torisel after the expiry date, which is stated on the vial label and carton. The first two numbers indicate the month; the next four numbers indicate the year.

Store in a refrigerator (2°C-8°C).

Do not freeze.

Keep the vials in the outer carton in order to protect from light.

After first dilution of Torisel 30 mg concentrate with 1.8 ml of withdrawn diluent, the mixture may be stored for up to 24 hours below 25 °C and protected from light prior to further dilution.

After further dilution of the concentrate-diluent mixture with sodium chloride 9 mg/ml (0.9%) solution for injection, the solution may be stored for up to 6 hours below 25°C and protected from light.

6. Further information

• What Torisel contains

The active substance is temsirolimus.

Each vial of Torisel concentrate contains 30 mg of temsirolimus. The other ingredients in Torisel are anhydrous ethanol, all-rac-a-tocopherol (E 307), propylene glycol and anhydrous citric acid (E 330). The diluent contains polysorbate 80 (E 433), macrogol 400 and anhydrous ethanol.

• What Torisel looks like and contents of the pack

Torisel is a concentrate for infusion supplied with a diluent.

The concentrate is a clear, colourless to light-yellow solution. The diluent is a clear to slightly turbid, light-yellow to yellow solution. The solutions are essentially free from visable particulates.

Each pack of Torisel contains one vial of 1.2 ml concentrate and one vial of 2.2 ml diluent.

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

During handling and preparation of admixtures, Torisel should be protected from excessive room light and sunlight.

Bags/containers that come in contact with Torisel must be made of glass, polyolefin, or polyethylene.

Polyvinyl chloride (PVC) bags and medical devices must not be used for the administration of preparations containing polysorbate 80, because polysorbate 80 leaches di-2-ethylhexylphthalate (DEHP) from PVC.

Dilution

Torisel 30 mg concentrate must be diluted with 1.8 ml of withdrawn diluent before administration in sodium chloride 9 mg/ml (0.9%) solution for injection.

Note: For mantle cell lymphoma, multiple vials will be required for each dose over 25 mg. Each vial of Torisel must be diluted according to the instructions below. The required amount of concentrate-diluent mixture from each vial must be combined in one syringe for rapid injection into 250 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.

In preparing the solution, the following two-step process must be carried out in an aseptic manner according to local standards for handling cytotoxic/cytostatic drugs:

STEP 1: DILUTION OF CONCENTRATE WITH THE SUPPLIED DILUENT

•     Withdraw 1.8 ml of the supplied diluent.

•     Inject the 1.8 ml of extracted diluent into the vial of Torisel 30 mg concentrate.

•     Mix the diluent and the concentrate well by inversion of the vial. Sufficient time should be allowed for air bubbles to subside. The solution should be a clear to slightly turbid, colourless to light-yellow to yellow solution, essentially free from visual particulates.

One vial of Torisel 30 mg concentrate contains 30 mg of temsirolimus: when the 1.2 ml concentrate is combined with 1.8 ml of withdrawn diluent, a total volume of 3.0 ml is obtained and the concentration of temsirolimus will be 10 mg/ml. The concentrate-diluent mixture is stable below 25°C for up to 24 hours.

STEP 2: ADMINISTRATION OF CONCENTRATE-DILUENT MIXTURE IN SODIUM CHLORIDE INFUSION

•     Withdraw the required amount of concentrate-diluent mixture (which contains temsirolimus 10 mg/ml) from the vial; i.e., 2.5 ml for a temsirolimus dose of 25 mg.

•     Inject the withdrawn volume rapidly into 250 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to ensure adequate mixing.

The admixture should be mixed by inversion of the bag or bottle, avoiding excessive shaking, as this may cause foaming.

The resulting solution should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. The admixture of Torisel

in sodium chloride 9 mg/ml (0.9%) solution for injection should be protected from excessive room light and sunlight.

For mantle cell lymphoma, multiple vials will be required for each dose over 25 mg.

Administration

• Administration of the final diluted solution should be completed within six hours from the time that the Torisel is first added to sodium chloride 9 mg/ml (0.9%) solution for injection.

• Torisel is infused over a 30- to 60-minute period once weekly. The use of an infusion pump is the preferred method of administration to ensure accurate delivery of the medicinal product.

• Appropriate administration materials must be composed of glass, polyolefin, or polyethylene to avoid excessive loss of medicinal product and to decrease the rate of DEHP extraction. The administration materials must consist of non-DEHP, non-PVC tubing with appropriate filter. An in-line polyethersulfone filter with a pore size of not greater than

5 microns is recommended for administration to avoid the possibility of particles bigger than 5 microns being infused. If the administration set available does not have an in-line filter incorporated, a filter should be added at the end of the set (i.e., an end-filter) before the admixture reaches the vein of the patient. Different end-filters can be used ranging in filter pore size from 0.2 microns up to 5 microns. The use of both an in-line and end-filter is not recommended.

