GAVISCON Oral suspension in sachets Ref.[115946] Active ingredients: Alginic acid Calcium carbonate Sodium bicarbonate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom

Product name and form

Gaviscon Double Action Liquid Sachets.

Pharmaceutical Form

Oral suspension in sachets.

Qualitative and quantitative composition

Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg.

Excipient(s) with known effect:

Methyl parahydroxybenzoate (E218) 40 mg/10 ml
Propyl parahydroxybenzoate (E216) 6 mg/10 ml
Sodium 127.88 mg/10 ml

For full list of excipients, see section 6.1.

Active Ingredient

Alginic acid is a polysaccharide distributed widely in the cell walls of brown algae which is hydrophilic and forms a viscous gum when hydrated. Its salts with metals such as sodium and calcium are known as alginates. It is a significant component of the biofilms produced by the bacterium Pseudomonas aeruginosa, a major pathogen found in the lungs of some people who have cystic fibrosis. The biofilm and P. aeruginosa have a high resistance to antibiotics and are susceptible to inhibition by macrophages.

Calcium carbonate releases, in a pH-dependent manner, calcium ions in the stomach. Calcium carbonate is widely used as antacid and extensively used as a dietary supplement.

Sodium bicarbonate has antacid properties. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.

List of Excipients

Sodium
Carbomer 974P
Methyl (E218) and propyl (E216) parahydroxybenzoate
Saccharin sodium
Peppermint flavour no. 2
Sodium hydroxide
Purified water

Pack sizes and marketing

A cardboard outer carton containing unit dose stick pack style sachets.

Pack sizes: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 and 36.

Not all pack sizes may be marketed.

The sachets are composed of polyester, aluminium and polyethylene.

Each sachet contains 10 ml of Gaviscon Double Action Liquid.

Marketing authorization holder

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom

Marketing authorization dates and numbers

PL 00063/0524

28/07/2008 / 07/08/2019

Drugs

Drug Countries
GAVISCON Austria, Cyprus, Ecuador, Spain, France, Hong Kong, Croatia, Ireland, Israel, Malta, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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