Gaviscon Infant.

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

Sachet of 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.

For infants aged 1 to 2 years. Not to be used in premature infants or infants under one year except under medical supervision.

For oral used after mixing with water or milk feed.

Mix immediately before use as directed below:

Infants under 4.5 kg (10lb) – one sachet should be used

Infants over 4.5kg (10lb) – two sachets should be used

Bottle fed infants

• Mix each sachet into 115ml (4 fl oz) of feed in the bottle

• Shake well.

• Feed as normal

Breast fed infants and other infants up to 2 years

• Mix each sachet with 5ml (1 teaspoon) of cooled boiled water until a smooth paste is formed

• Add another 10ml (2 teaspoons) of cooled boiled water and mix

• For breast fed infants give Gaviscon Infant part way through each feed or meal using a spoon or feeding bottle

• For all other infants give Gaviscon Infant at the end of each meal using a spoon, or feeding bottle.

Not suitable for children over 2 years, adults or the elderly

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

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

Not to be used except on a doctor or other health 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 applicable.

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 and colloidal silica.

None known.

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 1652 laminate (18 gsm).

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 Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS.

PL 0063/0099.

21^st April, 1997.

08/02/2011