• Torisel, when diluted, contains polysorbate 80, which is known to increase the rate of DEHP extraction from PVC. This incompatibility has to be considered during the preparation and administration of Torisel. It is important that the recommendations in sections 4.2 and 6.6 in the SPC be followed closely.

Disposal

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

 

Tomudex 2mg Injection

Raltitrexed

1.  What Tomudex is and what it is used for

Tomudex contains a medicine called raltitrexed. This belongs to a group of medicines known as chemotherapy. These are used to treat cancer.

Tomudex is used to treat cancer which affects the colon and rectum (parts of your ‘bowel’ or gut).

It works by killing cells within your body which cause certain types of cancer. Your doctor will probably explain this to you in more detail.

2.   Before you are given Tomudex

Do not have Tomudex if:

•    You have severe kidney disease.

•    You are pregnant, think you might be pregnant, are trying for a baby or you are breastfeeding.

Do not have Tomudex if any of the above apply to you. If you are not sure, talk to your doctor or nurse before having Tomudex.

Tomudex should not be given to children.

Take special care with Tomudex

Check with your doctor or nurse before having Tomudex if you have ever had:

•    Any problems with your blood, kidneys or liver.

•    Any stomach or bowel (gut) problems.

•    Radiotherapy (treatment with high dose X-rays).

If you are elderly, your doctor or nurse will monitor you more closely for side effects. Elderly people can be more affected by the side effects of this kind of medicine.

If you have any other treatment for other problems or illnesses, tell your doctor, nurse or pharmacist that you are having Tomudex.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Tomudex.

Taking other medicines

Please tell your doctor, nurse or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Tomudex can affect the way some medicines work and some medicines can have an effect on Tomudex.

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

•    Folinic or folic acid.

•    Vitamins or vitamin supplements.

•    Medicines to thin your blood and stop it clotting (anti-coagulants).

Pregnancy and breast-feeding

•    Do not have Tomudex if you are pregnant, think you may be pregnant or might become pregnant. This is because it may affect your baby.

•    You should not try for a baby when either partner is having Tomudex, during the treatment or for at least 6 months after stopping treatment. This is because it may affect the baby.

•    Do not have Tomudex if you are breast-feeding.

Driving and using machines

You may feel generally unwell or have flu-like symptoms for a short time after having Tomudex. If this happens, do not drive or use any tools or machines.

3.   How Tomudex will be given

•    You will be given Tomudex by a doctor or nurse who is a specialist in the use of this type of medicine.

•     Tomudex will be injected slowly into one of your veins. The injection will usually take 15 minutes.

•     The exact dose you are given will be decided by your doctor. It will depend on your size and how you react to your treatment.

•     The usual dose is 3 milligrams for each square metre of your body surface area. Your doctor will calculate this from your height and weight.

•    Your doctor will need to take regular samples of your blood while you are having Tomudex. The results of your blood tests will also help the doctor to decide what dose you will receive. The dose you are given may be different each time.

•     Tomudex is usually given every 3 weeks, but it could be less often, depending on the results of your blood tests.

You should follow any instructions that your doctor gives you about your treatment. If you are not sure about anything ask your doctor or nurse.

4.  Possible side effects

Like all medicines, Tomudex can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Tell your doctor or the hospital straight away if you notice any of the following side effects – you may need urgent medical treatment:

•   Diarrhoea.

•   Being sick (vomiting).

•   High temperature (fever) or chills.

•   Sore throat.

•   Any infections.

•   Soreness or ulcers inside your mouth.

•   Bleeding from the gut. This may be connected to mucositis (inflammation of the mouth and gut lining).

Other possible side effects are:

Stomach and gut

•    Loss of appetite.

•    Indigestion.

•    Feeling sick (nausea).

•     Stomach pain.

•     Constipation.

•    Weight loss.

Joints and muscles

•    Painful joints.

•    Muscle cramps.

Skin and hair

•     Swollen hands, ankles or feet.

•    Itchy rash.

•    Red or peeling skin.

•    Yellow skin and eyes (jaundice).

•     Tenderness and swelling under the skin (cellulitis).

•     Sweating.

•    Hair loss or thinning.

Blood

Tomudex may cause changes to your blood. These occur because of effects on your bone marrow and your liver. Your doctor will take regular blood samples to check your blood.

Other

•    Feeling thirsty or dry skin (signs of dehydration).

•    Headache.

•    Altered taste.

•    Red or itchy eyes (conjunctivitis).

•    Weakness (sometimes flu-like symptoms).

Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

5. How to store Tomudex

This medicine will normally be stored for you by the hospital. The doctor and hospital pharmacist are responsible for storing, using and disposing of Tomudex correctly.

•    Keep out of the reach and sight of children.

•    Keep unopened vials in the outer carton to protect them from light.

•    Do not store above 25°C.

