GAVISCON DOUBLE ACTION MIXED BERRIES FLAVOUR

For oral administration, after being thoroughly chewed.

Adults and children 12 years and over:

Two to four tablets 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. 4).

Adverse events which have been associated with sodium alginate, sodium hydrogen carbonate 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.

System Organ Class Frequency Adverse Events Immune System Disorders Very Rare Anaphylactic reaction, anaphylactoid reaction. Hypersensitivity reactions such as urticaria. Metabolism and Nutritional Disorders Not Known Alkalosis1, acid rebound1, Hypercalcaemia1, Milk-alkali Syndrome1 Respiratory, Thoracic and Mediastinal Disorders Not known Respiratory effects such as bronchospasm.

Very Rare Abdominal pain, acid rebound, diarrhoea, nausea, vomiting Gastrointestinal Disorders Not Known Constipation1 Skin and Subcutaneous Tissue Disorders Very Rare Rash Pruritic 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

This medicine may cause allergic reactions and may have a mild laxative effect Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

If symptoms do not improve after 7 days, the clinical situation should be reviewed. Prolonged use should be avoided. As with other antacid products, taking Gaviscon Double Action Mixed Berries Flavour Chewable Tablets can mask the symptoms of other more serious, underlying medical conditions.

8 % of the WHO recommended maximum daily intake for sodium. 7% of the WHO recommended maximum daily intake for sodium. This product is considered high in sodium. 5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

86 mg aspartame in each Tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

1.