Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
Pirfenidone
Roche Registration GmbH
L04AX05
pirfenidone
Immunosuppressants
Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.
Revision: 33
Authorised
2011-02-27
80 B. PACKAGE LEAFLET _ _ 81 PACKAGE LEAFLET: INFORMATION FOR THE USER ESBRIET 267 MG HARD CAPSULES pirfenidone 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 Esbriet is and what it is used for 2. What you need to know before you take Esbriet 3. How to take Esbriet 4. Possible side effects 5 How to store Esbriet 6. Contents of the pack and other information 1. WHAT ESBRIET IS AND WHAT IT IS USED FOR Esbriet contains the active substance pirfenidone and it is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults. IPF is a condition in which the tissues in your lungs become swollen and scarred over time, and as a result makes it difficult to breathe deeply. This makes it hard for your lungs to work properly. Esbriet helps to reduce scarring and swelling in the lungs, and helps you breathe better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESBRIET _ _ DO NOT TAKE ESBRIET ● if you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6) ● if you have previously experienced angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue which may be associated with difficulty breathing or wheezing ● if you are taking a medicine called fluvoxamine (used to treat depression and obsessive compulsive disorder [OCD]) ● if you have severe or end stage liver disease ● if you have severe or end stage kidney disease requiring dialysis. If any of the above affects you, do not take Esbriet. If you are u Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ _ _ 2 1. NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 267 mg pirfenidone. _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Two piece capsules with a white to off-white opaque body and white to off-white opaque cap imprinted with “PFD 267 mg” in brown ink and containing a white to pale yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Esbriet should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF. Posology _Adults_ Upon initiating treatment, the dose should be titrated to the recommended daily dose of nine capsules per day over a 14-day period as follows: ● Days 1 to 7: one capsule, three times a day (801 mg/day) ● Days 8 to 14: two capsules, three times a day (1602 mg/day) ● Day 15 onward: three capsules, three times a day (2403 mg/day) The recommended maintenance daily dose of Esbriet is three 267 mg capsules three times a day with food for a total of 2403 mg/day. Doses above 2403 mg/day are not recommended for any patient (see section 4.9). Patients who miss 14 consecutive days or more of Esbriet treatment should re-initiate therapy by undergoing the initial 2-week titration regimen up to the recommended daily dose. _ _ For treatment interruption of less than 14 consecutive days, the dose can be resumed at the previous recommended daily dose without titration. _Dose adjustments and other considerations for safe use _ _Gastrointestinal events:_ In patients who experience intolerance to therapy due to gastrointestinal undesirable effects, patients should be reminded to take the medicinal product with food. If symptoms persist, the dose of pirfenidone may be reduced to 1-2 capsules (267 mg – 534 mg) two to thre Đọc toàn bộ tài liệu