ESBRIET 267 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PIRFENIDONE

Available from:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC code:

L04AX05

Pharmaceutical form:

HARD CAPSULE

Composition:

PIRFENIDONE 267 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

F. HOFFMANN-LA ROCHE LTD.

Therapeutic area:

PIRFENIDONE

Therapeutic indications:

Esbriet is indicated in adults for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF).27/01/2019 בקשה לתוספת התויה Renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment. Esbriet should be used with caution in patients with moderate (CrCl 30-50 ml/min) renal impairment.

Authorization date:

2015-07-29

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
ESBRIET
®
267 MG
HARD CAPSULES
Composition:
EACH CAPSULE CONTAINS: Pirfenidone 267 mg
INACTIVE INGREDIENTS SEE IN SECTION 6 ”FURTHER INFORMATION”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
Keep this leaflet; you may need to read it again.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others. It may harm them even if it seems to
you that their ailment is similar.
This medicine is not intended for children and adolescents under
18 years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
ESBRIET contains the active ingredient PIRFENIDONE and is used for
the treatment of mild to moderate idiopathic pulmonary fibrosis
(IPF) in adults.
THERAPEUTIC GROUP:
ESBRIET is an immunosuppressant.
Idiopathic pulmonary fibrosis is a condition in which the lung tissues
become swollen and scarred over time and as a result, it is difficult
to breathe deeply. This makes it hard for the lungs to function
properly. ESBRIET helps to reduce scarring and swelling in the lungs,
and helps you breathe better.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
∙ you are allergic to the active ingredient pirfenidone, or to any
of
the additional ingredients of the medicine mentioned in section 6
”Further Information”
∙ you have previously experienced angioedema with pirfenidone,
including symptoms such as swelling of the face, lips and/or
tongue which may be associated with breathing difficulties and
wheezing
∙ you are taking a medicine called fluvoxamine (used to treat
depression and obsessive compulsive disorder)
∙ you have a severe or end-stage liver disease
∙ you have a severe or end-stage kidney disease requiring
dialysis
If any of the aforementioned conditions apply to

Summary of Product characteristics

1
Ref:
EU SPC and PIL EMEA/H/C/002154/X/0035/G
Esbriet PI Ver 3
ע עבקנ הז ןולע טמרופ
"
תואירבה דרשמ י
,
ודי לע רשואו קדבנ ונכות
ב
יאמ
2017
ESBRIET
®
r
pirfenidone
HARD CAPSULES 267 MG
1.
NAME OF THE MEDICINAL PRODUCT
Esbriet 267 mg
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 mild to moderate
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).
2
Ref:
EU SPC and PIL EMEA/H/C/002154/X/0035/G
Esbriet PI Ver 3
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 experien