Country: Malta
Language: English
Source: Medicines Authority
CALCIUM CARBONATE, MAGNESIUM CARBONATE, HEAVY
Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland
A02AC01
CALCIUM CARBONATE 680 mg MAGNESIUM CARBONATE, HEAVY 80 mg
CHEWABLE TABLET
CALCIUM CARBONATE 680 mg MAGNESIUM CARBONATE, HEAVY 80 mg
OTC
DRUGS FOR ACID RELATED DISORDERS
Authorised
2017-03-20
1 BCH22024 Package leaflet: Information for the user Rennie ® SUGAR FREE 680mg / 80mg CHEWABLE TABLETS Calcium carbonate and Magnesium carbonate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet, you may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must contact a doctor if you do not feel better or if you feel worse after 7 days. WHAT IS IN THIS LEAFLET 1. WHAT RENNIE ® SUGAR FREE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE ® SUGAR FREE 3. HOW TO TAKE RENNIE ® SUGAR FREE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE RENNIE ® SUGAR FREE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT RENNIE ® SUGAR FREE IS AND WHAT IT IS USED FOR? RENNIE ® SUGAR FREE Chewable Tablets get to work within minutes to provide fast, effective relief from heartburn, indigestion and acid reflux. Each tablet contains two antacids – calcium carbonate and magnesium carbonate – that work quickly and effectively to neutralise excess acid in the stomach. Through this neutralisation they protect the stomach and the food pipe against damaging effects of the excess acid. You must contact a doctor if you do not feel better or if you feel worse after 7 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE ® SUGAR FREE DO NOT TAKE RENNIE ® SUGAR FREE: • If you have severe kidney disease or suffer from kidney stones. • If you have high calcium levels in the blood, kidneys or urine. • If you have low phosphate levels in the blood. • If you are allergic (hypersensitive) to any of the ingredients _(listed in Section 6)._ WARNINGS AND PRECAUTIONS: As with other antacid products, taking these tablets can mask the Read the complete document
BCH22024 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rennie Sugar Free 680mg / 80mg Chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Calcium Carbonate 680 mg (272 mg elemental calcium) Heavy Magnesium Carbonate 80 mg (20 mg elemental magnesium) Excipient with known effect: Sorbitol (E420) 400 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet Square, bevel-edged white tablets with rounded corners and a spearmint odour impressed with “RENNIE” in central concave depression. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications For relief of stomach upsets due to hyperacidity and heartburn. 4.2 Posology and method of administration Posology Tablets to be taken orally, sucked or chewed. Adults Only: One or two tablets to be sucked or chewed as required, to a maximum of eleven tablets a day and should not be taken continuously for longer than 2 weeks. Paediatric population: Not recommended for use in children and adolescents below age 18 due to a lack of sufficient data on safety and efficacy. Elderly persons: No special dosage regimen is required, but care should be taken to observe the contraindications and warnings. Rennie Sugar Free is suitable for diabetics. BCH22024 2 Method of administration For oral use. 4.3 Contraindications Rennie Sugar Free should not be administered in the following cases: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Hypercalcaemia, hypercalciuria and/or conditions resulting in hypercalcaemia e.g sarcoidosis Nephrolithiasis due to calculi containing calcium deposits Severe renal insufficiency Hypophosphatemia 4.4 Special warnings and precautions for use Prolonged use should be avoided. Do not exceed the stated dose and if symptoms persist after seven days, further medical advice should be sought. Caution should generally be exercised in the case of patients with impaired renal function. If Rennie Sugar Free is to be used in these patients, pla Read the complete document