Reckitt Benckiser Ireland Limited

Gaviscon Advance Chewable Tablets.

Each tablet contains sodium alginate 500 mg and potassium bicarbonate 100 mg.

For excipients, see Section 6.1.

Chewable tablet.

An off-white to cream, circular, flat with bevelled edges tablet with the odour and flavour of peppermint. Each tablet is imprinted with a "Sword and Circle" on one side and "GA 500" on the reverse.

Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion (related to reflux), for example, following meals, or during pregnancy, or in patients with symptoms related to reflux oesophagitis.

For oral administration, after being thoroughly chewed.

Adults and children 12 years and over: One to two tablets after meals and at bedtime.

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 103 mg (4.5 mmol) and a potassium content of 78 mg (2.0 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 or when taking drugs which can increase plasma potassium levels.

Each two-tablet dose contains 200 mg (2.0 mmol) of calcium carbonate. 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.

May cause central nervous depression in the presence of renal insufficiency and should not be used in patients with renal failure.

There is a possibility of reduced efficacy in patients with very low levels of gastric acid.

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.

None known.

An open controlled study in 146 pregnant women did not demonstrate any significant adverse effects of this product on the course of pregnancy or on the health of the foetus/new-born child.

Based on this and previous experience, this 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.

None.

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

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

Pharmacotherapeutic classification: A02BX 13. Other drugs for peptic ulcer and gastro-oesophageal reflux disease.

On ingestion Gaviscon Advance Tablets react 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.

The mode of action of Gaviscon Advance Tablets 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.

Calcium carbonate

Macrogol 20,000

Mannitol (E421)

Aspartame (E951)

Copovidone

Mint flavour no. 3

Magnesium stearate

Acesulfame potassium

Not applicable.

Two years.

Do not store above 30°C. Store in the original package.

White, rigid, injection-moulded, polypropylene cylinder with snap-bead neck finish.

Container containing 20 or 60 tablets. Pack sizes are comprised of either three 20-tablet containers packed into a carton or one 60-tablet container. For some markets the 60-tablet container will be packed into a carton.

Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.

Blister tray containing six individually sealed tablets. Two or four blister trays in a carton.

Not all pack sizes may be marketed.

No special requirements

Reckitt Benckiser Ireland Limited,

7 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland.

PA 979/11/8.

Date of first authorisation: 10th February 2006

Date of last renewal: 05^th January 2010

November 2011