Mycofenolaat mofetil STADA 500 mg, filmomhulde tabletten

Land: Nederländerna

Språk: nederländska

Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiva substanser:

MYCOFENOLAATMOFETIL

Tillgänglig från:

Stada Arzneimittel AG

ATC-kod:

L04AA06

INN (International namn):

Mycophenolate mofetil

Läkemedelsform:

Filmomhulde tablet

Sammansättning:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Administreringssätt:

Oraal gebruik

Terapiområde:

Mycophenolic Acid

Tillstånd datum:

2009-03-20

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYCOPHENOLATE MOFETIL STADA 500 MG, FILM-COATED TABLETS
Mycophenolate mofetil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Mycophenolate mofetil is and what it is used for
2. What you need to know before you take Mycophenolate mofetil
3. How to take Mycophenolate mofetil
4. Possible side effects
5. How to store Mycophenolate mofetil
6. Contents of the pack and other information
1. WHAT MYCOPHENOLATE MOFETIL IS AND WHAT IT IS USED FOR
The full name of your medicine is Mycophenolate mofetil STADA 500 mg,
film-coated tablets.

In this leaflet the shorter name Mycophenolate mofetil is used.
This medicine contains mycophenolate mofetil.

This belongs to a group of medicines called “immunosuppressants”.
Mycophenolate mofetil is used to prevent your body rejecting a
transplanted organ:

A kidney, heart or liver.
Mycophenolate mofetil should be used together with other medicines:

Ciclosporin and corticosteroids.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOPHENOLATE MOFETIL
WARNING
Mycophenolate causes birth defects and miscarriage. If you are a woman
who could become
pregnant, you must provide a negative pregnancy test before starting
treatment and must
follow the contraception advice given to you by your doctor.
Your doctor will speak to you and give you written information,
particularly on the effects of
mycophenolate on unborn babies. Read the information carefully and
follow the instructions.
If you do not fully understand these instru

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Mycophenolate mofetil STADA 500 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg mycophenolate mofetil.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
Lavender coloured, capsule shaped, film-coated tablet, engraved with
“APO” on one side
and “MYC500” on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mycophenolate mofetil is indicated in combination with ciclosporin and
corticosteroids for the
prophylaxis of acute transplant rejection in patients receiving
allogeneic renal, cardiac or
hepatic transplants.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with mycophenolate mofetil should be initiated and
maintained by appropriately
qualified transplant specialists.
Posology
USE IN RENAL TRANSPLANT
_Adults _
Oral
mycophenolate
mofetil
therapy
should
be
initiated
within
72 hours
following
transplantation. The recommended dose in renal transplant patients is
1 g administered twice
daily (2 g daily dose).
_Paediatric population aged 2 to 18 years _
The recommended dose of mycophenolate mofetil is 600 mg/m
2
administered orally twice
daily
(up
to
a
maximum
of
2 g
daily).
Mycophenolate
mofetil
tablets
should
only
be
prescribed to patients with a body surface area greater than 1.5 m
2
, at a dose of 1 g twice
daily (2 g daily dose). As some adverse reactions occur with greater
frequency in this age
group (see section 4.8) compared with adults, temporary dose reduction
or interruption may
be required; these will need to take into account relevant clinical
factors including severity of
reaction.
_Paediatric population < 2 years _
There are limited safety and efficacy data in children below the age
of 2 years. These are
insufficient to make dosage recommendations and therefore use in this
age group is not
recommended.
2
USE IN CARDIAC TRANSPLANT
_Adults _
Oral
mycophenolate
mofetil
therapy
should
be
initiated
within
5 days
following
tran