Mag2 1.5g/10ml 20 sachets oral solution

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Magnesium deficiency states.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Severe renal insufficiency (creatinine clearance less than 30 mL/min). Not to be administered to subjects undergoing digitalis therapy.

WARNINGS AND PRECAUTIONS FOR USE

If there is concomitant calcium deficiency, the magnesium deficiency must be corrected before administering supplemental calcium. In patients with moderate renal insufficiency it is necessary to reduce the dosage and monitor renal function and magnesemia, due to the risk associated with hypermagnesemia. It is appropriate to consider the possibility that depression of cardiovascular activity may occur during treatment. Each vial of MAG2 solution contains 3.5 g of sucrose. Each single-dose sachet of MAG2 solution contains 3.5 g of sucrose. Each sachet of MAG2 powder contains 2.985 g of sucrose. If taken in accordance with the recommended dose, the daily intake of sucrose corresponds to 10.5 g for vials and single-dose sachets of solution and 5.97 g for sachets of powder. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. MAG2 oral solution contains parahydroxybenzoates (sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate): may cause allergic reactions (even delayed). MAG2 vials, single-dose sachets of solution and powder for oral solution contain less than 1 mmol (23 mg) sodium per vial or sachet, i.e. they are essentially “sodium-free”.

INTERACTIONS

In case of concomitant treatment with oral tetracyclines, the administration of MAG2 must be delayed for at least 3 hours. Quinolones should be administered at least 2 hours before or 6 hours after administration of magnesium products to avoid interference with their absorption. Concomitant administration of magnesium-based products and cholecalciferol (vitamin D3) can lead to the appearance of hypercalcemia. The concomitant use of preparations containing calcium or phosphate salts is not recommended as these products prevent the intestinal absorption of magnesium. The simultaneous intake of magnesium-based products with drugs that depress the Central Nervous System can enhance the effects of magnesium on the CNS and must be carefully evaluated.

SIDE EFFECTS

The following convention has been used for the classification of undesirable effects: very common ≥ 1/10; common ≥ 1/100 and < 1/10; uncommon ≥ 1/1000 and < 1/100; rare ≥ 1/10,000 and < 1/1,000); very rare < 1/10,000 and not known (frequency cannot be estimated from the available data). Gastrointestinal disorders. Frequency not known: gastrointestinal disorders, diarrhoea, abdominal pain. Pathologies of the skin and subcutaneous tissue. Frequency not known: skin reactions. Immune system disorders. Frequency not known: hypersensitivity. Exceptional cases of individual intolerance to magnesium have been reported, which can be treated with oral or parenteral antihistamines. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse.