Mycophenolate Mofetil Accord 250 mg capsules

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Mycophenolate mofetil

Disponibil de la:

Accord Healthcare Limited

Codul ATC:

L04AA; L04AA06

INN (nume internaţional):

Mycophenolate mofetil

Dozare:

250 milligram(s)

Forma farmaceutică:

Capsule

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Selective immunosuppressants; mycophenolic acid

Statutul autorizaţiei:

Marketed

Data de autorizare:

2011-12-16

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
Mycophenolate Mofetil
Accord 250 mg 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 further questions, please 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 Accord is and
what it is used for
2. What you need to know before you take
Mycophenolate Mofetil Accord
3. How to take Mycophenolate Mofetil Accord
4. Possible side effects
5. How to store Mycophenolate Mofetil Accord
6. Contents of the pack and other information
1.
WHAT MYCOPHENOLATE MOFETIL
ACCORD IS AND WHAT IT IS USED
FOR
Immunosuppressant.
Mycophenolate Mofetil Accord are used to
prevent your body rejecting a transplanted
kidney, heart or liver.
Mycophenolate Mofetil Accord may be used
together with other medicines known as
ciclosporin and corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE MYCOPHENOLATE
MOFETIL ACCORD
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�

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mycophenolate Mofetil Accord 250 mg 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
Capsule, hard
Light blue/peach size ‘1’ hard gelatin capsule imprinting with
‘MMF’ on cap and ‘250’ on body, containing white to
off white powder
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 should be initiated within 72 hours
following transplantation.
The recommended dose in
renal transplant patients is 1.0 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 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 belo