Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation,heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result ofhiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal refluxsuch as hoarseness and other voice disorders, sore throats and cough. It can also be used to treat the symptoms ofgastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.

Adults and children 12 years and over: 5-10 ml after meals and at bedtime (one to two 5 ml measuring spoons).
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modification is required for this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).

If symptoms do not improve after 7 days, the clinical situation should be reviewed.
This medicinal product contains 57.85 mg sodium per 5 ml, equivalent to 2.9 % of the WHO recommended maximumdaily intake for sodium.
The maximum daily dose of this product is equivalent to 23.14 % of the WHO recommended maximum daily intake forsodium.
This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet(e.g. in some cases of congestive heart failure and renal impairment).
Potassium: This medicine contains 1.0 mmol (39.06 mg) Potassium per 5 ml. To be taken into consideration by patientswith reduced kidney function or patients on a controlled potassium diet.
Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients withhypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
This medicinal product contains Methyl hydroxybenzoate and Propyl hydroxybenzoate, which may cause allergicreactions (possibly delayed).

A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinalproducts, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, andestramustine.

Pregnancy:
Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experienceindicate no malformative nor foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, ifclinically needed.
Breast feeding:
No known effect on breast fed infants. Gaviscon can be used during breast feeding.
Fertility:
No known effect on human fertility.

Not relevant.

Adverse reactions have been ranked under headings of frequency using the following convention: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Symptoms
Symptoms are likely to be minor; some abdominal discomfort may be experienced.
Management
In the event of overdose, symptomatic treatment should be given.

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 rapidly form a raft of alginic acid gel having a near-neutral pHwhich floats on the stomach contents quickly and effectively impeding gastro-oesophageal reflux for up to 4 hours, andprotecting the oesophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed into theoesophagus in preference to the stomach contents and exert a demulcent effect. In addition in vitro evidence hasshown that the raft has a secondary action and is able to entrap bile and pepsin within its structure, further protectingthe oesophagus from these gastric components.

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

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

Calcium carbonate
Carbomer 974P
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Saccharin sodium
Peppermint flavour
Sodium hydroxide for pH adjustment
Purified water

Not applicable.

Do not refrigerate.

Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expandedpolyethylene wad. The bottles are enclosed in a cardboard outer containing either a measuring device (naturalpolypropylene) containing 5, 10, 15 and 20 ml graduations or a clear injection moulded crystal polystyrene measuringspoon 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 suspension. Not all pack sizes may be marketed. The carton and measuring device orspoon may not be made available in all markets/pack sizes.

No special requirements.