Nchi: Armenia
Lugha: Kiingereza
Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
tamoxifen (tamoxifen citrate)
Apotex Inc.
L02BA
tamoxifen (tamoxifen citrate)
20mg
tablets
(100) plastic container
Prescription
Registered
2015-05-15
Page 13 of 36 INFORMATION FOR THE CONSUMER APO-TAMOX TAMOXIFEN CITRATE TABLETS, BP 10 MG AND 20 MG DESCRIPTION APO-TAMOX is a medicine that blocks the effects of the hormone estrogen in the body. It is used to treat breast cancer. The exact way that tamoxifen works against cancer is not known, but it may be related to the way it blocks the effects of estrogen on the body. APO-TAMOX is available only with your doctor’s prescription. WHAT DOES APO-TAMOX CONTAIN? In addition to the active ingredient tamoxifen citrate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. BEFORE USING THIS MEDICATION In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. Before taking tamoxifen, tell your doctor if any of the following apply to you: If you have ever had any unusual or allergic reaction to APO-TAMOX or to any one of its ingredients (See WHAT DOES APO-TAMOX CONTAIN?). If you intend to become pregnant. It is best to use some kind of birth control while you are taking APO-TAMOX and for about two months after you stop taking it. Please see your doctor for advice on what contraceptive precautions you should take, as some may be affected by APO-TAMOX. Tell your doctor right away if you think you have become pregnant while taking tamoxifen or within two months of having stopped it. Page 14 of 36 It is important that you tell your doctor immediately if you have any unusual vaginal bleeding or other gynaecological symptoms (such as pelvic pain or pressure) when you are taking APO-TAMOX or anytime afterwards. This is because a number of changes to the lining of the womb (the endometrium) may occur, some of which may be serious and could include cancer. If you are breastfeeding or intend to breastfeed. If you are taking or have recently taken any other prescription, including antid Soma hati kamili
Page 1 of 36 PRODUCT MONOGRAPH APO-TAMOX TAMOXIFEN CITRATE TABLETS, BP 10 MG AND 20 MG (TAMOXIFEN AS TAMOXIFEN CITRATE) ANTINEOPLASTIC AGENT APOTEX INC. DATE OF PREPARATION: 150 SIGNET DRIVE October 17, 1989 TORONTO, ONTARIO DATE OF REVISION: M9L 1T9 FEBRUARY 19, 2018 Control Number: 201525 Page 2 of 36 PRODUCT MONOGRAPH APO-TAMOX Tamoxifen Citrate Tablets, BP 10 mg and 20 mg THERAPEUTIC CLASSIFICATION Antineoplastic Agent (non-steroidal antiestrogen) TAMOXIFEN CITRATE THERAPY WAS ASSOCIATED WITH SERIOUS AND LIFE-THREATENING EVENTS INCLUDING UTERINE MALIGNANCIES, STROKE, PULMONARY EMBOLISM, AND DEEP VEIN THROMBOSIS IN THE NSABP P-1 TRIAL FOR THE PREVENTION OF BREAST CANCER. THE USE OF TAMOXIFEN CITRATE FOR BREAST CANCER PREVENTION IS NOT AN APPROVED INDICATION IN CANADA. IN THE NSABP P-1 TRIAL, THE RELATIVE RISK OF TAMOXIFEN CITRATE COMPARED TO PLACEBO WAS 3.1 FOR ENDOMETRIAL CANCER, 4.0 FOR UTERINE SARCOMAS, 1.6 FOR STROKE, 3.0 FOR PULMONARY EMBOLISM, AND 1.6 FOR DEEP VEIN THROMBOSIS. THESE EVENTS WERE FATAL IN SOME PATIENTS. HEALTH CARE PROVIDERS SHOULD BE AWARE OF THE POSSIBLE RISKS ASSOCIATED WITH APO- TAMOX THERAPY AND SHOULD DISCUSS THEM WITH THEIR PATIENTS. THE BENEFITS OF TAMOXIFEN CITRATE THERAPY OUTWEIGH THE RISKS IN THE MAJORITY OF WOMEN BEING TREATED ACCORDING TO THE APPROVED CANADIAN INDICATION FOR THE TREATMENT OF BREAST CANCER. ACTIONS AND CLINICAL PHARMACOLOGY Tamoxifen citrate, the active ingredient, is a non-steroidal agent which has demonstrated potent antiestrogenic properties in animal test systems. The antiestrogenic effects are related to its ability to compete with estrogen for binding sites in target tissues such as breast and uterus. Tamoxifen citrate inhibits the induction of rat mammary carcinoma induced by dimethylbenzanthracene (DMBA) and causes the regression of already established DMBA- induced tumours. In this rat model, tamoxifen citrate appears to exert its antitumour effects by binding to estrogen receptors. In cytosols derived from human endometrium and human breast and uterin Soma hati kamili