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GAVISCON INFANT

Active substance(s): MAGNESIUM ALGINATE / SODIUM ALGINATE / MAGNESIUM ALGINATE / SODIUM ALGINATE / MAGNESIUM ALGINATE / SODIUM ALGINATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Infant.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each unit dose sachet of 0.65 g powder contains 225 mg sodium alginate and
87.5 mg magnesium alginate.
For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM
Sachet of powder.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
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.

4.2

Posology and method of administration
If symptoms persist for more than 7 days, or worsen, seek medical advice.
Posology
For infants aged 1 to 2 years. Not to be used in premature infants or infants
under one year except under medical supervision.
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 115 ml (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 5 ml (1 teaspoon) of cooled boiled water until a smooth
paste is formed.
• Add another 10 ml (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.
Treatment should not be administered more than six times in any 24 hour
period.
Not suitable for children over 2 years of age, adults or the elderly.
Renal Insufficiency: Not to be used when treating infants with known or
suspected impairment of renal function (see section 4.3).
Method of administration:
For oral used after mixing with water or milk feed
4.3

Contraindications
Hypersensitivity to sodium alginate and magnesium alginate or 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 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.
Not to be used except on a doctor or other health professional's
recommendation.

4.4

Special warnings and precautions for use
A medical review of the patient’s condition should be undertaken seven days
after initiating treatment or before if symptoms worsen.
Significant or sustained changes in bowel habit or stool consistency e.g.
diarrhoea or constipation, should be investigated.
Follow dosage instructions exactly to avoid an excessive amount of product
per feed and the possible risk of hypernatraemia.
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.
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.

4.5.

Interaction with other Medicinal Products and other Forms of Interaction
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.

4.6

Fertility, pregnancy and lactation
Pregnancy:
Not relevant.
Breastfeeding:
Not relevant.
Fertility:
Not relevant.

4.7.

Effects on Ability to Drive and Use Machines
Not applicable.

4.8

Undesirable effects

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.
Adverse events which have been associated with sodium alginate and
magnesium alginate are given below, tabulated by system organ class and
frequency. Frequencies are defined as: Very common (≥1/10); Common
(≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and
<1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the
available data). Within each frequency grouping, adverse events are presented
in order of decreasing seriousness.
System Organ
Class
Immune System
Disorders
Gastrointestinal
Disorders

Frequency Adverse Events
Not known

Hypersensitivity

Very rare
Not known

Constipation and diarrhoea.
Intestinal obstruction, flatulence, abdominal
distension and bezoar.

Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme
at: http://www.mhra.gov.uk/yellowcard

4.9

Overdose
Symptoms
Overdosage with Gaviscon Infant may lead to the formation of an intragastric
mass.
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.
Management
In the event of overdose, symptomatic treatment should be given.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Other drugs for peptic ulcer and gastrooesophageal reflux disease (GORD); ATC Code: A02BX13
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.

5.2.

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

5.3.

Pre-clinical Safety Data
No preclinical findings of relevance to the prescriber have been reported.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Mannitol and colloidal silica.

6.2.

Incompatibilities
None known.

6.3.

Shelf-Life
Three years.

6.4.

Special Precautions for Storage

Do not store above 30ºC.

6.5.

Nature and Contents of Container
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).

6.6

Special precautions for disposal
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.

7.

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS.

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0099.

9.
DATE OF FIRST AUTHORISATION / RENEWAL OF
AUTHORISATION
21st April, 1997.

10

DATE OF REVISION OF THE TEXT
10/09/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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