TORASEMIDE

Posology Adults The usual dose is 5 mg orally once daily. Usually this is the maintenance dose. Treatment with 10 mg torasemide is indicated when the normal dose of 5 mg torasemide per day is insufficient. In these cases, 10 mg torasemide are taken daily, depending on the severity of the clinical picture, the dose can be increased to up to 20 mg torasemide.

Elderly There are no deviating dose recommendations for elderly. However there are insufficient comparative studies between elderly and younger patients. Renal impairment Clearance is reduced in patients with renal insufficiency, but total plasma concentration is not significantly affected.

2). 3). Special caution is required for patients with hepatic cirrhosis and ascites. Extreme caution is required when torasemide is administered in patients with a history of hepatic encephalopathy. Paediatric population There is no experience of use of torasemide in children below the age of 12 years.

Method of administration Oral use. The tablets should be taken in the morning, without chewing, with a small quantity of liquid. Torasemide is usually given for long-term treatment or until disappearance of oedema.

g. hypovolaemia, hypokalaemia and/or hyponatraemia. Symptoms and signs of electrolyte and volume depletion, such as headache, dizziness, hypotension, weakness, drowsiness, confusional states, loss of appetite and cramps, if diuresis is marked (especially at the start of treatment and in elderly patients) - dose adjustment may be necessary.

Nervous system disorders Common:

Headache, dizziness Uncommon: Limb paraesthesia Not known: Cerebral ischaemia, confusion Eye disorders Very rare: Visual disturbance Ear and labyrinth disorders Very rare: Tinnitus, hearing loss Cardiac disorders Very rare: On account of haemoconcentration, hypotension as well as cardiac and central circulatory disorders (including cardiac ischaemia) can occur.

g. arrhythmias, angina pectoris, acute myocardial infarction, or syncopes. g. loss of appetite, abdominal pain upper, nausea, vomiting, diarrhoea, constipation), particularly at the beginning of treatment Uncommon: Xerostomia Very rare: Pancreatitis Hepatobiliary disorders Common: Increases in certain liver enzyme concentrations, eg.

g. g. g. due to prostatic hyperplasia), increased urinary production can lead to urinary retention and overexpansion of the bladder. 3 mM/l. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

g. thrombocytopenia or anaemia in patients without renal insufficiency) Micturition disorders must be corrected prior treatment start with torasemide. Note On long-term treatment with torasemide, regular monitoring of the electrolyte balance (particularly serum potassium and in particular in patients with concomitant therapy with digitalis glycosides, glucocorticoids, mineralocorticoids or laxatives), glucose, uric acid, creatinine and lipids in the blood and the blood cells (red and white blood cells and platelets), is recommended.

Since an increase in blood glucose can occur, carbohydrate metabolism in latent or manifest diabetes mellitus should be monitored. The blood counts (erythrocytes, leukocytes, thrombocytes) are also to be monitored at regular intervals.

Be aware of signs of electrolyte loss and haemoconcentration, particularly at the beginning of treatment and in older patients. In patients with arrhythmias, the administration of loop diuretics may be potentially life-threatening due to changes in electrolyte levels (potassium, sodium, calcium, and magnesium).

There should be regular blood control of the electrolyte composition. The use of torasemide can lead to positive results in doping controls. The use of torasemide as a doping agent can be harmful to health. Excipient(s) Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

g. g. sino-atrial -block, atrioventricular-block second or third degree) • Concomitant treatment with aminoglycosides or cephalosporins • Renal impairment due to nephrotoxic agents