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GAVISCON DOUBLE ACTION TABLETS

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 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) 5.863mg per tablet
Carmoisine Lake (E122) 0.375mg per tablet

For a 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 acid related symptoms of gastro-oesophageal reflux such as acid
regurgitation, heartburn and indigestion, for example following meals or during
pregnancy.

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
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.

4.4

Special warnings and precautions for use
The sodium content of a two-tablet dose is 110.75 mg (4.82 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 two-tablet dose contains 150 mg (3.75 mmol) of calcium. Care needs to be
taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent
calcium containing renal calculi.
Due to its aspartame content this product should not be given to patients with
phenylketonuria.
If symptoms do not improve after seven days, the clinical situation should be
reviewed.
Prolonged use should be avoided.
As with other antacid products, taking Gaviscon Double Action Tablets can mask
the symptoms of other more serious, underlying medical conditions.
Gaviscon Double Action Tablets should not be used in the following cases:
• Patients with server/impaired renal function/-insufficiency
• Patients with hypophosphatemia
There is a possibility of reduced efficacy in patients with very low levels of
gastric acid.
There is increased risk for hypernatremia in children with gastroenteritis or
suspected renal insufficiency.

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

4.6

Pregnancy and lactation
Pregnancy:
A moderate amount of data on pregnant women (between 300-1000 pregnancy
outcomes) indicate no malformative or feto/neonatal toxicity of the active
substances.
Based on this and previous experience the medicinal product may be used during
pregnancy and lactation, if clinically needed.
Nevertheless, taking into account the presence of calcium carbonate it is recommended to
limit the treatment duration as much as possible.

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.
Fertility:
Pre-clinical animal investigations have revealed alginate has no negative effect on
parental or offspring fertility or reproduction.
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

Immune System
Disorders
Metabolism and
Nutritional
Disorders
Respiratory, Thoracic
and Mediastinal
Disorders
Gastrointestinal
Disorders
Skin and Subcutaneous
Tissue Disorders

Frequency
Very Rare

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

Not Known

Alkalosis1, Hypercalcaemia1, Milk-alkali
Syndrome1

Not known

Respiratory effects such as bronchospasm.

Very Rare
Not Known

Abdominal pain, acid rebound, diarrhoea,
nausea, vomiting
Constipation1

Very Rare

Rash Pruritic

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: www.mhra.gov.uk/yellowcard

4.9

Overdose
Symptoms
Some abdominal distension may be noticed.
Management
In the event of overdosage symptomatic treatment should be given

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Pharmacotherapeutic group: 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. 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 10 mEqH+.

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.

Pre-clinical 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 (contains carmellose sodium)

6.2.

Incompatibilities
Not applicable.

6.3

Shelf life
2 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 to protect
from moisture.
Flip-top lid containers: Do not store above 25°C. Store in the original package to
protect from moisture.

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 2, 4, 6 or 8 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.

Instructions for use and handling
No special instructions.

7.

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

8.

MARKETING AUTHORISATION NUMBER
PL 00063/0157

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26/01/2006

10

DATE OF REVISION OF THE TEXT
23/05/2016

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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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