Mycophenolate Mofetil 250mg Capsules

Land: Malta

Språk: engelska

Källa: Malta Medicines Authority

Aktiva substanser:

MYCOPHENOLATE MOFETIL

Tillgänglig från:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC-kod:

L04AA06

INN (International namn):

MYCOPHENOLATE MOFETIL 250 mg

Läkemedelsform:

HARD CAPSULE

Sammansättning:

MYCOPHENOLATE MOFETIL 250 mg

Receptbelagda typ:

POM

Terapiområde:

IMMUNOSUPPRESSANTS

Bemyndigande status:

Authorised

Tillstånd datum:

2009-10-13

Bipacksedel

PAGE 1 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYCOPHENOLATE MOFETIL 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 any 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 Capsules is and what it is used for
2. What you need to know before you take Mycophenolate Mofetil
Capsules
3. How to take Mycophenolate Mofetil Capsules
4. Possible side effects
5. How to store Mycophenolate Mofetil Capsules
6. Contents of the pack and other information
1. WHAT MYCOPHENOLATE MOFETIL CAPSULES IS AND WHAT IT IS USED FOR
The full name of your medicine is Mycophenolate Mofetil 250 mg
Capsules.
Mycophenolate Mofetil 250 mg Capsules contains mycophenolate mofetil.
This belongs to a group of
medicines called “immunosuppressants”.
Mycophenolate Mofetil capsules are used to prevent your body rejecting
a transplanted kidney, heart
or
liver.
Mycophenolate Mofetil capsules should be used together with other
medicines known as ciclosporin
and corticosteroids.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOPHENOLATE MOFETIL
CAPSULES
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.
PAGE 2 OF 8
If you do not fully

Produktens egenskaper

PAGE 1 OF 22
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mycophenolate Mofetil 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).
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 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
PAGE 2 OF 22
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 i