Reckitt Benckiser Ireland Limited

Gaviscon Oral Suspension

500mg/10ml sodium alginate

267mg/10ml sodium bicarbonate

160mg/10ml calcium carbonate

Other ingredients include:

Methyl parahydroxybenzoate (E218) 40mg/10 ml and Propyl parahydroxybenzoate (E216) 6mg/10 ml

For a full list of excipients, see section 6.1.

Oral suspension.

An opaque, pink, viscous oral suspension with an odour of fennel.

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

For oral administration.

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.

None known.

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.

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 or anaphylactoid reactions.

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

On ingestion Gaviscon Suspension 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 Suspension 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

Store below 30°C. Do not refrigerate.

Amber glass Type III bottles with a polypropylene cap with a polyethylene tamper-evident band lined with an expanded polyethylene wad containing 100ml, 200ml or 500 ml. Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/15/1.

Date of first authorisation: 3rd May, 1978

Date of last renewal: 3^rd May 2008

September 2008