Reckitt Benckiser Ireland Limited

Gaviscon Extra Chewable Tablets.

Sodium alginate 250mg

Sodium bicarbonate 106.5mg

Calcium carbonate 187.5mg

Each tablet contains sodium alginate 250 mg, sodium bicarbonate 106.5 mg and calcium carbonate 187.5 mg.

For a full list of excipients, see Section 6.1.

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.

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

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.

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.

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 Extra Chewable Tablets can mask the symptoms of other more serious, underlying medical conditions.

Gaviscon Extra Chewable 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.

Due to the presence of calcium carbonate which acts as an antacid, a time-interval of 2 hours should be considered between Gaviscon intake and 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

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. Nevertheless, taking into account the presence of calcium carbonate it is recommended to limit the treatment duration as much as possible.

Not relevant.

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

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

Pharmacotherapeutic group: 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 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+.

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

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

Not applicable.

2 years.

Polypropylene container: Use within 3 months of opening.

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.

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.

No special instructions.

Reckitt Benckiser Ireland Ltd,

7 Riverwalk Citywest,

Business Campus,

Dublin 24

979/15/12

Date of first authorisation: 01^st October 2010

Date of last renewal: 26^th January 2011

November 2011