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Summary of Product Characteristics Sandoz Business use only Page 1 of 9 1.3.1 spc-label-pl - common-spc – 11,006 20191218 (DE/H/1772/001-002-003 – 155347 - validation) TORASEMIDE 100 MG, 200 MG, 50 MG, TABLET 721-6534.01, 721-6535.01, 721-6536.01 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [Nationally completed name] 50 mg tablets [Nationally completed name] 100 mg tablets [Nationally completed name] 200 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of torasemide. Each tablet contains 100 mg of torasemide. Each tablet contains 200 mg of torasemide. For excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. 50 mg tablets: White to off-white round tablet. 100 mg tablets: White to off-white round tablet with break notch. The tablet can be divided into equal doses. 200 mg tablets: White to off-white round tablet with cross break notch on both sides. The tablet can be divided into four equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications The administration of [Nationally completed name] 50 mg/- 100 mg/- 200 mg tablets is exclusively indicated in patients with highly reduced renal function (creatinine clearance less than 20 ml/min and/or serum creatinine concentration greater than 6 mg/dl). For maintenance of residual diuresis in case of severe renal insufficiency – even on dialysis if there is a considerable residual diuresis (more than 200 ml/24 hours) – if oedemas, effusions and/or hypertension exist. Note: [Nationally completed name] 50 mg/- 100 mg/- 200 mg tablets tablets are to be used only in case of highly impaired and not in normal renal function. 1 | Page Sandoz Business use only Page 2 of 9 1.3.1 spc-label-pl - common-spc – 11,006 20191218 (DE/H/1772/001-002-003 – 155347 - validation) TORASEMIDE 100 MG, 200 MG, 50 MG, TABLET 721-6534.01, 721-6535.01, 721-6536.01 4.2 Posology and method of administration Posology Adults Individual dose depending on the degree of renal function impairment. The therapy should be started with 50 mg torasemide a day. If the dose of 50 mg does not yield an adequate response, the dose may be increased to 100 mg torasemide a day and, if necessary, gradually increased thereafter to a maximum of 200 mg once daily, preferably at breakfast time. The highest daily dose to have been used in long-term treatment is 200 mg. Daily doses of 200 mg should only be used in patients with severe renal insufficiency (creatinine- clearance < 20 ml/min and/or creatinine-levels > 530 µmol/l). It should be confirmed that diuresis is at least 200ml/ 24 h. Elderly No dose adjustments are necessary. Hepatic insufficiency Caution should be exercised in patients with hepatic insufficiency since plasma concentrations might be increased (see section 5.2). Experience is, however, insufficient to establish general recommendations in this patient population. Paediatric population There is no experience of use of torasemide in children below the age of 12 years. For doses not realisable/practicable with this strength other strengths of this medicinal product are available. Method of administration For oral use. 4.3 Contraindications Hypersensitivity to the active substance and sulfonylureas or to any of the excipients listed in section 6.1 Renal insufficiency with anuria Hepatic coma (until the improvement of this condition) Hypotension Hypovolaemia Hyponatriaemia Hypokalaemia Severe micturition disorders (e.g. due to prostatic hyperplasia) Normal or only moderately impaired renal function (creatinine clearance > 30 ml/min and/or serum creatinine levels < 3.5 mg/dl), since there is the risk of excessive water and electrolyte losses. Lactation (see section 4.6) Gout Cardiac arrhythmias (e.g. sino-atrial-block, atrioventricular-block second or third degree) Concomitant treatment with aminoglycosides or cephalosporins 2 | Page Sandoz Business use only Page 3 of 9 1.3.1 spc-label-pl - common-spc – 11,006 20191218 (DE/H/1772/001-002-003 – 155347 - validation) TORASEMIDE 100 MG, 200 MG, 50 MG, TABLET 721-6534.01, 721-6535.01, 721-6536.01 Renal insufficiency due to nephrotoxic agents 4.4 Special warnings and precautions for use Due to insufficient experience with torasemide treatment, torasemide should not be used in: Pathological changes of the acid-base balance Pathological changes of the blood cells (e.g. thrombocytopenia or anaemia in patients without renal insufficiency) Creatinine clearance between 20 ml/min – 30 ml/min and/or serum creatinine levels between 3.5 mg/dl – 6 mg/dl Micturition disorders must be corrected prior treatment start with torasemide. Note Longer-term therapy with torasemide requires regular monitoring of the electrolyte balance, particularly serum potassium. Glucose, uric acid, creatinine and lipids in the blood are to be monitored as well at regular intervals. Since an increase in blood glucose can occur, careful monitoring of the carbohydrate balance is recommended in patients with latent or manifest diabetes mellitus. 