Reckitt Benckiser Ireland Limited

Gaviscon Advance Oral suspension.

1 ml contains sodium alginate 100 mg and potassium hydrogen carbonate 20 mg.

Excipients: methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216).

For a full list of excipients, see Section 6.1.

Oral suspension.

Off-white, viscous suspension.

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.

Adults and children 12 years and over: 5-10 ml after meals and at bedtime.

Children under 12 years: Should be given only on medical advice.

Elderly: No dose modification is required for this age group.

If symptoms do not improve after seven days, the clinical situation should be reviewed

Shake well before use. Check that the cap seal is unbroken before first taking the product.

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

Each 10 ml dose has a sodium content of 106 mg (4.6 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 10 ml 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.

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

Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.

None known.

An open, uncontrolled 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, however it is recommended to limit the treatment duration as much as possible.

No studies have been performed.

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: A02E A01 Anti-regurgitant.

On ingestion the suspension reacts with gastric acid to form a raft of alginic acid gel having a near-neutral pH and which floats on the stomach contents effectively (up to 4 hours) 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 this product is physical and does not depend on absorption into the systemic circulation.

No preclinical findings of relevance to the prescriber have been reported.

Calcium carbonate

Carbomer 974P

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Saccharin sodium

Fennel flavour

Sodium hydroxide (for pH adjustment)

Purified water

Ingredients of fennel flavour:

Fennel anethol

Benzyl alcohol

Not applicable.

Shelf life: 2 years.

Shelf life after opening: 6 months.

Do not refrigerate.

Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad and containing 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml suspension.

Or

Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad with either a measuring device (natural polypropylene) containing 5, 10, 15 and 20 ml graduations, or a measuring spoon (crystal polystyrene) containing 2.5 ml and 5 ml measure and containing 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml suspension.

Not all pack sizes may be marketed. The carton and measuring device or spoon may not be made available in all markets/pack sizes.

Any unused product or waste material should be disposed of in accordance with local requirements.

Reckitt Benckiser Ireland Ltd

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/11/1

14th August, 1998 / 29th September, 2006

September 2009.