GAVISCON Oral suspension in sachets Ref.[115946] Active ingredients: Alginic acid Calcium carbonate Sodium bicarbonate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom

4.1. Therapeutic indications

Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity). Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.

4.2. Posology and method of administration

For oral administration.

Adults and children 12 years and over

One to two sachets (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.

Hepatic Impairment

No dose modification necessary.

Renal Insufficiency

Caution if highly restricted salt diet is necessary (see section 4.4).

4.9. Overdose

Symptoms

Symptoms are likely to be minor in acute overdose; some abdominal distension may be noticed. Milk-alkali syndrome has occurred in individuals taking large doses of calcium carbonate per day for prolonged periods.

Management

In the event of overdosage symptomatic treatment should be given.

6.3. Shelf life

Two years.

6.4. Special precautions for storage

Do not store above 25°C and store in the original package. Do not refrigerate or freeze.

6.5. Nature and contents of container

A cardboard outer carton containing unit dose stick pack style sachets.

Pack sizes: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 and 36.

Not all pack sizes may be marketed.

The sachets are composed of polyester, aluminium and polyethylene.

Each sachet contains 10 ml of Gaviscon Double Action Liquid.

6.6. Special precautions for disposal and other handling

None required.

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