Torasemid-BP

Torasemidum

1 tablet contains torasemide 5 mg or 10 mg. Excipient with known effect: lactose monohydrate (57.60 mg in the 5 mg tablet; 115.20 mg in the 10 mg tablet).

Indication: Oedema caused by congestive heart failure; hepatic or renal oedema; treatment of hypertension.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance, to sulfonylureas, or to any of the excipients listed in section 6.1; − renal failure with anuria, − significant urinary disorders (e.g. due to prostatic hypertrophy), − hepatic coma and pre-coma, − hypotension, − hypovolaemia, − cardiac arrhythmias, − concomitant administration of lithium, platinum-derivative cytostatics, aminoglycosides and cephalosporins, or renal impairment resulting from the use of other nephrotoxic medicines. − children and adolescents under 18 years of age. − breast-feeding.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Before starting treatment, hypokalaemia, hyponatraemia, hypovolaemia and voiding disorders must be corrected. Particularly at the start of treatment and in elderly patients, attention should be paid to signs of electrolyte loss and haemoconcentration. During long-term treatment with torasemide, periodic monitoring of electrolyte balance, plasma glucose, uric acid, creatinine and lipid levels, as well as blood parameters (erythrocytes, leukocytes, platelets), is recommended. Volaemia and electrolyte imbalances Patients treated with diuretics must be closely monitored for clinical signs of electrolyte imbalance, hypovolaemia or pre-renal azotaemia, which may include: dry mouth, thirst, fatigue, lethargy, drowsiness, restlessness, pain or cramps […]