INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ULCETAB TABLETS

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

ULCETAB TABLETS

COMPOSITION:
Each tablet contains 1 g
Sucralfate

PHARMACOLOGICAL CLASSIFICATION:
A11.4.3 Other.

PHARMACOLOGICAL ACTION:
Ulcetab is therapeutically anti-ulcerogenic and capable of inhibiting the proteolytic action of pepsin.
Ulcetab forms a protective film over the mucosa in ulcerated or inflamed areas of the stomach and protects the gastric mucosa, and has the ability to adsorb pepsin, trypsin and bile acids.

INDICATIONS:
Gastric ulcer, duodenal ulcer, chronic gastritis and reflux esophagitis.
Ulcetab produces relief of subjective symptoms of peptic ulceration e.g. epigastric pain, hyperchlorhydria, vomiting, etc.
Maintenance treatment after successful endoscopically proven, recently healed duodenal ulcer.

DOSAGE AND DIRECTIONS FOR USE:
The usual adult dosage is one tablet three or four times a day between meals and at bedtime.
A dosage regimen of 2 g twice daily (i.e. 2 tablets mornings and evenings) has also been shown to be effective for the treatment of duodenal ulcer.

Reflux Esophagitis
One tablet mixed with water four times a day between meals and at bedtime.

Maintenance Treatment after Successful Healing of Duodenal Ulcer
One Ulcetab tablet twice daily i.e. one tablet half an hour before breakfast and one tablet half an hour before supper on an empty stomach. Treatment should be continued for 12 months.

Relief is usually experienced by peptic ulcer patients following the administration of Ulcetab alone, although a short-term regime with additional analgesic and spasmolytic agents may be of greater benefit in some patients with incipient clinical manifestations, especially severe pain in the epigastrium.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Constipation may occur after prolonged use.
The safety and efficacy of the maintenance treatment exceeding a period of 12 months have not been established.
Concomitant use of Ulcetab may reduce the bio-availability of certain medicines such as tetracyclines, phenytoin, cimetidine, digoxin, ciprofloxacin, norfloxacin, ranitidine and theophylline. Administration of these medicines should be separated by two hours. Since Ulcetab may hinder warfarin absorption caution should be exercised when used together. Because of the potential of Ulcetab to affect the absorption of some medicines from the gastrointestinal tract, it is advisable to separate the administration of Ulcetab from other medicines when alterations in their bio-availability are considered to be critical.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment should be symptomatic and supportive.

IDENTIFICATION:
Tablets:
White capsule-shaped tablets, scored on one side and engraved "ULCETAB" on the other side.

PRESENTATION:
Tablets:
Container of 120 tablets.

STORAGE INSTRUCTIONS:
Store in a dry place below 25°C
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
W/11.4.3/460

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
3.10.89 K87

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