País: Israel
Idioma: inglés
Fuente: Ministry of Health
EXEMESTANE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
L02BG06
COATED TABLETS
EXEMESTANE 25 MG
PER OS
Required
PFIZER ITALIA S.R.L, ITALY
EXEMESTANE
EXEMESTANE
Aromasin is indicated for the treatment of advanced breast cancer (ABC) in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy alone. Aromasin is also indicated for the treatment of postmenopausal women with ABC whose disease has progressed following multiple hormonal therapies. Aromasin is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breas cancer following 2-3 years of initial adjuvant tamoxifen therapy.
2020-07-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only AROMASIN ® COATED TABLETS 25 MG The active ingredient and its quantity: Each coated tablet contains: exemestane 25 mg Inactive ingredients and allergens: See section 2 "Important information about some of this medicine’s ingredients", section 6 "Additional information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. This medicine is not intended for children. 1. WHAT IS THIS MEDICINE INTENDED FOR? Aromasin ® 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. Additionally, Aromasin ® is used for the treatment of hormone dependent advanced breast cancer in women in postmenopausal status (natural or induced) whose disease has progressed following a single hormonal (anti-estrogen) therapy or several hormonal therapies. THERAPEUTIC GROUP: Steroidal inhibitors of the enzyme aromatase, anti-neoplastic (anti- cancer) agents. Aromasin ® belongs to a group of medicines known as aromatase inhibitors; aromatase is an enzyme required for the production of the female sex hormones, estrogens, especially in postmenopausal women. Reduction in estrogen levels in the body is a way of treating hormone dependent breast cancer. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • you are or have previously been sensitive (allergic) to the active ingredient (exemestane) or to any of the other ingredients of this medicine. For additional information, please see section 6. • you are pregnant, likely to be pregnant or breastfeeding. • you are not po Leer el documento completo
Aromasin LPD CC 040523 1 2021-0068642 PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT AROMASIN ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 25 mg exemestane. Excipients with known effect: Each tablet contains 30.2 mg of sucrose and 0.003 mg of methyl parahydroxybenzoate. -For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Coated tablet Round, biconvex, off-white coated tablet marked 7663 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aromasin 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. Aromasin is indicated for the treatment of advanced breast cancer (ABC) in women with natural or induced postmenopausal status whose disease has progressed following anti- oestrogen therapy alone. Aromasin is also indicated for the treatment of postmenopausal women with ABC whose disease has progressed following multiple hormonal therapies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult and elderly patients The recommended dose of Aromasin is one 25 mg tablet to be taken once daily, preferably after a meal. In patients with early breast cancer, treatment with Aromasin should continue until completion of five years of adjuvant endocrine therapy, or until local or distant recurrence or new contralateral breast cancer. In patients with advanced breast cancer, treatment with Aromasin should continue until tumour progression is evident. No dose adjustments are required for patients with hepatic or renal insufficiency (see section 5.2). Aromasin LPD CC 040523 2 2021-0068642 Paediatric population 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 Aromasin should not be administered to women with pre-menopausal endocri Leer el documento completo