Bisodol

Bisodol Extra Strong Mint Tablets

Active ingredients per tablet:

Chewable tablet.

For relief from indigestion, dyspepsia, heartburn, acidity and flatulence.

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.

Hypophosphataemia, and avoid in patients with heart or renal failure.

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.

Antacids are known to reduce the absorption of certain medicines including tetracyclines and iron salts.

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.

None stated.

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.

Hypermagnesaemia – intravenous administration of calcium salts. Hypernatraemia – give plenty of salt free liquids. 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.

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.

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.

The active ingredients in Bisodol Tablets have a well-established safety record.

Saccharin SolubleStarchSucroseCalcium StearatePeppermint Essential Oil

None known.

60 months.

Store at a temperature not exceeding 25°C.

None.

Forest Laboratories UK Limited,

Whiddon Valley,

Barnstaple,

North Devon,

EX32 8NS,

United Kingdom.

PL 0108/0125

22^nd November 1993/26^th May 2004

14/10/2015