Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example, following meals or during pregnancy.

For oral administration, after being thoroughly chewed.

Adults and children 12 years and over: Two to four 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.

Hepatic Impairment: No dose modification necessary.

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

This medicinal product is contraindicated in patients with known or suspected

hypersensitivity to the active substances or to any of the excipients.

If symptoms do not improve after 7 days, the clinical situation should be reviewed.

This medicinal product contains 254.84 mg (11.08 mmol) of sodium per four-tablet dose, equivalent to 12.74% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 50.96 % of the WHO adult recommended maximum daily intake for sodium. 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).

Each four-tablet dose contains 320 mg (3.2 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.

A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, biphosphonates (diphosphonates) and estramustine. See also 4.4.

Pregnancy:

Clinical studies in more than 500 pregnant women as well as a large amount of data from postmarketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed.

Breast feeding:

No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. Gaviscon can be used during breast-feeding.

Fertility:

Pre-clinical investigations have revealed alginate has no negative effect on parental or offspring fertility or reproduction.

Clinical data do not suggest that Gaviscon has an effect on human fertility.

None.

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 of Suspected Adverse Reactions

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 classification: A02E A01 Anti-regurgitant.

On ingestion Gaviscon Strawberry 250 mg 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, quickly and effectively impeding gastro-oesophageal reflux, for up to 4 hours. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.

The mode of action of Gaviscon Strawberry Flavour Tablets 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.

Mannitol

Macrogol 20,000

Aspartame

Magnesium stearate

Xylitol and Carmellose sodium

Red iron oxide

Strawberry cream flavour (Strawberry cream PHS-048481)

Ingredients of the strawberry cream flavour:

Maltodextrin

Modified starch E1450

Vegetable oil

Propylene glycol E1520

Not applicable.

Two years.

Do not store above 25° C.

Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.

Pack sizes: 2, 4, 6, 8,16, 24, 32, 48, 60, 64, 72, 80.

Polypropylene container.

Pack sizes 8, 12, 16, 32.

Not all pack sizes may be marketed.

No special instructions.