Gaviscon Advance Chewable Tablets

1. Name Of The Medicinal Product

Gaviscon Advance Chewable Tablets.

2. Qualitative And Quantitative Composition

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

For excipients, see Section 6.1.

3. Pharmaceutical Form

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.

4. Clinical Particulars

4.1 Therapeutic Indications

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.

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

None.

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 overdosage symptomatic treatment should be given. The patient may notice abdominal distension.

5. Pharmacological Properties

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

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

The mode of action of Gaviscon Advance Tablets is physical and does not depend on absorption into the systemic circulation.

5.3 Preclinical Safety Data

No pre-clinical findings of any relevance to the prescriber have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Mannitol

Calcium carbonate

Polyethylene glycol 20,000

Magnesium stearate

Aspartame

Mint flavour no. 3

Acesulfame potassium

Copovidone

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

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.

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 00063/0144.

9. Date Of First Authorisation/Renewal Of The Authorisation

15th January 2005.

10. Date Of Revision Of The Text

April 2006-