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

This medicinal product contains 127.88 mg sodium per 1 sachet (10 ml) dose, equivalent to 6.4% of the WHO recommended maximum daily intake for sodium.

The maximum daily dose of this product is equivalent to 51.15% of the WHO 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 2 sachets (20 ml) dose contains 260 mg (6.5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.

If symptoms persist, or treatment is required for more than 7 days continuously, medical advice should be sought.

As with other antacid products, taking this product can mask the symptoms of other more serious, underlying medical conditions.

Contains methyl parahydroxybenzoate (E218) 40 mg/10 ml and propyl parahydroxybenzoate (E216) 6 mg/10ml which may cause allergic reactions (possibly delayed).

Due to the presence of calcium and carbonates which act as an antacid, a time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially H₂-antihistaminics, tetracyclines, digoxine, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, diphosphonates, and estramustine. See also section 4.4.

Pregnancy

Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience the medicinal product may be used during pregnancy, if clinically.

Breastfeeding

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

Fertility

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

This product has no or negligible influence on the ability to drive and use machines.

Adverse events which have been associated with sodium alginate, sodium bicarbonate and calcium carbonate are given below, tabulated by system organ class and frequency. Frequencies are defined as: 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); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

Description of Selected Adverse Reactions

¹ Usually occurs following larger than recommended dosages.

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: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.