ESBRIET 801 MG TABLETS

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

PIRFENIDONE

Beschikbaar vanaf:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC-code:

L04AX05

farmaceutische vorm:

FILM COATED TABLETS

Samenstelling:

PIRFENIDONE 801 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

F. HOFFMANN-LA ROCHE AG, SWITZERLAND

Therapeutisch gebied:

PIRFENIDONE

therapeutische indicaties:

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

Autorisatie datum:

2023-10-31

Bijsluiter

IF YOU STOP TAKING THE MEDICINE
In certain situations, the doctor will advise you to stop taking
ESBRIET.
If for any reason you have to stop taking ESBRIET for more than 14
consecutive days, the doctor will restart treatment with ESBRIET 267
MG
and will instruct you to first take 1 unit 3 times a day, and will
then
gradually increase the dosage to 801 mg, 3 times a day.
DO NOT TAKE MEDICINES IN THE DARK! CHECK THE LABEL AND THE DOSE
EACH TIME YOU TAKE A MEDICINE. WEAR GLASSES IF YOU NEED THEM.
IF YOU HAVE FURTHER QUESTIONS REGARDING USE OF THE MEDICINE,
CONSULT THE DOCTOR OR PHARMACIST. . SIDE EFFECTS
As with any medicine, use of ESBRIET may cause side effects in some
users. Do not be alarmed by the list of side effects. You may not
suffer
from any of them.
STOP TAKING ESBRIET AND INFORM THE DOCTOR IMMEDIATELY IF YOU SUFFER
FROM THE FOLLOWING EFFECTS:
•
swelling of the face, lips and/or tongue, itching, urticaria,
breathing
difficulties or wheezing, or fainting sensation, which are signs of
angioedema, a severe allergic reaction or anaphylaxis.
•
yellowing
of
the
eyes
or
skin,
dark
urine,
which
may
also
be
accompanied by itching of the skin, pain in the upper right side of
the
abdomen, loss of appetite, bleeding or bruising more easily than in
the
past, or feeling tired. These may be signs of impaired liver function
and can indicate liver injury, which is an uncommon side effect.
•
reddish non-elevated, or circular patches on the trunk, often with
central blisters, skin peeling, ulcers of mouth, throat, nose,
genitals
and eyes. These serious skin rashes can be preceded by fever and
flu-like symptoms. These signs and symptoms may indicate Stevens-
Johnson syndrome or toxic epidermal necrolysis.
ADDITIONAL SIDE EFFECTS:
Inform the doctor if you experience any side effect.
Very common side effects (may affect more than 1 in 10 patients):
•
infections of the throat or the airways going into the lungs and/or
sinusitis
•
feeling sick (nausea)
•
stomach problems such as acid reflux, vomiting, and feeling
con

Productkenmerken

1
Esbriet Tabs PI Ver 8
ESBRIET
® TABLETS

pirfenidone
FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Esbriet 267 mg film-coated tablets
Esbriet 801 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 267 mg pirfenidone.
Each film-coated tablet contains 801 mg pirfenidone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Esbriet 267 mg film-coated tablets are yellow, oval, approximately 1.3
x 0.6. cm biconvex film-coated
tablets, debossed with “PFD”.
Esbriet 801 mg film-coated tablets are brown, oval, approximately 2 x
0.9 cm biconvex film-coated
tablets, debossed with “PFD”.
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 2403 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 (1602
mg/day)
●
Day 15 onward: a dose of 801 mg administered three times a day (2403
mg/day)
The recommended maintenance daily dose of Esbriet is 801 mg 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