EPSOM SALTS BP Crystals or Crystalline Powder Ref.[6958] Active ingredients: Magnesium sulfate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: L.C.M. Ltd., Linthwaite Laboratories, Huddersfield, HD7 5QH

Contraindications

Internal use is contraindicated in all cases of acute gastro-intestinal conditions (except constipation), renal impairment, and in children with intestinal parasitic diseases.

Do not give internally to children under 12 years old.

Hypersensitivity to magnesium sulfate.

Special warnings and precautions for use

Keep out of the sight and reach of children.

Avoid prolonged use.

If symptoms persist for longer than 7 days consult your doctor.

Laxatives should not be taken where there is severe abdominal pain.

Osmotic laxatives may produce dehydration so sufficient water should always be taken.

Use with caution in elderly or debilitated patients.

Interaction with other medicinal products and other forms of interaction

Oral magnesium salts have the properties of antacids therefore it is recommended that this product is not taken within two to four hours of any other medicinal products to minimise interactions.

There is a risk of metabolic alkalosis when oral magnesium salts are given with polystyrene sulphonate resins. Magnesium salts, taken internally, potentiate the effects of competitive neuromuscular blocking drugs such as tubocurarine.

Magnesium salts may interfere with the absorption of many drugs including (but not limited to) ACE inhibitors (captopril, enalapril, fosinopril); antibacterials and antifungals (azithromycin, cefaclor, cefpodoxime, isoniazid, itraconazole, ketoconazole, methenamine, tetracyclines, rifampicin and quinolone antibacterials); antivirals (atazanavir and tipranavir); antihistamines (fexofenadine); bisphosphonates; corticosteroids (deflazacort); dipyridamole; antiepileptics (gabapentin and phenytoin); ulcer healing drugs (lansoprazole); levothyroxine; mycophenolate; rosuvastatin; antipsychotics (sulpiride and phenothiazines); chloroquine and hydroxychloroquine; penicillamine, and digoxin if given concomitantly.

Alkaline urine may result, increasing excretion of aspirin. Magnesium salts possibly reduce absorption of bile acids and may reduce absorption of eltrombopag (give at least 4 hours apart). The plasma concentration of ulipristal may be reduced. Magnesium salts possibly reduce the plasma concentration of erlotinib (give at least 4 hours before or 2 hours after erlotinib).

Pregnancy and lactation

Do not use in pregnancy or while breastfeeding.

Effects on ability to drive and use machines

No or negligible influence.

Undesirable effects

Hypermagnesaemia may occur after prolonged usage of magnesium sulfate as a purgative. May cause colic. Ingestion of magnesium salts may cause gastrointestinal irritation and watery diarrhoea. Rarely paralytic ileus has been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Incompatibilities

Magnesium sulfate is incompatible with polymyxin B sulfate, with sodium and potassium tartrates, with soluble phosphates and arsenates and with alkali carbonates and bicarbonates in concentrated solution.

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