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Medrone (Methylprednisolone)

Medrone Tablets 100 mg

(Methylprednisolone)

Medrone (Methylprednisolone)1. What Medrone is and what it is used for

Medrone Tablets contain methylprednisolone. Methylprednisolone belongs to a group of medicines called steroids. Their full name is corticosteroids. Corticosteroids are produced naturally in your body and are important for many body functions.

Boosting your body with extra corticosteroid such as Medrone can help following surgery (e.g. organ transplants), injuries or other stressful conditions. These include inflammatory or allergic conditions affecting the:

• brain (e.g. meningitis)

• bowel and gut (e.g. ‘Crohn’s disease)

• blood or blood vessels (e.g. leukaemia or arteritis, inflammation of the arteries)

• joints (e.g. rheumatic fever)

• lungs (e.g. asthma, tuberculosis)

•  muscle (e.g. dermatomyositis and polymyositis)

• skin (e.g. pemphigus vulgaris, an ‘auto-immune disorder in which the body’s immune system is overactive causing the skin to blister)

Medrone may be prescribed to treat conditions other than those listed above. Ask your doctor if you are unsure why you have been given this medicine.

2. Before you take Medrone Do not take Medrone if:

You think you have ever suffered an allergic reaction, or any other type of reaction after being given Medrone, any other steroid medicine or any of the ingredients in Medrone tablets (Section 6 contains a list of the ingredients). An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath.

You have any fungal infection (such as thrush) or any other infection which is not being treated with an antibiotic or antiviral medicine.

If you get a rash or another symptom of an infection tell your doctor immediately.

Medrone (Methylprednisolone)Take special care before taking Medrone:

You must tell your doctor before you take this medicine if you have any of the following conditions.

Your doctor may have to monitor your treatment more closely, alter your dose or give you another medicine.

• Chickenpox, measles, shingles or a herpes eye infection. If you think you have been in contact with someone with chickenpox, measles or shingles and you have not already had these illnesses, or if you are unsure if you have had them.

• Severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Medrone, or having a family history of these illnesses.

• Diabetes (or if there is a family history of diabetes).

• Epilepsy

• Glaucoma (increased blood pressure in the eye) or if there is a family history of glaucoma.

• You recently suffered a heart attack.

• Heart problems, including heart failure or infections.

• Hypertension (high blood pressure).

• Hypothyroidism (an under-active thyroid).

• Kidney or liver disease.

• Karposi’s sarcoma (a type of skin cancer).

• Muscle problems (pain or weakness) have happened while taking steroid medicines like Medrone in the past.

• Myasthenia gravis (a condition causing tired and weak muscles).

• Osteoporosis (brittle bones).

• Skin abscess.

• Stomach ulcer or other serious stomach or intestinal problems.

• Thrombophlebitis – vein problems due to thrombosis (clots in the veins) resulting in phlebitis (red, swollen and tender veins).

• Tuberculosis (TB) or if you have suffered tuberculosis in the past.

Taking other medicines

Always tell your doctor or pharmacist if you are taking any medicines (including any you have bought without a prescription) as taking Medrone with other medicines could be harmful.

You should tell your doctor if you are taking any of the following medicines which can affect the way Medrone or the other medicine works:

•Acetazolamide – used to treat glaucoma and epilepsy

•Aminoglutethimide – used for treating cancer

•Anticoagulants – used to ‘thin’ the blood such as acenocoumarol, phenindione and warfarin

•Anticholinesterases – used to treat myasthenia gravis (a muscle condition) such as distigmine and neostigmine

•Antibiotics (such as erythromycin)

•Aspirin and non-steroidal anti-inflammatory medicines (also called NSAIDs) such as ibuprofen used to treat mild to moderate pain

•Barbiturates, carbamazepine, phenytoin and primidone – used to treat epilepsy

• Carbenoxolone and cimetidine – used for heartb^jma arm acid indigestion

• Ciclosporin – used to treat conditions such as severe rheumatoid arthritis, severe psoriasis or following an organ or bone marrow transplant

• Digoxin – used for heart failure and/or an irregular heart beat

• Diltiazem or mibefradil – used for heart problems or high blood pressure

• Diuretics – sometimes called water tablets.

• Ketoconazole or itraconazolft – used to treat fungal infections

• Pancuronium – or other medicines called neuromuscular blocking agents which are used in some surgical procedures

• Rifampicin and rifabutin – antibiotics used to treat tuberculosis (TB)

Vaccines – tell your doctor or nurse if you have recently had, or are about to have any vaccination. You should not have ‘live’ vaccines while using this medicine. Other vaccines may be less effective

If you are taking long term medication(s)

If you are being treated for diabetes, high blood pressure or water retention (oedema) tell your doctor as he/she may need to adjust the dose of the medicines used to treat these conditions.

