Superdrug Effervescent Health Salts
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Asda Effervescent Health Salts Boots Effervescent Health Salts Morrisons Health Salts Sainsbury’s Effervescent Health Salts Superdrug Effervescent Health Salts Wilko Effervescent Health Salts
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.
3 PHARMACEUTICAL FORM
Effervescent Powder.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
This product is recommended for symptomatic relief of upset stomach, heartburn, indigestion and biliousness and as a laxative.
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.
Childrens dosage
Not suitable for children under 3 years old.
For children over 3 years old reduce the dose appropriately depending on size and age.
Method of administration: oral after addition to water.
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.
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.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
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.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Colic, diarrhoea, belching; and on prolonged use alkalosis and hypermagnesaemia may occur.
4.9 Overdose
None stated.
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.
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.
5.3 Preclinical safety data
N/A.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose. The product contains 8.1mmol Sodium per 3g (level teaspoonful)
6.2 Incompatibilities
None stated.
6.3. Shelf Life
36 months.
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.
6.5 Nature and contents of container
Foil lined composite drum with foil membrane and polyethylene lever lid containing 113g or 227g.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Wrafton Laboratories Limited Wrafton
Braunton North Devon EX33 2DL United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 12063/0039
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20th August 2003
10 DATE OF REVISION OF THE TEXT
31/03/2015