PIRFENIDONE SANDOZ pirfenidone 801 mg film-coated tablet bottle

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

pirfenidone, Quantity: 801 mg

Boleh didapati daripada:

Sandoz Pty Ltd

Borang farmaseutikal:

Tablet

Komposisi:

Excipient Ingredients: pregelatinised starch; croscarmellose sodium; hyprolose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Laluan pentadbiran:

Oral

Unit dalam pakej:

90

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

PIRFENIDONE SANDOZ is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Ringkasan produk:

Visual Identification: Dark pink, oval, biconvex, film-coated tablet, debossed SD801 on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status kebenaran:

Registered

Tarikh kebenaran:

2022-03-16

Risalah maklumat

PIRFENIDONE SANDOZ®
1
PIRFENIDONE SANDOZ®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING PIRFENIDONE SANDOZ?
PIRFENIDONE SANDOZ contains the active ingredient pirfenidone.
PIRFENIDONE SANDOZ is used to treat Idiopathic Pulmonary
Fibrosis (IPF).
For more information, see Section 1. Why am I using PIRFENIDONE
SANDOZ? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PIRFENIDONE SANDOZ?
Do not use PIRFENIDONE SANDOZ if you have ever had an allergic
reaction to pirfenidone or any of the ingredients listed at the
end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
PIRFENIDONE SANDOZ? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PIRFENIDONE SANDOZ and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE PIRFENIDONE SANDOZ?
•
The recommended dose of PIRFENIDONE SANDOZ is:
DAYS 1 TO 7: one 267 mg tablet, three times a day with food
DAYS 8 TO 14: two 267 mg tablets or one 534 mg tablet, three times a
day with food
DAY 15 ONWARD: three 267 mg tablets or one 801 mg tablet, three times
a day with food
More instructions can be found in Section 4. How do I use PIRFENIDONE
SANDOZ? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PIRFENIDONE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
PIRFENIDONE SANDOZ.
•
PIRFENIDONE SANDOZ can cause low sodium levels in the blood. Tell your
doctor if you experience
nausea, headache or dizziness. Your doctor may monitor your sodium
levels while you are taking
PIRFENIDONE SANDOZ.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or lower the dosage without checking
wi

Ciri produk

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Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
PIRFENIDONE SANDOZ
® (PIRFENIDONE)
1.
NAME OF THE MEDICINE
Pirfenidone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PIRFENIDONE SANDOZ 267 mg film coated tablets contain 267 mg
pirfenidone.
PIRFENIDONE SANDOZ 801 mg film coated tablets contain 801 mg
pirfenidone.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
PIRFENIDONE SANDOZ 267 mg tablets are yellow, oval, biconvex,
film-coated tablets,
debossed SD267 on one side.
PIRFENIDONE SANDOZ 801 mg tablets are dark pink, oval, biconvex,
film-coated tablets,
debossed SD801 on one side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
PIRFENIDONE SANDOZ is indicated for the treatment of idiopathic
pulmonary fibrosis (IPF)
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Treatment with PIRFENIDONE SANDOZ should be initiated by physicians
experienced in
the diagnosis and treatment of IPF.
ADULTS
The recommended daily dose of PIRFENIDONE SANDOZ for patients with IPF
is 801 mg
three times a day with food, for a total of 2403 mg/day. It is
recommended that dose titration
occur with the 267 mg tablets.
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)
Doses above 2403 mg/day are not recommended for any patient (see
section 4.9 Overdose).
230504-pirfenidone-pi
Page 2 of 15
MISSED DOSES
Patients who miss 14 consecutive days or more of PIRFENIDONE SANDOZ
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 CONSIDERA