Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
LETROZOLE
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
L02BG04
LETROZOLE 2.5 mg
FILM-COATED TABLET
LETROZOLE 2.5 mg
POM
ENDOCRINE THERAPY
Withdrawn
2012-07-26
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ LETROZOLE FAIR-MED HEALTHCARE 2.5MG FILM COATED TABLETS Letrozole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. _ _ IN THIS LEAFLET: 1. What Letrozole Fair-Med Healthcare is and what it is used for 2. Before you take Letrozole Fair-Med Healthcare 3. How to take Letrozole Fair-Med Healthcare 4. Possible side effects 5. How to store Letrozole Fair-Med Healthcare 6. Further information 1. WHAT LETROZOLE FAIR-MED HEALTHCARE IS AND WHAT IT IS USED FOR WHAT LETROZOLE FAIR-MED HEALTHCARE IS Letrozole Fair-Med Healthcare contains an active substance called letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (“endocrine”) breast cancer treatment. WHAT LETROZOLE FAIR-MED HEALTHCARE IS USED FOR Letrozole Fair-Med Healthcare is used to prevent breast cancer happening again. It can be used as a first treatment after breast surgery or following five years of treatment with tamoxifen. Letrozole Fair-Med Healthcare is also used to prevent breast tumours spreading to other parts of the body in patients with advanced breast cancer. Letrozole Fair-Med Healthcare should only be used for: – oestrogen receptor-positive breast cancer and – only in women after menopause i.e cessation of periods. HOW LETROZOLE FAIR-MED HEALTHCARE WORKS Growth of breast cancer is frequently stimulated by oestrogens, which are female sex hormones. Letrozole Fair-Med Healthcare r Đọc toàn bộ tài liệu
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Letrozole Fair-Med Healthcare 2.5 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Letrozole Each film-coated tablet contains: 2.5 mg letrozole. Excipients: Sunset yellow FCF (E110). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet Yellow, round, biconvex, film-coated, tablets. Debossed "2.5" on one side, plain on reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. Extended adjuvant treatment of hormone-dependent early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years. First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer. Advanced breast cancer in women with natural or artificially induced postmenopausal status after relapse or disease progression, who have previously been treated with anti-oestrogens. Efficacy has not been demonstrated in patients with hormone receptor negative breast cancer 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult and elderly patients The recommended dose of Letrozole Fair-Med Healthcare is 2.5 mg once daily. No dose adjustment is required for elderly patients. In the adjuvant setting, it is recommended to treat for 5 years or until tumour relapse occurs.. In the adjuvant setting, clinical experience is available for 2 years (median duration of treatment was 25 months). In the extended adjuvant setting, clinical experience is available for 4 years (median duration of treatment). In patients with advanced or metastatic disease, treatment with Letrozole Fair-Med Healthcare should continue until tumour progression is evident. Children Not applicable. Patients with Đọc toàn bộ tài liệu