Ülke: Malta
Dil: İngilizce
Kaynak: Malta Medicines Authority
Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia
L02BX03
ABIRATERONE ACETATE 500 mg
FILM-COATED TABLET
ABIRATERONE ACETATE 500 mg
POM
ENDOCRINE THERAPY
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-06-13
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ABIRATERONE SANDOZ 250 MG FILM-COATED TABLETS ABIRATERONE SANDOZ 500 MG FILM-COATED TABLETS abiraterone acetate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Abiraterone Sandoz is and what it is used for 2. What you need to know before you take Abiraterone Sandoz 3. How to take Abiraterone Sandoz 4. Possible side effects 5. How to store Abiraterone Sandoz 6. Contents of the pack and other information 1. WHAT ABIRATERONE SANDOZ IS AND WHAT IT IS USED FOR Abiraterone Sandoz contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. Abiraterone Sandoz stops your body from making testosterone; this can slow the growth of prostate cancer. When Abiraterone Sandoz is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy). When you take this medicine your doctor will also prescribe another medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABIRATERONE SANDOZ DO NOT TAKE ABIRATERONE SANDOZ - if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6). - if you are Belgenin tamamını okuyun
Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Abiraterone Sandoz 250 mg film-coated tablets Abiraterone Sandoz 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate. Excipient with known effect Each film-coated tablet contains 32.3 mg of lactose (34 mg as monohydrate). Each film-coated tablet contains 64.6 mg of lactose (68 mg as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film – coated tablet. White to off-white, oval-shaped film-coated tablets, debossed with “250” on one side, with dimensions of 14.2 mm x 7.2 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abiraterone Sandoz is indicated with prednisone or prednisolone for: • the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) • the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) • the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should be prescribed by an appropriate healthcare professional. Posology The recommended dose is 1,000 mg (four 250 mg tablets or two 500 mg tablets) as a single daily dose that must not be taken with food (see “Method of administration” below). Taking the tablets with food increases systemic exposure to abiraterone (see sections 4.5 and 5.2). _Dosage of _ prednisone or _prednisolone _ For mHSPC, Abiraterone is used with 5 mg prednisone or prednisolone daily. Purple, oval-shaped film-coated tablets, debossed with “500” on one side, with dimen Belgenin tamamını okuyun