MYFORTIC 180MG GASTRO-RESISTANT TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MYCOPHENOLIC ACID (AS SODIUM SALT)

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

MYCOPHENOLIC ACID (AS SODIUM SALT)

Unit dalam pakej:

50Tablet Tablets; 100Tablet Tablets; 120Tablet Tablets

Dikeluarkan oleh:

NOVARTIS PHARMA PRODUKTIONS GMBH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
MYFORTIC
® GASTRO-RESISTANT TABLETS
Mycophenolic acid (180mg, 360mg)
1
WHAT IS IN THIS LEAFLET
1.
What Myfortic is used for
2.
How Myfortic works
3.
Before you use Myfortic
4.
How to use Myfortic
5.
While using Myfortic
6.
Side effects
7.
Storage and Disposal of Myfortic
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT MYFORTIC IS USED FOR
Myfortic gastro-resistant tablets belong
to the class of drugs known as
immunosuppressants.
Immunosuppressants reduce your
body’s response to anything that it sees
as “foreign” – which includes transplant
organs.
HOW MYFORTIC WORKS
Myfortic is used to prevent your body
from rejecting a transplanted kidney.
Myfortic is used together with other
medicines containing ciclosporin and
corticosteroids.
If you have any questions about how
Myfortic works or why this medicine
has been prescribed for you, ask your
doctor.
BEFORE YOU USE MYFORTIC
Myfortic will only be prescribed for you
by a doctor experienced in
transplantation medicine. Follow your
doctor’s instructions carefully. They
might differ from the general
information contained in this leaflet.
_- When you must not use it _
_DO NOT TAKE MYFORTIC _
•
If you are allergic (hypersensitive)
to mycophenolic acid,
mycophenolate sodium or
mycophenolate mofetil or to any of
the other ingredients of Myfortic
listed at the end of this leaflet.
•
if you are a woman who could be
pregnant and you have not provided
a negative pregnancy test before
your first prescription, as
mycophenolate causes birth defects
and miscarriage
•
if you are pregnant or planning to
become pregnant or think you may
be pregnant
•
if you are not using effective
contraception (see Contraception in
women and men).
•
if you are breast-feeding (see also
“Pregnancy and breast-feeding”).
If any of the above apply to you, tell
your doctor without taking Myfortic.
_PREGNANCY AND BREAST-FEEDING _
If you are pregnant or breast-feeding,
think you may be pre

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Novartis
Page 2
Malaysia Package Leaflet
31-May-2021
Myfortic
MYFORTIC

Immunosuppressant
DESCRIPTION AND COMPOSITION
180 mg Myfortic tablet comes as a lime green, film-coated, round
tablet, with beveled edges
and the imprint (debossing) “C” on one side.
360 mg Myfortic
_ _
tablet comes as a pale orange-red, film-coated, ovaloid tablet with
imprint
(debossing) “CT” on one side.
PHARMACEUTICAL FORM
Gastro-resistant tablets
ACTIVE SUBSTANCE
Each gastro-resistant tablet contains 180 mg or 360 mg mycophenolic
acid (MPA) equivalent
to 192.4 mg and 384.8 mg mycophenolate sodium.
The two dosage strengths may not be available in all countries.
EXCIPIENTS
Maize starch; povidone (K-30); crospovidone; lactose; colloidal
silicon dioxide; magnesium
stearate.
The gastro resistant tablet coating of 180 mg Myfortic consists of
hypromellose phthalate/
hydroxypropylmethylcellulose phthalate; titanum dioxide; iron oxide
yellow; indigotin.
The gastro resistant tablet coating of 360 mg Myfortic consists of
hypromellose phthalate/
hydroxypropylmethylcellulose phthalate; titanium dioxide; iron oxide
yellow; iron oxide red.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Myfortic is indicated in combination with ciclosporin and
corticosteroids for the prophylaxis
of acute transplant rejection in adult patients receiving allogeneic
renal transplants.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
The recommended dose is 720 mg (four 180 mg or two 360 mg Myfortic
gastro-resistant
tablets) twice daily (1,440 mg daily dose). In patients receiving 2 g
mycophenolate mofetil
(MMF), treatment can be replaced by 720 mg twice daily (1,440 mg daily
dose) of Myfortic.
GENERAL TARGET POPULATION
Novartis
Page 3
Malaysia Package Leaflet
31-May-2021
Myfortic
Treatment with Myfortic should be initiated and maintained by
appropriately qualified
transplant specialists.
Myfortic
_ _
should be initiated in
_de-novo_
patients within 48 hours following transplantation.
Myfortic can be taken with or without food.
SPECIAL POPULA