PATIENT INFORMATION LEAFLET

ADCORTYL™

INTRA-ARTICULAR/INTRADERMAL INJECTION 10 mg/ml

Triamcinolone acetonide

Your doctor has prescribed Adcortyl injection for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give

it to anyone else. It may harm them even if they have the same symptoms as you

Q. WHAT IS IN ADCORTYL INTRA-ARTICULAR/INTRADERMAL (IA/ID) INJECTION?

A. Adcortyl IA/lD injection contains triamcinolone acetonide which is a member of the group of medicines known as steroids. The injection contains triamcinolone acetonide 10mg/ml and is supplied in 1.0 ml glass ampoules or 5ml glass vials. The other ingredients are benzyl alcohol, polysorbate 80, sodium carboxymethylcellulose, sodium chloride and water.

UK PRODUCT LICENCE

Held by: E R Squibb & Sons Limited, 141-149 Staines Road, Hounslow TW3 3JA

IRISH PRODUCT AUTHORISATION

Held by: Bristol-Myers Squibb Pharmaceuticals Ltd, Dublin, Ireland

MANUFACTURER

Bristol-Myers Squibb GmbH, Donaustauferstrasse 378, D-93055 Regensburg,

Germany

Q. WHAT IS THIS MEDICINE FOR?

A. Adcortyl IA/ID injection is for the treatment of joint pain, swelling and stiffness in inflammatory disorders such as rheumatoid arthritis. It is also used to treat various forms of allergic dermatitis, skin overgrowths such as thickened scar tissue, and patchy baldness, which is usually reversible.

BEFORE RECEIVING YOUR MEDICINE

Q. Should I be receiving Adcortyl IA ID injection?

A. You should not receive this medicine if you have ever had an allergic reaction to similar medicines or to any of the ingredients in Adcortyl IA ID injection. You should not receive this medicine if you are suffering from an infection unless your doctor has also prescribed a treatment for the infection.

Q. Is there anything else I should discuss with my doctor before receiving Adcortyl IA/ID injection?

A. Check with your doctor before receiving Adcortyl IA ID injection if you have had any recent infection, tuberculosis (TB), bowel disorders, an ulcer blood clots cancer, thin (brittle) bones, high blood pressure or heart failure, mental disorders, epilepsy, myasthenia gravis or glaucoma (increased pressure in your eyes).

Q. What if I have been in contact with someone who has Chickenpox or Shingles?

A. Tell your doctor immediately if you have not had chickenpox yourself as these diseases can be dangerous to patients taking steroid medicines as the steroids suppress your body's natural immune responses.

Q. Can I be immunised (vaccinated)?

A. While you are being treated with this medicine (or if you have recently stopped a course of treatment) do not have any immunisation without consulting your doctor.

Q. What if I am pregnant or think I may be pregnant? What if I am planning to become pregnant? What if I am breast-feeding?

A. You should make sure you discuss this with your doctor as soon as possible before receiving Adcortyl IA/ID injection.

Q. What if I have had problems with my kidneys, liver or thyroid?

A. Remind your doctor as the dose of Adcortyl may need to be adjusted.

Q. Can I take other medicines?

A. Do not take aspirin while receiving Adcortyl IA/ID injection if you have blood disorders. Always tell your doctor about all other medicines you are taking, even those you have bought at a pharmacy or other places, e.g. supermarket. Some medicines used to treat epilepsy, tuberculosis or breast cancer can reduce the effectiveness of Adcortyl. On the other hand, Adcortyl can affect the action of some medicines used to treat diabetes, high blood pressure or to thin the blood.

Q. Is it all right to take exercise?

A. You must take care not to over-use a joint which feels better after you receive Adcortyl IA ID injection as the joint will still need to recover from the inflammation which caused your symptoms.

Continued

Q Is it all right to drive?

A This medicine does not usually affect your ability to drive but it can affect your eyesight. Tell your doctor immediately if you have any pain in the eyes or visual disturbances.

Q. Is it all right to drink alcohol?

A There is no known interaction between Adcortyl and alcohol.

Q. What if I am diabetic?

A. Remind your doctor as your insulin dose may need to be changed

Q. Who should I tell that I have received this injection?

A. Your doctor or pharmacist will have given you a Steroid Treatment Card with your prescription or medicine. YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be shown to any of the following persons:

Doctor or Nurse - before having any surgery or emergency treatment or if any new treatment is prescribed.

Dentist - before having any dental surgery Pharmacist - before buying any medicines

Optician - it is advisable to have regular eye tests.

ADMINISTRATION OF YOUR MEDICINE

Q. How will Adcortyl IA/ID injection be given and how often?

A. The effect of the injection will vary from patient to patient and further injections may be given when symptoms return and not at regular intervals.

Use in inflammatory joint disorders:

The dose of injection to be given into a joint or into a tendon sheath depends upon the size of the joint to be treated and the seventy of the condition. Doses of 2.5-5 mg (0.25-0.5 ml) for smaller joints and 5-15 mg (0.5-1.5 ml) for larger joints usually give relief of symptoms. This medicine should not be used for injection into the Achilles tendon.

Use in allergic dermatitis:

The dose is usually 2-3 mg (0.2-0.3 ml) depending on the size of the problem area of the skin but no more than 5 mg (0.5 ml) should be injected at any one site. If several sites are injected the total dose given should not exceed 30 mg (3 ml). Further doses may be given if necessary at one or two week intervals.

Children: Adcortyl IA/ID is not recommended for children under 6 years of age. It may be given to older children but the dose is adjusted according to their size and weight and is always kept as low as possible for the shortest possible time.

During times of illness or stress, patients on long-term treatment may require the addition of oral steroid tablets or, if they have recently finished a course of Adcortyl IA/ID injections, may need to start taking oral steroid tablets for a while.

Q. How long should I continue receiving Adcortyl IA/ID injection?

A. Your doctor will advise you whether it is wise for you to have further injections. Treatment with steroids is usually kept as short as possible and must not be stopped abruptly. Joints may become permanently damaged by repeated injections over a long period of time.

When the treatment is stopped you may notice flu-like symptoms, runny nose or itchy eyes or skin.

UNDESIRABLE EFFECTS

Q. Are there any unwanted effects of Adcortyl IA/ID injection?

A. All medicines may cause some unwanted or "side" effects. Some which can occur with steroid treatment are as follows. Tell your doctor immediately if you get ulcer pains in your stomach or severe pain in your abdomen. Patients have reported increased appetite, weight gain, indigestion, sickness, feeling tired or weak. Steroid treatment may cause increased risk of infection, thinning of bones or tendons causing fractures or torn muscles, water retention, irregular heart beat, high blood pressure or blood clots. Skin disorders or eye problems, including glaucoma and cataracts, may occur and wounds or broken bones may be slow to heal . Treatment with steroids can stop the body from producing some hormones and may slow or stop children's growth rate If you are female. your periods may become irregular. Elevation or depression of mood. sleeplessness and severe headaches have been reported.

In particular, when Adcortyl IA/ID is injected into a joint you may notice some indentation appearing after a while in the surrounding area. Similarly, injections given under the skin may cause slight changes in skin colour around the site of injection. These changes should disappear in time.

Tell your doctor or pharmacist if you notice any other troublesome side effects.

LOOKING AFTER YOUR MEDICINE

Adcortyl IA ID injection will be kept in the pharmacy until it is given to you by your doctor or nurse. It should be kept at room temperature (below 25°C) and not allowed to freeze. It should not be used after the expiry date shown on the outer packaging.

DATE OF LAST REVISION

August 1995 C80002GB 68005D 12/95