GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Andrews Liver Salts Effervescent Powder

Effervescent powder containing magnesium sulphate (dihydrate) 17.4% w/w, Sodium Hydrogen Carbonate 22.6 % w/w and Citric Acid (anhydrous) 19.5% w/w

Excipient: Sucrose 40.5% w/w

For a full list of excipients, see section 6.1.

Effervescent powder.

A white free-flowing powder which effervesces on addition to water.

The product is recommended as a laxative and as an antacid for the treatment of dyspeptic symptoms.

For oral use only.

Adults (including the elderly): As an antacid, one to two level spoonfuls (5-10 ml) in a glass of water. As a laxative, two level spoonfuls (10 ml) in a glass of water to be taken before breakfast or at bedtime.

Children (aged over 6 years): Half the adult dose.

Not suitable for children under 6 years of age except under medical advice.

This product should not be given to patients with a hypersensitivity to any component of Andrews Liver Salts or any previous hypersensitivity to Andrews Liver Salts.

This product should not be given to patients with symptoms of appendicitis, intestinal obstruction, inflammatory bowel disease, or abdominal pain of unknown origin.

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. Magnesium salts may cause central nervous depression in patients with renal dysfunction.

Because of the sucrose content, diabetics should use with caution. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

If a laxative is required every day, if there is persistent abdominal pain, or if symptoms persist consult your doctor. Prolonged continuous use is not recommended.

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 (particularly during the first trimester) or lactating 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 bicarbonate exerts an immediate antacid effect in the stomach by neutralising acid secretion with the liberation of carbon dioxide.

Citric acid and sodium bicarbonate in solution have a buffering capacity which alleviates discomfort caused by excess 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 bicarbonate is retained by the kidney to meet any deficit of bicarbonate in the plasma.

Citric acid is absorbed by the gastrointestinal tract and is oxidised in the body to carbon dioxide and water.

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

Sucrose

Not applicable.

Tinplate tin: Five years.

Plastic container: Three years.

Use within 3 months of opening.

Do not store above 25°C. Keep the container tightly closed.

Tinplate tin with tamper evident bleached kraft seal and pressfit lid containing 113 g or 227 g.

White oval plastic containers sealed with aluminium foil and fitted with a blue plastic overcap with hinged lid containing 150 g or 250 g.

Not all pack sizes may be marketed.

No special requirements.

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

Stonemasons Way

Rathfarnham

Dublin 16

PA 678/43/1

Date of first authorization: 25 February 1992

Date of last renewal: 25 February 2007

June 2009