Gaviscon Infant, Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium alginate; Magnesium alginate

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

A02BX; A02BX13

INN (International Name):

Sodium alginate; Magnesium alginate

Dosage:

225 mg/87.5 milligram(s)

Pharmaceutical form:

Powder for oral suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); alginic acid

Authorization status:

Marketed

Authorization date:

1991-07-12

Patient Information leaflet

Reckitt Benckiser
0005 PA979-12-1 CCDS Update RFI
1.3.1 Package Leaflet
Gaviscon Infant National 930318
Page 1

Summary of Product characteristics

Health Products Regulatory Authority
20 February 2020
CRN008SRW
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Infant, Powder for Oral Suspension
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.
Each doses contains 23.9 mg sodium.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Oral Suspension
Sachet containing an off-white 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
INFANTS AGED 1 TO 2 YEARS:
Infants under 4.5kg: use 1 sachet
Infants 4.5kg and over: use 2 sachets
Bottle fed infants:
- Mix each sachet into 115ml of feed in the bottle
- Shake well
- Feed as normal
Breast fed infants and weened infants up to 2 years:
- Mix each sachet with 5ml (1 teaspoon) of cooled boiled water until
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 spoon or feeding bottle.
Treatment should not be administered more than 6 times in any 24
hours.
Not to be used in infants under 1 year of age except under medical
supervision.
Not suitable for children over 2 years of age, adults or the elderly.
HEPATIC IMPAIRMENT: No modification necessary
Renal Impairment: Not to be used when treating infants with known or
suspected impairment of renal function (see section 4.3)
Not to be used in premature infants except under medicinal sup