Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
CALCIUM CARBONATE; DIMETICONE; MAGNESIUM CARBONATE, HEAVY
Bayer PLC
A02AX
CALCIUM CARBONATE; DIMETICONE; MAGNESIUM CARBONATE, HEAVY
CHEWABLE TABLET
CALCIUM CARBONATE 680 mg; DIMETICONE 25 mg; MAGNESIUM CARBONATE, HEAVY 80 mg
OTC
DRUGS FOR ACID RELATED DISORDERS
Authorised
2006-08-16
05/05/17 TL016840 102723 / 0117GB 85546864-85546856 C TR1223051 NEIL THEOBALD G=1; O=0; R=0; - NT - 05/05/17 07:19:00 Code 128 53% N/A N/A N/A Delpharm Gaillard Imprimerie Lefrancq (Cande, France) White Paper 1 LTH PROCESS BLACK COLOURS 102723 / 0117GB HEARTBURN, INDIGESTION & WIND RELIEF Read all of this leaflet carefully because it contains important information for you. THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL NEED TO TAKE RENNIE HEARTBURN, INDIGESTION & WIND RELIEF TABLETS CAREFULLY TO GET THE BEST RESULTS FROM THEM. KEEP THIS LEAFLET, YOU MAY NEED TO READ IT AGAIN. ASK YOUR PHARMACIST IF YOU NEED MORE INFORMATION OR ADVICE. YOU MUST CONTACT A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE. IF YOU HAVE ANY UNUSUAL EFFECTS AFTER TAKING RENNIE HEARTBURN, INDIGESTION & WIND RELIEF, TELL YOUR DOCTOR OR PHARMACIST. IN THIS LEAFLET 1. WHAT IS RENNIE HEARTBURN, INDIGESTION & WIND RELIEF AND WHAT IS IT USED FOR? 2. BEFORE YOU TAKE RENNIE HEARTBURN, INDIGESTION & WIND RELIEF 3. HOW TO TAKE RENNIE HEARTBURN, INDIGESTION & WIND RELIEF 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE RENNIE HEARTBURN, INDIGESTION & WIND RELIEF 6. FURTHER INFORMATION 1. WHAT IS RENNIE® HEARTBURN, INDIGESTION & WIND RELIEF AND WHAT IS IT USED FOR? Rennie Heartburn, Indigestion & Wind Relief IS AN ANTACID TABLET WHICH NEUTRALISES EXCESS ACID TO RELIEVE ACID INDIGESTION, NERVOUS INDIGESTION, HEARTBURN, FLATULENCE, UPSET STOMACH, BILIOUSNESS; AND INDIGESTION AND HEARTBURN DURING PREGNANCY. IT IS ALSO FORMULATED WITH SIMETICONE, A HIGHLY EFFECTIVE INGREDIENT WHICH RELIEVES PAINFUL TRAPPED WIND AND ITS ASSOCIATED SYMPTOMS OF UNCOMFORTABLE BLOATING, PRESSURE AND FULLNESS AFTER FOOD. IT ACTS GENTLY TO DISPERSE THE TRAPPED AIR BUBBLES THUS HELPING TO ELIMINATE THE SYMPTOMS DISCREETLY AND WITHOUT EMBARRASSMENT. 2. BEFORE YOU TAKE RENNIE® HEARTBURN, INDIGESTION & WIND RELIEF Do not take Rennie Heartburn, Indigestion & Wind Relief: • IF YOU HAVE SEVERE KIDNEY DISEASE. • IF YOU HAVE HIGH CALCIUM IN THE URINE OR KIDNEY STONES Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rennie Deflatine Chewable Tablets Rennie Heartburn, Indigestion and Wind Relief 680mg/80mg/25mg Chewable Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Calcium Carbonate 680.0 mg Magnesium Carbonate, heavy 80.0 mg Simethicone 25.0 mg Also contains Sorbitol (E420) For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Chewable Tablet Cream white flat round tablet, scored on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the effective relief of acid indigestion, nervous indigestion, heartburn, upset stomach, uncomfortable bloating, biliousness, flatulence, painful trapped wind, and indigestion and heartburn during pregnancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Tablets to be taken orally, sucked or chewed. Adults and children over 12 years: One or two tablets to be sucked or chewed as required. A maximum daily dose of 8g calcium carbonate, corresponding to 11 tablets a day, must not be exceeded. Children: Not recommended for children under 12 years. As with all antacids, if symptoms persist despite 14 days of continuous therapy, diagnostic measures are strongly recommended in order to rule out a more serious disease. 4.3 CONTRAINDICATIONS Rennie should not be administered to patients with: Hypersensitivity to any of the ingredients of the product Hypercalcaemia and/or conditions resulting in hypercalcaemia Nephrolithiasis due to calculi containing calcium deposits Severe renal insufficiency Hypophosphataemia 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Prolonged use should be avoided. The stated dose should not be exceeded. If, after 14 days of treatment, symptoms persist or only partly disappear the patient should consult a doctor. Caution should be exercised in patients with mild to moderate impairment of renal function (see section 4.3 – contraindication in severe renal insufficiency). If Rennie is used in such patients, plasma calcium and magnesium l Leggi il documento completo