Country: Sweden
Language: Swedish
Source: Läkemedelsverket (Medical Products Agency)
erlotinibhydroklorid
Orion Corporation
L01EB02
erlotinib hydrochloride
25 mg
Filmdragerad tablett
erlotinibhydroklorid 27,3 mg Aktiv substans; laktos (vattenfri) Hjälpämne
Receptbelagt
Förpacknings: Blister, 30 tabletter
Avregistrerad
2019-01-15
PACKAGE LEAFLET: INFORMATION FOR THE USER ERLOTINIB ORION 25 MG FILM-COATED TABLETS ERLOTINIB ORION 100 MG FILM-COATED TABLETS ERLOTINIB ORION 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 any 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 Orion is and what it is used for 2. What you need to know before you take Erlotinib Orion 3. How to take Erlotinib Orion 4. Possible side effects 5. How to store Erlotinib Orion 6. Contents of the pack and other information 1. WHAT ERLOTINIB ORION IS AND WHAT IT IS USED FOR Erlotinib Orion contains the active substance erlotinib. Erlotinib Orion 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 Orion 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 ORION Do not take Erlotinib Orion: - if you are allergic to erlotinib or any of the ingredients of this medicine Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Erlotinib Orion 25 mg film-coated tablets Erlotinib Orion 100 mg film-coated tablets Erlotinib Orion 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Erlotinib Orion 25 mg film-coated tablets Each tablet contains erlotinib hydrochloride equivalent to 25 mg of erlotinib. Erlotinib Orion 100 mg film-coated tablets Each tablet contains erlotinib hydrochloride equivalent to 100 mg of erlotinib. Erlotinib Orion 150 mg film-coated tablets Each tablet contains erlotinib hydrochloride equivalent to 150 mg of erlotinib. Excipient(s) with known effect: Each 25 mg film-coated tablet contains 29 mg lactose and 0.34 mg sodium. Each 100 mg film-coated tablet contains 115 mg lactose and 1.4 mg sodium. Each 150 mg film-coated tablet contains 173 mg lactose and 2.1 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 25 mg: White to off-white, round, biconvex coated tablet, diameter 5.6 mm. Engraved “ER” over “25” on one side, “APO” on the other side. 100 mg: White to off-white, round, biconvex coated tablet, diameter 8.7 mm. Engraved “ER” over “100” on one side, “APO” on the other side. 150 mg: White to off-white, round, biconvex coated tablet, diameter 10.3 mm. Engraved “ER” over “150” on one side, “APO” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Non-Small Cell Lung Cancer (NSCLC):_ Erlotinib Orion 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 Orion 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 Orion 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 w Read the complete document