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THE BOOTS COMPANY PLC

1 Thane Road West, Beeston, Nottingham, NG2 3AA
Telephone: +44 (0)1159 595 165
Fax: +44 (0)1159 592 565

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?


Summary of Product Characteristics last updated on the eMC: 27/02/2012
SPC Boots Effervescent Health Salts


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1. NAME OF THE MEDICINAL PRODUCT

Asda Effervescent Health Salts

Boots Effervescent Health Salts

Morrisons Health Salts

Safeway Health Salts

Sainsbury’s Effervescent Health Salts

Sterwin Health Salts

Superdrug Effervescent Health Salts

Unichem Health Salts

Wilko Effervescent Health Salts


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Effervescent powder containing Magnesium Sulphate 17.4% w/w, Sodium Bicarbonate Ph Eur 22.6% w/w and Citric Acid (anhydrous) Ph Eur 19.5% w/w.


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3. PHARMACEUTICAL FORM

Effervescent Powder.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

This product is recommended for symptomatic relief of upset stomach, heartburn, indigestion and biliousness, and as a laxative.


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4.2 Posology and method of administration

Dosage:

Adults:

Upset stomach, heartburn, indigestion and biliousness; Take 1 or 2 teaspoonfuls in a glass of water.

As a laxative: Take two teaspoonfuls in a glass of water before breakfast or at bedtime.

Children's dosage:

Not suitable for children under 3 years old.

For children over 3 years old, reduce the dosage appropriately depending on size and age.

Method of administration: oral after addition to water.


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4.3 Contraindications

Do not use in children under 3 years old.

Hypersensitivity to any of the ingredients. Do not use in patients with acute gastrointestinal conditions.


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4.4 Special warnings and precautions for use

Because of the sodium content, frequent use by patients on a low sodium diet should be avoided. This includes patients with hypertension and cardiac and renal dysfunction. Because of the sucrose content, diabetics should use with caution.

If a laxative is needed every day, or there is persistent abdominal pain, consult your doctor.

Not suitable for children under 3 years old. Keep out of the reach of children.

Caution should be taken in pregnancy and in the elderly and debilitated. Avoid prolonged use.


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4.5 Interaction with other medicinal products and other forms of interaction

None stated.


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4.6 Pregnancy and lactation

As with other medicines, caution should be exercised in pregnancy. Magnesium is known to cross the placenta. Patients should seek the doctor's advice if pregnant or breastfeeding.


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4.7 Effects on ability to drive and use machines

None stated.


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4.8 Undesirable effects

Colic, diarrhoea, belching; and on prolonged use alkalosis and hypermagnesaemia may occur.


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4.9 Overdose

None stated.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Sodium bicarbonate is an antacid, citric acid increases the secretion of urine and renders it less acid and magnesium sulphate is a saline purgative.


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5.2 Pharmacokinetic properties

The therapeutic action of this product occurs within the gastrointestinal tract. Bioavailability studies are irrelevant to a product of this nature.


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5.3 Preclinical safety data

N/A


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Sucrose. The product contains 8.1 mmol Sodium per 3 g (level teaspoonful).


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6.2 Incompatibilities

None stated.


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6.3 Shelf life

60 months.


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6.4 Special precautions for storage

Store below 25°C in a dry place and away from strong odours. Once opened use within 3 months.


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6.5 Nature and contents of container

Foil lined composite drum with foil membrane and polyethylene lever lid containing 113 g or 227 g.


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6.6 Special precautions for disposal and other handling

None.


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Administrative Data

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7. MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited,

Wrafton,

Braunton,

North Devon

EX33 2DL

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PL 12063/0039


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

20 August 2003


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10. DATE OF REVISION OF THE TEXT

January 2012 (change to section 4.4).



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/23480/SPC/


Active Ingredients/Generics

 
   sodium bicarbonate
   citric acid, anhydrous
   magnesium sulphate