Bisodol Indigestion Relief Tablets - Product Information
|Manufacture:||Forest Laboratories, Inc.|
|Condition:||Acid reflux (GERD), Heartburn (GERD)|
|Ingredients:||calcium carbonate, magnesium carbonate, sodium bicarbonate, saccharin soluble, maize starch, sugar, calcium stearate, peppermint essential oil hanningtons white diamond|
Name of the Medicinal Product
Bisodol Indigestion Relief Tablets
Qualitative and Quantitative Composition
|Sodium Bicarbonate Ph.Eur.||64mg/tablet|
|Calcium Carbonate Ph.Eur.||522mg/tablet|
|Magnesium Carbonate Light Ph.Eur.||68mg/tablet|
Chewable tablet for oral administration.
For relief of the symptoms of gastric hyperacidity, variously called indigestion, heartburn, dyspepsia and flatulence.
Posology and Method of Administration
Adults, Elderly and Children Over 12 Years
Suck slowly or chew one or two tablets as required.
Children Under 12 Years
Hypophosphataemia, and avoid in patients with heart failure or renal failure.
Special Warnings and Precautions for Use
If symptoms persist, consult your doctor.
Keep all medicines out of the reach of children.
Not to be taken during the first three months of pregnancy.
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.
Pregnancy and Lactation
Animal studies are insufficient with respect to effects on pregnancy/embryonal/foetal development/parturition and postnatal development.
Caution should be exercised when prescribing to pregnant women.
Effects on Ability to Drive and Use Machines
Calcium salts can have a constipating effect and magnesium salts can have a laxative effect. The specific 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 medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Hypermagnesaemia – intravenous administration of calcium salts.
Hypernatraemia – give plenty of salt free fluids.
Hypercalcaemia – remove source of calcium.
Sodium bicarbonate, calcium carbonate and magnesium carbonate are antacids. They act by neutralising the hydrochloric acid produced by the stomach and thus reducing gastric and duodenal irritation.
Calcium carbonate is converted to calcium chloride by gastric acid. Some of the calcium is absorbed from the intestines but about 85% is reconverted to insoluble calcium salts, such as the carbonate and is excreted in the faeces.
Magnesium carbonate reacts with gastric acid to form soluble magnesium chloride and carbon dioxide in the stomach. Some magnesium is absorbed but is usually excreted rapidly in the urine.
Administration of sodium bicarbonate by mouth causes neutralisation of gastric acid with the production of carbon dioxide. Bicarbonate not involved in that reaction is absorbed and in the absence of a deficit of bicarbonate in the plasma, bicarbonate ions are excreted in the urine that is rendered alkaline with an accompanying diuresis.
Preclinical Safety Data
The active ingredients in Bisodol Indigestion Relief Tablets have a well documented safety record.
List of Excipients
Peppermint Essential Oil Hanningtons White Diamond (374611E)
|Polypropylene packs:||36 months.|
|Other packs:||60 months.|
Special Precautions for Storage
Store at a temperature not exceeding 25°C.
Nature and Contents of Container
|Cellulose over wrapped shell and slide cardboard cartons.|
|Pack sizes:||12, 30.|
|250 micron UPVC /20 micron coated aluminium blister packs in cardboard cartons.|
|Pack sizes:||24, 48.|
|Cellophane overwrapped carton of 5 rolls of 20 tablets in wax laminated foil with paper labels.|
|Polypropylene roll holder with a polypropylene cap attached by a banding strip to the 100 tablet carton.|
|Amber glass bottle with black plastic cap.|
|Rolls of 20 tablets in wax laminated foil with paper label.|
|Polypropylene container and polypropylene lid.|
|Pack sizes:||30, 50.|
|Two rolls of 20 tablets in wax laminated foil packed together in cardboard carton.|
|Three rolls of 20 tablets in wax laminated foil packed together in cardboard carton.|
|Not all pack sizes may be marketed.|
Special Precautions for Disposal and Other Handling
Marketing Authorisation Holder
Forest Laboratories UK Limited,
Marketing Authorisation Number(s)
Date of First Authorisation/Renewal of the Authorisation
29th January 1987 / 20th January 2004
Date of Revision of the Text
Company Contact Details
Forest Laboratories UK Limited (a subsidiary of Actavis PLC)
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 346106
Medical Information e-mail
+44 (0)1271 311 200
Medical Information Direct Line
+44(0)1271 385 257