Magnesia Bisurata Aromatic 40 tablets

INDICATIONS

Symptomatic treatment of upper digestive tract pathologies characterized by hyperacidity.

ACTIVE INGREDIENTS

Each tablet contains: Active ingredients: Magnesium Carbonate 71.0 mg, Sodium bicarbonate 64.2 mg, Calcium carbonate 525.0 mg. Excipients with known effects: sucrose, sodium saccharin. For the full list of excipients, see section 6.1

EXCIPIENTS

Sodium saccharin, sucrose, corn starch, calcium stearate, mint essential oil.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substances or to any of the excipients, listed in paragraph 6.1. Renal failure. Do not administer simultaneously with tetracyclines (see section 4.5). Do not administer other drugs within 1 or 2 hours of using the product (see section 4.5). Administration of the medicine in pediatric age is not recommended.

DOSAGE

One tablet to dissolve slowly in the mouth after meals and whenever you feel pain. If necessary, repeat after a quarter of an hour. DO NOT EXCEED THE RECOMMENDED DOSES Use only for short treatment periods. Patients with renal insufficiency: the reduced ability to eliminate the exogenous salt supplement provided by antacids with urine can lead to potentially severe electrolyte imbalances. Treatment with magnesium and calcium salts requires periodic checks of magnesium and calcium levels.

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

In patients with severe renal insufficiency, plasma magnesium levels tend to increase. In these patients, long exposures to high doses of magnesium can lead to encephalopathy or worsening of dialysis-induced osteomalacia. Generally, caution should be exercised in patients with impaired renal function. In these patients, plasma calcium and magnesium levels should be monitored regularly. Important information about some excipients Magnesia Bisurata Aromatic contains sucrose. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. Magnesia Bisurata Aromatic contains less than 1 mmol (23 mg) sodium per tablet, i.e. essentially 'sodium-free'.

INTERACTIONS

It should be kept in mind that antacids can, through different mechanisms, interfere with the oral administration of other drugs. In particular, the simultaneous administration of tetracyclines can give rise to insoluble complexes, with a reduction in the absorption of these antibiotics. However, it is advisable not to administer other drugs within 1 or 2 hours of using the product. Associations to avoid: tetracyclines: formation of insoluble complexes with reduction in the absorption and activity of these antibiotics. Association not recommended: quinidine: increased plasma levels of quinidine and risk of overdose due to decreased excretion. Associations that require precautions for use: indomethacin, phosphorus, dexamethasone, digitalis, iron salts, nitrofurantoin, lincomycin.

SIDE EFFECTS

Based on the available bibliographic data, there are no known side effects related to the specialty. 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/content/segnalazioni-reazioni-avverse.

OVERDOSE

Experience with deliberate overdose is very limited. As in all cases of overdose, treatment should be symptomatic, adopting general supportive measures.

PREGNANCY AND BREASTFEEDING

Although no adverse reactions are known, the product must be used under direct medical supervision in pregnant and breastfeeding women.

EFFECTS ON DRIVING ABILITY

Magnesia Bisurata Aromatic does not alter the ability to drive and use machines.