SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Gastrocote Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Alginic acid BP

Dried aluminium hydroxide gel BP Magnesium trisilicate BP Sodium bicarbonate BP

3 PHARMACEUTICAL FORM

Tablet uncoated

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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.

4.2 Posology and method of administration

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.

4.3    Contraindications

Hypersensitivity to any of the ingredients.

4.4    Special warnings and precautions for use

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.

4.5    Interaction with other medicinal products and other forms of interaction

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.

4.6 Pregnancy and lactation

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).

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Adverse effects are unlikely. Flatulence may occur.

4.9 Overdose

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

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

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

6.2 Incompatibilities

None stated.

6.3 Shelf life

60 months unopened.

6.4 Special precautions for storage

Store in a cool dry place below 25 °C

6.5 Nature and contents of container

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.

6.6 Special precautions for disposal

Not applicable

7    MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland.

8    MARKETING AUTHORISATION NUMBER(S)

PL 30306/0077

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1 March 2003

DATE OF REVISION OF THE TEXT

02/02/2011