Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Erlotinib hydrochloride
Zentiva Pharma UK Ltd
L01EB02
Erlotinib hydrochloride
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 08594739244078
PACKAGE LEAFLET: INFORMATION FOR THE USER ERLOTINIB 25 MG FILM-COATED TABLETS ERLOTINIB 100 MG FILM-COATED TABLETS ERLOTINIB 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 is and what it is used for 2. What you need to know before you take Erlotinib 3. How to take Erlotinib 4. Possible side effects 5 How to store Erlotinib 6. Contents of the pack and other information 1. WHAT ERLOTINIB IS AND WHAT IT IS USED FOR Erlotinib contains the active substance erlotinib. Erlotinib 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 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 DO NOT TAKE ERLOTINIB: • if you are allergic to erlotinib or any of the ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS: • if you are taking o Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Erlotinib 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride). Excipient(s) with known effect: Each film-coated tablet contains 95.93 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to yellowish, round biconvex, film-coated tablet, engraved with ‘100’ on one side and approximately 8.9 mm in diameter. 4.1 THERAPEUTIC INDICATIONS Non-Small Cell Lung Cancer (NSCLC) Erlotinib is indicated for the first-line treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations. Erlotinib 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 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 is indicated when other treatment options are not considered suitable. When prescribing Erlotinib, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with EGFR-IHC negative tumours (see section 5.1). Pancreatic cancer Erlotinib in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Erlotinib, factors associated with prolonged survival should be taken into account (see sections 4.2 and 5.1). No survival advantage could be shown for patients with locally advanced disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Erlotinib treatment should be supervised by a physician experienced in the use of anti-cance Read the complete document