Mycophenolate mofetil Clonmel 500 mg film-coated tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Mycophenolate mofetil

から入手可能:

Clonmel Healthcare Ltd

ATCコード:

L04AA; L04AA06

INN（国際名）:

Mycophenolate mofetil

投薬量:

500 milligram(s)

医薬品形態:

Film-coated tablet

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

Selective immunosuppressants; mycophenolic acid

認証ステータス:

Not marketed

承認日:

2010-10-08

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYCOPHENOLATE MOFETIL CLONMEL 500 MG, 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 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
The full name of your medicine is Mycophenolate mofetil Clonmel 500
mg, film-coated tablets.

In this leaflet the shorter name Mycophenolate mofetil is used.
This medicine contains mycophenolate mofetil.

This belongs to a group of medicines called “immunosuppressants”.
Mycophenolate mofetil is used to prevent your body rejecting a
transplanted organ:

A kidney, heart or liver.
Mycophenolate mofetil should be used together with other medicines:

Ciclosporin and corticosteroids.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOPHENOLATE MOFETIL
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 in

製品の特徴

Health Products Regulatory Authority
05 May 2022
CRN00CTSR
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mycophenolate mofetil Clonmel 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
Lavender coloured, capsule shaped, film-coated tablet, engraved with
“APO” on one side and “MYC500” on the other.
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 therapy 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 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.
_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
_Adults_
Oral mycophenolate mofet