Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EXEMESTANE
PFIZER (MALAYSIA) SDN. BHD.
EXEMESTANE
90Tablet Tablets; 30Tablet Tablets
Pfizer Italia S.r.l.
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ AROMASIN ® TABLET Exemestane (25 mg) 1 WHAT IS IN THIS LEAFLET 1. What Aromasin is used for 2. How Aromasin works 3. Before you use Aromasin 4. How to use Aromasin 5. While you are using it 6. Side Effects 7. Storage and Disposal of Aromasin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT AROMASIN IS USED FOR Aromasin is used to treat hormone dependent early breast cancer in post- menopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen. Aromasin is indicated for the second- and third-line treatment of advanced breast cancer (ABC) in women with post- menopausal status whose disease has progressed following anti-estrogen therapy alone or following multiple hormonal therapies respectively. HOW AROMASIN WORKS Aromasin is an irreversible, steroidal aromatase inhibitor. It interferes with the normal estrogen production by blocking the enzyme aromatase, which is used to convert androgens (hormones produced by adrenal glands) into estrogen. It thereby helps lower estrogen production in postmenopausal women. Estrogen deprivation hampers the growth of hormone dependent breast cancer. BEFORE YOU USE AROMASIN - _When you must not use it_ - If you are or have previously been allergic (hypersensitive) to exemestane (the active ingredient in Aromasin) or any of the other ingredients of Aromasin. See section “Product description” for full list of other ingredients. _Pregnancy and lactation_ Do not take Aromasin if you are pregnant, trying to get pregnant or think you may be pregnant because it may cause harm to the fetus. In animal reproductive studies, exemestane demonstrated some toxic effects. Do not take Aromasin if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it_ - Tell your doctor if you have a history or are suffering from any condition, which affects the strength of you Baca dokumen lengkap
Pfizer Confidential CLD Title : Exemestane CLD Date : 17 August 2021 Country : Malaysia Reference Document: CDS Version 11.0 dated 03 June 2021; USPI dated May 2018 (Indication 1.1 only) LAB-0098-20.0 Reason for change : PfLEET 2021-0068641 (S2): To update section 4.8 addition of ADR’s. Pfizer Confidential 1. TRADE NAME OF THE MEDICINAL PRODUCT Aromasin. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sugar-coated tablet contains 25 mg exemestane. 3. PHARMACEUTICAL FORM Coated tablets. 3.1 DESCRIPTION Sugar-coated tablets for oral administration. Aromasin tablets are round, biconvex, off-white to slightly greyish sugar-coated tablets, about 6 mm diameter printed with numbers 7663 on one side in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Exemestane is indicated for the adjuvant treatment of post-menopausal women with estrogen receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to Exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy. Exemestane is indicated for the second-line treatment of advanced breast cancer (ABC) in women with natural or induced post-menopausal status whose disease has progressed following anti-estrogen therapy alone. Exemestane is also indicated for the third-line treatment in post-menopausal woman with ABC whose disease has progressed following multiple hormonal therapies. Efficacy has not been demonstrated in patients with estrogen receptor negative status. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult and Elderly Patients The recommended dose of exemestane is one 25 mg tablet to be taken once daily, preferably after a meal. In patient with early breast cancer, treatment with exemestane should continue until completion of five years of adjuvant endocrine therapy, or until local or distant recurrence or new contralateral breast cancer. In patient with advanced breast cancer, treatment with exemestane should continue until tumor progression is evident. Hepatic or Renal Insuffic Baca dokumen lengkap