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 gastro-oesophageal 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 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, beta-blockers (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 gastro-oesophageal 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

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/11/2009

DATE OF REVISION OF THE TEXT

12/10/2016