Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
11. Legal Category
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1. NAME OF THE MEDICINAL PRODUCT
Bisodol Antacid Chewable Tablets
Calcium Carbonate 522mg
Light Magnesium Carbonate 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 Light Magnesium Carbonate
Each chewable tablet contains 538.3mg of sucrose.
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
Two tablets as required.
Children under 12 years: not recommended
Do not take more than 12 tablets in 24 hours.
4.3 Contraindications
Hypersensitivity to any of the ingredients
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 symptoms persist, medical advice should be sought.
• Do not exceed the stated dose except on medical advice.
• Ingestion of large amounts of antacid tablets may cause milk-alkali syndrome.
4.5 Interaction with other medicinal products and other forms of interaction
As with other antacids, Bisodol Antacid Chewable Tablets may form complexes with certain drugs e.g. tetracyclines, digoxin and vitamins resulting in decreased absorption. Bisodol Antacid Chewable Tablets should not be administered within two hours of taking such drugs. Bisodol Antacid Chewable Tablets can also impede the absorption of phosphates.
4.6 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.
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 specific mixture of antacids is intended to avoid the lower gastrointestinal effects seen with a single antacid preparation. No side effects are associated with sodium bicarbonate except when taken in excess. Rebound hyperacidity may occur with prolonged usage.
4.9 Overdose
Chronic intake can lead to hypercalcaemia, hypercalcuria, nephrolithiasis, metabolic alkalosis and renal insufficiency. Acid rebound may also occur.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic properties
Calcium Carbonate
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
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.
Sodium Bicarbonate
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, which is rendered alkaline with an accompanying diuresis.
5.3 Preclinical safety data
None stated
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Saccharin soluble
Maize starch
Sucrose
Calcium stearate
Peppermint Essential Oil
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
The shelf life is five years from the date of manufacture.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Pack sizes of 100 contained in cellophane over wrapped carton of 5 rolls of 20 tablets in wax laminated foil with paper labels.
Pack sizes of 30 contained in cellulose over wrapped shell and slide cartons.
Pack sizes of 30 contained in polypropylene container with polypropylene lid.
Pack sizes of 20 contained in wax laminated foil with paper label.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements
7. MARKETING AUTHORISATION HOLDER
Forest Laboratories UK Limited
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent
DA2 6SL
8. MARKETING AUTHORISATION NUMBER(S)
PA 100/47/1
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 1st April 1983
Date of last renewal: 1st April 2008
10. DATE OF REVISION OF THE TEXT
October 2009
11. Legal Category
GSL
