Mycophenolate mofetil Teva

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

mycophenolate mofetil

Available from:

Teva Pharma B.V.

ATC code:

L04AA06

INN (International Name):

mycophenolate mofetil

Therapeutic group:

Immunosuppressants

Therapeutic area:

Graft Rejection

Therapeutic indications:

Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Product summary:

Revision: 25

Authorization status:

Authorised

Authorization date:

2008-02-21

Patient Information leaflet

52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYCOPHENOLATE MOFETIL TEVA 250 MG HARD CAPSULES
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mycophenolate mofetil Teva is and what it is used for
2.
What you need to know before you take Mycophenolate mofetil Teva
3.
How to take Mycophenolate mofetil Teva
4.
Possible side effects
5.
How to store Mycophenolate mofetil Teva
6.
Contents of the pack and other information
1.
WHAT MYCOPHENOLATE MOFETIL TEVA IS AND WHAT IT IS USED FOR
Mycophenolate mofetil Teva is a medicine that is used to suppress
immune activity.
The active substance in this medicine is called mycophenolate mofetil.
Mycophenolate mofetil Teva is used to prevent your body rejecting a
transplanted kidney, heart or
liver. It is used in combination with other medicines with a similar
function (i.e. ciclosporin and
corticosteroids).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOPHENOLATE MOFETIL TEVA
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 instructions, please ask your
doctor to explain them again before
you take myc

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Mycophenolate mofetil Teva 250 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg mycophenolate mofetil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule)
The capsule body is caramel opaque, printed with ‘250’ axially in
black ink.
The capsule cap is light blue opaque printed ‘M’ axially in black
ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mycophenolate mofetil Teva 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 should be initiated and maintained by appropriately
qualified transplant specialists.
Posology
_Use in renal transplant _
Adults
Treatment 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). Capsules should only be prescribed to
patients with a body surface area of at
least 1.25 m
2
. Patients with a body surface area of 1.25 to 1.5 m
2
may be prescribed mycophenolate
mofetil capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Patients with a body surface area
greater than 1.5 m
2
may be prescribed mycophenolate mofetil capsules 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 ar