GAVISCON DOUBLE ACTION MINT FLAVOUR CHEWABLE TABLETS
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 Double Action Mint Flavour Chewable Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 250 mg, sodium bicarbonate 106.5 mg and
calcium carbonate 187.5 mg.
Excipients aspartame (E951) and carmoisine lake (E122).
For full list of excipients, see Section 6.1.
A flat, circular, bi-layer tablet with bevelled edges. One layer of the tablet is pink and
slightly mottled, and the other white.
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation,
heartburn and indigestion, for example following meals or during pregnancy, and for
symptoms of excess stomach acid (hyperacidity).
Posology and method of administration
For oral administration, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets after meals and at
bedtime, up to four times per day.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
Hypersensitivity to any of the ingredients.
Special warnings and precautions for use
The sodium content of a four-tablet dose is 221.5 mg (9.64 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 four-tablet dose contains 300 mg (7.5 mmol) of calcium. Care needs to be taken
in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium
containing renal calculi.
This medicinal product contains aspartame (E951), a source of phenylalanine. May
be harmful or people with phenylketonuria.
This medicine contains Carmoisine lake (E122). This may cause allergic reactions.
If symptoms do not improve after seven days, the clinical situation should be
Treatment of children younger than 12 years of age is not generally recommended,
except on medical advice.
Interaction with other medicinal products and other forms of interaction
Due to the presence of calcium carbonate which act as an antacid, a time-interval of 2
hours should be considered between Gaviscon intake an the administration of other
medicinal products, especially H2-antihistaminics tetracyclines, digoxine,
fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroxine, penicilamine, betablockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, and
Pregnancy and lactation
Open controlled studies in 281 pregnant women did not demonstrate any significant
adverse effects of Gaviscon on the course of pregnancy or on the health of the
foetus/new-born child. Based on this and previous experience, the medicinal product
may be used during pregnancy and lactation.
Effects on ability to drive and use machines
Very rarely (<1/10,000) patients sensitive to the ingredients may develop allergic
manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid
Ingestion of large quantities of calcium carbonate may cause alkalosis,
hypercalcaemia, acid rebound, milk alkali syndrome or constipation. These usually
occur following larger than recommended dosages.
In the event of overdosage, symptomatic treatment should be given. The patient may
notice abdominal distension.
Pharmacotherapeutic classification: A02BX, other drugs for peptic ulcer and gastrooesophageal reflux disease.
The medicinal product is a combination of two antacids (calcium carbonate and
sodium bicarbonate) and an alginate.
On ingestion, the medicinal 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
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.
Calcium carbonate neutralises gastric acid to provide fast relief from indigestion and
heartburn. This effect is increased by the addition of sodium bicarbonate which also
has a neutralising action. The total neutralising capacity of the product at the lowest
dose of two tablets is approximately 10mEqH+.
The mode of action of the medicinal product is physical and does not depend on
absorption into the systemic circulation.
Preclinical safety data
No pre-clinical findings of any relevance to the prescriber have been reported.
List of excipients
Carmoisine Lake (E122)
Polypropylene container: Use within 3 months of opening.
Special precautions for storage
Blister trays: Do not store above 30°C. Store in the original package.
Flip-top lid containers: Do not store above 25°C. Store in the original package.
Nature and contents of container
Unprinted, glass, clear, thermoformable laminate of uPVC/PE/PVdC with aluminium
foil lidding blisters packed into cartons.
Blister tray containing two, four, six or eight sealed tablets. Pack sizes: 4, 6, 8, 16,
24, 32, 48, 60, 62, 64 and 80 chewable tablets.
Coloured, opaque, injection-moulded, polypropylene flip-top lid containers
containing 8, 10, 12 or 16 tablets.
Not all pack sizes may be marketed.
Special precautions for disposal
No special instructions.
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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