Country: Malta
Language: English
Source: Medicines Authority
BICALUTAMIDE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
L02BB03
BICALUTAMIDE 150 mg
FILM-COATED TABLET
BICALUTAMIDE 150 mg
POM
ENDOCRINE THERAPY
Withdrawn
2014-08-27
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER BICALUTAMIDE ACTAVIS 150 MG FILM-COATED TABLETS bicalutamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Bicalutamide Actavis is and what it is used for 2. What you need to know before you use Bicalutamide Actavis 3. How to use Bicalutamide Actavis 4. Possible side effects 5. How to store Bicalutamide Actavis 6. Contents of the pack and other information 1. WHAT BICALUTAMIDE ACTAVIS IS AND WHAT IT IS USED FOR The growth of prostatic tumours is dependent on stimulation by male hormones (androgens). Bicalutamide Actavis contains the active substance bicalutamide, which prevents this stimulation. Bicalutamide Actavis is used in adult men for the treatment of locally advanced prostate cancer where there is a high risk that the cancer continues to grow or spread. It can be used alone or in combination with radiotherapy or prostate surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BICALUTAMIDE ACTAVIS DO NOT USE BICALUTAMIDE ACTAVIS - if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6). - if you are a woman or a child - if you are already taking any medicine c Read the complete document
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bicalutamide Actavis 150 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ One film-coated tablet contains 150 mg bicalutamide. Excipient with known effect: One film-coated tablet contains 169.68 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Bicalutamide Actavis 150 mg film-coated tablets are round, biconvex, white, 10 mm in diameter, with “B 150” printed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bicalutamide Actavis 150 mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adult males including the elderly: _ One tablet daily. The tablet should be swallowed whole with liquid. Bicalutamide 150 mg tablets should be taken continuously for at least 2 years or until disease progression. _Paediatric population _ Bicalutamide is not indicated in children and adolescents. _Renal impairment _ No dose adjustment is necessary for patients with renal impairment. _Hepatic impairment _ No dose adjustment is necessary for patients with mild hepatic impairment. The medicinal product may accumulate in patients with moderate to severe hepatic impairment (see section 4.4.). Page 2 of 8 4.3 CONTRAINDICATIONS Bicalutamide Actavis is contraindicated in females and children (see section 4.6). Bicalutamide Actavis must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any of the excipients listed i Read the complete document