Leaflet GEFITINIB ACCORD 250mg film-coated tablets

Indicated for: non-small cell lung cancer

Route of administration: oral

Substance: gefitinib (tyrosine kinase inhibitor)

ATC: L01EB01 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors)

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.

Avoid grapefruit
Avoid grapefruit

Avoid grapefruit and grapefruit juice.

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.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Gefitinib is a medication used for the treatment of non-small cell lung cancer, particularly in patients with epidermal growth factor receptor (EGFR) mutations. It is a tyrosine kinase inhibitor.

This medication works by blocking signals that promote the growth and division of cancer cells. It is taken orally, usually once daily, as directed by a doctor.

Common side effects include diarrhea, skin rash, nausea, and fatigue. In rare cases, severe reactions such as interstitial lung disease may occur.

It is important to follow your doctor's instructions closely and report any side effects or unusual symptoms. Regular monitoring is necessary to assess treatment effectiveness.

General data about GEFITINIB ACCORD 250mg

  • Substance: gefitinib
  • Date of latest medicines list: 01-06-2026
  • Product code: W65738001
  • Concentration: 250mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 30
  • Product type: Generic medicine
  • Price: 2442.81 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: LABORATORI FUNDACIÓ DAU - SPANIA
  • Holder: ACCORD HEALTHCARE POLSKA SP. Z O.O. - POLONIA
  • Number: 15421/2024/01
  • Shelf life: 3 years;dupa dispersi in apa trebuie utilizat in 90 min.

Compensation lists for GEFITINIB ACCORD 250mg Accord

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

2442.81 RON

2442.81 RON

0.00 RON