Mycophenolate mofetil Clonmel 250 mg capsules hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mycophenolate mofetil

Available from:

Clonmel Healthcare Ltd

ATC code:

L04AA; L04AA06

INN (International Name):

Mycophenolate mofetil

Dosage:

250 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Selective immunosuppressants; mycophenolic acid

Authorization status:

Not marketed

Authorization date:

2010-10-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYCOPHENOLATE MOFETIL CLONMEL 250 MG, CAPSULES, HARD
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 250
mg, capsules, hard.

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 instructions

Summary of Product characteristics

Health Products Regulatory Authority
05 May 2022
CRN00CTSR
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mycophenolate mofetil Clonmel 250 mg capsules hard
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.
Hard gelatin capsule, size 1, containing white to off-white powder,
with a blue opaque capsule cap and a pink opaque capsule
body, printed with ‘APO’ and ‘M250’ in black ink.
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/m2
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 of at least 1.25 m2. Patients with
a body surface area of 1.25 to 1.5 m2 may be prescribed mycophenolate
mofetil at a dose of 750 mg twice daily (1.5 g daily
dose). Patients with a body surface area greater than 1.5 m2 may be
prescribed mycophenolate mofetil 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.
_Paed