Leaflet BICALUTAMIDA ALVOGEN 50mg film-coated tablets


Indicated for: prostate cancer

Route of administration: oral

Substance: bicalutamide (antiandrogen)

ATC: L02BB03 (Antineoplastic and immunomodulating agents | Hormone antagonists and related agents | Anti-androgens)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Teratogenic / fetal risk
Teratogenic / fetal risk

This medicine may affect fetal development.

Bicalutamide is an antiandrogen medication primarily used for the treatment of advanced prostate cancer. It works by blocking androgen receptors, thereby reducing the effects of male hormones (testosterone) on prostate cancer cells. It is often used in combination with other therapies, such as gonadotropin-releasing hormone (GnRH) analogs.

Bicalutamide is taken orally, usually once daily, and is well-tolerated by most patients. Common side effects include hot flashes, breast tenderness or enlargement (gynecomastia), fatigue, and nausea. In rare cases, it may affect liver function, so regular liver monitoring is recommended.

The medication is contraindicated in women, especially during pregnancy or breastfeeding, and is not recommended for use in children. It is important for patients to strictly follow their doctor’s instructions and not discontinue treatment without medical advice.

General data about BICALUTAMIDA ALVOGEN 50mg

  • Substance: bicalutamide
  • Date of last drug list: 01-01-2019
  • Commercial code: W58039001
  • Concentration: 50mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 28
  • Product type: generic
  • Prescription restrictions: P-6L - Medicines prescription that isn't retained in the pharmacy (can be renewed); the prescription can be used for 6 months from the moment of release.

Marketing authorisation

  • Manufacturer: GENEPHARM S.A. - GRECIA
  • Holder: ALVOGEN MALTA OPERATIONS (ROW) LTD. - MALTA
  • Number: 12193/2019/01
  • Shelf life: 5 years

Concentrations available for bicalutamide

  • 150mg
  • 50mg