Mycophenolate Mofetil 500mg Film-Coated Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Mycophenolate mofetil

Verfügbar ab:

Wockhardt UK Limited

ATC-Code:

L04AA; L04AA06

INN (Internationale Bezeichnung):

Mycophenolate mofetil

Dosierung:

500 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Selective immunosuppressants; mycophenolic acid

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2011-04-08

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
MYCOPHENOLATE MOFETIL 500MG 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, please 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 Tablets are and what they are used for
2. What you need to know before you take Mycophenolate Tablets
3. How to take Mycophenolate Tablets
4. Possible side effects
5. How to store Mycophenolate Tablets
6. Contents of the pack and other information
1.
WHAT MYCOPHENOLATE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Mycophenolate Mofetil 500mg Film-Coated
Tablets (referred
to Mycophenolate Tablets in this leaflet).
Mycophenolate Tablets contain the active substance mycophenolate
mofetil. Mycophenolate
Mofetil belongs to a group of medicines called immunosuppressants,
which are used to
inhibit the activity of the immune system (your body’s defence
mechanism against infection).
Mycophenolate Tablets should be used in combination with other
medicines called
ciclosporin and corticosteroids, to prevent your body rejecting a new
kidney, liver or heart
following a transplant.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOPHENOLATE TABLETS
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

Fachinformation

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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mycophenolate Mofetil 500mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg mycophenolate mofetil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets
Purple coloured, debossed with ‘W417’ on one side and plain on the
other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mycophenolate mofetil 500mg film-coated tablets are 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 500mg film-coated tablets should
be initiated
and maintained by appropriately qualified transplant specialists.
Posology
_Use in renal transplant_
Adults
Mycophenolate mofetil 500mg film-coated tablets should be initiated
within 72
hours following transplantation. The recommended dose in renal
transplant patients
is 1g 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
500mg
film-coated 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
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Page 2 of 24
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 the