Patient Information Leaflet

CORTISTAB TABLETS 5mg and 25mg

Cortisone Acetate

Please read this leaflet carefully before you start to take your tablets. It provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

•    Cortistab is a steroid medicine, prescribed for many different conditions, including serious illnesses.

•    You need to take it regularly to get the maximum benefit.

•    Don't stop taking this medicine without talking to your doctor - you may need to reduce the dose gradually.

•    Cortistab can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed, or 'high') or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away.

•    Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information).

•    If you take this medicine for more than three weeks, you will get a blue 'steroid card': always keep it with you and show it to any doctor or nurse treating you.

•    Keep away from people who have chicken-pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken-pox or shingles, see your doctor straight away.

Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you. This leaflet was last updated on 31/01/08

Cortistab - benefit information.

Cortistab belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Cortistab) is an effective way to treat various illnesses involving inflammation in the body. Cortistab reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

In this leaflet:

1.    What is in Cortistab Tablets and what they are used for

2.    Before you take Cortistab Tablets

3.    How to take Cortistab Tablets

4    Possible Side Effects

5.    Looking after Cortistab Tablets

1. What is in Cortistab Tablets and what they are used for

The name of your medicine is Cortistab Tablets 5mg or 25mg.

The active ingredient in Cortistab Tablets is cortisone acetate. Each tablet contains 25 mg of Cortisone Acetate Ph Eur with lactose, maize starch and calcium stearate.

Each bottle contains 100 tablets.

Product licence holder: Waymade PLC (Trading as Sovereign Medical), Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, England.

Manufactured by: BCM Ltd, 1 Thane Road West, Nottingham, NG2 3AA, England.

Cortistab tablets belong to a group of medicines called steroid hormones.

Cortistab tablets are used to treat a shortage of adrenal hormones in the body.

2. Before you take Cortistab Tablets

You should not take this medicine and tell your doctor if:

•    you are sensitive to any of the ingredients in the tablets, or have you ever had problems taking steroids before

•    you have any infections or are you taking any antibiotics Remember, this does not just mean bacterial infections, but also infections caused by a virus or fungus. Conditions such as athlete’s foot, thrush, the common cold, and cold sores are all types of infections

•    you pregnant, trying to become pregnant or breast feeding

•    you have recently been vaccinated with a live vaccine e.g. smallpox or rubella vaccines Check with your doctor first

•    If you have ever had severe depression or manic-depressive illness (bipolar disorder). This includes having had depression before while taking steroid medicines like Cortistab.

•    If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking Cortistab.

Make sure your doctor knows if:

•    you ever had TB (tuberculosis), or you currently receiving any medication to treat TB

•    you have, or is there a family history of diabetes or glaucoma (eye disease)

•    You have a previous history of myopathy (weak muscles) when taking corticosteroids

•    you suffer from, or take medicines for, high blood pressure, severe mental disorders, osteoporosis (thinning of the bones), stomach ulcers or epilepsy

•    you suffer from liver, kidney or heart disease, or an underactive thyroid

Cortistab Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Taking other Medicines

Before taking Cortistab Tablets, tell your doctor if you are taking any of the medicines listed below:

•    barbiturates e.g. phenobarbitone

•    treatment for epilepsy e.g. phenytoin, primidone or carbamazepine

•    antibiotics such as rifampicin, rifabutin or amphotericin

•    diuretics (water tablets) e.g. bumetamide, furosemide or bendroflumethiazide

•    drugs used to lower high blood pressure e.g. methyldopa, clonidine or moxonidine

•    medicines for thrombosis (sometimes called anticoagulants or "blood thinners") e.g. warfarin

•    diuretics (water tablets)

•    aspirin or medicines containing aspirin(salicylates)

•    insulin or other medicines for diabetes (You may need to change the dose).

•    amphotericin for fungal infections

•    a medicine for arthritis, crohn’s disease or cancer called methotrexate

•    oral contraceptives

Mental health problems while taking Cortistab

Mental health problems can occur while taking steroids like Cortistab (see also section 4 Possible Side Effects).

•    These illnesses can be severe.

•    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 problems do occur they might need treatment.

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

Special warning for patients taking Cortistab Tablets:

Tell the doctor that you are taking a steroid:

^ before having any vaccination ^ before surgery or any emergency treatment ^ if you get an infection or injury ^ if you catch chickenpox

! If you have never had chickenpox before, it is very important that you avoid exposure to people who have chickenpox or shingles. If exposed, you must contact your doctor immediately.

! Tell your dentist that you are taking a steroid if you need to have any dental surgery or treatment.

! If you have been given a steroid card, always carry it with you.

