Patient Information Leaflet on Asacol® (mesalazine) Suppositories

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).

Please keep this leaflet. You may want to read it again.

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

What is in Asacol Suppositories?

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).

What is Asacol?

Asacol contains mesalazine which is an anti-inflammatory drug.

What is Asacol used for?

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.

Before using your suppositories

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 any of the ingredients, aspirin or other salicylates?
• Are you allergic to Witepsol (Hard fat)?
• 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?
• Is the patient a child under two years of age?
• Are you pregnant or do you think you may be?
• Are you breast-feeding?

 

Using your suppositories

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.
• 2. Remove the plastic wrapping from the suppository.
• 3. Squat or bend forward.
• 4. Gently, but firmly, place the suppository – pointed end first, into the back passage. If necessary, grease the tip of the suppository with petroleum jelly.
• 5. Wash your hands again.
• 6. 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.

Do not use more suppositories than your doctor has recommended.

Asacol Suppositories are not recommended for children.

What unwanted effects might your suppositories cause?

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, heart, liver or kidney and other kidney problems, hair loss and damage to peripheral nerves giving rise to numbness and tingling can also occur rarely as unwanted effects.

Local irritation may occur rarely.

Tell your doctor if you start to bruise easily or if you get any of the following symptoms: fever, sore throat, spots under your skin, or swollen ankles or unusual bleeding (e.g. unexplained nose bleeds). You should also check with your doctor immediately if you experience a rash on your skin combined with flaking, boils or sore lips or mouth.

Allergic reactions to mesalazine can occur. Tell your doctor if you get a rash (with or without itching), any shortness of breath, palpitations (rapid heart beat) or chest pain. These effects will usually disappear when mesalazine is stopped.

Very rarely, symptoms of colitis can worsen in patients taking mesalazine.

Tell your doctor or pharmacist if you notice any of these effects or any other unwanted effects not mentioned above.

Storing your suppositories

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

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

Keep all medicines out of the reach of children – preferably in a locked cupboard or medicine cabinet.

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.