PRECORTISYL FORTE TABLETS (Prednisolone 25mg) CSE 39690

Please read this leaflet carefully before you start to take this medicine. If you do not understand it or you want to know more, ask your doctor or pharmacist. Keep the leaflet, you may want to read it again.

WHAT IS IN YOUR MEDICINE?

The name of your medicine is Precortisyl Forte. Each tablet contains 25mg of the active ingredient, Prednisolone BR.

The tablets also contain lactose, potato starch, pregelatinised maize starch, magnesium stearate and purified talc. Precortisyl Forte is available in packs of 56 tablets.

Prednisolone, the active ingredient, is a glucocorticoid. This means that it is a type of steroid. This is nothing to worry about. It is not an anabolic steroid, the type of steroid abused by athletes who do not use it for the correct reasons.

Precortisyl Forte works by reducing inflammation in the body, for example swelling, pain and redness. It can also be used to stop autoimmune reactions which occur when your natural defences start to attack your body.

WHO HAS MADE YOUR MEDICINE?

The Product Licence for Precortisyl Forte is held by Roussel Laboratories Ltd, Broadwater Park, North Orbital Road, Denham, Uxbridge. Middlesex, UB9 5HR.

It is manufactured by Roussel Laboratories Ltd, Covingham, Swindon, Wiltshire, SN3 5BZ.

WHAT IS YOUR MEDICINE USED FOR?

Your medicine can be used to treat many different conditions, for example: blood disorders, such as anaemia and leukaemia; certain skin and kidney problems; ulcerative colitis; a stomach problem; and diseases of the connective tissue collagen, such as rheumatic fever and systemic lupus erythematosus.

BEFORE YOU TAKE YOUR MEDICINE . . .

Before you take Precortisyl Forte, please read the following questions. If the answer is YES to ANY of these questions, you MUST tell your doctor before taking your medicine.

Conditions such as athletes foot, thrush, the common cold and cold sores are all types of infection.

If possible, AVOID all contact with people who may have either chicken pox or shingles whilst you are taking this medicine or have stopped it within the last three months. If you do come into contact with someone with the infection, you must see your doctor or pharmacist as soon as you can. Precortisyl forte lowers your body's resistance so you are more likely to catch an infection. It may be necessary to give you a vaccination. If you do catch chicken pox or shingles, your doctor will advise you how to take your medicine. You may need to increase the number of tablets that you take.

You may be given a blue "steroid card" from either your doctor or pharmacist when you are given your medicine. It is in your best interest to carry the card with you at all times because it contains, as well as your dosage instructions, information which would be very important if you were, for example, to fall ill or be involved in an accident.

ARE YOU TAKING ANY OTHER MEDICINES?

Precortisyl Forte and other medicines that you may be taking sometimes affect each other's action. These include medicines taken for the conditions listed above, plus pain killers like aspirin. aminoglutethimide which is used to treat some types of cancer and any medicine used to stop your blood clotting, for example warfarin. Your doctor will know about these and may change your dose of medication to deal with this.

You should mention to your doctor or pharmacist any other medicines that you are taking including any that you can buy without a prescription

If you have just had, or are due to have any injections or vaccinations such as those needed for a foreign holiday, you should mention to the nurse or doctor that you are taking Precortisyl Forte.

HOW SHOULD YOU TAKE YOUR MEDICINE?

Precortisyl Forte tablets should be taken WITH or AFTER food/meals i.e. on a full stomach. You should swallow your tablet with a glass of water. It is important to take your medication at the right times.

ADULTS: When you start to take your medicine, you will probably need to take three tablets each day. The tablets should be taken separately i.e. split up during the day so that you take them at three different times. Your doctor may decide that you need more tablets than this, but this is not unusual so you should not worry about it

NOTE: Your doctor may advise you to take this medicine in a different way for example taking a different dose of Precortisyl Forte every other day in the morning only. Sometimes when you have been taking this medicine for a long time, your dose may need to be changed if you become ill or are to have a surgical operation. Because of this, you should always follow your doctor s advice about how and when to take your medicine and always read the label. Your pharmacist may also help you if you are not sure.

