Gastrocote Liquid

Sodium Alginate 220mg

Dried aluminium hydroxide gel 80mg

Magnesium trisilicate 40mg

Sodium bicarbonate 70mg

Also contains:

Sodium Methylhydroxybenzoate (E219)

Sodium Propylhydroxybenzoate (E217)

Oral suspension

Gastrocote Liquid 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 children over 12: One - three 5ml spoonfuls to be taken four times daily, that is, after main meals and at bedtime.

Children 6 to 12 years: One – two 5ml spoonfuls to be taken four times daily, that is, after main meals and at bedtime.

Not recommended for children under 6 years of age.

Hypersensitivity to any of the ingredients.

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. This medicinal product contains 2.13mmol (or 49mg) sodium per 5ml dose.

If symptoms persist consult your doctor.

Gastrocote liquid contains sunset yellow (E110) and hydroxybenzoates which may cause allergic reactions (possibly delayed).

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 liquid and other substances.

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

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

No known effects.

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 of 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.

Aluminium magnesium silicate

Sunset yellow FCF (E110)

Butterscotch liquid flavour

Peppermint liquid

Saccharin sodium

Sodium methyl hydroxybenzoate (E219)

Sodium propyl hydroxybenzoate (E217)

Purified water.

None known.

18 months unopened.

1 month after opening.

Store below 25^oC.

100ml, 150ml, 200ml, 250ml, 500ml: HDPE bottle with a tamper evident screw cap with EPE/Saranex liner.

Not applicable.

Actavis Group PTC ehf

Reykjavíkurvegi 76-78

220 Hafnarfjordur

Iceland.

PL 30306/0076

16 May 2003

02/02/2011

(IF APPLICABLE)

(IF APPLICABLE)