Mycophenolate mofetil 500mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Mycophenolate mofetil

Sẵn có từ:

Mylan

Mã ATC:

L04AA06

INN (Tên quốc tế):

Mycophenolate mofetil

Liều dùng:

500mg

Dạng dược phẩm:

Tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 08020100; GTIN: 5016695003474

Tờ rơi thông tin

PAGE 1 OF 8
PACKAGE LEAFLET
PAGE 2 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYCOPHENOLATE MOFETIL 500 MG FILM-COATED TABLETS
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 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 Mofetil is and what it is used for
2.
What you need to know before you take Mycophenolate Mofetil
3.
How to take Mycophenolate Mofetil
4.
Possible side effects
5.
How to store Mycophenolate Mofetil
6.
Contents of the pack and other information
1.
WHAT MYCOPHENOLATE MOFETIL IS AND WHAT IT IS USED FOR
Mycophenolate Mofetil contains the active substance mycophenolate
mofetil, which belongs to a
group of medicines called immunosuppressants. These medicines are used
to prevent your body
rejecting a transplanted kidney, heart or liver. Mycophenolate Mofetil
should be used together with
other medicines known as ciclosporin and corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOPHENOLATE MOFETIL
WARNING
Mycophenolate mofetil 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 mofetil 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 mofetil. See also further information in t

Đặc tính sản phẩm

OBJECT 1
MYCOPHENOLATE MOFETIL 500 MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 15-Dec-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Mycophenolate Mofetil 500 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each tablet contains 500 mg mycophenolate mofetil.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated Tablet
Light pink film-coated, oval, biconvex, bevelled edge tablet debossed
with “MYLAN” on one side of the
tablet and “472” on the 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
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 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 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.
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 therefore use in this age group is not
recommended.
Use in cardiac transplant
A