Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
EXEMESTANE
Creative Pharma Solutions s.r.o.
EXEMESTANE
25 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-04-01
ID: PL 156M – IE Nat VERSION: 06 EFFECTIVE DATE: 07/02/2013 Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER EXMACHAN 25 MG FILM-COATED TABLETS (EXEMESTANE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. IN THIS LEAFLET: 1. What Exmachan is and what it is used for 2. Before you take Exmachan 3. How to take Exmachan 4. Possible side effects 5. How to store Exmachan 6. Further information 1. WHAT EXMACHAN IS AND WHAT IT IS USED FOR Your medicine is called Exmachan. Exmachan belongs to a group of medicines known as aromatase inhibitors. These drugs 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. Exmachan 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. Exmachan 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. BEFORE YOU TAKE EXMACHAN DO NOT TAKE EXMACHAN if you are or have Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Exmachan 25 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg exemestane. For a 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 Exmachan is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2 – 3 years of initial adjuvant tamoxifen therapy. Exmachan 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 Oral Adult and elderly patients The recommended dose of Exmachan is one 25 mg tablet to be taken once daily, preferably after a meal. In patients with early breast cancer, treatment with Exmachan should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by Exmachan), or earlier if tumour relapse occurs. In patients with advanced breast cancer, treatment with Exmachan should continue until tumour progression is evident. No dose adjustments are required for patients with hepatic or renal insufficiency (see section 5.2, Pharmacokinetic Properties). Children Not recommended for use in children. 4.3 CONTRAINDICATIONS Exmachan is contraindicated in patients with a known hypersensitivity to the active substance or to any of the excipients, in pre-menopausal women and in pregnant or lactating women. IRISH MEDICINES BOARD ____________________________________________________________________ Đọc toàn bộ tài liệu