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.

Hypersensitivity to any of the ingredients.

Care should be exercised in treating diabetic patients as the tablets contain approximately 1 g of sugar.

Should be used with caution in patients with renal dysfunction due to increased risk of aluminium toxicity (e.g. aluminium induced encephalopathy).

Caution should also be taken in patients on a low phosphate diet.

The content of sodium should also be taken into account by patients on a sodium controlled diet. Each tablet also contains 21mg (0.91Meq) of sodium.

If symptoms persist consult your doctor.

The absorption of the following substances may be decreased by simultaneous use of antacids:

- Quinolones (e.g. ciprofloxacin, norfloxacin and ofloxacin)

- Tetracycline derivatives (e.g. tetracycline and doxycycline)

A minimum interval of two hours is recommended between taking Gastrocote tablets and other substances.

Low doses of Gastrocote tablets are less likely to cause interactions.

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.

Adverse effects are unlikely.

Flatulence may occur.

In the event of overdose symptomatic treatment should be given. Abdominal distension 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

02/02/2011

Not Applicable

Not Applicable