MAGNESIUM ASPARTATE KORA HEALTHCARE

The duration of magnesium treatment required will depend on the clinical circumstances of each patient. g. every 3-6 months, particularly in children and in patients with renal impairment. 3).

Method of administration:

For oral use after solution in water. Magnesium Aspartate Kora Healthcare can be dissolved in 50-200 mL of water. Stir until the solution in water is cloudy to transparent. In orange juice or tea inactive particles will be visible. If necessary, Magnesium Aspartate Kora Healthcare in 200ml water can be administered via a gastric, duodenal, and nasal feeding tube.

This should be administered immediately following reconstitution or within 24 hours when dissolved in bottled water and stored below 25°C.

The assessment of side 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 (frequency cannot be estimated from the available data). MedDRA System Organ Class Frequency Undesirable Effects 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 it occurs, the daily dose should be reduced and gradually increase later if needed. Signs of tiredness may occur with high-dose, prolonged use of Magnesium Aspartate Kora Healthcare. This may be an indication that an elevated magnesium level has been achieved.

In this case, the dose should be reduced, or the medication should be temporarily discontinued. Reporting 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.

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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. 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.

The bioavailability of magnesium preparations can vary; therefore, caution should be exercised when switching between magnesium preparations to ensure tolerability and equivalent therapeutic effect.

Excipients:

Sorbitol is a source of fructose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. This medicinal product contains 435 mg sodium per dose, equivalent to 7 % of the WHO recommended maximum daily intake for sodium.

The maximum daily dose of this product is equivalent to 14 % of the WHO recommended maximum daily intake for sodium. Magnesium Aspartate Kora Healthcare is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

1. - Severe renal impairment (glomerular filtration rate < 30 ml/min). - Disorders of cardiac conduction (eg. AV block, bradycardia).