Mycophenolate Mofetil 500mg film-coated Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Mycophenolate mofetil

Verfügbar ab:

Accord Healthcare 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:

Marketed

Berechtigungsdatum:

2008-11-28

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 further questions, ask your doctor, pharmacist or nurse.

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 Tablets is and what it is used for
2. What you need to know before you take Mycophenolate Mofetil Tablets
3. How to take Mycophenolate Mofetil Tablets
4. Possible side effects
5. How to store Mycophenolate Mofetil Tablets
6. Contents of the pack and other information
1. WHAT MYCOPHENOLATE MOFETIL TABLETS IS AND WHAT IT IS USED FOR
Immunosuppressants.
Mycophenolate Mofetil Tablets are used to prevent your body rejecting
a transplanted kidney, heart or liver.
Mycophenolate
Mofetil
Tablets
is
used
together
with
other
medicines
known
as
ciclosporin
and
corticosteroids.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOPHENOLATE MOFETIL 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 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
mycophenolate. See also further information in this section under
“Warnings and precautions” and
“Pregnancy and breast-feeding�

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mycophenolate Mofetil 500mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Mycophenolate Mofetil 500 mg.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Purple colored, capsule shaped, biconvex, film coated tablet debossed
‘AHI’ on one side and ‘500’ on other side.
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
Posology
Treatment with Mycophenolate Mofetil should be initiated and
maintained by appropriately qualified transplant
specialists.
Use in renal transplant:
Adults: Oral Mycophenolate Mofetil 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).
Children and adolescents (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 500 mg 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.
Children (< 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.
Use in cardiac transplant:
Adults: Oral Mycophenolate Mofetil should be initiated within 5 days
following transplantation. The recommended