ANTEPSIN Tablet Ref.[6447] Active ingredients: Sucralfate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2013  Publisher: Chugai Pharma UK Ltd., Mulliner House, Flanders Road, Turnham Green, London, W4 1NN, U.K.

Therapeutic indications

Antepsin is indicated in adults and adolescents over 14 years old for treatment of duodenal ulcer, gastric ulcer, chronic gastritis.

Posology and method of administration

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. For ease of administration, Antepsin Tablets may be dispersed in 10-15 mL of water. 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.

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

Paediatric population: The safety and efficacy of Antepsin in children under 14 years of age has not been established. Currently available data are described in section 5.1 but no recommendation on posology can be made.

Overdose

In a clinical trial on healthy men of overdose with sucralfate, most cases remained asymptomatic, but symptoms of abdominal pain, nausea, and vomiting were reported in a few cases. Acute oral toxicity studies in animals, using doses up to 12g/kg body weight, could not find a lethal dose. Risks associated with overdose, should, therefore, be minimal.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Blister packs (pack size 50 tablets).

Special precautions for disposal and other handling

No special requirements.

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