Leaflet HYDREA 500mg capsules

Indicated for: myeloproliferative neoplasms; sickle cell disease

Route of administration: oral

Substance: hydroxycarbamide (antineoplastic agent)

ATC: L01XX05 (Antineoplastic and immunomodulating agents | Other antineoplastic agents)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

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.

Hydroxyurea is a medication used to treat certain types of cancer, such as chronic myeloid leukemia, and other conditions like sickle cell anemia. It works by inhibiting DNA synthesis, which slows the growth of cancerous or abnormal cells.

The medication is taken orally, as directed by a doctor.

Side effects may include nausea, vomiting, decreased blood cell counts, fatigue, or skin rashes. In rare cases, severe allergic reactions or hematologic toxicity may occur.

Patients should be closely monitored during treatment and inform their doctor about any other medications they are taking. Pregnant or breastfeeding women should not use this medication.

General data about HYDREA 500mg

  • Substance: hydroxycarbamide
  • Date of latest medicines list: 01-06-2026
  • Product code: W03542001
  • Concentration: 500mg
  • Pharmaceutical form: capsules
  • Quantity: 100
  • Product type: Original
  • Price: 121.69 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: CORDEN PHARMA LATINA S.p.A. - ITALIA
  • Holder: BRISTOL MYERS SQUIBB KFT - UNGARIA
  • Number: 11474/2019/01
  • Shelf life: 3 years

Pharmaceutical forms available for hydroxycarbamide

Concentrations available for hydroxycarbamide

  • 1000mg
  • 500mg

Compensation lists for HYDREA 500mg Bristol Myers Squibb

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

121.69 RON

121.69 RON

0.00 RON