Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
Pirfenidone
Viatris Limited
L04AX05
pirfenidone
Immunosuppressants
Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
Revision: 1
Authorised
2023-01-10
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER PIRFENIDONE VIATRIS 267 MG FILM-COATED TABLETS PIRFENIDONE VIATRIS 534 MG FILM-COATED TABLETS PIRFENIDONE VIATRIS 801 MG FILM-COATED TABLETS 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 Pirfenidone Viatris is and what it is used for 2. What you need to know before you take Pirfenidone Viatris 3. How to take Pirfenidone Viatris 4. Possible side effects 5. How to store Pirfenidone Viatris 6. Contents of the pack and other information 1. WHAT PIRFENIDONE VIATRIS IS AND WHAT IT IS USED FOR Pirfenidone Viatris 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. Pirfenidone Viatris helps to reduce scarring and swelling in the lungs, and helps you breathe better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIRFENIDONE VIATRIS DO NOT TAKE PIRFENIDONE VIATRIS • if you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6) • if you have previously expe rienced 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 comp Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pirfenidone Viatris 267 mg film-coated tablets Pirfenidone Viatris 534 mg film-coated tablets Pirfenidone Viatris 801 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pirfenidone Viatris 267 mg film-coated tablets Each tablet contains 267 mg of pirfenidone. Pirfenidone Viatris 534 mg film-coated tablets Each tablet contains 534 mg of pirfenidone. Pirfenidone Viatris 801 mg film-coated tablets Each tablet contains 801 mg of pirfenidone. 3. PHARMACEUTICAL FORM Film-coated tablet Pirfenidone Viatris 267 mg film-coated tablets Pirfenidone Viatris 267 mg film-coated tablets are yellow, oval shaped, approximately 13 x 6 mm biconvex film-coated tablets, plain on both sides. Pirfenidone Viatris 534 mg film-coated tablets Pirfenidone Viatris 534 mg film-coated tablets are orange, oval shaped, approximately 16 x 8 mm biconvex film-coated tablets, plain on both sides. Pirfenidone Viatris 801 mg film-coated tablets Pirfenidone Viatris 801 mg film-coated tablets are brown, oval shaped, approximately 20 x 9 mm biconvex film-coated tablets, plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pirfenidone Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Pirfenidone Viatris should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF. 3 Posology _Adults _ Upon initiating treatment, the dose should be titrated to the recommended daily dose of 2 403 mg/day over a 14-day period as follows: • Days 1 to 7: a dose of 267 mg administered three times a day (801 mg/day) • Days 8 to 14: a dose of 534 mg administered three times a day (1 602 mg/day) • Day 15 onward: a dose of 801 mg administered three times a day (2 403 mg/day) The recommended maintenance daily dose of Pirfenidone Viatris is 801 mg three times a day with food for a total of 2 403 mg/day. Doses above 2 403 mg/ Perskaitykite visą dokumentą