Pirfenidone Viatris

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Pirfenidone

Available from:

Viatris Limited

ATC code:

L04AX05

INN (International Name):

pirfenidone

Therapeutic group:

Immunosuppressants

Therapeutic area:

Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Therapeutic indications:

Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).

Product summary:

Revision: 1

Authorization status:

Authorised

Authorization date:

2023-01-10

Patient Information leaflet

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

Summary of Product characteristics

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/