PHARMACOR DEFERASIROX FC deferasirox 90 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

deferasirox, Quantity: 90 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; sodium stearylfumarate; hydrogenated castor oil; colloidal anhydrous silica; poloxamer; povidone; sodium hydroxide; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; macrogol 4000; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

60's, 10's, 90's, 30's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. Deferasirox is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective.,Deferasirox is also indicated for the treatment of chronic iron overload in patients with nontransfusion-dependent thalassemia syndromes aged 10 years and older.

Product summary:

Visual Identification: Light blue colour, film coated oval shaped biconvex tablets, debossed with 'DFX' on the one side and '90' on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-03-22

Patient Information leaflet

PHARMACOR DEFERASIROX FC
1
PHARMACOR DEFERASIROX FC
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 PHARMACOR DEFERASIROX FC?
PHARMACOR DEFERASIROX film-coated tablets contains the active
ingredient Deferasirox. PHARMACOR DEFERASIROX FC is
used to treat a condition called iron overload, which happens when the
body has too much iron.
For more information, see Section 1. Why am I using PHARMACOR
DEFERASIROX FC? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PHARMACOR DEFERASIROX FC?
Do not use if you have ever had an allergic reaction to PHARMACOR
DEFERASIROX FC 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
PHARMACOR DEFERASIROX FC? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PHARMACOR DEFERASIROX FC 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 PHARMACOR DEFERASIROX FC?
•
The dose of PHARMACOR DEFERASIROX FC is related to body weight for all
patients. Your doctor will calculate the dose
you need and tell you how many tablets to take each day.
•
Take PHARMACOR DEFERASIROX FC once a day, every day, at about the same
time each day with some water.
More instructions can be found in Section 4. How do I use PHARMACOR
DEFERASIROX FC? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PHARMACOR DEFERASIROX FC?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
PHARMACOR DEFERASIROX FC.
•
Keep all of your doctor's appointments so that your progress can be
checked. Your doctor will do
regular tests (blood, urine or Magnetic Resonance Imaging (MRI)) to
make sure the

Summary of Product characteristics

PHARMACOR DEFERASIROX FC
1
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR DEFERASIROX FC (DEFERASIROX) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Deferasirox
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Deferasirox is a white to slightly yellow powder and is a non-chiral
compound. At the
physiological pH of the intestine, the solubility is about 40 mg/L. It
is practically insoluble in
water and across the pH range 1.2 – 6.00, and soluble at pH 8.00.
PHARMACOR
DEFERASIROX
FC
90
MG
:
Each
film-coated
tablet
contains
90
mg
deferasirox.
PHARMACOR DEFERASIROX FC
180 MG
: Each film-coated tablet contains 180 mg
deferasirox.
PHARMACOR DEFERASIROX FC
360 MG
: Each film-coated tablet contains 360 mg
deferasirox.
Excipient with known effect: Not Applicable
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet.
PHARMACOR DEFERASIROX FC
90 MG:
Light blue color, film coated oval shaped
biconvex tablets, debossed with ‘DFX’ on the one side and ‘90’
on other side.
PHARMACOR DEFERASIROX FC
180 MG:
Blue color, film coated oval shaped biconvex
tablets, debossed with ‘DFX’ on the one side and ‘180’ on
other side.
PHARMACOR DEFERASIROX FC
360 MG:
Dark blue color, film coated, oval shaped,
biconvex tablets, debossed with ‘DFX’ on the one side and
‘360’ on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The
treatment
of
chronic
iron
overload
due
to
blood
transfusions
(transfusional
haemosiderosis)
in
adults
and
paediatric
patients
6
years
and
older.
PHARMACOR
DEFERASIROX FC is also indicated for the treatment of chronic iron
overload in paediatric
patients aged 2 to 5 years who are unable to take desferrioxamine
therapy or in whom
desferrioxamine has proven ineffective.
PHARMACOR DEFERASIROX FC
2
PHARMACOR
DEFERASIROX
FC
is also indicated for the treatment of chronic iron
overload in patients with non-transfusion-dependent thalassemia
syndromes aged 10 years
and older.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
TRANSFUSIONAL IRON OVERLOAD (PHARM