MAY 2*OS FREE 20BUST 2,25G

Therapeutic indications

Magnesium deficiency states.

Dosage and method of use

Posology For adults only : 3 vials or 3 single-dose sachets of solution or 2 sachets of powder per day. Pediatric population In children, the dosage can be established by the doctor previously consulted. Warning: use only for short periods of treatment. Instructions for use MAG2 1.5 g/10 ml oral solution : It is advisable to shake before use. To open the vial, turn the top and remove it. Take the contents of the vial as it is or dilute it in water. MAG2 2.25 g powder for oral solution : Dissolve the contents of one sachet in water.

Contraindications

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

Side effects

Rare digestive disorders, diarrhea, abdominal pain. 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 after authorization 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 national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

In patients with renal insufficiency it is necessary to reduce the dosage and monitor renal function and magnesium levels. The possibility of cardiovascular and respiratory depression occurring during treatment should be considered. 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 with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. MAG2 oral solution contains parahydroxybenzoates (methyl parahydroxybenzoate sodium and propyl parahydroxybenzoate sodium): they can cause allergic reactions (possibly delayed).

Pregnancy and breastfeeding

It is recommended that during pregnancy and breastfeeding the intake of the drug takes place under medical supervision and in cases of real need. Magnesium is considered compatible with breastfeeding.

Expiration and conservation

Oral solution : store below 25°C. Powder for oral solution : This medicinal product does not require any special storage conditions.

Interactions with other drugs

The oral administration of magnesium can cause a reduced absorption of tetracyclines, therefore it is recommended not to administer MAG2 at the same time as tetracycline-based drugs, but to maintain at least 3-4 hours between the two administrations. Quinolones should be administered at least 2 hours before or 6 hours after the administration of magnesium products to avoid interference with their absorption. In the case of concomitant administration of products based on magnesium and colecalciferol (vitamin D3) it is advisable to control the calcium level to avoid the possible onset of hypercalcemia. Concomitant use of preparations containing calcium or phosphate salts is not recommended as these products prevent the absorption of magnesium. Concomitant intake of magnesium-based products with drugs that depress the central nervous system may potentiate the CNS effects of magnesium and should be carefully evaluated.

Overdose

Cases of hypermagnesaemia have been reported following massive administration of magnesium or during the treatment of patients with severe renal insufficiency. Symptoms observed include cardiac rhythm disturbances, respiratory depression and neuromuscular transmission disorders. Treatment should include rehydration with restoration of copious diuresis or forced diuresis. In the presence of renal insufficiency, dialysis treatment is necessary.

Active principles

A vial of oral solution contains : active ingredient : magnesium pidolate 1,500 g (corresponding to 122 mg of Mg ⁺⁺ ion) . Excipients with known effect: sucrose, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate. A single-dose sachet of oral solution contains : active ingredient : magnesium pidolate 1,500 g (corresponding to 122 mg of Mg ⁺⁺ ion) . Excipients with known effect: sucrose, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate. A sachet of powder for oral solution contains : active principle : magnesium pidolate 2,250 g (corresponding to 184 mg of Mg ⁺⁺ ion) . Excipients with known effect: sucrose. For the full list of excipients, see section 6.1.

Excipients

MAG2 1.5 g/10 ml oral solution Sucrose , orange flavour, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate , purified water. MAG2 2.25 g powder for oral solution Saccharin sodium, citric acid monohydrate, sucrose , lemon flavour.