Each 5 mL dose contains 1 gram sucralfate.

Oral Suspension White to off-white viscous suspension with an odour of aniseed/caramel.

Treatment of duodenal ulcer, gastric ulcer, chronic gastritis, and the prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients.

For oral administration.

Duodenal ulcer, gastric ulcer, chronic gastritis:

Adults: The usual dose is 2 grams twice daily to be taken on rising and at bedtime, or 1 gram 4 times a day to be taken 1 hour before meals and at bedtime. Maximum daily dose: 8 grams.

Four to six weeks' treatment is usually needed for ulcer healing, but up to twelve weeks may be necessary in resistant cases.

Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Antepsin.

Children and Elderly: see below

Prophylaxis of gastrointestinal haemorrhage from stress ulceration:

Adults: The usual dose is 1 gram six times a day. A maximum dose of 8 grams daily should not be exceeded. Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Antepsin.

Elderly: There are no special dosage requirements for elderly patients but as with all medicines, the lowest effective dose should be used.

Children: Safety and effectiveness in children has not been established.

Contraindicated in individuals who are hypersensitive to any of the ingredients of Antepsin.

The product should only be used with caution in patients with renal dysfunction, due to the possibility of increased aluminium absorption.

In patients with severe renal impairment or on dialysis, Antepsin should be used with extreme caution and only for short-term treatment. The concomitant use of other aluminium containing medications is not recommended in view of the enhanced potential for aluminium absorption and toxicity. Antepsin may also cause allergic reactions (possibly delayed).

Bezoars (an insoluble mass formed with the gastric lumen) have been reported occasionally in patients taking Antepsin Suspension. The majority of these patients had underlying conditions that may predispose to bezoar formation such as delayed gastric emptying, or were receiving concomitant enteral feeding (see under Interactions). Bezoars have been reported after administration of Antepsin Suspension to severely ill patients in ITU, especially in premature infants in whom the use of sucralfate is not recommended.

Concomitant administration of Antepsin may reduce the bioavailability of certain drugs including tetracycline, ciprofloxacin, norfloxacin, ketoconazole, digoxin, warfarin, phenytoin, theophylline, thyroxine, quinidine and H₂ antagonists. The bioavailability of these agents may be restored by separating the administration of these agents from Antepsin by two hours. This interaction appears to be non systemic in origin presumably resulting from these agents being bound by Antepsin in the gastrointestinal tract. Because of the potential of Antepsin to alter the absorption of some drugs from the gastrointestinal tract, the separate administration of Antepsin from that of other agents should be considered when alterations in bioavailability are felt to be critical for concomitantly administered drugs.

The administration of Antepsin Suspension and enteral feeds by nasogastric tube should be separated by one hour in patients receiving Antepsin Suspension for the prophylaxis of stress ulceration. In rare cases bezoar formation has been reported when Antepsin and enteral feeds have been given too closely together.

Adverse reactions to Antepsin in clinical trials were minor and only rarely led to discontinuation of the drug. Adverse events seen during use of Antepsin have included constipation, diarrhoea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth, rash, back pain, dizziness, headache, vertigo, drowsiness and hypersensitivity reactions including pruritus, oedema, urticaria and shortness of breath.

Chugai Pharma UK Limited

POM

04 June 2009