Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN
Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom
A02BX
SODIUM ALGINATE 250 mg/5ml SODIUM HYDROGEN CARBONATE 133.5 mg/5ml CALCIUM CARBONATE 80 mg/5ml
ORAL SUSPENSION
SODIUM ALGINATE 250 mg/5ml SODIUM HYDROGEN CARBONATE 133.5 mg/5ml CALCIUM CARBONATE 80 mg/5ml
OTC
DRUGS FOR ACID RELATED DISORDERS
Authorised
2006-04-24
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Original Aniseed Relief 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gaviscon Original Aniseed Relief contains 250mg sodium alginate, 133.5mg sodium bicarbonate and 80mg calcium carbonate per 5ml. For excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. An opaque, pink suspension with the odour and flavour of fennel. 4 CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults and children over 12 years: 10-20ml after meals and at bedtime. Elderly: No dosage modification is required in this age group. Children 6 to 12 years: 5-10ml after meals and at bedtime. Children under 6 years: Not recommended. 4.3. CONTRA-INDICATIONS This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4). 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE If symptoms do not improve after seven days, the clinical situation should be reviewed. Page 2 of 5 Each 10 ml dose has a sodium content of 141 mg (6.2 mmol). This should be taken into account when a highly restricted salt diet is recommended. e.g. in some cases of congestive cardiac failure and renal impairment. Each 10 ml dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). 4.5. INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION A time-interval Perskaitykite visą dokumentą