TRIFAS 200 mg. 30 tablets

INGREDIENTS:
Active substance - 1 tablet contains 200 mg torasemide. Contained in the tablets Trifas torasemide modification is stable in form I


INDICATIONS:
Trifas is indicated especially in patients with severely impaired renal function.
In order to maintain the residual urine production in patients with severe renal failure, dialysis asashto and if there is negligible residual urine production in the presence of edema, effusions and / or high blood pressure.

Note: The use of Trifas is shown only in patients with severely impaired renal function, but not in patients with normal renal function.


DOSAGE AND METHOD OF APPLICATION:
The dosage should be determined on an individual basis and severity of renal failure.

Treatment should be initiated by a quarter tablet Trifas 200 mg daily. Depending insufficient urine output, this dose may be increased up to half a tablet Trifas 200 / equivalent to 100 mg of torasemide / day and a maximum of 1 tablet / equivalent 200mg torasemide /.
Tablets Trifas 200 are accepted without chewing enough water in the morning. The biological availability of torasemide is independent of food intake.

Note: During treatment with Trifas 200 is careful monitoring of the patient by a doctor.

Patients with liver failure

Treatment should be conducted with caution in patients with hepatic insufficiency, since it may increase plasma levels of torasemide.

Elderly
There is no need to change the dose in the elderly. However, there is enough trials comparing the elderly to younger patients.


CONTRAINDICATIONS:
Trifas should not apply in the case of:
- Hypersensitivity to the active substance torasemide, sulfonylureas or any of the excipients of Trifas.
- Kidney failure with anuria
- Hepatic coma and coma
- hypotension
- hypovolemia
- Hiponatrieminya, hypokalemia
- Significant interference with micturition
- breastfeeding
- Normal or only mildly impaired renal function, due to the risk of severe loss of fluids and electrolytes.

Pregnancy and lactation
pregnancy
There is not enough clinical experience on the effects of torasemide on embryonic and fetal development in humans.
Experiments on animals have shown reproductive toxicity. In experiments in animals torasemide passes through the placenta.
The accumulation of sufficient data torasemide can be used during pregnancy only if clearly defined need. In these cases should only be used at the lowest effective dose.
Diuretics are not suitable for routine treatment of hypertension and swelling during pregnancy because it can disrupt perfuziata of placental barrier and thus disrupt and fetal development. If you do not have use of torasemide for heart and kidney failure in pregnant women, electrolytes and hematocrit and fetal growth should be closely monitored.

breastfeeding
No evidence of the passage of torasemide in human breast milk or animals. Therefore the application of torasemide during lactation is contraindicated. If you must use during lactation, breast-feeding should be discontinued.

Effects on ability to drive and use machines
Even when properly used torasemide can affect reactivity to such an extent as to affect the ability to participate actively in traffic or operate machinery or work without stable support.
This applies particularly when starting treatment or increasing the dose in cases of exchange of medicinal products or initiation of concomitant therapy and in combination with alcohol.


SIDE EFFECTS
Metabolism / electrolytes

Common - worsening metabolic alkalosis. Muscle cramps. Increased concentration of uric acid and glucose levels, and blood lipid / triglyceride, cholesterol /. Hypokalaemia, in combination with a diet low in potassium, emesis, diarrhea, after use of high doses of laxatives, as well as in patients with chronic liver dysfunction.

Depending on the dose and duration of treatment may show abnormal fluid and electrolyte balance, especially hypovolemia, hypokalemia and / or hyponatremia.

Cardiovascular system:
Very rare - depending on hemoconcentration may occur thromboembolic complications, states of confusion, and cardiac and central circulatory disorders. This can lead for example. arrhythmias, angina pectoris, acute myocardial infarction or syncope.

Gastrointestinal tract
Common - gastrointestinal disorders eg. lack of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation / especially at the beginning of treatment.
Very rare - pancreatitis

Kidney and urinary system:
Uncommon - increased levels of creatinine and blood urea.
In patients with impaired micturition, increased formation of urine can lead to urinary retention and the hyperextension of the bladder.

Liver
Common - elevated levels of certain liver enzymes in the blood.

Skin, allergic reactions
Very rare - allergic reactions, severe skin reactions

Blood and haematopoietic system
Very rare - reduced number of platelets, red blood cells and / or leukocytes

General:
Common - headache, dizziness, fatigue, weakness
Uncommon - dry mouth, paraesthesia
Very rare - visual disturbances, tinnitus, hearing loss