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 [Nationally completed name] may produce positive results in doping controls. The possible health effects of using [Nationally completed name] as a doping agent cannot be predicted, severe health hazards cannot be excluded. 4.5 Interaction with other medicinal products and other forms of interaction The following interactions of this medicinal product must be considered: Torasemide may reduce the effect of antidiabetics. Torasemide enhances the effect of other antihypertensive medicinal products, particularly that of ACE inhibitors. If ACE inhibitors are given in addition or directly following therapy with torasemide, the blood pressure can fall excessively. The risk of ACE-induced renal insufficiency may be increased. Torasemide-induced hypokalaemia can enhance and increase the incidence of adverse events of concomitantly administered digitalis preparations (risk of intoxication). Concomitant colestyramine therapy may reduce absorption and hence efficacy of orally administered torasemide. 3 | Page Sandoz Business use only Page 4 of 9 1.3.1 spc-label-pl - common-spc – 11,006 20191218 (DE/H/1772/001-002-003 – 155347 - validation) TORASEMIDE 100 MG, 200 MG, 50 MG, TABLET 721-6534.01, 721-6535.01, 721-6536.01 The action of curare-containing muscle relaxants and of theophylline can be influenced (potentiated or attenuated) by torasemide. Monitoring of serum theophylline levels is recommended. The kaliuretic effect of mineralo-and glucocorticoids and laxatives may be increased. In concomitant use of torasemide and lithium serum-concentrations and hence effects and adverse events of lithium may be increased. Probenecid and anti-inflammatory agents of the NSAID type (e.g. indomethacin, propionic acid derivatives or acetylsalicylic acid) may reduce the diuretic and antihypertensive effects of torasemide. Diuretics may increase the risk of NSAID-induced renal failure. In high dose salicylate therapy, torasemide may enhance the neurotoxic effects of salicylate. In addition, the risk of recurrent gout attacks is increased in patients taking salicylates. Torasemide, especially at high doses, may enhance the following adverse events: Ototoxic and nephrotoxic effects of aminoglycoside antibiotics (e.g. kanamycin, gentamicin, tobramycin), cytotoxicity of platin derivatives and the nephrotoxic effects of cephalosporins. Torasemide may reduce the vasoconstrictive effects of catecholamines (e.g. adrenalin, noradrenalin). Torasemide is a substrate for cytochrome P450 CYP2C8 and CYP2C9. There may be an interaction between the ligands for the same enzyme. Therefore, concomitant administration of medicinal products that are also catalyzed by these cytochrome isoforms should be closely monitored to avoid undesirable serum levels of these medicinal products. This interaction has been demonstrated for coumarin derivatives. The potential for drug-drug interaction may be critical for substances with a narrow therapeutic range. 4.6 Fertility, pregnancy and lactation Pregnancy There is insufficient clinical experience in humans on the effect of torasemide on the embryo and foetus. Animal studies have shown reproductive toxicity. In animal studies torasemide passed the placenta (see section 5.3). Until further experience is available, torasemide must only be given during pregnancy in compelling indication. The lowest effective dose should be used. Diuretics are not suited for routine therapy of hypertension and oedema during pregnancy, since they can impair placental perfusion and thus intrauterine growth. If, in case of cardiac or renal insufficiency, torasemide must be administered to a pregnant woman, electrolytes and haematocrit as well as foetal growth must be thoroughly monitored. Breast-feeding There is insufficient information on whether torasemide passes into breast milk. A risk for the newborn/child can not be excluded. Loop diuretics can reduce milk production. Therefore, torasemide must not be used during breast-feeding (see section 4.3). A decision must be made as to whether breast-feeding should be interrupted or whether treatment with torasemide should
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