Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
CALCIUM CARBONATE; MAGNESIUM CARBONATE
BAYER ISRAEL LTD
A02AC10
CHEWABLE TABLETS
CALCIUM CARBONATE 680 MG; MAGNESIUM CARBONATE 80 MG
PER OS
Not required
DELPHARM GAILLARD, FRANCE
COMBINATIONS
COMBINATIONS
Relief of hyperacidity and heartburn.
2015-07-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a doctor's prescription RENNIE ® ORANGE CHEWABLE TABLETS ACTIVE INGREDIENTS: Every chewable tablet contains: Calcium carbonate 680 mg (equivalent to 272 mg calcium) Magnesium carbonate (heavy) 80 mg INACTIVE INGREDIENTS AND ALLERGENS: see section 2 under "Important information about some of this medicine’s ingredients" and section 6 "Additional information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. Take the medicine according to the instructions in the section about dose in this leaflet. Consult your pharmacist if you need further information. Contact a doctor if your symptoms of illness get worse or do not improve after 14 days. 1. WHAT IS THE MEDICINE INTENDED FOR? This medicine is intended for the relief of gastric hyperacidity and heartburn. THERAPEUTIC GROUP: antacid. Rennie is used for treatment of symptoms resulting from reflux of acidic gastric content to the oesophagus and mouth, causing a sensation of burning or pain behind the sternum. Rennie is also used for treatment of symptoms caused by hyperacidity of gastric content, e.g. in case of heartburn. Rennie can also be used for the treatment of symptoms caused by an ulcer in the upper digestive tract. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are sensitive (allergic) to calcium carbonate or to magnesium carbonate or to any of the additional ingredients contained in the medicine (for the list of the inactive ingredients, see section 6 "Additional information"). • you suffer from a severe kidney dysfunction or kidney stones. • you suffer from high calcium levels or low phosphate levels in the blood. SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE STARTING TREATMENT WITH THE MEDICINE, TELL YOUR DOCTOR IF: • you suffer from sarcoidosis (an infl Przeczytaj cały dokument
1. NAME OF THE MEDICINAL PRODUCT Rennie Orange 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 680 mg calcium carbonate, equivalent to 272.3 mg calcium and 80 mg magnesium carbonate, equivalent to 23.1 mg magnesium. Excipients with known effect: each chewable tablet contains 475 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablets. Rennie is a creamy-white coloured, square tablet with rounded edges inscribed with “RENNIE” on both sides; the tablet has an orange flavour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of hyperacidity and heartburn. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For adults and children over the age of 12 years: 1 -2 tablets are to be sucked or chewed, as needed, preferably circa 1 hour after food and before going to bed. For the treatment of heartburn, an additional 1 -2 tablets may be taken between those times. Do not take more than 10 tablets per day. The patient must be advised to consult a doctor if the symptoms persist for longer than 14 days. It is advisable to wait roughly 1 -2 hours between taking other medicines and taking Rennie. Paediatric patients: This medicine is not to be taken by children under the age of 12 years. The safety and efficacy in children aged under 12 years have not yet been established. Method of administration: For oral use. To be chewed or sucked. The tablets can be taken without water. As with all antacids, in the event of persistent symptoms, diagnostic measures are recommended to exclude serious diseases. For special warnings and precautions during use: see section 4.4. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Severe renal insufficiency, hypercalcaemia and/or conditions resulting in hypercalcaemia. - Pre-existing hypophosphataemia. - Nephrolithiasis due to calcium-containing stones. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged use should be avoided. If symptoms persist Przeczytaj cały dokument