CELLCEPT Capsule 250 mg

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

MYCOPHENOLATE MOFETIL

Dostopno od:

ROCHE (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

MYCOPHENOLATE MOFETIL

Enote v paketu:

100Capsule Capsules

Izdeluje:

Delpharm Milano s.r.l

Navodilo za uporabo

Consumer Medication Information Leaflet (RiMUP)
CellCept
®
250 MG CAPSULES & 500 MG TABLETS
Mycophenolate Mofetil (250 mg & 500 mg)
1
What is in this leaflet
1.
What CellCept is used for
2.
How CellCept works
3.
Before you use CellCept
4.
How to use CellCept
5.
While you are using it
6.
Side effects
7.
Storage and disposal of CellCept
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial number
What CellCept is used for
CellCept 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.
CellCept 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 CellCept has
been prescribed for you. Your doctor
may have prescribed CellCept for
another reason.
This medicine is available only with
a doctor's prescription.
How CellCept works
CellCept contains mycophenolate
mofetil. This belongs to a group of
medicines called
“immunosuppressants”.
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 CellCept
- When you must not use it
Do not take CellCept if:
1. You have had an allergy to:
• CellCept 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
• CellCept 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 CellCept during pregnancy.
• You must tell your doctor if you
are pregnant or plan to become
pregnant.
3. You are breastfeeding
• CellCept may pass into human
brea

Lastnosti izdelka

PACK INSERT FOR MALAYSIA
CellCept

Mycophenolate mofetil
1.
DESCRIPTION
1.1
THERAPEUTIC/ PHARMACOLOGIC CLASS OF DRUG
Selective Immunosuppressive agent – Mycophenolic acid (ATC Code:
L04AA06)
1.2
TYPE OF DOSAGE FORM
Oral administration:
CellCept is supplied as capsules and tablets.
1.3
ROUTE OF ADMINISTRATION
Oral administration.
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: mycophenolate mofetil.
Oral administration:
Each capsule contains 250 mg mycophenolate mofetil; each tablet
contains 500 mg mycophenolate mofetil.
Excipients:
Capsule 250 mg: pregelatinised starch, croscarmellose sodium, povidone
K90, magnesium stearate.
Capsule shell: red iron oxide, yellow iron oxide, titanium dioxide,
FD&C blue2, bovine gelatin
Tablet 500 mg: microcrystalline cellulose, croscarmellose sodium,
povidone K90, magnesium stearate,
Opdaryl Lavender Y-5R-10272-A
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
CellCept capsules and tablets are indicated for the prophylaxis of
acute organ rejection in patients receiving
allogeneic renal transplants.
CellCept capsules and tablets are indicated for the prophylaxis of
acute organ rejection in patients receiving
allogeneic cardiac transplants.
CellCept capsules and tablets are indicated for the prophylaxis of
acute organ rejection in patients receiving
allogeneic hepatic transplants.
CellCept should be used concomitantly with ciclosporin and
corticosteroids.
CellCept is indicated for induction and maintenance treatment of lupus
nephritis. CellCept should be used
concomitantly with corticosteroids.
2.2
DOSAGE AND ADMINISTRATION
Please refer to full prescribing information for corticosteroids and
either ciclosporin or tacrolimus, which are
used in combination with CellCept.
Transplant patients
Standard dosage for prophylaxis of renal rejection
A dose of 1 g administered orally twice a day (daily dose of 2 g) is
recommended for use in renal transplant
patients. Although a dose of 1.5 g administered twice daily (daily
dose of 3 g) was used in clinical trials and