FIBRIDONER®
Pirfenidone 200 mg
Film-coated tablets

Argentine Industry
Rx only

THIS PRODUCT HAS BEEN INCLUDED IN THE RISK MANAGMENT PLAN

Composition:

Each FIBRIDONER® film-coated tablet contains pirfenidone 200 mg, lactose, povidone K-30, sodium croscarmellose, magnesium staearate, and Opadry II White.

Indications: 

FIBRIDONER® is indicated for the treatment of mild to moderate idiopathic pulmonary fibrosis in adults. 

Storage:

Keep at room temperature (below 30 °C), in the marketed packing.

Marketed presentations:

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.