MAGNASPARTATE

2 Therapeutic indications Magnaspartate is indicated for the treatment and prevention of magnesium deficiency in adults and children aged 2 years and above. 2 Posology and method of administration 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. Posology Adults (> 18 years) 1-2 sachets daily (243-486 mg magnesium or 10-20 mmol magnesium) Children and adolescents: 10 to 18 years One sachet daily (equal to 243 mg magnesium) dissolved in 50-200ml of water, tea, or orange juice.

Children: 4-10 years One sachet daily (equal to 243 mg magnesium) dissolved in 50-200ml of water, tea, or orange juice. 5 mg magnesium). 5 mg magnesium). The safety and efficacy of Magnaspartate in children below 2 years has not been established.

3). There is no dose adjustment necessary in patients with mild to moderate renal impairment.

Elderly:

No dose adjustment is necessary. Method of administration For oral use after solution in water, tea or orange juice. Magnaspartate can be dissolved in 50-200mL water, tea or orange juice. Stir until the solution in water is cloudy to transparent.

In orange juice or tea inactive particles will be visible. The solution should be taken immediately following reconstitution or within 24 hours when dissolved in bottled water and stored below 25°C. Note If necessary, Magnaspartate 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 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). MedDRA System Organ Class Frequency Undesirable Effects Gastrointestinal disorders Uncommon Soft stools or diarrhoea following high dosage General disorders and Very rare fatigue if used long-term administration site conditions 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

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:

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. 706 g of sucrose per sachet. This should be taken into account in patients with diabetes mellitus.

May be harmful to the teeth. This medicinal product contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’

1. • Severe renal impairment (glomerular filtration rate < 30 ml/min) • Disorders of Cardiac conduction (bradycardia)