Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Magaldrate; Alginic acid; Sodium bicarbonate
Forest Laboratories UK Ltd
n/a
Magaldrate; Alginic acid; Sodium bicarbonate
400mg ; 200mg ; 100mg
Oral tablet
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF:
Page 1 of 4 BISODOL EXTRA STRONG MINT TABLETS LABEL-LEAFLET TEXT (USED ON 30 TABLETS PACK) AS THIS IS TEXT, PLEASE NOTE THAT IF AN ARTWORK IS PRODUCED THAT THE ACTUAL TEXT ON EACH PAGE MAY VARY DEPENDING ON HOW THE TEXT FITS. CARRIER: Bisodol ® Extra Strong Mint KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Forest logo Forest Laboratories UK Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom. Barcode PL 0108/0125 Malta MA 003/01402 Component code number CARRIER SIDE: BN: EXP: Pharmacode LEAFLET FACE: Page 1 BISODOL EXTRA STRONG MINT TABLETS – a unique triple action formula to provide effective, rapid relief from acid indigestion, heartburn and trapped wind. DOSAGE: Suck or chew one or two tablets as required. Not recommended for children under 12 years. If symptoms persist, please consult your doctor. If you are pregnant talk to your doctor before using this medicine. READ INSIDE THIS LABEL BEFORE FIRST USE. REMOVE DISC UNDER CAP - IF MISSING DO NOT USE. Each tablet contains: calcium carb. 522mg, light mag. carb. 68mg, sod. bicarbonate 64mg. Sodium content 18mg per tablet. Also contains: saccharin, sugar. Do not store above 25°C KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Forest logo Forest Laboratories UK Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom. PL 0108/0125 Malta MA 003/01402 Component code number 1 Barcode Braille reads: mint tablets Page 2 of 4 Page 9 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 product, ask your pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Bisodol Extra Strong Mint Tablets can cause side effects, although not everybody gets them. Some patients may experience side effects such as constipation or diarrhoea. 9 Page 10 REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report sid Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisodol Extra Strong Mint Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredients per tablet: Calcium Carbonate PhEur 522mg Magnesium Carbonate Light PhEur 68mg Sodium Bicarbonate PhEur 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, the 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 CONTRAINDICATIONS 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 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Antacids are known to reduce the absorption of certain medicines including tetracyclines and iron salts. 4.6 FERTILITY, 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 authorisation of the medici Olvassa el a teljes dokumentumot