Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Letrozole
Rowa Pharmaceuticals Limited
L02BG; L02BG04
Letrozole
2.5 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Aromatase inhibitors; letrozole
Not marketed
2009-08-28
PACKAGE LEAFLET: INFORMATION FOR THE USER Eirfem 2.5 mg film coated tablets Rowa® letrozole Pharmaceuticals Ltd. The name of your medicine is Eirfem 2.5 mg film coated tablets, which will be referred to as Eirfem tablets throughout the rest of this document. Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor or your pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFIET: 1. What Eirfem tablets are and what they are used for 2. What you need to know before you take Eirfem tablets 3. How to take Eirfem tablets 4. Possible side effects 5. How to store Eirfem tablets 6. Contents of the pack and other Information 1. WHAT EIRFEM TABIETS ARE AND WHAT THEY ARE USED FOR Eirfem tablets contain an active substance called letrozoIe. Letrozole belongs to a group of medicines called aromatase inhibitors. It is a hormonal (endocrine) breast cancer treatment. Eirfem tablets are used to - prevent breast cancer recurrences as first treatment after breast surgery or following five years of treatment with tamoxifen - prevent breast tumours spreading to other parts of the body in patients in advanced stages of the disease EIRFEM TABLETS SHOULD BE USED ONLY FOR OESTROGEN RECEPTOR-POSITIVE BREAST CANCER AND ONLY IN WOMEN AFTER MENOPAUSE (WHEN YOUR PERIODS HAVE STOPPED COMPLETELY). Growth of breast cancer is frequently stimulated by oestrogens, which are female sex hormones. Eirfem tablets reduce the amount of oestrogen by blocking an enzyme (aromatase) involved in the production of oestrogens. As a consequence tumour cells slow or stop growing and/or spreading to other parts o Læs hele dokumentet
Health Products Regulatory Authority 14 November 2019 CRN009D01 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eirfem 2.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 2.5 mg letrozole. Excipients with known effect: Also contains sunset yellow FCF (E110). For the 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 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 Oral use Adult and older people The recommended dose of Eirfem 2.5 mg film coated tablets 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 Eirfem 2.5 mg film coated tablets should continue until tumour progression is evident. Paediatric population Not applicable. Patients with hepatic and/or renal impairment No dosage adjustment is required for patients with renal insufficiency wi Læs hele dokumentet