Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Pirfenidone
Norton Waterford
L04AX05
Pirfenidone
Film-coated tablet
pirfenidone
Marketed
2022-06-24
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PIRFENIDONE TEVA 267 MG FILM-COATED TABLETS PIRFENIDONE TEVA 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 Teva is and what it is used for 2. What you need to know before you take Pirfenidone Teva 3. How to take Pirfenidone Teva 4. Possible side effects 5. How to store Pirfenidone Teva 6. Contents of the pack and other information 1. WHAT PIRFENIDONE TEVA IS AND WHAT IT IS USED FOR Pirfenidone Teva 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 Teva helps to reduce scarring and swelling in the lungs, and helps you breathe better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIRFENIDONE TEVA DO NOT TAKE PIRFENIDONE TEVA • 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 o Baca dokumen lengkap
Health Products Regulatory Authority 21 December 2023 CRN00DWYP Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pirfenidone Teva 267 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 267 mg pirfenidone. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). Pirfenidone Teva 267 mg film-coated tablets are yellow, oval, approximately 12.9 x 5.9 mm, debossed with 3610 on one side and T to the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pirfenidone Teva is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Pirfenidone Teva 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 2403 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 (1602 mg/day) Day 15 onward: a dose of 801 mg administered three times a day (2403 mg/day) The recommended maintenance daily dose of Pirfenidone Teva is 801 mg 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 Pirfenidone Teva 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 Health Products Regulatory Authority 21 December 2023 CRN00DWYP Page 2 of 13 without titration. _Dose adjustments and other considerations for safe use _ _Gastrointestinal events_ In patients who experience intolerance to therapy due to gastrointestinal undesirable effects, Baca dokumen lengkap