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Forest Laboratories UK Limited

Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL

Telephone: +44 (0)1322 421 800
Fax: +44 (0)1322 291 306
WWW: http://www.forestlabs.com
Medical Information e-mail: medinfo@forest-labs.co.uk

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Summary of Product Characteristics last updated on the eMC: 23/03/2010

SPC	Bisodol Indigestion Relief Tablets

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 Indigestion Relief Tablets

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients:

Sodium Bicarbonate Ph.Eur.	64mg/tablet
Calcium Carbonate Ph.Eur.	522mg/tablet
Magnesium Carbonate Light Ph.Eur.	68mg/tablet

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3. PHARMACEUTICAL FORM

Chewable tablet for oral administration.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For relief of the symptoms of gastric hyperacidity, variously called indigestion, heartburn, dyspepsia and flatulence.

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4.2 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:

Not recommended.

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4.3 Contraindications

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

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4.4 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.

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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.

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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.

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4.7 Effects on ability to drive and use machines

None stated.

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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 single antacid preparations. No side effects associated with sodium bicarbonate except when taken in excess.

Rebound hyperacidity may occur with prolonged dosage.

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4.9 Overdose

Hypermagnesaemia – intravenous administration of calcium salts.

Hypernatraemia – give plenty of salt free fluids.

Hypercalcaemia – remove source of calcium.

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5. PHARMACOLOGICAL PROPERTIES

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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.

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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.

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5.3 Preclinical safety data

The active ingredients in Bisodol Indigestion Relief Tablets have a well documented safety record.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Saccharin Soluble

Maize Starch

Sugar

Calcium Stearate

Peppermint Essential Oil Hanningtons White Diamond (374611E)

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6.2 Incompatibilities

None stated.

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6.3 Shelf life

Polypropylene packs:	36 months.
Other packs:	60 months.

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6.4 Special precautions for storage

Store at a temperature not exceeding 25°C.

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6.5 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.
Pack size:	100.
Polypropylene roll holder with a polypropylene cap attached by a banding strip to the 100 tablet carton.
Amber glass bottle with black plastic cap.
Pack size:	250.
Rolls of 20 tablets in wax laminated foil with paper label.
Pack size:	20.
Polypropylene container and polypropylene lid.
Pack sizes:	30, 50.
Two rolls of 20 tablets in wax laminated foil packed together in cardboard carton.
Pack size:	40.
Three rolls of 20 tablets in wax laminated foil packed together in cardboard carton.
Pack size:	60.
Not all pack sizes may be marketed.