MAGNASPARTATE Powder for oral solution Ref.[7306] Active ingredients: Magnesium aspartate

In the case of confirmed magnesium deficiency, concomitant hypocalcaemia and hypokalaemia should be suspected and corrected if confirmed since magnesium deficiency is frequently secondary to those conditions.

Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Frequent and long-term use of Magnaspartate 243 mg may be harmful to the teeth (caries).

If an undesirable effect occurs, such as diarrhoea, the therapy should be temporarily interrupted and can be restarted after improvement and/or elimination of the symptoms with a reduced dosage.

As magnesium and other medicinal products may mutually influence each other’s absorption, a time interval of 2 to 3 hours should generally be respected if possible.

This specifically applies to:

• Cellulose sodium phosphate; edetate disodium: concurrent use with magnesium supplements may result in binding of magnesium; patients should be advised not to take magnesium supplements within 1 hour of cellulose sodium phosphate or edentate disodium.
• Fluorides and tetracycline: if they must be used, the doses must be separated by 2 to 3 hours or more to prevent their admixture in the gut.
• Aminoquinolines, quinidine and quinidine derivatives nitrofurantoin, penicillamine, iron, bisphosphonates, eltrombopag, nitroxoline: to avoid impairment of absorption, magnesium preparations should be taken 3 to 4 hours before or after the administration of those drugs.

Because of increased magnesium losses, a dose adjustment of magnesium may be necessary when taking the following substances:

• Aminoglycoside antibiotics, cisplatinum and ciclosporin A
• Diuretics (such as thiazide and furosemide)
• EGF-receptor antagonists (such as cetuximab and erlotinib)
• Proton pump inhibitors (such as omeprazole and pantoprazole) and
• Viral DNA polymerases-inhibiting foscarnet, pentamidine, rapamycin and amphotericin B

For further information on mechaninsms of drug interactions see section 5.2.

Pregnancy

A large amount of data on pregnant women over 16 weeks gestation (more than 1000 pregnancy outcomes) indicate no malformative nor feto/neonatal toxicity of magnesium.

Magnaspartate can be used during pregnancy if clinically needed.

Administration of aminoglycoside antibiotics should be avoided during this period, as there are indications of interactions (see 4.5).

Lactation

Magnaspartate can be used during breast-feeding.

Magnesium aspartate/metabolites are excreted in human milk, but at therapeutic doses of Magnaspartate no effects on the breastfed newborns/infants are anticipated.

Fertility

Based on long-term experience, no effects of magnesium on male and female fertility are anticipated.

Magnaspartate has no or negligible influence on the ability to drive and use machines.

The evaluation of undesirable effects is based on the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Gastrointestinal disorders

Uncommon: Soft stools or diarrhoea following high dosage

General disorders and administration site conditions

Very rare: fatigue if used long-term

At high dosage diarrhoea or gastrointestinal irritation may occur. If diarrhoea occurs, the daily dose should be reduced and gradually increased later if needed.

In cases of high doses and long-term use fatigue may be experienced. This may be an indication that an elevated magnesium level has been achieved. Hypermagnesemia is rare after oral administration of magnesium salts, unless there is renal dysfunction.

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.

Media to be used for reconstitution; see section 4.2.