MILK OF MAGNESIA Oral Suspension Ref.[6420] Active ingredients: Magnesium hydroxide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2013  Publisher: Omega Pharma Ltd., 1<sup>st</sup> Floor, 32 Vauxhall Bridge Road, LONDON, SW1V 2SA, United Kingdom

Contraindications

Hypersensitivity to any of the ingredients.

Special warnings and precautions for use

Adequate fluid intake should be maintained during use. If diarrhoea occurs especially in children or the elderly, discontinue use immediately. In case of renal impairment a doctor should be consulted as hypermagnesaemia may occur. If symptoms persist or worsen, a doctor or pharmacist should be consulted.

Do not use as a laxative for more than three consecutive days, or as an antacid for more than fourteen consecutive days.

If a laxative dose is needed every day or if there is a persistent abdominal pain further medical advice should be sought.

Users taking medicines either physician prescribed or self-prescribed should consult a doctor or pharmacist before use.

Keep out of the reach and sight of children.

Interaction with other medicinal products and other forms of interaction

Magnesium hydroxide may interfere locally with the absorption of other drugs taken orally by increasing gastric pH. This can be avoided by giving other drugs 2-3 hours before the administration of magnesium hydroxide on the advice of a doctor.

Milk of Magnesia may interact with tetracycline, digoxin, dicoumerol and cimetidine. Magnesium hydroxide may increase the absorption of ibuprofen and decrease the absorption of penicallamine, bisphosphates, ketoconazole and tetracycline.

The excretion of salicylates will be increased by changes in urinary pH.

Co-administration of sodium polystyrene sulphonate results in a relative excess of bicarbonate ions, which are absorbed, and may lead to metabolic alkylosis.

Pregnancy and lactation

For Magnesium hydroxide 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.

Magnesium crosses the placenta and is excreted in small amounts in breast milk. Use during pregnancy and lactation should be avoided unless on the advice of a doctor.

Effects on ability to drive and use machines

Magnesium hydroxide is unlikely to cause any effects on the ability to drive and use machines.

Undesirable effects

Diarrhoea may occur which is dose related.

In patients with impaired renal function there may be sufficient accumulation of magnesium to produce toxic effects (see section 4.9).

Incompatibilities

None.

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