Leaflet GEFITINIB FLOMI 250mg film-coated tablets

Product code:
W67582001
Quantity:
30
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 FLOMI 250mg

Substance:
gefitinib
Date of latest medicines list:
01-06-2021
Product code:
W67582001
Concentration:
250mg
Pharmaceutical form:
film-coated tablets
Quantity:
30
Product type:
Generic medicine
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
GENEPHARM S.A. - GRECIA
Holder:
GENEPHARM S.A. - GRECIA
Number:
13055/2020/01
Shelf life:
3 years