MYCOPHENOLATE SANDOZ mycophenolate mofetil 250mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mycophenolate mofetil, Quantity: 250 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Mycophenolate mofetil

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: magnesium stearate; pregelatinised maize starch; titanium dioxide; povidone; croscarmellose sodium; Gelatin; indigo carmine; iron oxide red; iron oxide yellow

Administration route:

Oral

Units in package:

100, 300

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Mycophenolate Sandoz is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. . Mycophenolate Sandoz is indicated for the prophylaxis of organ rejection in paediatric patients (6 to 18 years) receiving allogeneic renal transplants.

Product summary:

Visual Identification: Capsule with blue opaque cap and orange opaque body.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-12-08

Patient Information leaflet

MYCOPHENOLATE SANDOZ
®
1
MYCOPHENOLATE
SANDOZ
®
_mycophenolate mofetil capsules and tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Mycophenolate
Sandoz.
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 this medicine
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 want to read it again.
WHAT MYCOPHENOLATE
SANDOZ IS USED FOR
Mycophenolate Sandoz contains the
active ingredient mycophenolate
mofetil.
Mycophenolate Sandoz belongs to a
group of medicines called
immunosuppressants.
Immunosuppressants are used to
prevent rejection of transplanted
organ and works 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.
Mycophenolate Sandoz may be used
together with other medicines known
as ciclosporin and corticosteroids.
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 available only with
a doctor's prescription.
Mycophenolate Sandoz is not
addictive.
BEFORE YOU TAKE
MYCOPHENOLATE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
mycophenolate mofetil, the active
ingredient, or to any of the other
ingredients listed at the end of
this leaflet under Product
description.
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.
Mycophenolate Sandoz is harmful to
an unborn baby when taken

Summary of Product characteristics

220223-Mycophenolate Sandoz-pi
Page 1 of 32
AUSTRALIAN PRODUCT INFORMATION
MYCOPHENOLATE SANDOZ
® (MYCOPHENOLATE MOFETIL)
1
NAME OF THE MEDICINE
Mycophenolate mofetil (MMF)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Mycophenolate Sandoz
®
250 mg capsules contains 250 mg mycophenolate mofetil.
Each Mycophenolate Sandoz
®
500 mg tablets contains 500 mg mycophenolate mofetil.
MMF is a white to off-white crystalline powder.
For the full list of excipients, see Section 6.1 List of excipients.
_Not all strengths may be marketed in Australia. _
3
PHARMACEUTICAL FORM
Mycophenolate Sandoz 250 mg capsules – Blue opaque cap with orange
opaque body,
containing white to off white coloured powder.
Mycophenolate Sandoz 500 mg tablets – Capsule shaped, lavender
coloured, film-coated
biconvex tablet, plain on both sides.
_Not all strengths may be marketed in Australia. _
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Mycophenolate Sandoz is indicated for the prophylaxis of solid organ
rejection in adults
receiving allogeneic organ transplants.
Mycophenolate Sandoz is indicated for the prophylaxis of organ
rejection in paediatric patients
(6 to 18 years) receiving allogeneic renal transplants.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The initial dose of Mycophenolate Sandoz should be given as soon as
clinically feasible
following transplantation.
_ADULTS _
_Renal Transplantation: _
The recommended dose in renal transplant patients is 1 g twice daily
(2 g daily dose).
_Cardiac Transplantation: _
The recommended dose in cardiac transplant patients is 1.5 g
administrated orally twice daily (3 g daily dose).
_Hepatic Transplantation: _
The recommended dose in hepatic transplant patients is 1 g twice
daily (2 g daily dose) followed by 1.5 g twice daily (3 g daily dose).
220223-Mycophenolate Sandoz-pi
Page 2 of 32
_Other Transplants: _
The recommended dose in other transplants is 2 to 3 g per day
depending
on the level of immunosuppression required.
_CHILDREN (6-18 YEARS) _
The recommended dose for renal transplant