Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE, MAGNESIUM CARBONATE LIGHT, SODIUM BICARBONATE
Forest Laboratories UK Ltd
A02AC01
CALCIUM CARBONATE, MAGNESIUM CARBONATE LIGHT, SODIUM BICARBONATE
522/68/64 Milligram
Tablets Chewable
Product not subject to medical prescription
Calcium compounds
Authorised
1999-08-23
dimensions: pharmacode: date sent: TECHNICAL APPROVAL min pt size: 1. Profile 2. Silicone Bisodol Extra Strong Mint 522mg/68mg/64mg Chewable Tablets x30 Back Label Leaflet - Ireland awstudio@actavis.co.uk print proof no: item no: origination date: originated by: revision date: supplier: technically app. date*: Non Printing Colours colours/plates 3. revised by: approved for print/date AAAH7852 11 09.04.15 DR 08-09-15 SA IL/Brunel Healthcare 55x204.5 5pt 09.04.15 1. 2. 3. 4. 5. 6. PMS 286 PMS 288 PMS 354 2 3 6 5 4 7 8 9 10 2 1 1 1 13 1 4 1 PA 100/46/1 AAAH7852 PHARM ACODE 3. HOW TO TAKE BISODOL EXTRA STRONG MINT CHEWABLE TABLETS Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. THE RECOMMENDED DOSE IS: • ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS Suck or chew one or two tablets, as required. • CHILDREN UNDER 12 YEARS NOT RECOMMENDED. Do not take more than 12 tablets in 24 hours. Prolonged use should be avoided. If symptoms persist medical advice should be sought. IF YOU TAKE MORE BISODOL EXTRA STRONG MINT CHEWABLE TABLETS THAN YOU SHOULD It is unlikely that they will cause you any harm. However, you may experience constipation, diarrhoea or feel bloated. Consult your doctor if these symptoms do not go away. IF YOU STOP TAKING BISODOL EXTRA STRONG MINT CHEWABLE TABLETS If you stop taking this medicine after you have been taking it for a long time, you may suffer a temporary worsening of symptoms. This is called rebound hyperacidity. Consult your doctor if this symptom does not go away. If you have any further questions on the use of this medicine, ask your pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may experience side effects such as constipation or diarrhoea. REPORTING OF SIDE EFFECTS If you get any side effe Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisodol Extra Strong Mint Chewable Tablets Calcium carbonate 522mg Magnesium carbonate light 68mg Sodium hydrogen carbonate 64mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Chewable tablet Circular, smooth, chewable tablet with bevelled edges and impressed ‘Bisodol ESM’ on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the relief of symptoms of indigestion, dyspepsia, heartburn, acidity and flatulence. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults_ One or two tablets as required. _Paediatric population_ Children under 12 years: not recommended Do not take more than 12 tablets in 24 hours. Method of administration Bisodol Chewable Tablets are to be administered orally. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Hypophosphataemia. Avoid in patients with renal failure. Hypercalcaemia and hypercalciuria. Each chewable tablet contains: Calcium carbonate 522 mg Magnesium carbonate light 68 mg Sodium hydrogen carbonate 64 mg Excipients with known effect: Each chewable tablet also contains sucrose 538.1mg Each chewable tablet also contains sodium 18mg For the full list of excipients, see section 6.1. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 12/07/2016_ _CRN 2177284_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Magnesium salts may cause central nervous depression in the presence of renal insufficiency. Persons with kidney disease or receiving medical treatment should consult their doctor before using. Prolonged use should be avoided. If symptoms persist, medical advice should be sought. Do not excee Les hele dokumentet