Spironolactone Sandoz tablets 50 mg 30 pcs.

Active ingredient: spironolactone;

1 tablet contains 50 mg or 100 mg of spironolactone;

Excipients: corn starch, calcium hydrogen phosphate dihydrate, povidone K 25, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate.

• Hypersensitivity to the active substance or any other excipients.
• Use in combination with mitotane, as it may block the action of mitotane.
• Anuria, acute renal failure, severe impairment of nitrogen-excreting renal function (glomerular filtration rate <10 ml/min).
• Severe renal failure accompanied by oliguria or anuria (creatinine clearance below 30 ml/min per 1.73 m2 ^of body surface area and/or serum creatinine above 1.8 mg/dl).
• Hyperkalemia (blood potassium levels > 5.0 mmol/L).
• Hyponatremia.
• Addison’s disease.
• Hypovolemia or dehydration.
• Concomitant use of eplerenone or other potassium-sparing diuretics.
• Pregnancy and breastfeeding.
• ACE inhibitors or AT1 receptor blockers in combination.

The dose is determined individually, depending on the severity and degree of hyperaldosteronism.

Primary hyperaldosteronism. In case of diagnosed primary hyperaldosteronism, the drug can be prescribed in preparation for surgery in a daily dose of 100-400 mg.

Pregnant women

Should not be used.

Children

Spironolactone Sandoz, 50 mg tablets can be used in pediatric practice.

Drivers

It is forbidden to drive a car or operate machinery.

Overdose may cause such conditions and symptoms as drowsiness/lethargy, confusion, nausea, vomiting, dizziness or diarrhea. Electrolyte disturbances, arrhythmia, cardiac conduction disturbances.

Treatment of hyperkalemia is symptomatic, there is no specific antidote. It is necessary to maintain water-electrolyte and acid-base balance by prescribing diuretics that remove potassium; parenteral administration of glucose with insulin, in difficult cases – hemodialysis.

• Metabolism and nutrition disorders: hyperkalemia.
• Cardiovascular system: arrhythmias.
• On the part of the reproductive system and mammary glands: decreased libido, erectile dysfunction, gynecomastia (in men), increased nipple sensitivity and breast tenderness, breast enlargement, menstrual disorders in women.

Use in combination with mitotane is contraindicated as it may block the action of mitotane.

Concomitant use of eplerenone or other potassium-sparing diuretics.

No special storage conditions are required.

Keep out of reach of children.

Shelf life – 2 years.