Original Andrews Salts

Original Andrews Salts

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.

Effervescent powder for oral use.

The product is recommended as a laxative and as an antacid for the relief of upset stomach, indigestion and biliousness.

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.

None.

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.

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.

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.

No effect on mental alertness.

Diarrhoea may occur with extensive usage. Frequent or prolonged use in patients with severe renal dysfunction may lead to hypermagnesaemia and hypocalcaemia.

Diarrhoea may occur with excessive usage. Hypermagnesaemia and hypocalcaemia may also occur in the presence of impaired renal function. Treatment is symptomatic and supportive.

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.

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.

There are no preclinical data of relevance to the prescriber which is additional to that already included in other sections of the SmPC.

Sucrose Ph Eur.

None known.

Five years (tin and laminate sachets).

Three years (plastic containers).

Store below 25°C and away from strong odours.

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.

Use within 3 months of opening (plastic container only).

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

PL 44673/0055

30 January 1990

January 2016