Gaviscon Advance - Peppermint

1. Name Of The Medicinal Product

Gaviscon Advance - Peppermint Flavour.

Oral Suspension

2. Qualitative And Quantitative Composition

Each 10ml dose contains sodium alginate 1000.0mg and potassium hydrogen carbonate 200.0mg. 1ml contains sodium alginate 100.0mg and potassium hydrogen carbonate 20.0mg.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral suspension.

Off-white viscous suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of symptoms of gastro-oesophageal reflux 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 or accompanying reflux oesophagitis.

4.2 Posology And Method Of Administration

Adults and children 12 years and over: 5-10ml after meals and at bedtime (one to two 5ml measuring spoons).

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

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

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients, including the esters of hydroxybenzoates (parabens).

4.4 Special Warnings And Precautions For Use

Each 10 ml dose has a sodium content of 106 mg (4.6mmol) and a potassium content of 78 mg (2.0mmol). 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.

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

This medicinal product contains Methyl hydroxybenzoate and Propyl hydroxybenzoate, which may cause allergic reactions (possibly delayed).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

An open, uncontrolled study in 146 pregnant women did not demonstrate any significant undesirable effects of Gaviscon Advance on the course of the pregnancy or on the health of the foetus/new-born child. Based on this and previous experience, Gaviscon Advance - Peppermint Flavour may be used during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

Not relevant.

4.8 Undesirable Effects

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

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD).

ATC code: A02BX

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 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.

5.2 Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Calcium carbonate

Carbomer

Methyl parahydroxybenzoate E218

Propyl parahydroxybenzoate E216

Saccharin sodium

Peppermint flavour

Sodium hydroxide for pH adjustment

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

Shelf life: 2 years.

Shelf life after opening: 6 months

6.4 Special Precautions For Storage

Do not refrigerate.

6.5 Nature And Contents Of Container

Amber glass bottles with moulded polypropylene cap having a tamper-evident strip and lined with an expanded polyethylene wad. The bottles are enclosed in a cardboard outer containing either a measuring device (natural polypropylene) containing 5, 10, 15 and 20 ml graduations or a clear injection moulded crystal polystyrene measuring spoon with one bowl containing 2.5 ml and 5 ml measure. The pack sizes are 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml of 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.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0103

9. Date Of First Authorisation/Renewal Of The Authorisation

15/03/2006

10. Date Of Revision Of The Text

04/04/2007