Country: Israel
Language: English
Source: Ministry of Health
ANASTROZOLE
TARO INTERNATIONAL LTD, ISRAEL
L02BG03
FILM COATED TABLETS
ANASTROZOLE 1.0 MG
PER OS
Required
HAUPT PHARMA MUNSTER GmbH, GERMANY
ANASTROZOLE
ANASTROZOLE
Treatment of advanced breast cancer in post menopausal women. Efficay has not been demonstrated in estrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen. Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. Adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
2022-03-31
Page 1 of 5 Patient leaflet in accordance with the Pharmacists’ Regulations (Preparations)- 1986 This medicine is dispensed with a doctor's prescription only Arimidex ® Film-coated tablets Composition: Each tablet contains: anastrozole 1 mg Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’, and 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 and adolescents. 1. What is this medicine intended for? Treatment of breast cancer in post-menopausal women. Therapeutic group: Aromatase enzyme inhibitors. Arimidex works by cutting down the amount of the hormone called estrogen that your body makes. Arimidex does this by blocking a natural substance (an enzyme) in your body called aromatase. 2. Before using this medicine Do not use this medicine if: You are sensitive (allergic) to the active ingredient anastrozole or to any of the other ingredients in this medicine (listed in section 6). You are pregnant or breast-feeding (see section ‘Pregnancy and breast-feeding’). Special warnings about using Arimidex Before treatment with Arimidex, tell your doctor if you: Still have menstrual periods and have not yet gone through the menopause. Are taking a medicine that contains tamoxifen or medicines that contain estrogen (see section ‘Drug interactions’). Have ever had a condition that affects the strength of your bones (osteoporosis). Have problems with your liver or kidneys. Additional warnings: If you go into the hospital, let the medical staff know you are taking Arimidex. Children and adolescents Arimidex should no Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS ARIMIDEX 1. NAME OF THE MEDICINAL PRODUCT ARIMIDEX 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg anastrozole. Excipients with known effect Each film-coated tablet contains 93 mg of lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex tablet with logo on one side and strength on the other. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of advanced breast cancer in postmenopausal women. Efficacy has not been demonstrated in estrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen. Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. Adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen. 4.2 Posology and method of administration Adults including the elderly: One 1 mg tablet to be taken orally once a day Children: Not recommended for use in children (see sections 5.1 and 5.2) Renal Impairment: No dose change is recommended in patients with mild or moderate renal impairment Hepatic Impairment: No dose change is recommended in patients with mild hepatic disease. For early disease, the recommended duration of treatment should be 5 years. 4.3 Contraindications Arimidex is contraindicated in: Pregnant or breastfeeding women. Patients with known hypersensitivity to anastrozole or to any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use General Arimidex should not be used in premenopausal women. The menopause should be defined biochemically (luteinizing-hormone [LH], follicle stimulating hormone [FSH], and/or estradiol levels) in any patient where there is doubt about menopausal status. There are no data to support the use of Arimidex with LHRH analogues. Co-administration of tamoxifen or estrogen-cont Read the complete document