Antepsin 1g tablets

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:

1gram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030300; GTIN: 5060069010018

Summary of Product characteristics

OBJECT 1
ANTEPSIN TABLETS 1G
Summary of Product Characteristics Updated 23-Oct-2013 | Chugai Pharma
UK Limited
1. Name of the medicinal product
Antepsin 1g Tablets
2. Qualitative and quantitative composition
Each tablet contains 1 gram of sucralfate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Biconvex, oblong, white tablets with a dividing score on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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.
4.2 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.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 Special warnings and precautions for use
The product should only be used with caution in patients with renal
dysfunction, due to the possibility of
increased aluminium absorption.
Sucralfate is not recommended for use in individuals on dialysis.