ESBRIET pirfenidone 267 mg hard capsule bottle

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

pirfenidone, Quantity: 267 mg

Pieejams no:

Roche Products Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

pirfenidone

Zāļu forma:

Capsule, hard

Kompozīcija:

Excipient Ingredients: microcrystalline cellulose; povidone; magnesium stearate; croscarmellose sodium; Gelatin; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; iron oxide yellow; iron oxide red; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Ievadīšanas:

Oral

Vienības iepakojumā:

270

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)

Produktu pārskats:

Visual Identification: Hard gelatin capsule with a white to off white opaque body, white opaque caps with PFD 267 mg printed in brown ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Autorizācija statuss:

Licence status A

Autorizācija datums:

2016-02-29

Lietošanas instrukcija

ESBRIET
®
_(ES-BR- EE-ET)_
_Pirfenidone_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Esbriet. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Esbriet against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ESBRIET IS USED
FOR
Esbriet contains the active ingredient
pirfenidone.
Esbriet is used to treat Idiopathic
Pulmonary Fibrosis (IPF).
IPF is a condition in which the
tissues in your lungs become swollen
and as a result makes it hard for your
lungs to work property.
Esbriet helps to reduce the scarring
and swelling in the lungs, and helps
you breathe better.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU TAKE
ESBRIET
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ESBRIET IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
pirfenidone
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT BREAST-FEED IF YOU ARE
TAKING THIS MEDICINE.
It is not known if pirfenidone passes
into breast milk. Talk to your doctor
or pharmacist before taking Esbriet,
your doctor will discuss the risks and
benefits of taking this medicine while
breast f

Produkta apraksts

AUSTRALIAN PRODUCT INFORMATION
ESBRIET
® (PIRFENIDONE) CAPSULES
Esbriet capsule 20210602
1
1.
NAME OF THE MEDICINE
Pirfenidone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Esbriet capsules contain 267mg pirfenidone.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Hard gelatin capsules with a white to off-white opaque body and a
white to off-white opaque
cap printed with “PFD” and “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
DOSE AND METHOD OF ADMINISTRATION
DOSE
Treatment with Esbriet should be initiated by physicians experienced
in the diagnosis and
treatment of IPF.
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 daily dose of Esbriet for patients with IPF 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 Overdose).
MISSED DOSES
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
Gastrointestinal events
In patients who experience intolerance to therapy due to
gastrointestinal side effects, patients
should be reminded to take the medicinal product with food. If
symptoms persist the dose of
Esbriet may be reduced to 267 mg – 534 mg taken two to three times a
day with food with re-
Esbriet capsule 20210602
2
escalation to the recommend