Reckitt Benckiser Ireland Limited

Gaviscon Liquid - Aniseed Flavour.

Oral suspension

Each 10 ml contains:

Sodium alginate 500 mg

Sodium bicarbonate 267 mg

Calcium carbonate 160 mg

Active Substancemg/10 ml

Sodium alginate 500.0

Sodium bicarbonate 267.0

Calcium carbonate 160.0

Each 10 ml dose contains 141 mg sodium and 46 mg Parahydroxybenzoate (E218 & E216).

For a full list of excipients, see 6.1.

Oral suspension.

Pink, opaque suspension, with odour and flavour of aniseed.

500 and 600 ml

For the management of gastric reflux, reflux oesophagitis, hiatus hernia, heartburn (including heartburn of pregnancy) and similar gastric distress.

100 , 150 and 300 ml

For the relief of stomach upset due to hyperacidity and heartburn (including heartburn of pregnancy).

For oral administration.

500 and 600 ml

Adults and children over 12 years: 10-20 ml (two to four 5ml spoonfuls) after meals and before retiring.

Children 6 to 12 years: 5-10 ml (one to two 5ml spoonfuls) after meals and before retiring.

100 , 150 ml and 300 ml

Adults and children over 12 years: 10-20 ml (two to four 5 ml spoonfuls) after meals and before retiring.

Children under 12 years: Should be given only on medical advice.

Not for use in children of 6 years or under.

Hypersensitivity to any of the ingredients, including the esters of hydroxybenzoates (parabens).

All sizes

Each 10 ml dose has a sodium content of 141 (6.2 mmol). This should be taken into account when a highly restricted salt diet is recommended.

100 , 150 and 300 ml only

If symptoms do not improve after seven days, consult your doctor.

Consult your doctor if you are over 40 years and have never suffered with heartburn and acid indigestion before.

None known.

Alginate has no systemic activity and consequently can be taken during pregnancy and lactation.

None.

Very rarely (<1/10,000) patients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic and anaphylactoid reactions.

In the event of overdosage symptomatic treatment should be given. The patient may notice abdominal distension.

On ingestion Gaviscon Liquid - Aniseed Flavour reacts with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents effectively impeding gastro-oesophageal reflux. In severe cases the raft itself may be refluxed into the oesophagus in preference to the stomach contents and exert a demulcent effect.

The mode of action of Gaviscon Liquid - Aniseed Flavour is physical and does not depend on absorption into the systemic circulation.

No preclinical findings relevant to the prescriber have been reported.

Carbomer

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Saccharin sodium

Fennel flavour

Erythrosine soluble

Sodium hydroxide

Purified water

Not applicable.

2 years.

Do not store above 30°C. Do not refrigerate.

Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident band with an expanded polyethylene wad containing 100, 150, 300, 500 and 600ml.

No special requirements.

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/15/3.

Date of first authorisation: 29th June 2001

Date of last renewal: 29th June, 2006

February 2007.