Stopping your treatment of Cortistab Tablets

If you have been taking more than approximately 40mg of Cortistab Tablets a day, for more than 3 weeks, your doctor will NOT stop your treatment abruptly (suddenly or too quickly). He/she will reduce your dose gradually depending on your condition. Your doctor may also want to monitor you during this time.

If you have been taking Cortistab Tablets for 3 weeks or less, your doctor may consider a gradual withdrawal of your treatment if:

•    you have had a repeat treatment of corticosteroids particularly if taken for longer than 3 weeks

•    you have been given a short course of corticosteroids within 1 year of stopping a long-term therapy (which lasted months or years)

•    you have low adrenal function (that is not caused by taking corticosteroids)

•    you are receiving doses of more than 200mg daily of cortisone (Cortistab Tablets)

•    you are repeatedly taking doses in the evening

If you become pregnant or you are breast feeding

Tell your doctor as soon as possible if you are being treated with Cortistab Tablets and you are pregnant, you become pregnant, or if you are breast feeding a baby.

Driving and Operating Machinery

Cortistab Tablets should not normally affect your ability to drive or operate machinery. However, if you think this medicine affects you, do not drive or operate machinery.

3. How to take Cortistab Tablets

Follow your doctor's directions about when and how to take your tablets. Follow the instructions on the steroid card (if you have been given one) and look at the label on the bottle. Your pharmacist may also help if you are not sure.

Cortistab Tablets should be swallowed with a glass of water. The usual doses are as follows:

Adults: Between 12.5 and 37.5 mg each day in divided doses.

Children: Between 5 and 25 mg each day in divided doses.

Elderly: Your doctor will recommend the right dose for you.

Cortistab is usually given in two doses each day. The first and larger dose should be taken in the morning, with the second (smaller) dose in the evening.

Remember: Stopping your treatment of Cortistab Tablets

DO NOT stop taking your medicine or change the dosage unless your doctor tells you to. It is very important that your medicine is not stopped abruptly (too quickly), or just because you feel better. Your doctor may want you to gradually cut down the number of tablets you take before stopping completely.

What to do if you miss a dose or take too many tablets

If you miss a dose, or if you cannot remember if you took it or not, take another as soon as you remember, rather than miss a dose altogether. Then go on as before. If you accidentally take too many tablets, contact your doctor immediately.

4 Possible Side Effects

Severe effects: tell a doctor straight away

Steroids including dexamethasone can cause severe mental health problems.

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

•    Feeling depressed, including thinking about suicide.

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

•    Feeling anxious, having problems sleeping, having 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.

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

As well as benefits, all medicines may sometimes have unwanted effects in some people. If you experience any of the following, please tell your doctor or pharmacist:

•    Thinning of the skin, bruising, slow healing of wounds, marks which look like stretch marks, acne.

•    Feeling sick, indigestion, abdominal pain, thrush.

•    Blurred vision, pain in the eyes, muscle weakness, fluid retention, feeling generally unwell.

•    Puffy face, increased hair growth, increased appetite, weight gain, irregular or absent menstrual periods.

•    Mood changes, difficulty sleeping.

Contact a doctor immediately if you experience severe headaches, severe indigestion or abdominal pain, dark brown or dark red vomit, or black tarry motions whilst taking Cortistab.

Rarely, allergic reactions may occur and you should contact a doctor immediately if you develop a rash, difficulty breathing or swelling of the face and mouth.

Other possible side effects with steroid tablets (particularly if used in high doses or for long periods of time) include blood sugar changes, raised blood pressure, blood clots, cataracts, increased risk and severity of infections, recurrence of TB (tuberculosis), changes in body chemistry, dependence, euphoria, depression, worsening of epilepsy (in epileptic patients), worsening of schizophrenia (in schizophrenic patients), and slowed growth in infants, children and teenagers. There could also be an increased risk of infections whilst you are taking Cortistab Tablets.

After stopping your treatment, you may feel generally unwell for a time whilst your body adjusts, with symptoms such as aching joints, a fever or loss of weight.

If you experience any other unusual or unexpected symptoms whilst taking Cortistab, tell your doctor or pharmacist.

Looking after Cortistab Tablets

Do not take your tablets after the "use by" date shown on the label. Keep them in a cool dry place, protected from direct light. Store them in a safe place where children cannot see or reach them.

If your doctor decides to stop the treatment, return any left over to your pharmacist. Only keep your medicine if your doctor tells you to.

Remember: This medicine is for you and has been prescribed for you by a doctor. Never give it to anybody else, even if their symptoms are the same as yours.

This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

Leaflet revised June 2005