Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Exemestane
Accord Healthcare Ireland Ltd.
L02BG; L02BG06
Exemestane
25 milligram(s)
Film-coated tablet
Aromatase inhibitors; exemestane
Marketed
2010-06-25
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EXEMESTANE 25 MG FILM-COATED TABLETS Exemestane READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINTS 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 Exemestane tablet is and what it is used for 2. What you need to know before you take Exemestane tablets 3. How to take Exemestane tablets 4. Possible side effects 5. How to store Exemestane tablets 6. Contents of the pack and other information 1. WHAT EXEMESTANE TABLET IS AND WHAT IT IS USED FOR Exemestane 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 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 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 TABLETS DO NOT TAKE EXEMESTANE TABLETS − if you are or have previously been allergic to exemestane 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 to be pregnant or breastfeeding. WARNINGS Baca dokumen lengkapnya
Health Products Regulatory Authority 27 April 2023 CRN00D6XF Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Exemestane 25mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg exemestane Excipients with known effect: Each film-coated tablet contains 90.40 mg mannitol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off-white, round, biconvex film coated tablets debossed with ‘E25’ on one side and plain on the other. 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 a daily, preferablyafter 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. No dose adjustments are required for patients with hepatic or renal insufficiency (see section 5.2). Paediatric population Not recommended for use in children. 4.3 CONTRAINDICATIONS Exemestane tablets are contraindicated in patients with a known 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 Baca dokumen lengkapnya