Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Calcium carbonate; Heavy magnesium carbonate
Bayer Limited
A01AC01; A02AA01; A02AX
Calcium carbonate; Heavy magnesium carbonate
680 mg/80 milligram(s)
Chewable tablet
Product not subject to medical prescription
triamcinolone; magnesium carbonate; Antacids, other combinations
Not marketed
2011-01-28
RESTRICTED Package leaflet: Information for the user Rennie ® ICE 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 talk to a doctor if you do not feel better or if you feel worse after 14 days. WHAT IS IN THIS LEAFLET 1. WHAT RENNIE ® ICE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE ® ICE 3. HOW TO TAKE RENNIE ® ICE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE RENNIE ® ICE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT RENNIE ® ICE IS AND WHAT IT IS USED FOR RENNIE ® ICE is an antacid tablet which relieves stomach upset due to excess acid and heartburn (acid indigestion). 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 talk to a doctor if you do not feel better or if you feel worse after 14 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE ® ICE DO NOT TAKE RENNIE ® ICE 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 to calcium carbonate, magnesium carbonate or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Consult your doctor before taking Rennie ® ICE if you have any kidney problems. As with other antacid p Read the complete document
Health Products Regulatory Authority 05 December 2022 CRN00D655 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rennie ICE 680 mg/ 80 mg Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: Calcium carbonate 680 mg (272 mg elemental calcium) Heavy Magnesium Carbonate 80 mg (20 mg elemental magnesium) Excipient(s) with known effect: Sucrose 475 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Chewable Tablet. Creamy white square tablets with occasional slight speckling with concave surfaces engraved ‘Rennie’ on both faces with odour of mint. 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: 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 or efficacy Elderly persons: No special dosage regimen is required, but care should be taken to observe the contraindications and warnings. Method of administration For oral use. 4.3 CONTRAINDICATIONS Rennie ICE 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 Health Products Regulatory Authority 05 December 2022 CRN00D655 Page 2 of 5 • 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 7 days, further medical advice should be sought. Caution should generally be exercised in the case of patients Read the complete document