Reckitt Benckiser Ireland Limited

Gaviscon Infant, Powder for Oral Suspension

Each unit dose sachet of 0.65 g powder contains 225 mg sodium alginate and 87.5 mg magnesium alginate.

Each dose contains 21 mg sodium

For a full list of excipients, see Section 6.1.

Powder for Oral Suspension.

Sachet containing an off-white powder.

Gaviscon Infant helps to prevent gastric regurgitation in infants where competence of the cardiac sphincter has not been fully established.

The indications for use are gastric regurgitation, gastro-oesophageal reflux and reflux associated with hiatus hernia in infants and young children.

Not to be used in premature infants or infants under one year except under medical supervision.

For oral use after mixing with water or milk feed.

Mix immediately before use as directed below:

Breast fed infants:

Under 4.5 kg (10 lb) - one dose.

Over 4.5 kg (10 lb) - two doses.

Add 5 mL of cooled, boiled water to the powder in a glass, mix to a smooth paste, add another 10 mL of the water and mix. Give after each feed using a spoon or feeding bottle.

Bottle fed infants:

Under 4.5 kg (10 lb) - one dose to be mixed into not less than 115 mL of each feed in the bottle and shaken well.

Over 4.5 kg (10 lb) - two doses to be mixed into not less than 225 mL of each feed in the bottle and shaken well.

Young children:

Two doses prepared as for breast fed infants, to be taken after each meal.

Not appropriate for adults or elderly.

Treatment should not be administered more than six times per 24 hours.

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1

Contraindicated in cases of intestinal obstruction and in cases of established diarrhoea.

Not to be used except on a doctor or other healthcare professional's recommendation.

Not to be used in situations where excessive water loss is likely, e.g. fever, diarrhoea, vomiting or high room temperature. Not to be used in gastroenteritis where the appropriate treatment is rehydration with fluid replacement.

Not to be used when treating infants with known or suspected impairment of renal function as the sodium content (approximately 21 mg or 0.92 mmol per dose) may add to the risk of hypernatraemia.

Follow dosage instructions exactly to avoid an excessive amount of product per feed and the possible risk of hypernatraemia.

Hypernatraemia should be treated with oral fluids and monitoring of the infant's electrolytes. Severe cases should be treated by the cautious use of hypo-osmotic solutions.

A medical review of the patient's condition should be undertaken seven days after initiating treatment or before if symptoms worsen.

Not to be used with thickening agents or infant milk preparations containing a thickening agent as this could lead to over-thickening of the stomach contents.

Not appropriate.

Not appropriate.

Gaviscon Infant's mode of action is physical, resulting in a thickening of the gastric contents. An excessive concentration of Gaviscon Infant may lead to gastric distension.

Rare instances have occurred in which an intragastric mass has developed comprising Gaviscon Infant and milk proteins. Overdosage may have contributed to the development of such masses. The majority resolved spontaneously when the child was admitted to hospital, Gaviscon Infant was discontinued and a regime of adequate fluid intake and monitoring of fluid and electrolyte balance was installed. If spontaneous resolution of the mass does not occur, removal by surgical or endoscopic means may be required.

The mode of action of Gaviscon Infant is physical. By reacting with acidic gastric contents to form a viscous gel it stabilises stomach activity so reducing the incidence of gastro-oesophageal reflux.

The mode of action of Gaviscon Infant is physical and does not depend on absorption into the systemic circulation.

No preclinical findings of relevance to the prescriber have been reported.

Mannitol (E421)

Colloidal silicon dioxide

Not applicable.

Three years.

Do not store above 30°C.

A cardboard outer carton containing 30 unit dose sachets joined in pairs. The sachets are composed of paper (41 gsm), low density polyethylene (12 gsm), aluminium foil (21.6 gsm) with Surlyn (ethylene/methacrylic acid co-polymer neutralised with zinc) 1652 laminate (18 gsm). Two joined sachets enclosed in an outer cardboard wallet are also available.

Gaviscon Infant should be mixed with milk or water before taking. As the powder is sterile the sachet should not be opened until immediately before mixing.

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/12/1

November 2011.