Mag 2 Orosolubile 20 Sachets 2.25 g

INDICATIONS

Magnesium deficiency states.

ACTIVE INGREDIENTS

One vial of oral solution contains: active ingredient: magnesium pidolate 1,500 g (corresponding to 122 mg of Mg ion⁺⁺). Excipients with known effects: 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 effects: sucrose, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate. One sachet of powder for oral solution contains: active ingredient: magnesium pidolate 2,250 g (corresponding to 184 mg of Mg ion⁺⁺). Excipients with known effects: 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 Sodium saccharin, citric acid monohydrate, sucrose, lemon flavour.

CONTRAINDICATIONS AND SIDE EFFECTS

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.

DOSAGE

Dosage 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 may be established by the doctor after consulting them. Warning: use only for short treatment periods. Instructions for use MAG2 1.5 g/10 ml oral solution: It is advisable to shake before use. To open the vial, twist the top and peel it off. Take the contents of the vial as is or dilute it in water. MAG2 2.25 g powder for oral solution: Dissolve the contents of a sachet in water.

CONSERVATION

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

WARNINGS

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.

OVERDOSE

Signs and symptoms Overdose of oral magnesium does not, in general, induce toxic reactions in the presence of normal renal function. Magnesium poisoning can, however, develop in cases of severe kidney failure. The toxic effect depends mainly on serum magnesium levels and the signs are as follows: drop in blood pressure, nausea, vomiting, depression of the Central Nervous System, decreased reflexes, ECG abnormalities (e.g. cardiac rhythm disturbances), onset of respiratory depression, coma, cardiac arrest, respiratory paralysis, anuric syndrome and disorders of neuromuscular transmission. Therapy Treatment must include rehydration with restoration of abundant diuresis or forced diuresis. In the presence of renal failure, hemodialysis or peritoneal dialysis is necessary.

PREGNANCY AND BREASTFEEDING

Limited data are available on the use of MAG2 in pregnant women. However, no conclusions can be drawn about whether the use of MAG2 is safe during pregnancy. MAG2 can be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus. Magnesium is considered compatible with breastfeeding.

EFFECTS ON DRIVING ABILITY

No particular recommendations.