Torasemide Biotech 5 / 10 / 20 5 mg / 10 mg / 20 mg Tablets.

Essential hypertension.

Oedema of cardiac and hepatic origin.

Pulmonary oedema due to acute cardiac insufficiency.

Posology

Essential hypertension: Treatment is initiated with 2,5 mg torasemide 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 mg per day. The usual maintenance dose is 5 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 per day has been administered.

Method of administration

For oral administration. Oral TORASEMIDE BIOTECH may be taken with some liquid on an empty stomach or at any time in relation to a meal, as convenient.

• Hypersensitivity to torasemide or any of the other ingredients of TORASEMIDE BIOTECH (see section 6.1).
• Renal failure with absence of urine production (anuria).
• Hepatic pre-coma and coma.
• Pregnancy and lactation (see section 4.6).
• Patients with known hypersensitivity to sulfonylureas.
• Hypovolaemia.
• Hyponatraemia, hypokalaemia.
• Severe disorders of micturition (e.g. prostate hypertrophy).
• TORASEMIDE BIOTECH should not be used in children of 12 years or younger.

TORASEMIDE BIOTECH should not be given in pre-comatose states associated with hepatic cirrhosis. Hypokalaemia, hyponatraemia, hypovolaemia disorders of micturition must be corrected before treatment. TORASEMIDE BIOTECH should be used with care in patients with prostatic hyperplasia or impairment of micturition since it can precipitate acute urinary retention. Careful monitoring of the carbohydrate metabolism is recommended in patients with latent or manifest diabetes mellitus, since a rise in blood glucose may occur. Long term treatment with TORASEMIDE BIOTECH requires regular monitoring of the electrolyte balance, glucose, uric acid, creatinine and lipid levels. Careful monitoring is required in patients with a tendency to hyperuricaemia and gout.

Patients with rare hereditary problems of lactose- or glucose intolerance, the Lapp lactase deficiency of glucose-galactose malabsorption should not take TORASEMIDE BIOTECH.

The effect of antihypertensive medicines may be potentiated when used in combination with TORASEMIDE BIOTECH. Consecutive treatment or start of a new co-medication with an ACE (angiotensin-converting enzyme) inhibitor may result in an excessive fall in blood pressure. The action of antidiabetic medicines may be reduced by TORASEMIDE BIOTECH. Dosage adjustment of hypoglycaemic medications may be necessary. Concurrent and/or sequential administration with TORASEMIDE BIOTECH and amphotericin B parenteral should be avoided, since the potential for nephrotoxicity may be increased, especially in the presence of renal function impairment. Anti-inflammatory medicines, nonsteroidal anti-inflammatory drugs (NSAIDs), especially indomethacin may reduce the natriuretic action of TORASEMIDE BIOTECH. When using TORASEMIDE BIOTECH simultaneously with digoxin, a potassium and/or magnesium deficiency may increase the sensitivity of the cardiac muscle to digoxin. Concurrent use of lithium with TORASEMIDE BIOTECH may promote lithium toxicity because of reduced renal clearance. Probenecid may reduce the diuretic and hypotensive effect of TORASEMIDE BIOTECH. The risk of hypokalaemia may be increased by TORASEMIDE BIOTECH. The kalidiuretic effect of mineralo- and glucocorticosteroids and laxatives may be increased. TORASEMIDE BIOTECH may potentiate the damaging effects of aminoglycocide antibiotics, cisplatin preparations and cephalosporins on the ear and kidney and the cardio-and neurotoxic effect of lithium, especially at high dose therapy. The action of curare containing muscle relaxants and of theophylline can be potentiated by TORASEMIDE BIOTECH. TORASEMIDE BIOTECH may decrease arterial responsiveness to pressor medicines, e.g. epinephrine (adrenaline) and norepinephrine (noradrenaline). In patients receiving high doses of salicylates, salicylate-toxicity may be increased by TORASEMIDE BIOTECH. On concomitant treatment with colestyramine, bioavailability and thus the efficacy of TORASEMIDE BIOTECH may be reduced. The anticoagulant effects of warfarin or heparin may be decreased when these medicines are used concurrently with TORASEMIDE BIOTECH. The concurrent use of sympathomimetics with TORASEMIDE BIOTECH may reduce the antihypertensive effects of TORASEMIDE BIOTECH.

Pregnancy

Safety and efficacy in pregnant women have not been established. TORASEMIDE BIOTECH is contraindicated during pregnancy (see section 4.3).

Breastfeeding

It is not known whether TORASEMIDE BIOTECH is distributed into breast milk. TORASEMIDE BIOTECH is contraindicated during lactation (see section 4.3).

Fertility

No data available.

Individually varying reactions can impair alertness (e.g. patientu2019s ability to drive vehicles or to operate machinery). This applies particularly when beginning treatment, switching from another medicine or starting a new co-medication and in conjunction with alcohol. Patients taking TORASEMIDE BIOTECH should be warned to take special caution when performing tasks requiring their attention, if they experience dizziness or related symptoms.

Blood and the lymphatic system disorders

Less frequent: Thrombocytopenia, leukopenia, anaemia.

Immune system disorders

Less frequent: Acute hypersensitivity reactions (which may be life-threatening).

Metabolism and nutrition disorders

Frequent: Metabolic alkalosis, fluid and electrolyte imbalance (e.g. hypovolaemia, hyponatraemia). Less frequent: Lowered potassium levels.

Nervous system disorders

Frequent: Headache, dizziness. Frequency unknown: Feelings of weakness, loss of appetite and cramps, confusional states, paraesthesia, cerebral ischaemia.

Eye disorders

Frequency unknown: Visual disturbances.

Ear and labyrinth disorders

Less frequent: Ototoxicity (ringing or buzzing in ears or loss of hearing).

Cardiac disorders

Frequency unknown: Thromboembolic complications and cardiac ischaemia or myocardial infarction, angina pectoris, syncope.

Vascular disorders

Less frequent: Hypotension. Frequency unknown: Embolism.

Gastrointestinal disorders

Frequent: Gastrointestinal symptoms (loss of appetite, upper abdominal pain, nausea, vomiting, diarrhoea, constipation). Frequency unknown: Dry mouth, pancreatitis.

Hepato-biliary disorders

Less frequent: Hepatic enzyme increase (e.g. Gamma-glutamyl transferase increase).

Skin and subcutaneous tissue disorders

Less frequent: Allergic skin reactions, e.g. pruritus and exanthema or photosensitisation. Frequency unknown: Serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Musculoskeletal and connective tissue disorders

Frequent: Muscle spasm.

Renal and urinary disorders

Less frequent: Urinary retention, bladder dilation, increased blood urea, increased blood creatinine. Frequency unknown: In patients with urinary obstructions, e.g. prostate hypertrophy, increased urine production can lead to urine retention resulting in distension of the bladder.

General disorders and administration site conditions

Frequent: Fatigue, asthenia.

Investigations

Less frequent: Increased blood uric acid, increased blood glucose, increased lipids (e.g. increased blood triglycerides, increased blood cholesterol.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of TORASEMIDE BIOTECH is important. It allows continued monitoring of the benefit/risk balance of TORESAMIDE BIOTECH. Healthcare providers are asked to report any suspected adverse reactions via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

In the event of overdosage 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. No specific antidote is known. Symptoms of overdosage generally disappear on reduction of the dose or withdrawal of the medicine and simultaneous replacement of fluid and electrolytes (to be monitored). Treatment is symptomatic and supportive.