•    Do not use Tomudex after the expiry date which is stated on the vial. The expiry date refers to the last day of that month.

6. Further information

What Tomudex contains

The active substance is raltitrexed. Each vial contains 2mg of raltitrexed.

The other ingredients are mannitol, dibasic sodium phosphate heptahydrate and sodium

hydroxide.

What Tomudex looks like and the contents of the pack

Tomudex comes in containers of single glass vials containing a powder which is then made into a solution for injection into a vein. The vials are packed in cartons.

 

Tobravisc 3.0 mg/ml eye drops, solution

Tobramycin

WHAT TOBRAVISC IS AND WHAT IT IS USED FOR

TOBRAVISC belongs to a group of medicines known as aminoglycoside antibiotics.

It is used for the treatment of bacterial infections of the surface of the eye and eyelids, such as conjunctivitis and blepharitis.

BEFORE YOU USE TOBRAVISC

Do not use TOBRAVISC.

•    If you are allergic to tobramycin, any other type of aminoglycoside antibiotic, or any of the other ingredients listed in section 6.

•    In CHILDREN under the age of 1 year.

Ask your doctor for advice.

Take special care.

•    If you suffer from liver or kidney disease. Tell your doctor if you are taking any other antibiotic medicines by mouth or by injection.

•    As with any antibiotic, use of TOBRAVISC for a long time may lead to other infections. If your symptoms get worse or suddenly return tell your doctor.

Pregnancy and breast-feeding

If you are pregnant or might get pregnant, or if you are breast-feeding a baby, talk to your doctor before you use TOBRAVISC.

Driving and using machines

You may find that your vision is blurred for a time just after you use TOBRAVISC. Do not drive or use any machines unless your vision is clear.

Using other medicines

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

If you are using other eye drops, wait at least 5-10 minutes after putting in TOBRAVISC before using the other drops.

Important Information if you wear Contact Lenses

Wearing contact lenses is not advisable during the treatment of an eye infection, as they may make your condition worse.

Do not use the drops while wearing contact lenses. Wait at least 15 minutes after using the eye drops before putting your lenses back in. There is a preservative in TOBRAVISC (benzododecinium bromide) that can affect soft contact lenses.

HOW TO USE TOBRAVISC

The usual dose

The usual dose in adults and children

1 year and older is 1 drop in your eye(s), twice a day-morning and evening for 7 days.

In severe infections, this may by increased to 1 drop 4 times a day for the first day, followed by 1 drop twice a day for 6 days.

Do not stop using TOBRAVISC before your doctor advises, even if your symptoms improve.

Remove the loose collar from the cap when the bottle is first opened.

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

HOW TO USE TOBRAVISC

How to use

•    Wash your hands before you start.

•    Twist off the bottle cap.

•    Hold the bottle pointing down, between your thumb and fingers.

•    Tilt your head back.

•    Pull down your lower eyelid with a finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here.

•    Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.

•    Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops.

•    Gently press on the base of the bottle to release one drop at a time.

•    Don’t squeeze the bottle, only a gentle press on the bottom is needed.

•    If you use drops in both eyes, repeat the steps for your other eye. Put the bottle cap firmly back on immediately after use.

•    If a drop misses your eye, try again.

•    If you forget to use TOBRAVISC, do not worry, just use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and and go back to your normal dosing schedule. Do not take a double dose to make up.

•   If you use more TOBRAVISC than you should, it can be, rinsed out with warm water.

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

POSSIBLE SIDE EFFECTS

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

•   You may experience some or all of the following effects in your eye(s):

Common (affect 1 to 10 people in 100): Itching, swelling, redness, watery eye(s).

Uncommon (affect 1 to 10 people in 1000): Discomfort, discharge, swelling of the surface of the eye and eyelid and redness of the eyelid.

•   Additional side effects that have been reported include:

Effects in the eye: Irritation, surface inflammation, pain, abnormal sensation, blurred vision.

General effects: Rash, abnormal skin sensation or skin redness.

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

HOW TO STORE TOBRAVISC

•    Keep out of the reach and sight of children.

•    Keep the bottle tightly closed.

•    Do not use the drops after the expiry date (marked ‘Exp’) on the bottle and the carton. The expiry date refers to the last day of that month.

•    Stop using the bottle 4 weeks after first opening, to prevent infections.

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

•    Do not pass this medicine on to others.

It may harm them, even if their symptoms are the same as yours.

FURTHER INFORMATION

What TOBRAVISC contains

•    The active substance is tobramycin 3 mg/ml.

•    The other ingredients are xanthan gum, benzododecinium bromide, mannitol, trometamol, boric acid, polysorbate 80, sulphuric acid and/or sodium hydroxide (to adjust pH) and purified water.

What TOBRAVISC looks like and contents of the pack

TOBRAVISC is a clear solution supplied in a pack containing a 5 ml plastic bottle with a screw cap.