Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LETROZOLE
SYNERRV SDN BHD
LETROZOLE
30 Tablets
Eugia Pharma Specialties Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ LETRODAY 2.5 (LETROZOLE TABLETS 2.5MG) Letrozole 2.5mg 1 WHAT IS IN THIS LEAFLET 1. What LETRODAY 2.5 is used for 2. How LETRODAY 2.5 works 3. Before you use LETRODAY 2.5 4. How to use LETRODAY 2.5 5. While you are using it 6. Side effects 7. Storage and Disposal of LETRODAY 2.5 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT IS LETRODAY 2.5 USED FOR Letrozole is used to treat breast cancer in women who have gone through menopause (i.e., cessation of periods). It is also used to prevent cancer from recurring. It can be used as first treatment before breast cancer surgery in case immediate surgery is not suitable or it can be used as first treatment after breast cancer surgery or following five years treatment with a medicine called Tamoxifen. Letrozole can be used to prevent the spread of breast tumour to other parts of the body in patients with advanced breast cancer. If you have any questions about how Letrozole works or why this medicine has been prescribed for you, please ask your doctor. HOW LETRODAY 2.5 WORKS LETRODAY 2.5 contains an active substance called Letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or ‘endocrine’) breast cancer treatment. Growth of breast cancer is frequently stimulated by oestrogens which are female sex hormones. Letrozole reduces the amount of oestrogen by blocking an enzyme called aromatase that is involved in the production of oestrogens and therefore may block the growth of breast cancer that requires oestrogens to grow. This results in slowed down or stopped tumour growth and/or spreading to other parts of the body. BEFORE YOU USE LETRODAY 2.5 _-When you must not use it _ Do not take this medicine if you are unsure about your menopausal status or if you are still having your period regularly. Please check with your doctor. If you are allergic to any of the ingredients of this product as listed at the end of this le Прочитайте повний документ
NAME OF THE PRODUCT: Letrozole Tablets 2.5 mg (TRADE) NAME OF PRODUCT: LETRODAY 2.5 STRENGTH: 2.5 mg PHARMACEUTICAL DOSAGE FORM: Film Coated Tablet QUALITATIVE AND QUANTITATIVE COMPOSITIONS: Each film-coated tablet contains: Letrozole Ph.Eur ……… 2.5 mg PHARMACEUTICAL FORM Letrozole Tablets 2.5 mg Dark yellow, film coated, round, slightly biconvex, with beveled edges tablet debossed with ‘L2.5’ on one side and plain on the other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. • Adjuvant treatment of postmenopausal women with early breast cancer (positive or unknown oestrogen or progesterone receptor status) who have received 5 years of adjuvant tamoxifen therapy (extended adjuvant therapy). • First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer. • Treatment of advanced breast cancer in women with natural or artificially induced postmenopausal status, who have previously been treated with antioestrogens. • Pre-operative therapy in postmenopausal women with localised hormone receptor positive breast cancer, to allow subsequent breast-conserving surgery in women not originally considered candidates for this type of surgery. Subsequent treatment after surgery should be in accordance with standard of care. POSOLOGY AND METHOD OF ADMINISTRATION Posology General target population _Adults_ The recommended dose of LETRODAY is 2.5 mg once daily. In the adjuvant and extended adjuvant setting, treatment with LETRODAY should continue for 5 years or until disease relapse/recurrence occurs, whichever comes first. In the large pivotal study of letrozole versus tamoxifen in the adjuvant setting, no benefit in efficacy or safety was obtained by sequential administration of these treatments compared with letrozole administered continuously for 5 years. In patients with metastatic disease, treatment with LETRODAY should continue until tumor progression is evident. In the pre-ope Прочитайте повний документ