Gastrocote Tablets

Tablet uncoated

Gastrocote is indicated in heartburn, including heartburn of pregnancy, reflux oesophagitis, particularly where associated with hiatus hernia and in all cases of epigastric distress with gastric reflux or regurgitations. It is also indicated in acid indigestion.

Oral

Adults and older children

One to two tablets to be chewed four times a day, that is, after main meals and at bedtime.

Not to be given to children under six years of age.

IMPORTANT: Tablets must be chewed before swallowing.

There are no specific contraindications in the use of gastrocote.

Care should be exercised in treating diabetic patients as the tablets contain approximately 1 g of sugar. Each tablet also contains 21mg (0.91Meq) of sodium, which may be important for patients on a low sodium diet. As gastrocote contains aluminium hydroxide, use with caution in patients with renal dysfunction or on a low phosphate diet.

None stated.

Gastrocote Tablets can be used in pregnancy. (General literature indicates no adverse effects for the active ingredients of Gastrocote Tablets on pregnancy or the health of the foetus/newborn child).

None stated.

None stated.

Overdose is virtually free of hazard although gastric bloating may occur.

Alginate antacid products form an alginate foam raft on top of the gastric contents. The antacid components remain entrained in the alginate raft and exert little or no effect on gastric pH.

The presence of the foam raft helps to impede gastro-oesophageal reflux. If reflux is forced the alginate antacid foam enters the oesophagus first coating it with a protective demulcent and antacid layer. This coating process is repeated as the reflux subsides. Any refluxed gastric acid is thus rapidly neutralised, the oesophageal mucosa is protected and any pre-existing oesophagitis or ulceration can heal normally.

There is very little absorption of aluminium hydroxide from the gastrointestinal tract. Only 5% of magnesium is absorbed. However, there is a theoretical possibility of accumulation of aluminium or magnesium in cases of severe renal failure. There is negligible absorption of alginate.

Not applicable.

Microcrystalline cellulose or powdered cellulose, carmellose sodium, butterscotch flavour, magnesium stearate, directly compressible sugar.

None stated.

60 months unopened.

Store in a cool dry place below 25°C

10, 12, 20, 40 or 100 tablets: securitainers or high-density polyethylene container with tamper evident low density polyethylene lid or blister pack of plastic/aluminium foil.

Not applicable.

Actavis Group PTC ehf

Reykjavíkurvegi 76-78

220 Hafnarfjordur

Iceland.

PL 30306/0077

1 March 2003

Not Applicable

Not Applicable