Risat 5 mg / 10 mg TABLET

RISAT tablets are indicated in:

• Essential hypertension.
• Oedema of cardiac and hepatic origin.
• Pulmonary oedema due to acute cardiac insufficiency.

Essential hypertension: Treatment is initiated with 2,5 mg RISAT per day. The usual maintenance dose is 2,5 mg per day. If this is insufficiently effective, the dose can be doubled to 5,0 mg per day. Higher doses will not lead to a further reduction of blood pressure.

Oedema of cardiac, hepatic and renal origin: Treatment is initiated with 5,0 mg torasemide per day. The usual maintenance dose is 5,0 mg per day. If this is insufficiently effective, the dose can be increased up to 20 mg per day depending on the severity of the disease. In individual cases as much as 40 mg torasemide per day has been administered. RISAT may be taken with or without meals.

RISAT tablets are contra-indicated in:

• hypersensitivity to torasemide or any of the ingredients of RISAT
• renal failure with absence of urine production (anuria)
• hepatic failure.
• during pregnancy and lactation
• patients with known hypersensitivity to sulfonylureas
• hypovolaemia
• hyponatraemia, hypokalaemia
• severe disorders of micturition (e.g. prostate hypertrophy)

Due to lack of clinical experience, RISAT should not be used in children of 12 years or younger.

Signs of electrolyte imbalance and volume depletion such as headache, dizziness, weakness, loss of appetite and cramps may occur, if diuresis is excessive, especially at the start of treatment and in elderly patients.

When used simultaneously with digoxin a potassium and/or magnesium deficiency may increase the sensitivity of the cardiac muscle to digoxin. The effect of antihypertensive medicines may be potentiated. Consecutive treatment or start of a new co-medication with an ACE-inhibitor may result in an excessive fall in blood pressure.

In patients receiving high doses of salicylates, salicylate-toxicity may be increased.

The kalidiuretic effect of mineralo - and glucocorticosteroids and laxatives may be increased. The effect of RISAT may be reduced by nonsteroidal anti-inflammatory medicines (NSAIDs). The action of antidiabetic medicines may be reduced. Torasemide may potentiate the damaging effects of aminoglycoside antibiotics, cisplatin preparations and cephalosporins on the ear and kidney especially at high dose therapy. The action of theophylline and of curare containing muscle relaxants can be potentiated. The arterial responsiveness to pressor agents, e.g. epinephrine (adrenaline) and norepinephrine (noradrenaline) may be decreased by torasemide. On concomitant treatment with cholestyramine, bioavailability and therefore the effectiveness of RISAT may be reduced. Concurrent use with antidysrhythmic medicines may lead to an increased risk of dysrhythmias associated with hypokalaemia. When RISAT and anticoagulants are used concurrently, the effects of the anticoagulants may be decreased. Because of reduced renal clearance, concomitant use with lithium may promote lithium toxicity. Probenecid may decrease the activity of torasemide.

RISAT is contra-indicated in pregnancy and lactation.

Individually varying reactions can impair alertness, (e.g. patient's ability to operate machinery or drive vehicles). This applies particularly when beginning treatment, switching from another medicine or starting a new co-medication and in conjunction with alcohol.

Side-effects: Metabolic and nutrition disorders: Less frequent: Disturbances of water and electrolyte balance, especially with limited salt intake. Hypokalaemia, hyponatraemia and hypochloraemic alkalosis. Blood and lymphatic system disorders: Less frequent: A decrease in the erythrocyte, leucocyte, and platelet counts. Vascular disorders: Less frequent: Hypotension. The following side-effects have been reported and frequencies are unknown: Thromboembolic complications. Cardiac disorders: The following side-effects have been reported and frequencies are unknown: Cardiac or cerebral ischaemia. Gastrointestinal disorders: Frequent: Constipation, nausea, vomiting. Less frequent: Gastrointestinal haemorrhage, dry mouth. The following side-effects have been reported and frequencies are unknown: Diarrhoea. Renal and urinary disorders: The following side-effects have been reported and frequencies are unknown: Increase in blood urea and creatinine, even in clinically healthy kidneys or in the presence of damaged kidneys. Skin and subcutaneous tissue disorders: Less frequent: Allergic skin reactions, e.g. pruritus and exanthema or photosensitisation. Nervous system disorders: Frequent: Dizziness, headache. Less frequent: Paraesthesia in the limbs. The following side-effects have been reported and frequencies are unknown: Due to haemoconcentration after marked diuresis, confusional states may occur. Eye disorders: Less frequent: Visual disturbances. Ear and labyrinth disorders: Less frequent: Ototoxicity. Investigations: The following side-effects have been reported and frequencies are unknown: Increases in Gamma-GT, alteration in the blood glucose and lipid metabolism and a rise in the uric acid level.

If overdosage occurs there may be a marked diuresis with the danger of loss of liquids and electrolytes which may lead to somnolence and confusion, hypotension, circulatory collapse and gastrointestinal symptoms. There is no known specific antidote. Symptoms of overdosage generally disappear on reduction of the dose or withdrawal of the medicament and simultaneous replacement of fluid and electrolytes (to be monitored).