This leaflet tells you about 'Asacol' Suppositories. Please read it before using your suppositories. If there is anything you do not understand, or if you want to know more about your suppositories, ask your doctor or pharmacist (chemist).

If you are helping someone else to use this medicine, please read this leaflet before you give the first dose.

Your suppositories contain the active ingredient mesalazine (also known as 5-aminosalicylic acid), 'Asacol' Suppositories are available in two strengths and contain either 250 milligrammes (mg) or 500 mg of mesalazine. Your doctor will have prescribed one strength of suppositories for you.

Your suppositories also contain an inactive ingredient. This is Witepsol W45 (Hard fat). There are no other ingredients.

Your suppositories are available in packs of 20 (250 mg strength) and 10 (500 mg strength).

The Product Licence Holder is Smith Kline & French Laboratories Ltd, Welwyn Garden City, Hertfordshire AL7 1EY, England.

'Asacol' Suppositories are manufactured by SmithKline Beecham Pharma GmbH, Germany.

'Asacol' contains mesalazine which is an anti-inflammatory drug.

Ulcerative colitis is a disease of the large bowel (colon) and back passage (rectum), in which the bowel lining becomes inflamed (red and swollen). 'Asacol' Suppositories act locally in the rectum to reduce this inflammation. They can also be used to prevent further episodes of ulcerative colitis.

'Asacol' Suppositories are particularly useful when the symptoms of ulcerative colitis affect the rectum.

If you answer Yes to any of the following questions go back to your doctor and ask what you should do. You may need to be given another medicine or the dose may need to be changed.

• Are you allergic to aspirin or other salicylates?
• Have you got any kidney problems?
• Have you had kidney problems whilst taking another medicine such as sulphasalazine?
• Have you had any problems with your blood whilst taking another medicine such as sulphasalazine?
• Are you pregnant or do you think you may be?
• Are you breast feeding?

Do not swallow your suppositories. They should be inserted into the back passage (rectum). The information below tells you how to insert a suppository:

1. Empty your bowels (if necessary) and wash your hands.
1. Remove the plastic wrapping from the suppository.
1. Squat or bend forward.
1. Gently, but firmly, place the suppository - pointed end first, into the back passage. If necessary, grease the tip of the suppository with petroleum jelly.
1. Wash your hands again.
1. Try not to empty your bowels for at least an hour after inserting the suppository. The usual adult dose of 'Asacol' Suppositories is:

Three to six 250 mg suppositories a day, with the last dose at bedtime.

or

One to three 500 mg suppositories a day, with the last dose at bedtime.

Do not use more than six 250 mg suppositories a day or more than three 500 mg suppositories a day.

The pharmacist's label on your carton will tell you how many suppositories your doctor would like you to use. Please read the label carefully.

'Asacol' Suppositories are not recommended for children.

Keep using your suppositories until the prescribed course is finished. Your symptoms may come back if you stop your treatment too early.

You should only use as many suppositories as your doctor or pharmacist has told you. If you use too many tell your doctor or hospital casualty department straight away. Take your suppository pack with you.

Drink plenty of water and tell your doctor or hospital casualty department straight away. Take your suppository pack with you.

If you forget to insert a suppository at the right time, insert it as soon as you remember. Then go on as before. Do not use more than two suppositories in one hour.

The most common unwanted effects with mesalazine (e.g. 'Asacol') are nausea (feeling sick), headache, diarrhoea and stomach pain.

Blood disorders, inflammation of the pancreas, liver problems and kidney problems can also occur rarely as unwanted effects.

Allergic reactions to mesalazine can occur. Tell your doctor if you get a rash, any shortness of breath, palpitations or chest pain. These effects will usually disappear when mesalazine is stopped.

Your suppositories will have an expiry date on the pack. You should not use your suppositories after this date.

The suppositories should be stored at or below room temperature, (25°C or 77°F) and protected from light, preferably in their original pack.

Remember this medicine has been prescribed just for you. Never offer your medicine to other people. It may not be suitable for them even if their symptoms seem the same as yours.

In addition to advice and information available from your doctor or pharmacist, you may wish to contact the National Association for Colitis and Crohn's Disease which offers information, advice and local support groups.

National Association for Colitis and Crohn's Disease

PO Box 205, St. Albans, Hertfordshire AL1 1NX

Smith Kline & French Laboratories

Authorised User of the trade mark 'Asacol' in the UK.

Leaflet prepared in October 1995. © 1995 Smith Kline & French Laboratories