Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
letrozole, Quantity: 2.5 mg
Medis Pharma Pty Ltd
Letrozole
Tablet, film coated
Excipient Ingredients: lactose monohydrate; maize starch; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350
Oral
30 tablets, 100 tablets
(S4) Prescription Only Medicine
Treatment of postmenopausal women with hormone receptor positive breast cancer (see Clinical Trials). The safety and efficacy of neoadjuvant use of letrozole has not been established. Letrozole is not indicated in hormone receptor negative disease.
Visual Identification: Round, yellow, lenticular film-coated tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2011-09-22
LETROZOLEACTAVIS/102011/CMI-1 1 Letrozole Actavis _contains the active ingredient letrozole _ CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about LETROZOLE ACTAVIS. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking LETROZOLE ACTAVIS against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. What LETROZOLE ACTAVIS is used for LETROZOLE ACTAVIS is used to treat breast cancer in women who are post-menopausal that is, women who no longer have periods, either naturally due to their age or after surgery or chemotherapy. LETROZOLE ACTAVIS belongs to a group of medicines called aromatase inhibitors also called ‘antioestrogens’. These medicines work by reducing the production of oestrogen in your body. Oestrogen stimulates the growth of certain types of breast cancer. These cancers are called "oestrogen-dependent." Reducing the production of oestrogen may help to keep the cancer from growing. This may be the first time you are taking an "antioestrogen" such as letrozole or you may have taken another "antioestrogen" such as tamoxifen in the past. Your doctor may have prescribed LETROZOLE ACTAVIS for another reason. Ask your doctor if you have any questions about why LETROZOLE ACTAVIS has been prescribed for you. LETROZOLE ACTAVIS is available only with a doctor's prescription. There is no evidence that LETROZOLE ACTAVIS is addictive. Before you take LETROZOLE ACTAVIS _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE LETROZOLE ACTAVIS IF YOU ARE ALLERGIC TO MEDICINES CONTAINING LETROZOLE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue whic Read the complete document
Letrozole Actavis PRODUCT INFORMATION NAME OF THE MEDICINE Letrozole. The chemical name for letrozole is 4, 4'-[(1H-1, 2, 4-triazol-1-yl)- methylene]bis- benzonitrile . Its structural formula is: C 17 H 11 N 5 Molecular weight: 285.3 CAS No.: 112809-51-5 DESCRIPTION Letrozole is a white to off-white, crystalline powder. It is practically insoluble in water, freely soluble in methylene chloride and sparingly insoluble in methanol. Letrozole Actavis tablets come in one strength and contain 2.5 mg of letrozole. The tablets also contain sodium starch glycollate, microcrystalline cellulose, magnesium stearate, maize starch, lactose, Opadry II 85F32410 Yellow (ARTG 107176). The tablets are gluten free. PHARMACOLOGY PHARMACOTHERAPEUTIC GROUP Non-steroidal aromatase inhibitor (inhibitor of oestrogen biosynthesis); antineoplastic agent. PHARMACODYNAMICS The elimination of oestrogen-mediated stimulatory effects is a prerequisite for tumour response in cases where the growth of tumour tissue depends on the presence of oestrogens. In postmenopausal women, oestrogens are mainly derived from the action of the aromatase enzyme, which converts adrenal androgens - primarily androstenedione and testosterone - to oestrone (E1) and oestradiol (E2). The suppression of oestrogen biosynthesis in peripheral tissues and the cancer tissue itself can, therefore, be achieved by specifically inhibiting the aromatase enzyme. Letrozole is a non-steroidal aromatase inhibitor. Data suggest it inhibits the aromatase enzyme by competitively binding to the haem of the cytochrome P450 subunit of the enzyme, resulting in a reduction of oestrogen biosynthesis in all tissues. In healthy postmenopausal women, single doses of 0.1, 0.5 and 2.5 mg letrozole suppressed serum oestrone and oestradiol by 75-78% and 78% from baseline, respectively. Maximum suppression was achieved in 48-78 h. LETROZOLE ACTAVIS – Product information Page 2 of 17 In postmenopausal patients with advanced breast cancer, daily doses of 0.1 to 5 mg letrozole suppressed plasma conce Read the complete document