Antepsin 1g/5ml oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sucralfate

Available from:

Chugai Pharma UK Ltd

ATC code:

A02BX02

INN (International Name):

Sucralfate

Dosage:

200mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030300; GTIN: 5010981059008

Summary of Product characteristics

OBJECT 1
ANTEPSIN 1G/5ML ORAL SUSPENSION
Summary of Product Characteristics Updated 13-Nov-2013 | Chugai Pharma
UK Limited
1. Name of the medicinal product
Antepsin 1g/5ml Oral Suspension
2. Qualitative and quantitative composition
Each 5 mL dose contains 1 gram sucralfate.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral Suspension
White to off-white viscous suspension with an odour of
aniseed/caramel.
4. Clinical particulars
4.1 Therapeutic indications
Antepsin is indicated in adults and adolescents over 14 years old for
treatment of duodenal ulcer, gastric
ulcer, chronic gastritis, and the prophylaxis of gastrointestinal
haemorrhage from stress ulceration in
seriously ill patients.
4.2 Posology and method of administration
For oral administration.
Antepsin must not be administered intravenously.
_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.
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.
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.
Paediatric population: The safety and efficacy of