Original Andrews Salts
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Original Andrews Salts
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Effervescent Powder containing magnesium sulphate 17.4% w/w, Sodium Hydrogen Carbonate Ph Eur 22.6% w/w and Citric Acid (anhydrous) Ph Eur 19.5% w/w.
3. PHARMACEUTICAL FORM
Effervescent powder for oral use.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
The product is recommended as a laxative and as an antacid for the relief of upset stomach, indigestion and biliousness.
4.2. Posology and Method of Administration
Adults (including the elderly): As an antacid, measure one level spoonful (5 ml spoonful) and take in a glass of water repeated as necessary, up to a maximum of four times a day.
As a laxative, measure two level spoonfuls (two 5 ml spoonfuls) and take in a glass of water before breakfast or at bedtime.
Children over 3 years: Half the adult dose.
Not suitable for children under 3 years of age.
4.3.
Contra-Indications
None.
4.4. Special Warnings and Special 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 or renal dysfunction. Because of the sucrose content, diabetics should use with caution. If a laxative is required every day, if there is persistent abdominal pain, or if symptoms persist consult your doctor.
4.5. Interactions with other Medicinal Products and other Forms of Interaction
Magnesium sulphate, in common with other magnesium salts, may interfere with the absorption of tetracycline and alkalinisation of the urine may modify excretion of drugs for which the excretion is pH sensitive.
4.6 Pregnancy and lactation
For Magnesium sulphate 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.
Caution should be exercised when recommending to pregnant women.
4.7 Effects on ability to drive and use machines
No effect on mental alertness.
4.8 Undesirable effects
Diarrhoea may occur with extensive usage. Frequent or prolonged use in patients with severe renal dysfunction may lead to hypermagnesaemia and hypocalcaemia.
4.9
Overdose
Diarrhoea may occur with excessive usage. Hypermagnesaemia and hypocalcaemia may also occur in the presence of impaired renal function. Treatment is symptomatic and supportive.
5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic Properties
Sodium hydrogen carbonate exerts an immediate antacid effect in the stomach by neutralising acid secretion with the liberation of carbon dioxide.
Citric acid and sodium hydrogen carbonate in solution have a buffering capacity which alleviates discomfort caused by acidity in the stomach.
Magnesium sulphate is not readily absorbed from the intestine and acts as a saline purgative. Magnesium ions in the gut have also been shown to cause secretion of cholecystokinin which favours intraluminal accumulation of water and electrolytes.
5.2 Pharmacokinetic properties
The product has a local gastrointestinal action and so detailed pharmacokinetic data are not available. It has been shown that less than 10% of ionic magnesium is absorbed when the product was given to healthy subjects. The magnesium that is absorbed is excreted by the kidney.
After absorption, the hydrogen carbonate is retained by the kidney to meet any deficit of hydrogen carbonate in the plasma.
Citric acid is absorbed by the gastrointestinal tract and is oxidised in the body to carbon dioxide and water.
5.3. Pre-clinical Safety Data
There are no preclinical data of relevance to the prescriber which is additional to that already included in other sections of the SmPC.
6.
PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Sucrose Ph Eur.
6.2 Incompatibilities
None known.
6.3 Shelf-life
Five years (tin and laminate sachets).
Three years (plastic containers).
6.4 Special precautions for storage
Store below 25°C and away from strong odours.
6.5 Nature and contents of container
Tin with tamper evident paper seal and pressfit lid containing 110 g, 113 g, 200 g or 227 g.
4 or 8 laminate sachets containing 5 g packed into cardboard cartons.
White oval plastic containers sealed with aluminium foil and fitted with a blue plastic overcap with hinged lid containing 150 g or 250 g.
6.6. Instructions for Use, Handling and Disposal
Use within 3 months of opening (plastic container only).
7 MARKETING AUTHORISATION HOLDER
SmithKline Beecham (SWG) Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK.
8. MARKETING AUTHORISATION NUMBER(S)
PL 00071/5000R
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
30 January 1990 / 28 November 1996
10 DATE OF REVISION OF THE TEXT
09/10/2006