GAVISCON COOL LIQUID
Active substance(s): CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM BICARBONATE / CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM BICARBONATE / CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM BICARBONATE
NAME OF THE MEDICINAL PRODUCT
Gaviscon Cool Liquid
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gaviscon Cool Liquid contains 250mg sodium alginate BP, 133.5 mg sodium
bicarbonate Ph. Eur. and 80 mg calcium carbonate Ph. Eur. per 5 ml.
Gastric reflux, hearburn, flatulence associated with gastric reflux, heartburn of
pregnancy, all cases of epigastric and retrosternal distress where the
underlying cause is gastric reflux.
Posology and method of administration
For oral administration.
Adults and children over 12: 10-20 ml after meals and at bedtime.
Elderly: No dose modification is required in this age group.
Children 6-12 years: 5-10 ml after meals and at bedtime.
Children under 6 years: Not recommended.
If symptoms persist consult your doctor.
This medicinal product is contraindicated in patients with known or suspected
hypersensitivity to the active substances or to any of the excipients listed in section
6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate
(E216) (see section 4.4).
Special warnings and precautions for use
If symptoms do not improve after seven days, the clinical situation should be
Each 10 ml dose has a sodium content of 141 mg (6.2 mmol). This should be taken
into account when a highly restricted salt diet is recommended. e.g. in some cases of
congestive cardiac failure and renal impairment.
Each 10 ml dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be
taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium
containing renal calculi.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate
(E216) which may cause allergic reactions (possibly delayed).
Interaction with other medicinal products and other forms of interaction
A time-interval of 2 hours should be considered between Gaviscon intake and the
administration of other medicinal products, especially tetracyclines, digoxine,
fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones,
penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid,
chloroquine and biphosphonates (diphosphonates) and estramustine. See also 4.4.
Fertility, pregnancy and lactation
Clinical studies in more than 500 pregnant women as well as a large amount of data from postmarketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances.
Gaviscon can be used during pregnancy, if clinically needed.
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers.
Gaviscon can be used during breast-feeding.
Pre-clinical investigations have revealed alginate has no negative effect on parental or offspring
fertility or reproduction.
Clinical data do not suggest that Gaviscon has an effect on human fertility.
Effects on ability to drive and use machines
Adverse reactions have been ranked under headings of frequency using the following
convention: 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) and not known
(cannot be estimated from the available data).
System Organ Class
Respiratory, Thoracic and
Anaphylactic and anaphylactoid reactions.
Hypersensitivity reactions such as
Respiratory effects such as bronchospasm.
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: www.mhra.gov.uk/yellowcard
In the event of overdosage symptomatic treatment should be given. The
patient may notice abdominal distension.
On ingestion the product reacts rapidly with gastric acid to form a raft of alginic acid
gel having a near neutral pH and which floats on the stomach contents, quickly and
effectively impeding gastro-oesophageal reflux, for up to 4 hours. In severe cases
the raft itself may be refluxed into the oesophagus, in preference to the stomach
contents, and exert a demulcent effect.
The mode of action of Gaviscon Cool Liquid is physical and does not depend
on absorption into the systemic circulation.
Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported
List of excipients
E218 (Methyl parahydroxybenzoate)
E216 (Propyl parahydroxybenzoate)
Mint flavour no. 4
Mint flavour no. 5
Special precautions for storage
Do not store above 30°C. Do not refrigerate or freeze.
Nature and content of container
Amber glass bottles with a polypropylene cap with a polyethylene tamperevident band lined with expanded polyethylene wad and containing 100, 150,
200, 300, 500 or 600 ml.
Instruction for use, handling and disposal
To be taken orally. If desired the standard dose of Gaviscon Cool Liquid may
be taken diluted with not more than an equal quantity of water well stirred.
MARKETING AUTHORISATION HOLDER
103-105 Bath Road
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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