ANTEPSIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SUCRALFATE

Available from:

Chugai Pharma UK Ltd

ATC code:

A02BX02

INN (International Name):

SUCRALFATE

Dosage:

1 Grams

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

sucralfate

Authorization status:

Not marketed

Authorization date:

2000-03-31

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ANTEPSIN 1G TABLETS
sucralfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effect not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Antepsin Tablets are and what they are used for
2.
What you need to know before you take Antepsin Tablets
3.
How to take Antepsin Tablets
4.
Possible side effects
5.
How to store Antepsin Tablets
6.
Contents of the pack and other information
1. WHAT ANTEPSIN TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Antepsin 1g Tablets (called Antepsin
Tablets in this leaflet).
Antepsin Tablets contain a medicine called sucralfate. This belongs to
a group of medicines
called “Ulcer-healing” medicines. It works by forming a protective
barrier over a stomach
ulcer and helps stop further irritation caused by stomach acid.
Antepsin Tablets are used to treat:
•
Stomach ulcers
•
Ulcers in your bowel
•
Inflammation of your stomach lining
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANTEPSIN TABLETS
DO NOT TAKE ANTEPSIN TABLETS:
•
If you are allergic (hypersensitive) to sucralfate or any of the other
ingredients of
Antepsin Tablets (listed in Section 6). Signs of an allergic reaction
include: a rash,
swallowing or breathing problems, swelling of your lips, face, throat
or tongue
•
If you are on dialysis for kidney problems
Do not take this medicine if any of the above apply to you. If you are
not sure talk to your
doctor or pharmacist before taking Antepsin.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Antepsin Tablets if:
•
You

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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 scoreline 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
the 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.
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