Pirfenidone Teva 267 mg film-coated tablets

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Pirfenidone

Disponibbli minn:

Norton Waterford

Kodiċi ATC:

L04AX05

INN (Isem Internazzjonali):

Pirfenidone

Għamla farmaċewtika:

Film-coated tablet

Żona terapewtika:

pirfenidone

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2022-06-24

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PIRFENIDONE TEVA 267 MG FILM-COATED TABLETS
PIRFENIDONE TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Pirfenidone Teva
3.
How to take Pirfenidone Teva
4.
Possible side effects
5.
How to store Pirfenidone Teva
6.
Contents of the pack and other information
1.
WHAT PIRFENIDONE TEVA IS AND WHAT IT IS USED FOR
Pirfenidone Teva 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 Teva helps to reduce scarring and swelling in the lungs,
and helps you breathe better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIRFENIDONE TEVA
DO NOT TAKE PIRFENIDONE TEVA
•
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 o

Karatteristiċi tal-prodott

Health Products Regulatory Authority
21 December 2023
CRN00DWYP
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pirfenidone Teva 267 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 267 mg pirfenidone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pirfenidone Teva 267 mg film-coated tablets are yellow, oval,
approximately 12.9 x 5.9 mm, debossed with 3610 on one side
and T to the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pirfenidone Teva is indicated in adults for the treatment of
idiopathic pulmonary fibrosis (IPF).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Pirfenidone Teva 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 Pirfenidone Teva 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 Pirfenidone Teva
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
Health Products Regulatory Authority
21 December 2023
CRN00DWYP
Page 2 of 13
without titration.
_Dose adjustments and other considerations for safe use _
_Gastrointestinal events_
In patients who experience intolerance to therapy due to
gastrointestinal undesirable effects,