Leaflet LAPATINIB STADA 250mg film-coated tablets

Product code:
W69108001
Quantity:
70
Indicated for:
cancer
Route of administration:
oral
Substance:
lapatinib (tyrosine kinase inhibitor)
ATC
L01EH01 — Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Human epidermal growth factor receptor 2 (HER2) 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.

Lapatinib is a medication used to treat advanced or metastatic breast cancer, particularly in cases where tumors overexpress the HER2 receptor. It is a tyrosine kinase inhibitor that blocks cellular signaling involved in cancer cell growth and survival.

The medication is taken orally, usually once daily, and is used in combination with other therapies such as capecitabine or letrozole. Treatment is carried out under the supervision of an oncologist.

Side effects may include diarrhea, nausea, skin rash, fatigue, or loss of appetite. In rare cases, severe adverse effects such as liver or cardiac toxicity may occur.

Patients should inform their doctor about any other medications they are taking and strictly follow the administration instructions. Pregnant or breastfeeding women should not use this medication.

General data about LAPATINIB STADA 250mg

Substance:
lapatinib
Date of latest medicines list:
01-10-2022
Product code:
W69108001
Concentration:
250mg
Pharmaceutical form:
film-coated tablets
Quantity:
70
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:
REMEDICA LTD. - CIPRU
Holder:
STADA M&D S.R.L. - ROMANIA
Number:
14607/2022/01
Shelf life:
30 months