GAVISCON DOUBLE ACTION

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.

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.

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, 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.

88 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. 80% of the WHO recommended maximum daily intake for sodium. 71% of the WHO recommended maximum daily intake for sodium.

This product is considered high in sodium. g. in some cases of congestive cardiac failure and renal impairment. 86 mg aspartame in each tablet. Aspartame is hydrolysed in the gastro-intestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine.

Due to its aspartame content this product should not be given to patients with phenylketonuria. If symptoms do not improve after seven days, the clinical situation should be reviewed. Prolonged use should be avoided. As with other antacid products, taking Gaviscon Double Action Tablets can mask the symptoms of other more serious, underlying medical conditions.

Gaviscon Double Action Tablets should not be used in the following cases: • Patients with server/impaired renal function/-insufficiency • Patients with hypophosphatemia There is a possibility of reduced efficacy in patients with very low levels of gastric acid.

There is increased risk for hypernatremia in children with gastroenteritis or suspected renal insufficiency. Treatment of children younger than 12 years of age is not generally recommended, except on medical advice. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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