Adcortyl Intra-Articular / Intradermal Injection 10mg / ml

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The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

ADCORTYL

INTRA-ARTICULAR/INTRADERMAL INJECTION 10 mg/ml

Triamcinolone acetonide

Adcortyl IA/ID Injection 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. Adcortyl IA/ID Injection 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 it for more than 3 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.

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/ID Injection 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 Adcortyl IA/ID Injection) is an effective way to treat various illnesses involving inflammation in the body. Adcortyl IA/ID Injection reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

The injection contains triamcinolone acetonide 10mg/ml and is supplied in packs of 5 x 1.0ml glass ampoules or a single 5ml glass vial. The other ingredients are benzyl alcohol, polysorbate 80, carmellose, sodium chloride and water for injection.

UK PRODUCT LICENCE

Held by:

E. R. Squibb & Sons Limited Uxbridge UB8 1DH England Tel.:0800 7311736

IRISH PRODUCT AUTHORISATION

Held by:

Bristol-Myers Squibb Pharmaceuticals Ltd. Swords County Dublin Tel.:1-800-749-749

MANUFACTURER

Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR) Italy 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).

Check with your doctor first:

If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Adcortyl IA/ID Injection. If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking Adcortyl IA/ID Injection.

Q. What if I have been in contact with someone who has an infectious disease such as Chickenpox, Shingles or Measles?

A. Steroid medicines suppress your body's natural immune response. Therefore, if you come into contact with anyone who has an infectious disease such as chickenpox, shingles or measles, consult your doctor promptly, especially if you have not had the disease before. You should take particular care to avoid these diseases.

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. Corticosteroids can increase the chance of bleeding from the gut caused by aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs). If you have hypothrombinaemia (a tendency to bleed), your doctor will be more careful about giving you Adcortyl IA/ID injection if you are taking ibuprofen or another NSAID. 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.

Always tell your doctor if you are taking oral contraceptives, hormone replacement therapy (HRT), growth hormone, thyroid drugs, cyclosporin, or medicines for treating fungal infections, or if you are to be vaccinated or to be given an anaesthetic.

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.

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 medicine Optician - it is advisable to have regular eye tests Q. Is there any important information about the ingredients of Adcortyl that I need to know?

A. Adcortyl IA/ID Injection contains 15mg/ml benzyl alcohol which may cause harmful or allergic reactions in infants and children. Adcortyl IA/ID injection must not be given to premature or newly born babies.

Administraton 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 severity of the condition. Doses of 2.5 - 5mg (0.25-0.5ml) for smaller joints and 5-15mg (0.5-1.5ml) 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 2-3mg (0.2-0.3ml) depending on the size of the problem area of the skin but no more than 5mg (0.5ml) should be injected at any one site. If several sites are injected the total dose given should not exceed 30mg (3ml). 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.

Mental problems while taking Adcortyl IA/ID injection

Mental health problems can happen while taking steroids like Adcortyl IA/ID Injection (see also section 4 Possible Side Effects).

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 problems do happen they might need treatment.

Talk to a doctor if you (or someone taking 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.

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, facial swelling or an unexpected rash. 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. Very rare instances of blindness have been reported following injection to the face.

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

Serious effects: tell a doctor straight away

Steroids including Adcortyl IA/ID injection 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 Adcortyl IA/ID injection.

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.

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

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 stored upright, at a temperature not exceeding 25°C and should not be allowed to freeze. After first opening, the 5ml multidose vial may be stored for 28 days below 25°C. It should not be used after the expiry date shown on the outer packaging. Keep out of reach and sight of children.

DATE OF LAST REVISION April 2008

1041116A7

Adcortyl Intra Articular Intradermal Injection 10mg ml

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