TOREM 10mg Tablet (2018)
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Περιεχόμενα
1. Name of the medicinal product
Torem 10mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 10.0mg torasemide. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets. White to off-white round tablets with the imprint T 10.0 and break mark on one side and plain on the other side.
4.1. Therapeutic indications
Oedema due to congestive heart failure; hepatic, pulmonary or renal oedema.
4.2. Posology and method of administration
Adults Oedema The usual dose is 5mg. once daily. If necessary, the dose can be increased stepwise up to 20mg once daily. In individual cases, as much as 40mg torasemide/day has been administered. Elderly ...
4.3. Contraindications
Renal failure with anuria; hepatic coma and pre-coma; hypotension; pre-existing hypovolaemia; pregnancy and lactation; hypersensitivity to torasemide and sulphonylureas; cardiac arrhythmias, simultaneous ...
4.4. Special warnings and precautions for use
Hypokalaemia, hyponatraemia, hypovolaemia and disorders of micturition must be corrected before treatment. On long-term treatment with torasemide, regular monitoring of the electrolyte balance, glucose, ...
4.5. Interaction with other medicinal products and other forms of interaction
When used simultaneously with cardiac glycosides, a potassium and/or magnesium deficiency may increase sensitivity of the cardiac muscle to such drugs. The kaliuretic effect of mineralo-and glucocorticoids ...
4.6. Pregnancy and lactation
There are no data from experience in humans of the effect of torasemide on the embryo and foetus. Whilst studies in the rat have shown no teratogenic effect, malformed foetuses have been observed after ...
4.7. Effects on ability to drive and use machines
As for other drugs which produce changes in blood pressure, patients taking torasemide should be warned not to drive or operate machinery if they experience dizziness or related symptoms.
4.8. Undesirable effects
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥1/10), ...
4.9. Overdose
Symptoms and signs No typical picture of intoxication is known. If overdosage occurs, then there may be marked diuresis with the danger of loss of fluid and electrolytes which may lead to somnolence, confusion, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> High ceiling diuretics, sulphonamide monodrugs <b>ATC code:</b> C03CA04 Torasemide is a loop diuretic. However, at low doses its pharmacodynamic profile resembles that ...
5.2. Pharmacokinetic properties
Absorption Torasemide is absorbed rapidly and almost completely after oral administration, and peak serum levels are reached after one to two hours. Serum protein binding More than 99% of torasemide is ...
5.3. Preclinical safety data
Acute toxicity Very low toxicity. Chronic toxicity The changes observed in toxicity studies in dogs and rats at high doses are attributable to an excess pharmacodynamic action (diuresis). Changes observed ...
6.1. List of excipients
Lactose monohydrate Maize starch Colloidal silicon dioxide Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 years.
6.4. Special precautions for storage
No special precautions for storage.
6.5. Nature and contents of container
Blister packs, PVC/aluminium, containing 14, 28, 100 or 112 tablets.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
8. Marketing authorization number(s)
PL 46302/0143
9. Date of first authorization / renewal of the authorization
8<sup>th</sup> September 2009
10. Date of revision of the text
February 2018
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