Reckitt Benckiser Ireland Limited

Gaviscon Liquid Peppermint Flavour

Oral Suspension

sodium alginate 500 mg

sodium bicarbonate 267 mg

calcium carbonate 160 mg

Each 10 ml contains 500 mg sodium alginate, 267 mg sodium bicarbonate and 160 mg calcium carbonate.

For excipients see 6.1.

Oral suspension.

Viscous, opaque, off-white to cream, peppermint flavoured suspension.

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 5 ml spoonfuls) after meals and before retiring.

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

100 , 150 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.

None known.

All sizes

Each 10 ml dose has a sodium content of 141 mg (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 Liquid Gaviscon 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 Liquid Gaviscon 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

Peppermint oil

Sodium hydroxide

Purified water.

Not applicable.

Two years.

Do not store above 30°C.

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

Not all pack sizes may be marketed.

No special requirements.

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/15/2.

Date of first authorisation: 3rd January, 1996.

Date of last renewal: 3rd January, 2006.

February, 2007.