Reckitt Benckiser Ireland Limited

Gaviscon Extra Oral Suspension.

Sodium alginate 500mg

Sodium bicarbonate 213mg

Calcium carbonate 325mg

Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg.

For a full list of excipients, see Section 6.1.

Oral suspension.

An off-white suspension with the odour and flavour of peppermint.

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.

Adults and children 12 years and over: 10-20 ml 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.

Each 10 ml dose has a sodium content of 127.25 mg (5.53 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 10 ml contains 130 mg (3.25 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

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

Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Prolonged use should be avoided.

As with other antacid products, taking Gaviscon Extra Oral Suspension can mask the symptoms of other more serious, underlying medical conditions.

Gavison Extra Oral Suspension 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 10 ml 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.

Carbomer,

Methyl parahydroxybenzoate

Propyl parahydroxybenzoate,

Saccharin sodium,

Peppermint flavour,

Sodium hydroxide

Purified water.

Not applicable.

Two years.

Use within six months of opening.

Do not store above 30°C. Do not refrigerate or freeze.

Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident band lined with expanded polyethylene wad with either a measuring device (natural polypropylene) containing 5 ml, 10 ml, 15 ml, and 20 ml graduations, or a measuring spoon (crystal polystyrene) containing 2.5 ml and 5 ml measure, and containing 150, 200, 300 and 600 ml.

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

None required.

Reckitt Benckiser Ireland Ltd.,

7 Riverwalk,

Citywest Business Campus,

Dublin 24

979/15/11

Date of first authorisation: 01^st October 2010

Date of last renewal: 26^th January 2011

November 2011