Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE
SSL International plc
A02AC01
CALCIUM CARBONATE
800 Milligram
Tablets Chewable
Product not subject to medical prescription
calcium carbonate
Not Marketed
1992-10-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Remegel 800 mg Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 800mg Calcium Carbonate. Excipients with known effect: each tablet contains 99.71mg sorbitol (E420), 1.47g sucrose and 992.5mg glucose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Light green, soft, chewable squares with bevelled edges and rounded corners. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Remegel tablets are indicated for the relief of stomach upsets due to hyperacidity and heartburn. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral. Tablets to be chewed and swallowed. ADULTS AND CHILDREN 12 YEARS AND OVER: One or two tablets of Remegel to be chewed as a single dose, when symptoms occur. Repeat as necessary. Maximum dose: 12 tablets in 24 hours. CHILDREN UNDER 12 YEARS OF AGE: Not recommended. THE ELDERLY: As for adults, see above. HEPATIC DYSFUNCTION: There is no specific information relating to the use of Remegel in hepatic impairment. Normal adult dosage is appropriate. RENAL DYSFUNCTION: Remegel should be used with caution in subjects with mild to moderate renal impairment (see section 4.4). Current use of calcium carbonate as a phosphate binder should be taken into account to prevent hypercalcaemia. Use in severe renal impairment is contraindicated (see sections 4.3). 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient or any of the excipients, refer to section 6.1 Hypercalcaemia Nephrocalcinosis Patients with renal calculi, or with history of renal calculi H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Прочитать полный документ