Pays: Israël
Langue: anglais
Source: 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
Relief of hyperacidity and heartburn.
2021-02-07
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a doctor's prescription RENNIE ® SPEARMINT 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 i Lire le document complet
1. NAME OF THE MEDICINAL PRODUCT Rennie Spearmint, chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per chewable tablet 680 mg calcium carbonate and 80 mg magnesium carbonate. Excipients: each chewable tablet contains 400 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablets. Rennie Spearmint is a creamy white, square tablet with rounded edges and the inscription “RENNIE” embossed on both sides; the tablet has a spearmint aroma. 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 Rennie Spearmint chewable tablets at a time, as needed, preferably to be taken about one hour after a meal and before going to bed. For the treatment of heartburn, an additional 1 -2 tablets may be taken between those times. The maximum daily dose of 10 tablets must not be exceeded. The patient must be advised to consult a doctor if 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: Only for use by adults and children over 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. The tablets can be chewed or sucked. The tablets can be taken without water. As with all antacids, if symptoms persist, diagnostic measures are recommended to rule out serious diseases. For special warnings and precautions for use, see section 4.4. 4.3 CONTRAINDICATIONS - Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1. - Severe renal impairment, hypercalcaemia and/or conditions resulting in hypercalcaemia. - Pre-existing hypophosphataemia. - Nephrolithiasis due to calculi containing calcium. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged use should be avoided. If the symptoms persist or only partially disappe Lire le document complet