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GAVISCON DOUBLE ACTION MINT

Active substance(s): CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM BICARBONATE / CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM BICARBONATE / CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM BICARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Double Action Mint Flavour Chewable Tablets

2

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.

3

PHARMACEUTICAL FORM
Chewable tablet.
A flat, circular, bi-layer tablet with bevelled edges. One layer of the tablet is pink and
slightly mottled, and the other white.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
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).

4.2

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.

4.3

Contraindications
Hypersensitivity to any of the ingredients.

4.4

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
reviewed.
Treatment of children younger than 12 years of age is not generally recommended,
except on medical advice.

4.5

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
diphosphonates.

4.6

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.

4.7

Effects on ability to drive and use machines
Not relevant.

4.8

Undesirable effects
Very rarely (<1/10,000) patients sensitive to the ingredients may develop allergic
manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid
reactions.
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.

4.9

Overdose
In the event of overdosage, symptomatic treatment should be given. The patient may
notice abdominal distension.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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+.

5.2

Pharmacokinetic properties
The mode of action of the medicinal product is physical and does not depend on
absorption into the systemic circulation.

5.3

Preclinical safety data
No pre-clinical findings of any relevance to the prescriber have been reported.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Macrogol 20,000
Mannitol (E421)
Copovidone
Acesulfame K
Aspartame (E951)
Mint flavour
Carmoisine Lake (E122)
Magnesium stearate
Xylitol DC

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Two years.
Polypropylene container: Use within 3 months of opening.

6.4

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.

6.5

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.

6.6

Special precautions for disposal
No special instructions.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0525

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13/11/2009

10

DATE OF REVISION OF THE TEXT
18/05/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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