País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Sodium alginate; Magnesium alginate
Reckitt Benckiser Ireland Ltd
A02BX; A02BX13
Sodium alginate; Magnesium alginate
225 mg/87.5 milligram(s)
Powder for oral suspension
Product not subject to medical prescription
Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); alginic acid
Marketed
1991-07-12
Reckitt Benckiser 0005 PA979-12-1 CCDS Update RFI 1.3.1 Package Leaflet Gaviscon Infant National 930318 Page 1 Leia o documento completo
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 Leia o documento completo