Mycophenolate mofetil 250mg capsules

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Mycophenolate mofetil

Tersedia dari:

Accord Healthcare Ltd

Kode ATC:

L04AA06

INN (Nama Internasional):

Mycophenolate mofetil

Dosis:

250mg

Bentuk farmasi:

Capsule

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 08020100; GTIN: 5060149314531

Selebaran informasi

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 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 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
Immunosuppressant.
Mycophenolate Mofetil capsules are used to prevent your body rejecting
a transplanted kidney, heart or liver.
Mycophenolate Mofetil capsules may 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.
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-

Karakteristik produk

OBJECT 1
MYCOPHENOLATE MOFETIL 250 MG CAPSULES
Summary of Product Characteristics Updated 06-Oct-2016 | Accord
Healthcare Limited
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).
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 po