Pirfenidone 200 mg
THIS PRODUCT HAS BEEN INCLUDED IN THE RISK MANAGMENT PLAN
Each FIBRIDONER® film-coated tablet contains pirfenidone 200 mg, lactose, povidone K-30, sodium croscarmellose, magnesium staearate, and Opadry II White.
FIBRIDONER® is indicated for the treatment of mild to moderate idiopathic pulmonary fibrosis in adults.
Keep at room temperature (below 30 °C), in the marketed packing.
Pack with 200 film-coated tablets.
Pack with 360 film-coated tablets (presentation for hospitals).
Information for the patient
"If any inconvenience is presented with the product, the patient can fill the sheet provided on the website of ANMAT: http://www.anmat.gov.ar/farmacovigilancia/Notificar.asp or call ANMAT, which responds to 0800-333 -1234 ".
Medicinal speciality authorised by the Ministry of Health.
Certificate No. 56695
Laboratorio DOSA S.A.
Girardot 1369 (C1427AKC) City of Buenos Aires, Argentina.
Pharmaceutical Director: María C. Terzo, Pharmacist.