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GAVISCON DOUBLE ACTION MINT

Active substance(s): 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 resulting from the reflux of acid, bile and pepsin into
the oesophagus such as acid regurgitation, heartburn and indigestion, for
example following meals or during pregnancy, and for symptoms of excess
stomach acid (hyperacidity). Can also be used to treat the symptoms of gastrooesophageal reflux during concomitant treatment with or following withdrawal
of acid suppressing therapy.

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 sodium alginate, sodium bicarbonate, calcium carbonate or to any
of the excipients listed in section 6.1.

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.
Treatment of children younger than 12 years of age is not generally
recommended, except on medical advice.
If symptoms persist, or treatment is required for more than seven days
continuously, medical advice should be sought.
As with other antacid products, taking this product can mask the symptoms of
other more serious, underlying medical conditions.
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.

4.5

Interaction with other medicinal products and other forms of interaction
Due to the presence of calcium and carbonates which act as an antacid, a timeinterval of 2 hours should be considered between intake of this product and the
administration of other medicinal products, especially H2-antihistaminics,
tetracyclines, digoxine, fluoroquinolones, iron salts, thyroid hormones,
ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol,
metoprolol, propanolol), glucocorticoid, chloroquine, diphosphonates, and
estramustine. See also section 4.4.

4.6

Fertility, pregnancy and lactation
Pregnancy
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, if clinically needed.
Breastfeeding:
No effects of the active substances have been shown in breastfed newborns/infants of
treated mothers. This product can be used during breast-feeding if clinically needed.
Fertility:
Clinical data do not suggest that this product has an effect on human fertility.

4.7

Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive and use
machines.

4.8

Undesirable effects

Adverse events which have been associated with sodium alginate, sodium bicarbonate
and calcium carbonate are given below, tabulated by system organ class and
frequency. Frequencies are defined as: 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); Not known (cannot be estimated from the available data). Within each
frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class

Frequency

Adverse Events

Immune System
Disorders

Very Rarely

Anaphylactic reaction, anaphylactoid reaction.
Hypersensitivity reactions such as urticaria.

Metabolism and
Nutritional Disorders
Respiratory, Thoracic
and Mediastinal
Disorders
Gastrointestinal
Disorders

Not Known

Alkalosis1, acid rebound1, Hypercalcaemia1, Milkalkali Syndrome1

Very Rarely

Respiratory effects such as bronchospasm.

Not Known

Constipation1

Description of Selected Adverse Reactions
1

Usually occurs following larger than recommended dosages.

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: http://www.mhra.gov.uk/yellowcard
4.9

Overdose

Symptoms
Symptoms are likely to be minor in acute overdose; some abdominal distension may be
noticed. Milk-alkali syndrome has occurred in individuals taking large doses of calcium
carbonate per day for prolonged periods.
Management
In the event of overdosage symptomatic treatment should be given.

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 studies have shown that the raft interacts
with and caps the acid pocket in the stomach, reducing oesophageal acid exposure.
The raft floats on the stomach contents effectively impeding gastro-oesophageal
reflux, for up to 4 hours, and protecting the oesophagus from acid, pepsin and bile. In
severe cases the raft itself may be refluxed into the oesophagus, in preference to the
stomach contents, and exert a demulcent effect. In addition in vitro evidence has
shown that the raft has a secondary action and is able to entrap bile and pepsin within
it structure, further protecting the oesophagus from these gastric components
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, 12,
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
14/03/2018

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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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