Letrozol Winthrop® 2,5 mg

Description

Directions for use and dosage

Intravenously, irrespective of meals.

The recommended dose is 2.5 mg once daily, every day. Treatment is given on a long-term basis. As extended adjuvant therapy, treatment should be continued for 5 years (but not longer than 5 years).

If signs of disease progression occur, the drug should be discontinued.

No dose adjustment is required for hepatic or renal impairment (creatinine clearance >10 ml/min), but patients with severe hepatic insufficiency (Child-Pugh class C) and severe renal insufficiency should remain under constant surveillance.

Undesirable effects

Adverse effects are listed according to their frequency of occurrence in the following gradation very common (>10%); common (>1% and <10%); uncommon (>0.1% and <1%); rare (>0.01% and <0.1%); very rare (<0.01%), including isolated reports

Gastrointestinal system: common – nausea, vomiting, indigestion, constipation, diarrhoea, anorexia; rare – abdominal pain, stomatitis, dry mouth, increased liver enzymes; very rare – hepatitis.