Treatment of duodenal ulcer, gastric ulcer, chronic gastritis.

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, Gastrofait 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 Gastrofait.
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 Gastrofait in children under 14 years of age has not been established. Currently available data are described in section 5.1.

The product should only be used with caution in patients with renal dysfunction, due to the possibility of increased aluminium absorption.

In patients with severe renal impairment or on dialysis, Gastrofait should be used with extreme caution and only for short-term treatment. The concomitant use of other aluminium containing medications is not recommended in view of the enhanced potential for aluminium absorption and toxicity.
Bezoars have been reported after administration of sucralfate mainly to severely ill patients in intensive care units. The majority of these patients (including neonates in whom sucralfate is not recommended) had underlying conditions that may predispose to bezoar formation (such as delayed gastric emptying due to surgery, drug therapy or diseases that reduce motility), or were receiving concomitant enteral tube feeding.
Paediatric Population:
Gastrofait is not recommended for use in children under 14 years of age due to insufficient data on safety and efficacy.

Concomitant administration of Gastrofait may reduce the bioavailability of certain drugs including tetracycline, ciprofloxacin, norfloxacin, ketoconazole, digoxin, warfarin, phenytoin, theophylline, thyroxine, quinidine and H2 antagonists. The bioavailability of these agents may be restored by separating the administration of these agents from Gastrofait by two hours. This interaction appears to be non systemic in origin presumably resulting from these agents being bound by Gastrofait in the gastrointestinal tract. Because of the potential of Gastrofait to alter the absorption of some drugs from the gastrointestinal tract, the separate administration of Gastrofait from that of other agents should be considered when alterations in bioavailability are felt to be critical for concomitantly administered drugs.
The administration of Gastrofait Tablets 1 g and enteral feeds by nasogastric tube should be separated by one hour in patients receiving Gastrofait Tablets 1 g for the prophylaxis of stress ulceration. In rare cases bezoar formation has been reported when Gastrofait and enteral feeds have been given too closely together.

Pregnancy: category B
Teratogenicity studies in mice, rats and rabbits at doses up to 50 times the human dose have revealed no evidence of harm to the foetus. Safety in pregnant women has not been established and Gastrofait should be used during pregnancy only if clearly needed.

Lactation:
It is not known whether this drug is excreted in human milk. Caution should be exercised when Gastrofait is administered to breast-feeding women.

Do not drive if you feel dizzy or drowsy.

Tabulated list of adverse reactions

¹Reported in patients with impaired gastric emptying, patients with enteral tube feeding or low birth weight infants.
²Reported in patients with chronic renal impairment.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the National Pharmacovigilance and drug safety center (NPC).
National pharmacovigilance & Drug safety centre (NPC):
Fax: +966-11-205-7662.
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000.
E-mail: npc.drug@sfda.gov.sa.
Website: www.sfda.gov.sa/npc.

There is no experience in humans with overdose. Acute oral toxicity studies in animals, however, using doses up to 12g/kg body weight, could not find a lethal dose. Risks associated with overdose, should, therefore, be minimal.

The action of Gastrofait is non-systemic as the drug is only minimally absorbed from the gastro-intestinal tract. The small amounts that are absorbed are excreted primarily in the urine. Gastrofait exerts a generalised cytoprotective effect by preventing gastro-intestinal mucosal injury.
Studies in humans and animal models show that Gastrofait forms an ulcer adherent complex with the proteinaceous exudate of the ulcer site. This property enables Gastrofait to form a protective barrier over the ulcer lesion giving sustained protection against the penetration and action of gastric acid, pepsin and bile.
Studies both in humans and animals demonstrate that Gastrofait protects the gastric mucosa against various irritants such as alcohol, acetylsalicyclic acid and sodium taurocholate.
Gastrofait also directly inhibits pepsin activity and absorbs bile salts. It has only weak antacid activity. It does not alter gastric emptying time, nor normal digestive function. Gastrofait has no demonstrated pharmacological effect on the cardiovascular or central nervous systems.

Paediatric population
In the literature, there are limited clinical data on the use of sucralfate in children, mainly for stress ulcer prophylaxis, reflux oesophagitis, and mucositis. The dose used in these studies was 0.5 – 1 g four times a day, depending on the children's age and the severity of the underlying disease, and was applied without major safety concerns. In view of the limited data, use of sucralfate in children under 14 years of age is currently not recommended.

Sucralfate is only minimally absorbed from the gastro-intestinal tract. The small amounts that are absorbed are excreted primarily in the urine. Absorption of aluminium from sucralfate may be increased in patients on dialysis or with renal dysfunction (see also “other special warnings and precautions”).

There was no evidence of carcinogenesis in mice and rats receiving oral sucralfate in dosages of up to 1 g/kg daily (12 times the usual human dosage) for 2 years. In animal studies there was no effect evidence of impaired fertility. The effect of sucralfate on human fertility is not known.

Maize starch, Polyethylene glycol 6000, Hydroxypropyl methyl cellulose, Povidone K30, Sodium lauryl sulphate, Magnesium stearate, Croscarmellose sodium.

Not applicable

Store at temperature not exceeding 30°C.

Blisters of 4 tablets each.
Boxes of 20, 1000 tablets each.

No special requirements.