What you should know about

What you should know about

Distamine

Please read this leaflet carefully before you start to take your medicine. It does not contain all the information about your medicine that you may need to know. Please ask your doctor or pharmacist if you have any questions. This leaflet only applies to Distamine.

What is in your medicine?

Your medicine is called Distamine, a brand of penicillamine. The active ingredient is D-penicillamine base.

The tablets come in two strengths (different sized tablets) containing 125mg and 250mg of the active ingredient, in bottles of 100 tablets. They all have a white coating. The 125mg tablets are 8mm across and are marked DS on one side and 125 on the other. The 250mg tablets are 10mm across and are marked DM on one side and 250 on the other.

All the tablets contain the inactive ingredients microcrystalline cellulose, polyvidone, sodium starch glycolate and stearic acid. The coating contains glycerol, E171 and methyl hydroxypropyl cellulose.

Distamine is a chelating agent. This means that it binds to certain metals, including lead and copper, to help remove them from your body if necessary. Distamine also helps to relieve the pain and stiffness of rheumatoid arthritis if other medicines and rest have not worked.

Distamine is made by Eli Lilly and Company Limited, Kingsclere Road, Basingstoke, Hampshire, RG21 6XA. The product licence is held by Dista Products Limited, Dextra Court, Chapel Hill, Basingstoke, Hampshire, RG21 5SY.

Why Distamine?

Distamine is used to treat serious, active rheumatoid arthritis, including Still’s disease in children. It also treats Wilson’s disease, a condition where the body cannot get rid of copper properly; a kidney problem called cystinuria; lead poisoning; and chronic active hepatitis, a liver disease.

Before taking your medicine
Make sure it is safe for you to take Distamine,

If you answer YES to any of the following questions, or you are not sure, tell your doctor or pharmacist.

Have you ever had a rash or other allergic reaction to Distamine? (An allergic reaction may be a rash, itching, swelling or breathing difficulties.)
Have you ever had agranulocytosis (fever, mouth ulcers and severe weakness) after taking penicillamine?
Have you ever had thrombocytopenia (bruising and continual bleeding) after taking penicillamine?
Have you had lupus erythematosus (LE)?
Are you pregnant or could you be?
Are you taking any other medicine, especially for arthritis, including aspirin or a non-steroidal anti-inflammatory medicine (NSAID)?
Have you got kidney problems?
Your doctor will ask you to have a blood test and have your kidneys checked before you start taking Distamine. He or she will test your blood and urine regularly while you are taking the medicine. This is so that your doctor can adjust your dose and look out for any side-effects.
If you are taking iron tablets, take them at least 2 hours after you have taken the Distamine.

Distamine is not a painkiller so you should not expect to feel better straight away. But after a few weeks you will feel better and your joints will be less stiff and painful.

Distamine can help to treat rheumatoid arthritis but not other kinds of arthritis.

Please read the back of this leaflet

What you should know about Distamine - continued
Taking your medicine

Follow your doctor s instructions carefully. Check the label for how many tablets to take and how often to take them. Never take more tablets than your doctor tells you to.

Usual doses

Adults

Rheumatoid arthritis: take 125 to 250mg a day for the first month. Your doctor will then tell you how to increase the dose gradually over several months until you are feeling better. He or she may then change your dose to keep you well. This new dose is usually 500 to 750mg a day, but it can be as high as 1 500mg.

It may be several months before you feel better. But if there is no improvement you should stop taking the tablets after a year.

If you stay well for 6 months your doctor may reduce the dose.

If you are elderly, you may be given a smaller dose. Do not take more than 1000mg a day

Wilson’s disease: take 1500 to 2000mg a day spread over 3 or 4 doses. Once you are better, your doctor may reduce your dose.

It is best not to take 2000mg a day for more than a year.

If you are elderly, your dose will depend on your weight The usual dose is 20mg a day for each kilogram of bodyweight.

Cystinuria: If you have cystine stones your dose will be 1000 to 3000mg a day. If you are taking the tablets to prevent stones, you will take 500 to 1500mg at bedtime.

If you are elderly, your dose may be smaller.

Lead poisoning: take 1000 to 1 500mg a day in 3 or 4 doses until your doctor tells you that the amount of lead in your urine is normal.

If you are elderly, your dose will depend on your weight. The usual dose is 20mg a day for each kilogram of bodyweight.

Chronic active hepatitis: Start with 500mg a day. Your doctor will gradually increase the dose over 3 months, to 1250mg a day.

Children

The dose depends on the weight of the child.

Rheumatoid arthritis: 15 to 20mg a day for each kilogram of body weight. You will start with a low dose for the first month and increase gradually.

Wilson’s disease: Start with 500mg a day. Your doctor will tell you when to increase the dose to 20mg a day for each kilogram of body weight.

Cystinuria: The dose will depend on how ill the child is.

Lead poisoning: 20mg a day for each kilogram of body weight.

If you are not sure how many tablets to take, ask your doctor or pharmacist or the staff at the hospital you visit for tests and treatment.

Swallow the tablets with water.

Always take your tablets at least half an hour before a meal, or at bedtime.

Take your tablets for as long as your doctor has told you to

If you miss a dose, take one as soon as you can. If you miss several doses, tell your doctor.

Do not take more tablets than your doctor tells you to. If you ever take too many, go to the nearest hospital casualty department or tell your doctor immediately.

While taking your medicine

The tablets may cause side-effects but increasing the dose very slowly will help to control them. When you start taking the tablets you may feel sick or even be sick. You may lose your appetite or notice that food tastes different. These side-effects usually wear off, but tell your doctor if they trouble you.

You will have regular blood and urine tests, especially when you start taking the tablets and when you increase the dose These are to check for changes in your blood cell counts and to look for protein or blood in your urine.

If you have redness, a rash or itching with a fever, bruises, boils or other infections, tell your doctor. Some patients have had other allergic reactions, kidney problems and anaemia.

Some patients have also had other skin problems, such as lupus erythematosus (LE) and pemphigus (a blistery, swollen skin), Goodpasture’s syndrome (lung and kidney problems) and painful, swollen joints. If you have these or any other ill-effects, tell your doctor or the staff at your outpatient clinic. They have more information about Distamine and will tell you what to do. They may tell you to reduce your dose for a time. or to stop it altogether.

Storing your medicine

Do not take the tablets after the ‘Use before’ date.

Keep your tablets at room temperature (not above 25°C) in a dry, safe place and where children cannot see or reach them. Your tablets could harm them.

If your doctor tells you to stop taking the tablets, we suggest that you take them back to the pharmacist for safe disposal Only keep the tablets if your doctor tells you to.

Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them, even if their symptoms are the same as yours.

Distamine is a registered trademark of Dista Products Limited

Date of Leaflet Preparation: February 1995

ARTHRITIS CARE

Patients requiring further independent information or advice should contact Arthritis Care, the UK’s largest voluntary organisation working with people with arthritis.

Arthritis Care works with and for all people with arthritis to promote their health, well-being and independence through services, support, self-help, influence and information.

Address: 18 Stephenson Way, London NW1 2HD Tel: (0171) 916 1500

Freephone Helpline (12 noon to 4pm Mon to Fri): 0800 289170.