Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
ERLOTINIB HYDROCHLORIDE
Pharmascience International Ltd Lampousas 1, 1095 Nicosia , Cyprus
L01XE03
ERLOTINIB HYDROCHLORIDE 150 mg
FILM-COATED TABLET
ERLOTINIB HYDROCHLORIDE 150 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2021-01-05
PAGE 1 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ERLOTINIB PHARMASCIENCE 100 MG FILM-COATED TABLETS ERLOTINIB PHARMASCIENCE 150 MG FILM-COATED TABLETS erlotinib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Erlotinib Pharmascience is and what it is used for 2. What you need to know before you take Erlotinib Pharmascience 3. How to take Erlotinib Pharmascience 4. Possible side effects 5 How to store Erlotinib Pharmascience 6. Contents of the pack and other information 1. WHAT ERLOTINIB PHARMASCIENCE IS AND WHAT IT IS USED FOR Erlotinib Pharmascience contains the active substance erlotinib. Erlotinib Pharmascience is a medicine used to treat cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR). This protein is known to be involved in the growth and spread of cancer cells. Erlotinib Pharmascience is indicated for adults. This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage. It can be prescribed as initial therapy or as therapy if your disease remains largely unchanged after initial chemotherapy, provided your cancer cells have specific EGFR mutations. It can also be prescribed if previous chemotherapy has not helped to stop your disease. This medicine can also be prescribed to you in combination with another treatment called gemcitabine if you have cancer of the pancreas at a metastatic stage. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERLOTINIB PHARMASCIENCE DO NOT TAKE ERLOTINIB PHARMASCIENCE • if you are Perskaitykite visą dokumentą
Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Erlotinib Pharmascience 100 mg film-coated tablets Erlotinib Pharmascience 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Erlotinib Pharmascience 100 mg film-coated tablets_ Each film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride). _Erlotinib Pharmascience 150 mg film-coated tablets_ Each film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride). Excipient(s) with known effect: _Erlotinib Pharmascience 100 mg film-coated tablets _ Each film-coated tablet contains 95.93 mg Lactose monohydrate. _Erlotinib Pharmascience 150 mg film-coated tablets _ Each film-coated tablet contains 143.90 mg Lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _Erlotinib Pharmascience 100 mg film-coated tablets _ White to yellowish, round biconvex, film-coated tablet, engraved with “100” on one side. The diameter of the tablet is 8.9 mm. _Erlotinib Pharmascience 150 mg film-coated tablets _ White to yellowish, round biconvex, film-coated tablet, engraved with “150” on one side. The diameter of the tablet is 10.5 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-Small Cell Lung Cancer (NSCLC): Erlotinib Pharmascience is indicated for the first-line treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with EGFR activating mutations. Erlotinib Pharmascience is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy. Erlotinib Pharmascience is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Erlotinib Pharmascience is indicated when other treatment options are not considered suitable. When prescribing Perskaitykite visą dokumentą