SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Gastrocote Liquid

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium Alginate 220mg Dried aluminium hydroxide gel 80mg Magnesium trisilicate 40mg Sodium hydrogen carbonate 70mg

Also contains:

Sodium Methylhydroxybenzoate (E219)

Sodium Propylhydroxybenzoate (E217)

3    PHARMACEUTICAL FORM

Oral suspension

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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.

4.2 Posology and method of administration

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.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4    Special warnings and precautions for use

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).

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 liquid and other substances.

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

4.6 Pregnancy and lactation

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).

4.7 Effects on ability to drive and use machines

No known effects.

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 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.

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

Aluminium magnesium silicate

Sunset yellow FCF (E110)

Butterscotch liquid flavour Peppermint liquid Saccharin sodium

Sodium methyl hydroxybenzoate (E219)

Sodium propyl hydroxybenzoate (E217)

Purified water.

6.2 Incompatibilities

None known.

6.3 Shelf life

18 months unopened.

1 month after opening.

6.4 Special precautions for storage

Store below 25^oC.

6.5 Nature and contents of container

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

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 30306/0076

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16 May 2003

10 DATE OF REVISION OF THE TEXT

28/11/2012