Bicalutamide 50 mg Film-coated Tablets
Product Description
In this section, undesirable effects are defined as follows: very common (≥1/10); common (≥1/100, < 1/10); uncommon (≥1/1,000, < 1/100); rare (≥1/10,000, < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Table 1 Frequency of Adverse Reactions
|
System Organ Class |
Frequency |
Event |
|
Blood and lymphatic system disorders |
Very common |
Anaemia |
|
Immune system disorders |
Uncommon |
Hypersensitivity, angioedema and urticaria |
|
Metabolism and nutrition disorders |
Common |
Decreased appetite |
|
Psychiatric disorders |
Common |
Decreased libido depression |
|
Nervous system disorders |
Very common |
Dizziness |
|
Common |
Somnolence |
|
|
Cardiac disorders |
Common |
Myocardial infarction (fatal outcomes have been reported)4, Cardiac failure4 |
|
Not known |
QT prolongation (see sections 4.4 and 4.5) |
|
|
Vascular disorders |
Very common |
Hot flush |
|
Respiratory, thoracic and mediastinal disorders |
Uncommon |
Interstitial lung disease5 (fatal outcomes have been reported). |
|
Gastrointestinal disorders |
Very common |
Abdominal pain constipation nausea |
|
Common |
Dyspepsia flatulence |
|
|
Hepato-biliary disorders |
Common |
Hepatotoxicity, jaundice, hypertransaminasaemia1 |
|
Rare |
Hepatic failure2 (fatal outcomes have been reported). |
|
|
Skin and subcutaneous tissue disorders |
Common |
Alopecia hirsutism/hair re-growth dry skin pruritus rash |
|
Rare |
Photosensitivity reaction |
|
|
Renal and urinary disorders |
Very common |
Haematuria |
|
Reproductive system and breast disorders |
Very common |
Gynaecomastia and breast tenderness3 |
|
Common |
Erectile dysfunction |
|
|
General disorders and administration site conditions |
Very common |
Asthenia oedema |
|
Common |
Chest pain |
|
|
Investigations |
Common |
Weight increased |
1. Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following cessation of therapy
2. Listed as an adverse drug reaction following review of post-marketed data. Frequency has been determined from the incidence of reported adverse events of hepatic failure in patients receiving treatment in the open-label bicalutamide arm of the 150 mg EPC studies.
3. May be reduced by concomitant castration.
4. Observed in a pharmaco-epidemiology study of LHRH agonists and anti-androgens used in the treatment of prostate cancer. The risk appears to be increased when bicalutamide was used in combination with LHRH agonists but no increase in risk was evident when bicalutamide was used as a monotherapy to treat prostate cancer.
5. Listed as an adverse drug reaction following review of post-marketed data. Frequency has been determined from the incidence of reported adverse events of interstitial pneumonia in the randomised treatment period of the 150 mg EPC studies.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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Address: 298 West Zhongshan Road.,Ningbo,Zhejiang
Contact Person: Medic Ren
Phone：86-574-87330957
Fax：86-574-87330957
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