Asacol^® Foam Enema.

Mesalazine (5-aminosalicylic acid), 1g per metered dose.

White, aerosol foam enema.

For the treatment of mild to moderate acute exacerbations of ulcerative colitis affecting the distal colon.

Route of administration: Rectal.

Adults: For disease affecting the rectosigmoid region, one metered dose 1g a day for 4 - 6 weeks; for disease involving the descending colon, two metered doses 2g once a day for 4 - 6 weeks.

Elderly: The normal adult dosage may be used unless renal function is impaired (see Section 4.4).

Children: There is no dosage recommendation.

A history of sensitivity to salicylates or renal sensitivity to sulphasalazine. Confirmed severe renal impairment (GFR less than 20 ml/min). Children under 2 years of age.

Use in the elderly should be cautious and subject to patients having a normal renal function.

Renal disorder: Mesalazine is excreted rapidly by the kidney, mainly as its metabolite, N-acetyl-5-aminosalicylic acid. In rats, large doses of mesalazine injected intravenously produce tubular and glomerular toxicity. Asacol should be used with extreme caution in patients with confirmed mild to moderate renal impairment (see section 4.3). Treatment with mesalazine should be discontinued if renal function deteriorates. If dehydration develops, normal electrolyte and fluid balance should be restored as soon as possible.

Serious blood dyscrasias have been reported very rarely with mesalazine. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Treatment should be stopped if there is suspicion or evidence of blood dyscrasia.

Concurrent use of other known nephrotoxic agents, such as NSAIDs and azathioprine, may increase the risk of renal reactions (see section 4.4).

No information is available with regard to teratogenicity; however, negligible quantities of mesalazine are transferred across the placenta and are excreted in breast milk following sulphasalazine therapy. Use of 'Asacol' during pregnancy should be with caution, and only if the potential benefits are greater than the possible hazards. 'Asacol' should, unless essential, be avoided by nursing mothers.

Not applicable.

The side effects are predominantly gastrointestinal, including nausea, diarrhoea and abdominal pain. Headache has also been reported.

There have been rare reports of leucopenia, neutropenia, agranulocytosis, aplastic anaemia and thrombocytopenia, alopecia, peripheral neuropathy, pancreatitis, abnormalities of hepatic function and hepatitis, myocarditis and pericarditis, allergic and fibrotic lung reactions, lupus erythematosus-like reactions and rash (including urticaria), interstitial nephritis and nephrotic syndrome with oral mesalazine treatment, usually reversible on withdrawal. Renal failure has been reported. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.

Mesalazine may very rarely be associated with an exacerbation of the symptoms of colitis, Stevens Johnson syndrome and erythema multiforme.

Other side effects observed with sulphasalazine such as depression of sperm count and function, have not been reported with 'Asacol'.

Rarely, local irritation may occur after administration of rectal dosage forms containing mesalazine.

Not applicable.

Mesalazine is one of the two components of sulphasalazine, the other being sulphapyridine. It is the latter which is responsible for the majority of the side effects associated with sulphasalazine therapy whilst mesalazine is known to be the active moiety in the treatment of ulcerative colitis.

The foam enema is intended to deliver mesalazine directly to the proposed site of action in the colon and rectum.

There are no preclinical data of relevance to the prescriber which are additonal to those already included in other sections of the SPC.

Sorbitan mono-oleate, polysorbate 20, emulsifying wax, colloidal anhydrous silica, sodium metabisulphite, disodium edetate, methylhydroxybenzoate, propylhydroxybenzoate, sodium phosphate dodecahydrate or heptahydrate, sodium acid phosphate, glycerol, Macrogol 300, purified water, propane, iso-butane, n-butane.

Not applicable.

Three years.

Store the foam enema below 30°C. This is a pressurised canister, containing a flammable propellant. It should be kept away from any flames or sparks, including cigarettes. It should be protected from direct sunlight and must not be pierced or burned even when empty.

Cartoned aerosol cans, each carton consisting of one aerosol can containing 14 metered doses, plus 14 disposable applicators and 14 disposable plastic bags.

Read the instructions carefully before using 'Asacol' Foam Enema for the first time.

Mix contents by shaking the can vigorously for about five seconds.

Before using the enema for the first time, remove the safety tag from under the dome.

Push the plastic applicator firmly on to the spout of the can and align the notch beneath the dome with the spout.

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 to the ground. (If the can is not upside down the foam will not come out properly.)

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.

To administer a dose, fully depress the dome 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 when held with the dome pointing down.

Remove the applicator and dispose of it in one of the plastic bags provided. Do not flush it down the toilet.

Procter & Gamble Pharmaceuticals UK Ltd.

Rusham Park

Whitehall Lane

Egham

Surrey

TW20 9NW

United Kingdom

PL 00364/0077

3.6.94/21.05.2002

October 2002

POM