Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Exemestane
Teva B.V.
L02BG; L02BG06
Exemestane
Film-coated tablet
Aromatase inhibitors; exemestane
Marketed
2010-10-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EXEMESTANE TEVA 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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Exemestane Teva is and what it is used for 2. What you need to know before you take Exemestane Teva 3. How to take Exemestane Teva 4. Possible side effects 5. How to store Exemestane Teva 6. Contents of the pack and other information 1. WHAT EXEMESTANE TEVA IS AND WHAT IT IS USED FOR Exemestane Teva 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. Exemestane Teva 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. Exemestane Teva 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 EXEMESTANE TEVA DO NOT TAKE EXEMESTANE TEVA - if you are or have previously been allergic to exemestane (the active ingredient in Exemestane Teva) or any of the other ingredients of this medicine (listed in section 6). - if you have NOT already been through ‘the menopause’, i.e. you are still having your monthly period. - if you are pregnant, likely Lestu allt skjalið
Health Products Regulatory Authority 19 January 2023 CRN00D8FF Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Exemestane Teva 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. Exemestane Teva 25 mg film-coated tablets are white, round, lenticular, with uniform appearance and intact edges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Exemestane Teva 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 Teva 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 Teva is one 25 mg tablet to be taken once daily, preferably after a meal. In patients with early breast cancer, treatment with Exemestane Teva should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by Exemestane Teva), or earlier if tumour relapse occurs. In patients with advanced breast cancer, treatment with Exemestane Teva should continue until tumour progression is evident. No dose adjustments are required for patients with hepatic or renal insufficiency (see section 5.2). _Paediatric population_ Exemestane Teva is not recommended for use in children. 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 lactating women. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Exemestane should not be administered to women with pre-meno Lestu allt skjalið