Erlotinib
Erlotinib Zentiva contains the active substance erlotinib. Erlotinib Zentiva is a medicine used to treat cancer. The mechanism of action of the medicine involves inhibiting the activity of a protein called epidermal growth factor receptor (EGFR). This protein is involved in the process of growth and spread of cancer cells. Erlotinib Zentiva is indicated for use in adult patients. This medicine may be prescribed to patients with advanced non-small cell lung cancer. It may be used as first-line treatment or when the disease has not progressed significantly after first-line chemotherapy and provided that the tumor cells have specific EGFR mutations. The medicine may also be used when previous chemotherapy has not stopped the progression of the disease. This medicine may also be prescribed in combination with another medicine called gemcitabine to patients with pancreatic cancer with metastases.
Tell your doctor before taking Erlotinib Zentiva:
See also below "Other medicines and Erlotinib Zentiva". You should tell your doctor
Liver or kidney disease It is not known whether the action of Erlotinib Zentiva may be affected in cases of impaired liver or kidney function. The use of this medicine is not recommended in patients with severe liver or severe kidney disease. Glucuronyl transferase conjugation disorders, such as Gilbert's syndrome Your doctor should exercise caution when treating patients with glucuronyl transferase conjugation disorders, such as those with Gilbert's syndrome. Smokers Patients treated with Erlotinib Zentiva are advised to stop smoking, as smoking may decrease the levels of the medicine in the blood.
Erlotinib Zentiva has not been studied in patients under 18 years of age. The use of this medicine is not recommended in children and adolescents.
Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.
Do not take Erlotinib Zentiva with food. See also section 3 "How to take Erlotinib Zentiva".
You should avoid becoming pregnant while taking Erlotinib Zentiva. Women who may become pregnant should use appropriate contraception during treatment and for at least 2 weeks after taking the last tablet. If you become pregnant while taking Erlotinib Zentiva, you should immediately tell your doctor, who will decide whether treatment can be continued. You should not breast-feed while taking Erlotinib Zentiva and for at least 2 weeks after taking the last tablet. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Erlotinib Zentiva has not been studied for its ability to affect your ability to drive or use machines. It is unlikely that this treatment will affect your ability to drive or use machines.
Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. The tablet should be taken at least one hour before a meal or at least two hours after a meal. The usual dose of Erlotinib Zentiva is 150 mg once daily for non-small cell lung cancer. For pancreatic cancer with metastases, the usual dose of Erlotinib Zentiva is 100 mg once daily. Erlotinib Zentiva is given in combination with gemcitabine. Your doctor may reduce the dose of Erlotinib Zentiva in steps of 50 mg. To allow for different dosing schedules, Erlotinib Zentiva is available in 25 mg, 100 mg and 150 mg film-coated tablets. The 100 mg tablet can be divided into equal doses.
Contact your doctor or pharmacist immediately. You may experience increased side effects and your doctor may stop your treatment.
It is important to take Erlotinib Zentiva every day as long as your doctor prescribes it. If you are not sure about your treatment, consult your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects, tell your doctor as soon as possible:
Very common side effects(may affect more than 1 in 10 people):
Common side effects(may affect up to 1 in 10 people):
Uncommon side effects(may affect up to 1 in 100 people):
Rare side effects(may affect up to 1 in 1,000 people):
Very rare side effects(may affect up to 1 in 10,000 people):
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after "EXP". The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Erlotinib Zentiva, 25 mg, film-coated tablets are white, round, biconvex tablets with "E9OB" engraved on one side and "25" on the other, approximately 6 mm in diameter. Erlotinib Zentiva, 100 mg, film-coated tablets are white, round, biconvex tablets with a break line on both sides, "E9OB" engraved above the break line and "100" below the break line on one side, approximately 10 mm in diameter. Erlotinib Zentiva, 150 mg, film-coated tablets are white, round, biconvex tablets with "E9OB" engraved on one side and "150" on the other, approximately 10.4 mm in diameter. Erlotinib Zentiva is available in packs of 30 film-coated tablets.
Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
Synthon Hispania, S.L., Calle Castello 1, Pol. Las Salinas, Sant Boi De Llobregat, 08830 Barcelona, Spain Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands
Netherlands, Germany, Portugal, France, Latvia, Poland, United Kingdom (Northern Ireland), Sweden, Slovakia, Czech Republic: Erlotinib Zentiva
Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, tel.: +48 22 375 92 00 Date of last revision of the leaflet:December 2023
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