Esbriet

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Pirfenidone

Available from:

Roche Registration GmbH

ATC code:

L04AX05

INN (International Name):

pirfenidone

Therapeutic group:

Immunosuppressants

Therapeutic area:

Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Therapeutic indications:

Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.

Product summary:

Revision: 33

Authorization status:

Authorised

Authorization date:

2011-02-27

Patient Information leaflet

80
B. PACKAGE LEAFLET
_ _
81
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESBRIET 267 MG HARD CAPSULES
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 Esbriet is and what it is used for
2.
What you need to know before you take Esbriet
3.
How to take Esbriet
4.
Possible side effects
5
How to store Esbriet
6.
Contents of the pack and other information
1.
WHAT ESBRIET IS AND WHAT IT IS USED FOR
Esbriet 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. Esbriet
helps to reduce scarring and swelling in the lungs, and helps you
breathe better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESBRIET
_ _
DO NOT TAKE ESBRIET
●
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 or end stage kidney disease requiring dialysis.
If any of the above affects you, do not take Esbriet. If you are
u

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
Esbriet 267 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 267 mg pirfenidone.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Two piece capsules with a white to off-white opaque body and white to
off-white opaque cap
imprinted with “PFD 267 mg” in brown ink and containing a white to
pale yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Esbriet is indicated in adults for the treatment of idiopathic
pulmonary fibrosis (IPF).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Esbriet 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 nine capsules
per day over a 14-day period as follows:
●
Days 1 to 7: one capsule, three times a day (801 mg/day)
●
Days 8 to 14: two capsules, three times a day (1602 mg/day)
●
Day 15 onward: three capsules, three times a day (2403 mg/day)
The recommended maintenance daily dose of Esbriet is three 267 mg
capsules 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 Esbriet 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 without titration.
_Dose adjustments and other considerations for safe use _
_Gastrointestinal events:_
In patients who experience intolerance to therapy due to
gastrointestinal
undesirable effects, patients should be reminded to take the medicinal
product with food. If symptoms
persist, the dose of pirfenidone may be reduced to 1-2 capsules (267
mg – 534 mg) two to thre