ESBRIET HARD CAPSULES 267MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

PIRFENIDONE

Boleh didapati daripada:

ROCHE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

PIRFENIDONE

Unit dalam pakej:

270capsule Capsules

Dikeluarkan oleh:

Catalent Pharma Solutions, LLC

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
ESBRIET
®
HARD CAPSULE
Pirfenidone (267 mg)
1
What is in this leaflet
1.
What Esbriet is used for
2.
How Esbriet works
3.
Before you use Esbriet
4.
How to use Esbriet
5.
While you are using Esbriet
6.
Side effects
7.
Storage and Disposal of Esbriet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
What Esbriet is used for
Esbriet
is
used
to
treat
idiopathic
pulmonary
fibrosis
(IPF).
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.
How Esbriet works
Esbriet contains the active ingredient,
pirfenidone. It belongs to the chemical
class
of
pyridine.
Esbriet
works
by
having
anti-fibrosis
and
anti-
inflammatory properties. Esbriet helps
to reduce scarring and swelling in the
lungs, and helps you breathe better.
Symptoms of IPF include shortness of
breath,
a
dry,
hacking
cough,
and
fatigue.
Ask
your
doctor
if
you
have
any
questions about why Esbriet has been
prescribed
for
you.
Your
doctor,
however, may have prescribed Esbriet
for another reason.
Before you use Esbriet
-
When you must not use it
Do not take Esbriet if:

you have had an allergic reaction
to
pirfenidone,
the
active
ingredient or any ingredients listed
at the end of this leaflet.

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.

you are taking a medicine called
fluvoxamine, a medicine used to
treat
depression
and
obsessive
compulsive disorder (OCD)

you have severe or end stage liver
disease.

you
have
severe
or
end
stage
kidney disease requiring dialysis.
If any of the above affects you, do not
take Esbriet. If you are unsure, ask your
doctor or pharmacist.
Do
not
take
this
medicine
if
the
packaging is torn or shows signs of
tampering.
Do
not
take
this
medication

Ciri produk

PACK INSERT FOR MALAYSIA
ESBRIET
®
Pirfenidone
1.
NAME OF 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.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esbriet is indicated 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 three times/day
with food with re-escalation to the recommended daily
dose a