Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
SODIUM BICARBONATE, CALCIUM CARBONATE, LIGHT MAGNESIUM CARBONATE
Forest Laboratories UK Ltd
A02AC01
SODIUM BICARBONATE, CALCIUM CARBONATE, LIGHT MAGNESIUM CARBONATE
522/68/64 Milligram
Tablets Chewable
Product not subject to medical prescription
Calcium compounds
Authorised
2003-04-01
dimensions: 117 x 320 pharmacode: date sent: 30.07.15 TECHNICAL APPROVAL min pt size: 8pt 1. black 2. pms 286 3. pms 288 4. pms 2995 5. 6. 1. Profile 2. Bisodol Original Peppermint 522mg, 68mg 64mg 100 Tablets PIL - Ireland item no: AAAI1732 print proof no: 06 origination date: 30.07.15 originated by: DR revision date: 25-08-2015 supplier: Brunel Healthcare technically app. date: Non Printing Colours colours/plates 3. revised by: SA approved for print/date BISODOL® ANTACID CHEWABLE TABLETS Calcium Carbonate 522 mg, Magnesium Carbonate, Light 68 mg, Sodium Hydrogen Carbonate 64 mg. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Bisodol Antacid Tablets carefully to get the best results. • Always use this medicine exactly 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • You must contact a doctor if your signs of illness worsen or do not improve. WHAT IS IN THIS LEAFLET: 1. What Bisodol Antacid Chewable Tablets are and what they are used for 2. What you need to know before you take Bisodol Antacid Chewable Tablets 3. How to take Bisodol Antacid Chewable Tablets 4. Possible side effects 5. How to store Bisodol Antacid Chewable Tablets 6. Contents of the pack and other information 1. WHAT BISODOL ANTACID CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR Bisodol Antacid Tablets are chewable tablets. They work by neutralising excess stomach acid. Bisodol Antacid Tablets treat the pain and discomfort of acid indigestion, heartburn and trapped wind. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISODOL ANTACID CHEWABLE TABLETS DO NOT T read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisodol Antacid Chewable Tablets Calcium Carbonate 522mg Magnesium Carbonate Light 68mg Sodium Hydrogen Carbonate 64mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: 64 mg of Sodium Hydrogen Carbonate 522 mg of Calcium Carbonate 68 mg of Magnesium Carbonate, Light Excipients with known effect: Each chewable tablet also contains 538.3mg of sucrose Each chewable tablets also contains 18mg of sodium For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable Tablet Circular, smooth white bevel-edged tablet marked Bisodol 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_ 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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 07/12/2015_ _CRN 2164483_ _page number: 1_ Hypophosphataemia. Avoid in patients with renal failure. Hypercalcaemia and hypercalciuria. 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 the symptoms persist, medical advice should be sought. Do not exceed the stated dose ex read_full_document