Patient Information Leaflet on ‘Asacol’ Foam Enema (mesalazine)

This leaflet tells you about 'Asacol' Foam Enema. Please read it before using this enema. If there is anything you do not understand or if you want to know more about your enema 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’ Foam Enema?

Your enema contains the active ingredient mesalazine (also known as 5- aminosalicylic acid). 'Asacol' Foam Enema is available in one strength, as 1 gram of mesalazine per dose.

Your enema also contains inactive ingredients. These are sorbitan mono-oleate, polysorbate 20, emulsifying wax, colloidal anhydrous silica, sodium metabisulphite, disodium edetate, methylhydroxybenzoate (E218), propylhydroxybenzoate(E216), sodium phosphate dodecahydrate or heptahydrate, sodium acid phosphate, glycerol (E 422), Macrogol 300, purified water, propane, iso-butane, n-butane.

Your enema is available in a pack containing a can of 14 doses with 14 disposable applicators and 14 disposable plastic bags.

What is ‘Asacol’ Foam Enema?

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

What is ‘Asacol’ Foam Enema used for?

Ulcerative colitis 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' Foam Enema acts locally in the further part of the colon to reduce this inflammation.

Before using your enema

Do NOT use the 'Asacol' Foam Enema if:

• The patient is a child under two years of age
• You have had kidney problems whilst taking another medicine such as sulfasalazine
• You are allergic to salicylates for example aspirin
• You have severe kidney problems

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?
• Have you got any kidney problems?
• Have you had problems with your blood whilst taking another medicine such as sulfasalazine?
• Are you pregnant or do you think you may be?
• Are you breast feeding?

'Asacol' Foam Enema contains glycerol that may have a mild laxative effect.

'Asacol' Foam Enema contains para-hydroxybenzoates that may cause an allergic reaction (possibly delayed)

Using your enema

This medicine should not be swallowed. It should be delivered to the back passage (rectum) as described below.

1. Mix contents by shaking the can vigorously for about five seconds.
2. Before using the enema for the first time, remove the safety tag from under the dome.
3. Push the plastic applicator firmly on to the spout of the can and align the notch beneath the dome with the spout.
4. Hold the can in the palm of one hand with the dome pointing downwards. This product must only be dispensed when the can is upside down, with the dome nearest the ground (if the can is not upside down, the foam will not come out properly).
5. You may find that the easiest way to use the enema is to raise one foot on to a firm surface, such as a stool or chair, and insert the applicator into the rectum as far as is comfortable. You can apply a lubricating jelly to the tip of the applicator for comfort if you wish.
6. To administer a dose, fully push the dome down once and release it. The foam will not come out of the can until you release the dome. To administer a second dose, press and release the dome again. Wait for 15 seconds before withdrawing the applicator. Note the can will only work properly when held with the dome pointing down.
7. Remove the applicator and dispose of it in one of the plastic bags provided. Do not flush it down the toilet. Note: Please use with care as this product may cause staining to clothing and household articles.

What unwanted effects might the enema cause?

The most common unwanted effects with this medicine 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, swollen ankles or unusual bleeding (e.g. unexplained nosebleeds). 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 this medicine 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 use of 'Asacol' foam enema is stopped.

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

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

STORING YOUR ENEMA

Your enema will have an expiry date on the pack. You should not use your enema after this date. Store the enema below 30ºC (86ºF). This is a pressurised canister, containing a flammable propellant. It should be kept away from flames or sparks, including cigarettes. It should be protected from direct sunlight and must not be pierced or burned even when empty.

Keep all medicines out of the sight and 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.