Država: Malta
Jezik: angleščina
Source: Medicines Authority
EXEMESTANE
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
L02BG06
EXEMESTANE 25 mg
FILM-COATED TABLET
EXEMESTANE 25 mg
POM
ENDOCRINE THERAPY
Authorised
2014-09-23
mt-pl-exedral-25mg-fc-tabs- a4 Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EXEDRAL_ _25, 25 MG FILM-COATED TABLETS_ _ exemestane 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Exedral 25 is and what it is used for 2. What you need to know before you take Exedral 25 3. How to take Exedral 25 4. Possible side effects 5. How to store Exedral 25 6. Contents of the pack and other information 1. WHAT EXEDRAL 25 IS AND WHAT IT IS USED FOR Your medicine is called Exedral 25. Exedral 25 belongs to a group of medicines known as aromatase inhibitors. These medicines interfere with a substance called aromatase, which is needed to make the female sex hormones, oestrogens, especially in postmenopausal women. Reduction in oestrogen levels in the body is a way of treating hormone dependent breast cancer. Exedral 25 is used to treat hormone dependent early breast cancer in postmenopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen. Exedral 25 is also used to treat hormone dependent advanced breast cancer in postmenopausal women when a different hormonal drug treatment has not worked well enough. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EXEDRAL 25 DO NOT TAKE EXEDRAL 25: • if you are or have previously been allergic to exemestane (the active ingredient in Exedral 25) or any of the other ingredients of this medicine (listed in section 6). mt-pl-exedral-25mg-fc-tabs- a4 Page 2 of 6 • if you have NOT already been through ‘the menopause’, i.e. you are still Preberite celoten dokument
mt-spc-exedral-25mg-fc-tabs-v02-r02-a0 Page 1 of 15 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Exedral 25, 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg exemestane. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Exemestane is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer (EBC), following 2 – 3 years of initial adjuvant tamoxifen therapy. Exemestane is indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti- oestrogen therapy. Efficacy has not been demonstrated in patients with oestrogen receptor negative status. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult and elderly patients _ The recommended dose of exemestane is one 25 mg tablet to be taken once daily, preferably after a meal. In patients with early breast cancer, treatment with exemestane should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by exemestane), or earlier if tumour relapse occurs. In patients with advanced breast cancer, treatment with exemestane should continue until tumour progression is evident. mt-spc-exedral-25mg-fc-tabs-v02-r02-a0 Page 2 of 15 No dose adjustments are required for patients with hepatic or renal insufficiency (see section 5.2). _Paediatric population _ Not recommended for use in children. Method of administration Oral use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In pre-menopausal women and in pregnant or breastfeeding women. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Exemestane should not be administered to women with pre-menopausal endocrine status. Therefore, whenever clin Preberite celoten dokument