This information is intended for use by health professionals

1. Name of the medicinal product

Bisodol Extra Strong Mint Tablets

2. Qualitative and quantitative composition

Active ingredients per tablet:

Calcium Carbonate Ph.Eur.

522mg

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 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 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 erucation 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

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.

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.

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 a polypropylene container with polypropylene lid.

Pack size:

30

Carton of 5 rolls of 20 tablets in wax laminated foil with paper label.

Pack size:

100

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

Forest Laboratories UK Limited,

Whiddon Valley,

Barnstaple,

North Devon,

EX32 8NS,

United Kingdom.

8. Marketing authorisation number(s)

PL 0108/0125

9. Date of first authorisation/renewal of the authorisation

22nd November 1993/26th May 2004

10. Date of revision of the text

14/10/2015

11. Legal category

GSL