Država: Malta
Jezik: engleski
Izvor: Medicines Authority
CALCIUM CARBONATE, MAGNESIUM CARBONATE, LIGHT, SODIUM HYDROGEN
Forest Laboratories UK Limited Whiddon Valley, Barnstaple North Devon, EX32 8NS, United Kingdom
A02AH
CALCIUM CARBONATE 522 mg MAGNESIUM CARBONATE, LIGHT 68 mg SODIUM HYDROGEN CARBONATE 64 mg
CHEWABLE TABLET
CALCIUM CARBONATE 522 mg MAGNESIUM CARBONATE, LIGHT 68 mg SODIUM HYDROGEN CARBONATE 64 mg
OTC
DRUGS FOR ACID RELATED DISORDERS
Withdrawn
2007-04-09
1 of 3 Bisodol ® Extra Strong Mint Tablets BISODOL ® EXTRA STRONG MINT TABLETS Calcium Carbonate 522 mg, Light Magnesium Carbonate 68 mg, Sodium Bicarbonate 64 mg. 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 Bisodol Extra Strong Mint Tablets carefully to get the best results from it. 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 any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Bisodol Extra Strong Mint Tablets are and what they are used for 2. Before you take Bisodol Extra Strong Mint Tablets 3. How to take Bisodol Extra Strong Mint Tablets 4. Possible side effects 5. How to store Bisodol Extra Strong Mint Tablets 6. Further information Diagram scored tablet 1. WHAT BISODOL EXTRA STRONG MINT TABLETS ARE AND WHAT THEY ARE USED FOR Bisodol Extra Strong Mint Tablets are antacids. They work by neutralising excess stomach acid. Bisodol Extra Strong Mint Tablets treat the pain and discomfort of acid indigestion, heartburn and trapped wind. Diagram X 2. BEFORE YOU TAKE BISODOL EXTRA STRONG MINT TABLETS DO NOT TAKE BISODOL EXTRA STRONG MINT TABLETS: If you are allergic to any of the ingredients (see Section 6 for ingredients), If you have been told the level of phosphate in your blood is low (hypophosphataemia), If you have heart or kidney problems. TAKE SPECIAL CARE WITH BISODOL EXTRA STRONG MINT TABLETS If you have been told by your doctor that you are intolerant to some sugars, speak to your doctor before taking Bisodol Extra Strong Mint Tablets. If you are following a controlled sodium diet, you should take into consideration that each tablet contains 18mg of sodium. TAKING OTHER MEDICINES If you are taking tetracy Pročitajte cijeli dokument
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Bisodol Extra Strong Mint Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients per tablet: Calcium Carbonate Ph.Eur. 522m g Magnesium Carbonate Light Ph.Eur. 68mg Sodium Bicarbonate Ph.Eur. 64mg 3. PHARMACEUTICAL FORM Chewable tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For relief from indigestion, dyspepsia, heartburn, acidity and flatulence. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, elderly and children over 12 years: Take one or two tablets as required. Suck slowly or chew as preferred. Children below 12 years: Not recommended. 4.3 CONTRA-INDICATIONS Hypophosphataemia, and avoid in patients with heart or renal failure. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The label will contain the following statements: 1. If symptoms persist, consult your doctor. 2. Keep all medicines out of the reach of children. 3. Not to be taken during the first three months of pregnancy. 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Antacids are known to reduce the absorption of certain medicines including Page 2 of 4 tetracyclines and iron salts. 4.6 PREGNANCY AND LACTATION No clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing to pregnant women. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None stated 4.8 UNDESIRABLE EFFECTS Calcium salts can have a constipating effect and magnesium salts can have a laxative effect. The mixture of antacids is intended to avoid the lower gastrointestinal effects seen with single antacid preparations. No side effects associated with sodium bicarbonate except when taken in excess. Rebound hyperacidity may occur with prolonged dosage. REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after Pročitajte cijeli dokument