Gaviscon Double Action Liquid 10 ml Suspension

Gaviscon Double Action Liquid is indicated for the following conditions: Gastric reflux, reflux oesophagitis, heartburn and indigestion.

Posology

Adults and children over 12 years: 10 - 20 ml after meals and at bedtime, up to four times per day.

Children under 12 years: Should be given only on medical advice.

Elderly: No dosage modifications necessary in this 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 seven days, the clinical situation should be reviewed.

Method of administration

For oral administration. SHAKE WELL BEFORE USE.

Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate, the esters of hydroxybenzoates (parabens) or to any of the excipients listed in section 6.1. GAVISCON DOUBLE ACTION LIQUID should not be used in patients with moderate or severe renal insufficiency.

Each 10 ml dose of Gaviscon Double Action Liquid contains 127.25 mg (5.53 mmoI) of sodium. Sodium bicarbonate should be administered with caution in patients with congestive heart failure, renal impairment, cirrhosis of the liver, hypertension, patients receiving corticosteroids, patients with metabolic or respiratory alkalosis, hypocalcaemia, hypochlorhydia or patients on a salt restricted diet.

Each 10 ml dose of Gaviscon Double Action Liquid contains 130 mg (3.25 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

High doses or prolonged use of calcium carbonate may lead to gastric hypersecretion and acid rebound. Hypercalcaemia/alkalosis can occur, especially in patients with renal function impairment or after high doses of calcium carbonate.

There have been rare reports of the milk-alkali syndrome associated with calcium carbonate. Contains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate which may cause allergic reactions (possibly delayed). Prolonged use of Gaviscon Double Action Liquid should be avoided. If symptoms do not improve after seven days, the clinical situation should be reviewed.

Large doses of Gaviscon Double Action Liquid may affect the rate and/or the extent of absorption of other oral medicines. A time interval of 2 hours should be considered between Gaviscon Double Action Liquid intake and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxin, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoid, chloroquine, bisphosphonates, and estramustine. Thiazide diuretics and vitamin D u2013 Hypercalcaemia has occurred when calcium salts are given with thiazide diuretics or vitamin D.

Pregnancy: Clinical studies as well as post-marketing data indicated no malformative nor feto/neonatal toxicity of Gaviscon Double Action Liquid.

Lactation: No effects of Gaviscon Double Action Liquid have been shown in breastfed newborns/infants of treated mothers. Gaviscon Double Action Liquid can be used during breastfeeding.

Fertility: Clinical Data do not suggest that Gaviscon Double Action Liquid has an effect on human fertility.

Gaviscon Double Action Liquid has no or negligible influence on the ability to drive and use machines.

Adverse reactions have been ranked under headings of frequency using the following convention: Very common: u2265 1/10; common: u2265 1/100 to < 1/10; uncommon: u2265 1/1,000 to < 1/100; rare: u2265 1/10,000 to < 1/1,000; very rare: < 1/10,000; Not known: cannot be estimated from the available data.

System Organ Class Frequency Adverse Events

Immune System Disorders Frequency unknown Anaphylactic reaction, Anaphylactoid reaction. Hypersensitivity reactions such as urticaria.

Metabolism and Nutritional Disorders Frequency unknown Alkalosis 1 Acid rebound 1 Hypercalcaemia 1 Milk-alkali Syndrome 1

Respiratory, Thoracic and Mediastinal Disorders Frequency unknown Respiratory effects such as bronchospasm.

Gastrointestinal Disorders Less frequent Stomach cramps Flatulence, Constipation 1 Nausea Vomiting Diarrhoea

Musculo-skeletal Disorders Less frequent Abdominal distension Abdominal cramps

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 medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 . Contact details for the reporting of side effects: 0861 11 1100

Symptoms

Very large doses may produce a feeling of abdominal distension. Milk-alkali syndrome has occurred in individuals taking large doses of calcium carbonate per day for prolonged periods.

Management

Treatment of overdosage is symptomatic and supportive.