MYCOFIT 250MG CAPSULE

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

MYCOPHENOLATE MOFETIL

Boleh didapati daripada:

JETPHARMA SDN. BHD.

INN (Nama Antarabangsa):

MYCOPHENOLATE MOFETIL

Unit dalam pakej:

30capsule Capsules; 50capsule Capsules; 100capsule Capsules

Dikeluarkan oleh:

INTAS PHARMACEUTICALS LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
MYCOFIT 250 MG CAPSULE
Mycophenolate Mofetil Capsules 250 mg
WHAT IS IN THIS LEAFLET
1.
What Mycofit capsule is
used for
2.
How Mycofit capsule works
3.
Before you use Mycofit
capsule.
4.
How
to
take
Mycofit
capsule
5.
While
you
are
using
Mycofit capsule.
6.
Side effects
7.
Storage and disposal of
Mycofit capsule.
8.
Product description.
9.
Manufacturer and Product
registration holder.
10.
Date of revision.
11.
Serial number
WHAT MYCOFIT CAPSULE IS USED
FOR
Mycophenolate capsule is used
to
prevent
your
body
from
rejecting
a
transplanted
organ
(kidney,
heart
or
liver)
and
it
should
be
used
together
with
other
medicines
known
as
ciclosporin and corticorsteroids.
Mycofit
capsule
is
used
for
treatment
of
kidney
inflammation;
lupus
nephritis
and it should be used together
with other medicine known as
corticosteroids.
Ask your doctor if you have any
questions
about
why
Mycofit
capsule has been prescribed for
you.
Your
doctor
may
have
prescribed Mycofit capsule for
another reason.
This medicine is available only
with a doctor's prescription.
HOW MYCOFIT CAPSULE WORKS
Mycofit
capsule
contains
the
active ingredient Mycophenolate
mofetil. It belongs to a group of
medicines
called
immune-
suppressants.
Immunosuppressants are used to
prevent
the
rejection
of
a
transplanted organ and work by
stopping
your
immune
system
from reacting to the transplanted
organ.
BEFORE
YOU
USE
MYCOFIT
CAPSULE
_When you must not take it_
_ _
Do not take Mycofit capsule if:
1. YOU HAVE HAD AN ALLERGY TO:
•
Mycofit
capsule
or
any
ingredients listed at the end of
this leaflet.
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, hives on the skin
2. YOU ARE PREGNANT
• Mycofit capsule is harmful to
an unborn baby when taken by a
pregnant woman.
•
There
have
been
cases
of
miscarriage
and
severe
birth
defects
reported
when
patients
took
Mycofit
capsule
during
pregnan

Ciri produk

For the Use of a Registered Medical Practitioner or a Hospital or a
Laboratory Only
MYCOFIT 250 CAPSULE
(MYCOPHENOLATE MOFETIL CAPSULES 250 MG)
NAME AND STRENGTH OF ACTIVE INGREDIENT
Mycophenolate Mofetil Ph.Eur. 250 mg
DOSAGE FORM
Capsule
PRODUCT DESCRIPTION
Light Blue/Peach size ‘1’ hard gelatin capsule imprinting with
‘MMF’ on cap and ‘250’
on Body and containing white to off white powder.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06
Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA. MPA is a
potent, selective,
uncompetitive and reversible inhibitor of inosine monophosphate
dehydrogenase, and
therefore
inhibits
the
_de _
_novo _
pathway
of
guanosine
nucleotide
synthesis
without
incorporation into DNA. Because T- and B-lymphocytes are critically
dependent for their
proliferation on _de novo _synthesis of purines whereas other cell
types can utilise salvage
pathways, MPA has more potent cytostatic effects on lymphocytes than
on other cells.
PHARMACOKINETIC PROPERTIES
Following oral
administration,
mycophenolate m o f e t i l u n d e r g o e s r a p i d a n d
e x t e n s i v e absorption and complete presystemic metabolism to
the active
metabolite, MPA. As evidenced by suppression
of acute rejection
following
renal
transplantation, the immunosuppressant
activity of Mycophenolate
Mofetil
is correlated
with MPA concentration. The mean bioavailability of oral mycophenolate
mofetil, based
on MPA AUC, is 94 % relative to IV mycophenolate mofetil. Food had no
effect on the
extent of absorption (MPA AUC) of mycophenolate mofetil when
administered at doses of
1.5 g BID to renal transplant patients. However, MPA C
max
was decreased by 40 % in the
presence
of
food.
Mycoph
enolate
mofetil
is
not
measurable
systemically
in
plasma
following oral administration. MPA at clinically relevant
concentrations is 97 % bound to
plasma albumin.
As
a
result
of
enterohepatic
recirculation,
secondary
increases
in
plasma
MPA
concentration are usually observed at appro