1. What Femzole® is and what it is used for?
Femzole® tablet is the preparation of Letrozole which is a nonsteroidal aromatase inhibitor. Femzole® (Letrozole) works by inhibiting aromatase enzyme. Therefore, Androgen conversion to Estrogen (through aromatization process) is Inhibited. This results in decreased amount of Estrogen.
Femzole® (Letrozole) is an FDA approved hormone therapy for breast cancer, which works by reducing the amount of estrogen. Decreasing estrogen production is a way to suppress the breast tumor tissue. Femzole® is indicated for the treatment of breast cancer postmenopausal women. Femzole® is also used for Ovulation Induction in female Infertility.
2. Before you take Femzole®
Femzole® is contraindicated in patient with known hypersensitivity to Letrozole or any of its excipients. Femzole® is also contraindicated in Pregnancy and Lactation.
Take special care with Femzole®
Check with your doctor before taking this medicine if:
If you have high cholesterol, osteoporosis (condition in which the bones are fragile and break easily), or liver disease. Be sure to mention any of the following: medications that contain estrogen such as hormone replacement therapy (HRT) and hormonal contraceptives (birth control pills, patches, rings, and injections) and tamoxifen. Since letrozole may make you drowsy, do not drive a car or operate machinery until you know how this medication affects you.
Taking other medicines
Coadministration of Letrozole & Tamoxifen 20 mg daily resulted in a reduction of Letrozole plasma levels of 38% on average. Clinical interaction studies with cimetidine and warfarin indicated that the coadministration of Letrozole with these drugs does not result in clinically-significant drug interactions.
Pregnancy and breast-feeding
Femzole® is contraindicated during pregnancy & Lactation as Letrozole has been assigned to Pregnancy Category D.
3. How to take Femzole®
Always use Femzole® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much to take?
Adult and Elderly Patients
The recommended dose of Femzole® tablet is 2.5 mg once daily, without regard to meals. Treatment with Letrozole should continue until tumor progression is evident.
No dose adjustment is required for elderly patients. Patients treated with Letrozole do not require glucocorticoid or mineralocorticoid replacement therapy.
Children: Not recommended for use in children.
Patients with hepatic and/or renal impairment
No dosage adjustment is required for patients with mild to moderate hepatic impairment (child-Pugh grade A and B) or renal impairment (creatinine clearance > 10 ml/ min).
If you take more Femzole® than you should
If you have too much of this medicine, talk to your doctor straight away.
If you forget to take Femzole®
If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Femzole®
Do not stop taking this medicine without talking to your doctor. You should not stop taking Femzole® just because you feel better. This is because the problem may come back or get worse again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Femzole® can cause side effects, although not everybody gets them.
Headache, Dizziness, Rash, Nausea, Vomiting, Constipation, Diarrhoea, Anorexia, Fatigue, Peripheral edema, Weight increase
Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.
5. How to store Femzole®?
Store in a cool and dry place. Protect from light.
Keep out of reach of children.