Country: Malta
Language: English
Source: Medicines Authority
ABIRATERONE ACETATE
Heaton k.s. Na Pankraci 14, 140 00 Praha 4, Czech Republic
L02BX03
ABIRATERONE ACETATE 500 mg
FILM-COATED TABLET
ABIRATERONE ACETATE 500 mg
POM
ENDOCRINE THERAPY
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-12-02
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ABIRATERONE HEATON 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Abiraterone Heaton is and what it is used for 2. What you need to know before you take Abiraterone Heaton 3. How to take Abiraterone Heaton 4. Possible side effects 5. How to store Abiraterone Heaton 6. Contents of the pack and other information 1. WHAT ABIRATERONE HEATON IS AND WHAT IT IS USED FOR Abiraterone Heaton 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 Heaton stops your body from making testosterone; this can slow the growth of prostate cancer. When Abiraterone Heaton 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 HEATON _ _ DO NOT TAKE ABIRATERONE HEATON: - if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6). - if you are a woman, especially if pregnant. Abiraterone Heaton is f Read the complete document
Page 1 of 26 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Abiraterone Heaton 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of abiraterone acetate. Excipients with known effect Each tablet contains 241 mg of lactose and 12 mg sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Oval-shaped purple film-coated tablet, approximately 19 mm long by 11 mm wide and debossed with “A7TN” on one side and “500” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abiraterone Heaton 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 (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 Heaton is used with 5 mg prednisone or prednisolone daily. Page 2 of 26 For mCRPC, Abiraterone Heaton is used with 10 mg prednisone or prednisolone daily. Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated. _Recommended monitoring_ Serum transaminases should be measur Read the complete document