Before you have any operation tell your doctor, dentist or anesthetist that you are taking Medrone.

If you require a test to be carried out by your doctor or in hospital it is important that you tell the doctor or nurse that you are taking Medrone. This medicine can affect the results of some tests.

Pregnancy and breast feeding

You must tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant as this medicine could slow the baby’s growth.

Tell your doctor if you are breast feeding as small amounts of corticosteroid medicines may get into breast milk.

3. How to take Medrone

Your doctor will tell you how many tablets to take and when to take them. Thrsjnformation can also be found on the pharmacy label placed on the tablet container.

If you are not sure how to take this medicine ask your doctor or pharmacist.

Steroid Cards

Remember to always carry a Steroid Treatment Card. Ma^^inie your doctor or pharmacist has filled out the details of your medicine, including the dose and how long you will require steroid treatment.

You should show your steroid card to anyone who give you treatment (such as a doctor, nurse or dentist) while you are taking Medrone, and for 3 months after you stop taking the tablets.

If you are admitted to hospital for any reason always tell your doctor or nurse that you are taking Medrone. You can also wear a medic-alert bracelet or pendant to let medical staff know that you are taking a steroid if you have an accident or become unconscious.

Adults

The normal daily dose is between 4 mg and 360 mg per day, depending on your condition and how severe it is. Your doctor will prescribe the lowest dose possible.

Your doctor may tell you to take your daily dose all in one go, split your daily dose throughout the day, or take it every other day at 8.00am.

Swallow the tablets whole with a drink of water.

If you are being given Medrone because your body cannot make its own corticosteroids, your doctor may also want you to take a second type of steroid to help your salt balance.

Your doctor may prescribe a higher dose at the start of your treatment to bring your condition under control.

When your doctor is happy that your condition has improved your dose will be reduced gradually. Normally the dose will be reduced by not more than 2 mg every 7 to 10 days.

Elderly:

Your doctor may want to see you more regularly to check how you are getting on with your tablets.

Children:

Corticosteroids can affect growth in children so your doctor will prescribe the lowest dose that will be effective for your child. Your doctor may tell you to give your child this medicine on every other day.

If you take more Medrone than you should

It is important that you do not take more tablets than you are told to take. If you accidentally take too many tablets, seek medical attention straight away.

If you forget to take your Medrone

Wait and take the next dose as normal. Do not take a dose to make up for the forgotten one but tell your doctor or pharmacist what had happened.

Stopping/reducing the dose of your Medrone

Your doctor will decide when it is time to stop your dose.

You must not stop taking Medrone suddenly, especially if you :

• have had more than 6 mg Medrone daily for more than 3 weeks;

• have been given high doses of Medrone (more than 32 mg daily) even if it was only for 3 weeks or less;

•have already had a course of corticosteroid tablets or injections in the last year;

• already had problems with your adrenal glands (adrenocortical insufficiency) before you started this treatment;

• take repeat doses in the evening.

You will need to come off Medrone slowly to avoid withdrawal symptoms. These symptoms may include itchy skin, fever, muscle and joint pains, runny nose, sticky eyes, sweating and weight loss.

If your symptoms seem to return or get worse as your dose of Medrone is reduced tell your doctor immediately

Mental problems while taking Medrone

Mental health problems can happen while taking steroids like Medrone

• These illnesses can be serious.

•Usually they start within a few days or weeks of starting the medicine.

• They are more likely to happen at high doses.

•Most of these problems go away if the dose is lowered or the medicine is stopped. However if the problems do happen they might need treatment.

Talk to a doctor if you (or someone using this medicine) shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases mental problems have happened when doses are being lowered or stopped.

4. Possible side effects

Like all steroids these tablets can cause side-effects, although not everybody gets them. Your doctor will have given you Medrone for a condition which if not treated properly could become serious.

Don’t stop taking Medrone, but go and SEE YOUR DOCTOR IMMEDIATELY, if you get any of the following symptoms:

Allergic reactions, such as skin rash, swelling of the face or wheezing and difficulty breathing. This type of side effect is rare, but can be serious.

•Acute pancreatitis, stomach pain spreading to your back, possibly accompanied by vomiting, shock and loss of consciousness.

•Burst or bleeding ulcers, symptoms of which are stomach pain (especially if it seems to spread to your back), bleeding from the back passage, black or bloodstained stools and/or vomiting blood.

