PC-MYCOPHENOLATE 500 mycophenolate mofetil 500mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mycophenolate mofetil, Quantity: 500 mg

Available from:

Pharmacor Pty Ltd

INN (International Name):

Mycophenolate mofetil

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; hyprolose; purified talc; titanium dioxide; hypromellose; iron oxide red; iron oxide black; macrogol 400; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

50 tablets, 150 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Prophylaxis of organ rejection in paediatric patients (with a body surface area > 1.5 m2) receiving allogeneic renal transplants.

Product summary:

Visual Identification: Purple colored, capsule shaped, biconvex, film coated tablets debossed 'AHI' on one side and '500' on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-12-16

Patient Information leaflet

Pc-Mycophenolate 500 (V 02)
Page 1 of 5
PC-MYCOPHENOLATE 500
_Mycophenolate mofetil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about Pc-
mycophenolate 500.
It does not contain all the
available information.
It does not take the place of
talking to your doctor,
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Pc-
mycophenolate 500 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 PC-MYCOPHENOLATE
500 IS USED FOR
Pc-mycophenolate 500 contains
the active ingredient
mycophenolate mofetil.
Pc-mycophenolate 500 belongs
to a group of
medicines called
immunosuppressants.
Immunosuppressants are used to
prevent the rejection of a
transplanted organs and work by
stopping your immune system
from reacting to the transplanted
organ.
There are many different types of
medicines used to prevent
rejection of a transplanted organ
Pc-mycophenolatePc-
mycophenolate 500 may be used
together with other medicines
known as cyclosporin and
corticosteroids.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
WHY
PC-
MYCOPHENOLATE
500
HAS
BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed Pc-mycophenolate 500
for another reason.
Pharmacor
Mycophenolate
500
is
not addictive
This medicine is available only with a
doctor’s prescription.
Pc-mycophenolate
BEFORE YOU TAKE PC-
MYCOPHENOLATE 500
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PC-MYCOPHENOLATE 500
IF:
1. YOU HAVE HAD AN ALLERGIC TO:Pc-
mycophenolate 500 or any
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 face, lips,
tongue or other parts of
the body

rash, itching, hives on the
skin
2. YOU ARE PREGNANT

Pc-mycophenolate 500 is
harmful to an unborn baby
when taken by a pregnant
woman.

Summary of Product characteristics

PC- Mycophenolate 500 (V-02)
1
AUSTRALIAN PRODUCT INFORMATION
PC-MYCOPHENOLATE 500 (MYCOPHENOLATE MOFETIL) TABLETS
1
NAME OF THE MEDICINE
Mycophenolate mofetil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pc-Mycophenolate 500 contains mycophenolate mofetil 500 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pc-Mycophenolate 500 are purple coloured, capsule shaped, biconvex,
film coated tablets
debossed ‘AHI’ on one side and ‘500’ on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS

Prophylaxis of solid organ rejection in adults receiving allogeneic
organ transplants.

Prophylaxis of organ rejection in paediatric patients (2-18 years)
receiving allogeneic
renal transplants.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The initial dose of Pc-Mycophenolate 500 should be given as soon as
clinically feasible
following transplantation. Intravenous administration is recommended
in those patients
unable to take oral medication. However, oral administration should be
initiated as soon as
possible.
ADULTS
_RENAL TRANSPLANTATION _
The
recommended
dose
in
renal
transplant
patients
is
1
g
administered
orally
or
intravenously twice daily (2 g daily dose).
_CARDIAC TRANSPLANTATION _
The recommended dose in cardiac transplant patients is 1.5 g
administrated orally or
intravenously twice daily (3 g daily dose).
_HEPATIC TRANSPLANTATION _
The recommended dose in hepatic transplant patients is 1 g
administrated intravenously
twice daily (2 g daily dose) followed by 1.5 g administered orally
twice daily (3 g daily dose).
PC- Mycophenolate 500 (V-02)
2
_OTHER TRANSPLANTS _
The recommended dose in other transplants is 2 to 3 g per day
depending on the level of
immunosuppression required.
_PAEDIATRICS (2 TO 18 YEARS) _
The recommended dose of for renal transplant patients is 600mg/m
2
of mycophenolate
mofetil (MMF) administered orally twice daily (up to a maximum of 2 g
daily.)
Pc-Mycophenolate
500
may
be
administered
in
combination
with
ciclosporin
and
corticosteroids