Letrocord 2.5 Special Precautions

Menopausal status: In patients whose menopausal status is unclear, luteinising hormone (LH), follicle-stimulating hormone (FSH) and/or oestradiol levels should be measured before initiating treatment with Letrozole tablet. Only women of postmenopausal endocrine status should receive Letrozole tablet.
Renal impairment: Letrozole Tablet has not been investigated in a sufficient number of patients with the creatinine clearance lower than 10 ml/min. The potential risk/benefit to such patients should be carefully considered before administration of Letrozole.
Hepatic impairment: In patients with severe hepatic impairment (Child-Pugh C), systemic exposure and terminal half-life were approximately doubled compared to healthy volunteers, such patient should therefore be kept under closed supervision.
Bone Effects: Letrozole Tablet is a potent oestrogen-lowering agent. Women with a history of osteoporosis and/or fractures, or who are at increased risk of osteoporosis, should have their bone mineral density formally assessed prior to the commencement of adjuvant and extended adjuvant treatment and monitored during and following treatment with letrozole. Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored. In the adjuvant setting, a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered depending on the patient's safety profile.
Other warnings: Co-administration of Letrozole with tamoxifen, other anti-oestrogens or oestrogen-containing therapies should be avoided as these substances may diminish the pharmacological action of letrozole.
As the tablets contain lactose, Letrozole Tablet is not recommended for patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption.
Effects on ability to drive and use machines: Letrozole tablet has minor influence on the ability to drive and use machines. Since fatigue and dizziness have been observed with the use of Letrozole tablets and somnolence has been reported uncommonly, caution is advised when driving or using machines.