Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
exemestane, Quantity: 25 mg
Sandoz Pty Ltd
Exemestane
Tablet, film coated
Excipient Ingredients: mannitol; polysorbate 80; microcrystalline cellulose; hypromellose; macrogol 400; colloidal anhydrous silica; titanium dioxide; magnesium stearate; sodium starch glycollate type A; crospovidone
Oral
15, 90, 30
(S4) Prescription Only Medicine
Exemestane Sandoz is indicated for the sequential adjuvant treatment of oestrogen receptor-positive early breast cancer in post-menopausal women who have received prior adjuvant tamoxifen therapy.,Exemestane Sandoz is indicated for the treatment of oestrogen receptor-positive advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy.
Visual Identification: White to off-white, round, biconvex film-coated tablets, debossed with 'E25' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-09-12
EXEMESTANE SANDOZ ® 1 EXEMESTANE SANDOZ ® _exemestane film-coated tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Exemestane Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EXEMESTANE SANDOZ IS USED FOR This medicine is used: • to treat breast cancer in women who no longer have their menstrual periods, either naturally due to their age (after menopause) or because they have had their ovaries surgically removed • to reduce the risk of recurrence or spreading of the breast cancer • when the cancer has not responded or has returned after treatment with another medicine or medicines. It contains the active ingredient exemestane. Exemestane is an aromatase inactivator. It works by significantly reducing the supply of oestrogen to cancer cells. This stops the growth of those cancer cells which need oestrogen, a natural female sex hormone, to grow. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE EXEMESTANE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • exemestane, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TA Прочитайте повний документ
220214-Exemestane Sandoz-pi Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION EXEMESTANE SANDOZ ® (EXEMESTANE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Exemestane 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Exemestane Sandoz 25 mg tablet contains 25 mg exemestane. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Exemestane Sandoz 25 mg film-coated tablets – White to off-white round, biconvex film- coated tablet, debossed with ‘E25’ on one side and plane on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Exemestane Sandoz is indicated for the sequential adjuvant treatment of oestrogen receptor- positive early breast cancer in post-menopausal women who have received prior adjuvant tamoxifen therapy. Exemestane Sandoz is indicated for the treatment of oestrogen receptor-positive advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE _Adults _ The recommended dose of Exemestane Sandoz in adults is one 25 mg tablet. In patients with early breast cancer, treatment should continue until completion of five years adjuvant hormonal therapy, or until tumour relapse occurs. In patients with advanced breast cancer, treatment with Exemestane Sandoz should continue until tumour progression is evident. No dose adjustments are required for patients with hepatic or renal insufficiency. Not recommended for use in children. METHOD OF ADMINISTRATION Taken once daily, preferably after a meal. 4.3 C ONTRAINDICATIONS Exemestane Sandoz tablets are contraindicated in pregnant or lactating women and in patients with a known hypersensitivity to the active ingredient or to any of the excipients. 220214-Exemestane Sandoz-pi Page 2 of 16 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE CHECK THE FOLLOWING BEFORE USE Because of its mode of action, exemestane should not be administered to women with pre- menopausal endocrine status. Whenever clinically app Прочитайте повний документ