Bisodol Extra Strong Mint Tablets
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 Take one or two tablets as required. Suck slowly or
children over 12 years: chew as preferred.
Children below 12 years: Not recommended.
4.3. Contraindications
Hypophosphataemia, and avoid in patients with heart or renal failure.
Special warnings and precautions for use
4.4.
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 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 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.
4.9. Overdose
Hypermagnesaemia - intravenous administration of calcium salts. Hypernatraemia - give plenty of salt free liquids.
Hypercalcaemia - remove source of calcium.
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.
Sodium Bicarbonate
Sodium Bicarbonate is a rapid-onset, short acting antacid which neutralises acid secretions in the gastrointestinal tract by reacting with hydrochloric acid to produce sodium chloride. During neutralisation carbon dioxide is released, facilitating eructation which provides a sense of relief.
Calcium Carbonate
Calcium carbonate is an antacid with a more prolonged effect than sodium bicarbonate. It rapidly reacts with gastric acid to produce calcium chloride.
Magnesium Carbonate
Magnesium carbonate reacts with gastric acid to form soluble magnesium chloride and carbon dioxide. Because of its crystalline structure it reacts less rapidly than sodium bicarbonate giving it a slower onset of action, and providing longer lasting relief.
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 that is rendered alkaline with an accompanying diuresis.
5.3. Preclinical safety data
The active ingredients in Bisodol Tablets have a well established safety record.
6 PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Saccharin Soluble
Starch
Sucrose
Calcium Stearate Peppermint Essential Oil
6.2. Incompatibilities
None known.
6.3. Shelf life
60 months.
6.4.
Special precautions for storage
Store at a temperature not exceeding 25°C.
6.5 Nature and contents of container
Tablets in polypropylene container with polypropylene lid.
Pack size: 30 tablets.
Carton of 5 rolls of 20 tablets in wax laminated foil with paper label.
Pack size: 100
Two rolls of 20 tablets in wax laminated foil packed together in a cardboard carton.
Pack size: 40
6.6. Instructions for use, handling and disposal
None.
7 MARKETING AUTHORISATION HOLDER
Forest Laboratories UK Limited,
Whiddon Valley,
Barnstaple,
North Devon,
EX32 8NS,
United Kingdom.
8. MARKETING AUTHORISATION NUMBER
PL 00108/0125
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24 September 2004
10
DATE OF REVISION OF THE TEXT
14/10/2015