Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
EXEMESTANE
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
L02BG06
EXEMESTANE 25 mg
FILM-COATED TABLET
EXEMESTANE 25 mg
POM
ENDOCRINE THERAPY
Withdrawn
2012-10-23
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER EXEMESTANE FAIR-MED HEALTHCARE 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 pharmacist. IN THIS LEAFLET: 1. What Exemestane Fair-Med Healthcare is and what it is used for 2. Before you take Exemestane Fair-Med Healthcare 3. How to take Exemestane Fair-Med Healthcare 4. Possible side effects 5. How to store Exemestane Fair-Med Healthcare 6. Further information 1. WHAT EXEMESTANE IS AND WHAT IT IS USED FOR Your medicine is called Exemestane Fair-Med Healthcare. Exemestane Fair-Med Healthcare 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 hormone, oestrogen, especially in postmenopausal women. Reducing oestrogen levels in the body is a way of treating hormone-dependent breast cancer. Exemestane Fair-Med Healthcare 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. It 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 EXEMESTANE FAIR-MED HEALTHCARE DO NOT TAKE EXEMESTANE FAIR-MED HEALTHCAR Perskaitykite visą dokumentą
Page 1 of 10 SUMMARY OF PORDUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Exemestane Fair-Med Healthcare 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Exemestane Each film coated tablet contains 25 mg exemestane. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white, round compound cup film coated tablet, with “25” on one side and plain on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Exemestane Fair-Med Healthcare 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. Exemestane Fair-Med Healthcare 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 Adult and elderly patients The recommended dose of Exemestane is one film-coated tablet (25mg) to be taken orally once a day, 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. No dose adjustments are required for patients with hepatic or renal insufficiency (see section 5.2). Children and adolescents Not recommended for use in children and adolescents 4.3 CONTRAINDICATIONS Page 2 of 10 Exemestane is contraindicated in: - premenopausal women. - women who are pregnant or breastfeeding - pat Perskaitykite visą dokumentą