Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ANASTROZOLE
EUCOGEN SDN BHD
ANASTROZOLE
14 X 2tablet Tablets
REMEDICA LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ AREMED 1 MG FILM-COATED TABLETS _®_ _ _ Anastrozole (1 mg) my-pl-aremed-fc-tabs-a4 Page 1 of 3 WHAT IS IN THIS LEAFLET 1. What Aremed is used for 2. How Aremed works 3. Before you use Aremed 4. How to use Aremed 5. While you are using it 6. Side effects 7. Storage and Disposal of Aremed 8. Product Description 9. Manufacturer and. Product Registration Holder 10. Date of revision WHAT AREMED IS USED FOR Aremed contains a substance called anastrozole. This belongs to a group of medicines called ‘aromatase inhibitors’. Aremed is used to treat breast cancer in women who have gone through the menopause. HOW AREMED WORKS Aremed works by cutting down the amount of the hormone called estrogen that your body makes. It does this by blocking a natural substance (an enzyme) in your body called ‘aromatase’. BEFORE YOU USE AREMED _- When you must not use it _ _ _ Do not take this medicine if: • you are a premenopausal women. • you are a pregnant or lactating women. • you are having severe renal impairment (creatinine clearance less than 20 ml/min). • you are having moderate or severe hepatic disease. • you have known hypersensitivity to anastrozole or to any of the excipients. • you are on oestrogen-containing therapies should not be co-administered with Aremed as they would negate its pharmacological action. Aremed is also contra-indicated in patients receiving concurrent tamoxifen therapy. Do not take Aremed if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Aremed. _- Before you start to use it _ _ _ Talk to your doctor or pharmacist before taking Aremed if: • you still have menstrual periods and have not gone through the menopause. • you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section called ‘Taking other medicines’). • you have ever had a condition that affects the strength of your bones (osteoporosis). • you have problems with your live Đọc toàn bộ tài liệu
my-pi-aremed-fc-tabs-a3 Page 1 of 10 PACKAGE INSERT 1. PRODUCT NAME Aremed 1mg film-coated tablet. 2. NAME AND STRENGTH OF ACTIVE INGREDIENT Each film-coated tablet contains 1 mg anastrozole. Excipient(s) with known effect This product contains 65 mg lactose. 3. PRODUCT DESCRIPTION Film-coated tablet. White, round, film-coated tablets with a diameter of 6,6 mm approximately 4. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMICS Pharmacotherapeutic group: Endocrine therapy; Hormone antagonists and related agents, ATC code: L02BG03 Mechanism of action and pharmacodynamics effects Aremed is a potent and highly selective non-steroidal aromatase inhibitor. In postmenopausal women, estradiol is produced primarily from the conversion of androstenedione to esterone through the aromatase enzyme complex in peripheral tissues. Esterone is subsequently converted to estradiol. Reducing circulating estradiol levels has been shown to produce a beneficial effect in women with breast cancer. In postmenopausal women, anastrozole at a daily dose of 1 mg produced estradiol suppression of greater than 80% using a highly sensitive assay. Anastrozole does not possess any progestogenic, androgenic or oestrogenic activity. Daily doses of anastrozole up to 10 mg do not have any effect on cortisol or aldosterone secretion, measured before or after standard ACTH challenge testing. Corticoid supplements are therefore not needed. Clinical efficacy and safety _ _ _Advanced breast cancer _ _First-line therapy in postmenopausal women with advanced breast cancer _ Two double-blind, controlled clinical studies of similar design (Study 1033IL/0030 and Study 1033IL/0027) were conducted to assess the efficacy of anastrozole compared with tamoxifen as first-line therapy for hormone receptor-positive or hormone receptor- unknown locally advanced or metastatic breast cancer in postmenopausal women. A total of 1,021 patients were randomised to receive 1 mg of anastrozole once daily or 20 my-pi-aremed-fc-tabs-a3 Page 2 of 10 mg of tamoxifen once daily. The primar Đọc toàn bộ tài liệu