Gaviscon Advance Mint 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 "GA500" on the reverse.

Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. It can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.

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 system 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 Gaviscon Advance on the course of pregnancy or on the health of the foetus/new-born child.

Based on this and previous experience, Gaviscon Advance Tablets 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 the Gaviscon Advance Tablets react with gastric acid to rapidly form a raft of alginic acid gel having a near-neutral pH which 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 its structure, further protecting the oesophagus from these gastric components.

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.

Mannitol

Calcium carbonate

Macrogol 20,000

Magnesium stearate

Aspartame

Mint flavour no. 3

Acesulfame potassium

Copovidone

Not applicable.

Two years.

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

White, rigid, injection-moulded, polypropylene cylinder container 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 Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.

PL 00063/0613.

28/09/2010

28/01/2011