Leaflet TEMOZOLOMIDA ACCORD 140mg capsules

Indicated for: malignant glioma

Route of administration: oral

Substance: temozolomide (alkylating antineoplastic agent)

ATC: L01AX03 (Antineoplastic and immunomodulating agents | Alkylating agents | Other alkylating 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.

Temozolomide is a chemotherapy agent used for the treatment of certain types of brain tumors, such as glioblastoma multiforme and anaplastic astrocytoma. It works by interfering with the DNA of tumor cells, thereby inhibiting their growth and division.

The medication is taken orally, usually once daily, as directed by a doctor. The dosage is adjusted based on body weight and the patient's overall condition.

Patients should be monitored for potential side effects, such as nausea, vomiting, or a decrease in blood cell counts. It is important to inform the doctor of any unusual symptoms.

Common side effects include nausea, vomiting, fatigue, and loss of appetite. In rare cases, severe reactions such as myelosuppression or serious infections may occur. Patients should be informed of these risks before starting treatment.

General data about TEMOZOLOMIDA ACCORD 140mg

  • Substance: temozolomide
  • Date of latest medicines list: 01-06-2026
  • Product code: W65712002
  • Concentration: 140mg
  • Pharmaceutical form: capsules
  • Quantity: 5
  • Product type: Generic medicine
  • Price: 428.53 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: ACCORD HEALTHCARE LIMITED - MAREA BRITANIE
  • Holder: ACCORD HEALTHCARE S.L.U. - SPANIA
  • Number: 615/2010/031
  • Shelf life: 2 years

Pharmaceutical forms available for temozolomide

Concentrations available for temozolomide

  • 100mg
  • 140mg
  • 180mg
  • 2.5mg/ml
  • 20mg
  • 240mg
  • 250mg
  • 5mg
PDF icon EMA leaflet
Published: 26/03/2010
Updated: 02/06/2025

Compensation lists for TEMOZOLOMIDA ACCORD 140mg Accord

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

428.53 RON

417.98 RON

10.55 RON