This leaflet tells you about 'Asacol' Tablets. Please read it before taking these tablets. If there is anything you do not understand, or ii you want to know more about your tablets, ask your doctor or pharmacist (chemist).

Your tablets contain the active ingredient mesalazine (also known as 5-aminosalicylic acid). 'Asacol' Tablets are available in one strength of 400 milligrammes (mg). They are covered with a coating called Eudragit S (also known as methacrylic acid copolymer) which allows the tablets to pass through the stomach without dissolving The tablet coating will break down in the bowel, where the active mesalazine is released. The tablets also contain inactive ingredients. These are lactose, sodium starch glycollate, magnesium stearate (E572), talcum (E553b), polyvinylpyrolidone, methacrylic acid copolymer, dibutylphthalate, polyethylene glycol, yellow iron oxide (E172), red iron oxide (E172). Your tablets contain 0.8 mg sodium. Your tablets are available in packs of 120.

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

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

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

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

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 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?
• Are you taking a medicine called lactulose for constipation?

The usual adult dosage is:

• For the treatment of ulcerative colitis, six tablets each day divided out throughout the day. For example, two tablets three times a day or three tablets twice a day.
• To prevent an episode of ulcerative colitis, between three and six tablets divided out throughout the day. For example, from one tablet three times a day to two tablets three times a day.
• Do not take more than six tablets per day.

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Doctors sometimes prescribe different doses to those given in this leaflet, if this applies to you, discuss it with your doctor if you have not already done so.

The pharmacist's label on your pack will tell you how much your doctor would like you to take. Please read the label carefully

'Asacol' Tablets are not recommended for children.

Keep taking your tablets for as long as the doctor has instructed Always finish the prescribed course. Your symptoms may come back if you stop your treatment too early.

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

If you forget to take a dose at the right time, take it as soon as you remember Then go on as before, but do not take two doses within one hour or so of each other.

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 (rapid heart beat) or chest pain These effects will usually disappear when mesalazine is stopped.

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

The tablets 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 and 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

© 1996 Smith Kline & French Laboratories 50104GB3