If you do forget to take a dose at the correct time, take your Precortisyl Forte as soon as you remember, then go on as before.

If you accidentally take too many tablets. contact your doctor or the hospital casualty department immediately.

REMEMBER:

Keep taking your medicine until your doctor tells you to stop.

Have you got a repeat prescription from your doctor? It is very important that you do not stop taking this medicine abruptly. Keep a supply in reserve so that you will not accidentally run out of tablets.

WITHDRAWAL

If your doctor tells you that you no longer need to take Precortisyl Forte, follow your doctor’s advice carefully about how to finish off your course of treatment. Sometimes problems can occur, for example fever, sickness, a runny nose, sore. red, sticky eyes, aching muscles and joints, itchy skin and weight loss if you stop them too quickly/abruptly. If you suffer low blood pressure making you feel faint and dizzy. you should contact your doctor, as this could be dangerous.

Your doctor may put you on a "reducing dose"; this means that the number of tablets that you take is gradually lowered over a period of either days or weeks so that you eventually end up having no tablets to take.

WHAT ABOUT SIDE EFFECTS?

Like all medicines, Precortisyl Forte may occasionally cause you some problems. It affects different people in different ways.

Your medicine may cause you to suffer from stomach or bowel trouble such as a feeling of fullness/being bloated or maybe some pain. If you notice any blood in your stools or vomit you should see your doctor. Sometimes the throat may become very sore. You may find that inside your mouth develops white areas on its surface. if this happens, you should see your doctor.

You may find that your appetite increases and that you gain some weight, perhaps around your face. Alternatively, you may find that you lose weight and feel weak. Osteoporosis may occur and sometimes it can become easier to fracture your bones and for your tendons to tear.

Women taking this medicine may find that their periods become irregular or stop altogether.

Your hair may grow faster and thicker than before you started this medicine. It has also been noted that some people develop signs of diabetes, for example increased thirst and frequency of going to the toilet. If you are already diabetic, you may find that you need to take more medication to balance the effect of Precortisyl Forte. You should discuss this with your doctor.

You may find that your blood pressure goes up and that you retain water. It could also be more likely that clots will form in your blood.

If you suffer from epilepsy, your doctor may wish to alter your dose of medication whilst you are taking Precortisyl Forte. This is because the symptoms of your epilepsy may become more prominent.

You may develop skin problems such as acne or find that any wounds or cuts do not heal as quickly as they did before you started this medicine. You may also find that your skin becomes flushed red and thinner than before and that stretch marks may appear.

You may notice that your moods change so that you feel either very happy or very depressed. You could also find it more difficult to fall asleep at night. These tablets affect people in many different ways.

if you find that your eyes are hurting, have any change in vision or that you have a bad headache, especially behind your eyes. you should check with your doctor. This may continue. or start to happen after you have been told to stop taking this medicine.

Precortisyl Forte can lower your resistance to infections. This means that patients sometimes find that they catch a cold or symptoms of a previous infection such as tuberculosis (TB), occur more easily than they did before they started to take this medicine. This is especially important to remember regarding chicken pox infections.

If you have any other problems and think that your medicine may be causing them, tell your doctor or pharmacist.

HOW SHOULD YOU STORE YOUR MEDICINE?

Do not use your medicine after the date shown on the label, (expiry date).

Keep this medicine at normal room temperature (25°C/77°F) and protect it from light. Keep it in the pack in which it was given to you. Do not transfer your medicine to another container.

Keep this medicine in a safe place where children cannot get at it. Your medicines could harm them.

If your doctor decides that you no longer need to take Precortisyl Forte and that your treatment is complete, return any left over medicine to a pharmacist. Only keep it if the doctor tells you to.

This leaflet was revised August 1995.