Country: Malta
Tungumál: enska
Heimild: Medicines Authority
LETROZOLE
Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland
L02BG04
LETROZOLE 2.5 mg
FILM-COATED TABLET
LETROZOLE 2.5 mg
POM
ENDOCRINE THERAPY
Authorised
2005-11-24
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER FEMARA ® 2.5 MG FILM-COATED TABLETS Letrozole 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, ask your doctor or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Femara is and what it is used for 2. What you need to know before you take Femara 3. How to take Femara 4. Possible side effects 5. How to store Femara 6. Contents of the pack and other information 1. WHAT FEMARA IS AND WHAT IT IS USED FOR WHAT FEMARA IS AND HOW IT WORKS Femara 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. Femara reduces the amount of oestrogen by blocking an enzyme (“aromatase”) involved in the production of oestrogens and therefore may block the growth of breast cancer that needs oestrogens to grow. As a consequence tumour cells slow or stop growing and/or spreading to other parts of the body. WHAT FEMARA IS USED FOR Femara is used to treat breast cancer in women who have gone through menopause i.e cessation of periods. It is used to prevent cancer from happening again _. _ 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 tamoxifen. Femara is also used to prevent breast tumour spreading to other parts of the body in patients with Lestu allt skjalið
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Femara 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: letrozole. Each film-coated tablet contains 2.5 mg letrozole. Excipient with known effect: each tablet contains 61.5 mg of lactose (monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Film-coated tablet, dark yellow, round, slightly biconvex with bevelled edges. One side bears the imprint “FV”, the other “CG”. 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-invasive 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 after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens. • Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated. Efficacy has not been demonstrated in patients with hormone receptor negative breast cancer. Page 2 of 17 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult and elderly patients _ The recommended dose of Femara is 2.5 mg once daily. No dose adjustment is required for elderly patients. In patients with advanced or metastatic breast cancer, treatment with Femara should continue until tumour progression is evident. In the adjuvant and extended adjuvant setting, treatment with Femara should continue for 5 years or until tumour relapse occurs, whichever is first. In the adjuvant setting a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) cou Lestu allt skjalið