•Infections. This medicine can hide or change the signs and symptoms of some infections, or reduce your resistance to the infection, so that they are hard to diagnose at an early stage. Symptoms might include a raised temperature and feeling unwell. Symptoms of a flare up of a previous TB infection could be coughing blood or pain in the chest. Medrone may also make you more likely to develop a severe infection.

•Pulmonary embolus (blood clots in the lung), symptoms of include sudden sharp chest pain, breathlessness and coughing up blood.

•Raised pressure within the skull of children (pseudotumour cerebri) symptoms of which are headaches with vomiting, lack of energy and drowsiness. This side-effect usually occurs after treatment is stopped.

• Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of which include painful swollen, red and tender veins.

It is important that if you develop any of the symptoms listed above you MUST SEE YOUR DOCTOR IMMEDIATELY

Don’t stop taking Medrone, but tell your doctor straight away if you experience any of the following side effects, or notice any other unusual effects not mentioned in this post:

Blood, heart and circulation

•Problems with the pumping of your heart (heart failure) symptoms of which are swollen ankles, difficulty in breathing and palpitations (awareness of heart beat) or irregular beating of the heart, irregular or very fast or slow pulse.

•High blood pressure, symptoms of which are headaches, or generally feeling unwell.

•Increased numbers of white blood cells (leucocytosis).

Body water and salts

• Swelling and high blood pressure, caused by increased levels of water and salt content.

• Cramps and spasms, due to the loss of potassium your body. In rare cases this can lead to congestive heart failure (when the heart cannot pump properly).

Digestive system

•Nausea (feeling sick) or vomiting (being sick).

•Ulcers or thrush in the gullet (discomfort on swallowing).

•Indigestion.

•Bloated stomach.

•Persistent hiccups, especially when high doses are taken.

Eyes

• Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches).

• Swollen optic nerve (papilloedema, indicated by sight disturbance).

•Damage to the optic nerve or cataracts (indicated by failing eyesight).

• Thinning of the clear part at the front of the eye (cornea) or of the white part of the eye (sclera).

•Worsening of viral or fungal eye infections.

•Protruding of the eyeballs).

Hormone and metabolic system

• Slowing of normal growth in infants, children and adolescents which may be permanent.

• Irregular or no periods in women.

• Increased hair on the body and face in women (hirsutism).

• Round or moon-shaped face (Cushingoid facies).

• Increased appetite and weight gain.

• Diabetes or worsening of existing diabetes.

• Prolonged therapy can lead to lower levels of some hormones which in turn can cause low blood pressure and dizziness. This effect may persist for months.

• The amount of certain chemicals (enzymes) called alanine transaminase, aspartate transaminase and alkaline phosphatase that help the body digest drugs and other substances in your body may be raised after treatment with a corticosteroid. The change is usually small and the enzyme levels return to normal after your medicine has cleared naturally from your system. You will not notice any symptoms if this happens, but it will show up if you have a blood test.

Immune system

• Increased susceptibility to infections which can hide or change normal reactions to skin tests, such as that for tuberculosis.

Muscles and bones

• Muscle weakness or wasting.

• Brittle bones (bones that break easily).

• Broken bones or fractures.

• Breakdown of bone due to poor circulation of blood, this causes pain in the hip.

• Torn muscle tendons causing pain and/or swelling.

• Muscle cramps or spasms.

Nervous system

Steroids including methylprednisolone can cause serious mental health problems.

These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like methylprednisolone.

• Feeling depressed, including thinking about suicide

• Feeling high (mania) or moods that go up and down.

• Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.

• Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

Skin

• Acne.

• Poor wound healing.

• Thinning of skin with streWh^jVrks.

• Bruising.

• Small purple/red patches on the skin or inside the mouth.

• Pale or darker patches on your skin, or raised patches which are an unusual color.

It is important if you are to have a blood test that you tell the doctor or nurse that you have been given treatment with Medrone.

If you notice any of these problems talk to a doctor straight away.

5. How to store Medrone

Medrone tablets should not be used after the expiry date ‘EXP’ shown on the bottle.

Keep your blister strips securely in the outer carton. If your medicine is out of date take it to your pharmacist who will dispose of it safely.

Keep your medicine in a safe place where children cannot reach or see it.

Store your medicine in a cool place below 25°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 protect the environment.

6. Further information

What Medrone tablets contain

Medrone tablets 100 mg contain 100 mg methylprednisolone.

The tablets also contain methylcellulose, sodium starch glycollate, microcrystalline cellulose, magnesium stearate and El32.

What Medrone tablets look like and contents of the pack

Medrone Tablets 100 mg are light blue, round, scored with a cross and marked ‘UPJOHN 3379.’.

Your pack contains 20 tablets.

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