Company Details

  • NINGBO VOICE BIOCHEMIC CO. LTD

  •  [Zhejiang,China]
  • Business Type:Manufacturer , Trade Company
  • Main Mark: Worldwide
  • Exporter:61% - 70%
  • Description:Bicalutamide Tablet 50mg,Bicalutamide 50 Mg,Bicalutamide 50 Mg Tablet
Inquiry Basket ( 0 )

NINGBO VOICE BIOCHEMIC CO. LTD

Bicalutamide Tablet 50mg,Bicalutamide 50 Mg,Bicalutamide 50 Mg Tablet

Home > Products > Finished Drugs > Others Finished Drugs > Bicalutamide 50 mg Film-coated Tablets

Bicalutamide 50 mg Film-coated Tablets

Share to:  

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

Looking for ideal Bicalutamide Tablet 50mg Manufacturer & supplier ? We have a wide selection at great prices to help you get creative. All the Bicalutamide 50 Mg are quality guaranteed. We are China Origin Factory of Bicalutamide 50 Mg Tablet. If you have any question, please feel free to contact us.

Product Categories : Finished Drugs > Others Finished Drugs

Email to this supplier
  • *Subject:
  • *Messages:
    Your message must be between 20-8000 characters
Communicate with Supplier?Supplier
Medic Ren Mr. Medic Ren
What can I do for you?
Contact Supplier