Mycolat 500 mg Film-coated tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Mycophenolate mofetil

Verfügbar ab:

Rowex Ltd

ATC-Code:

L04AA; L04AA06

INN (Internationale Bezeichnung):

Mycophenolate mofetil

Dosierung:

500 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Selective immunosuppressants; mycophenolic acid

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2008-11-14

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYCOLAT 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 Mycolat is and what it is used for
2.
What you need to know before you take Mycolat
3.
How to take Mycolat
4.
Possible side effects
5.
How to store Mycolat
6.
Contents of the pack and other information
1.
WHAT MYCOLAT IS AND WHAT IT IS USED FOR
Mycolat contains mycophenolate mofetil. This belongs to a group of
medicines called
“IMMUNOSUPPRESSANTS”.
Mycolat is used to prevent your body rejecting a transplanted organ:

A kidney, heart or liver.
Mycolat should be used together with other medicines:

Ciclosporin and corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOLAT
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-feeding”.
DO NOT TAKE MYCOLAT:

If you are allergic (hypersensitive) to mycophenolate mofetil,

Fachinformation

Health Products Regulatory Authority
24 March 2022
CRN00CS8D
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mycolat 500 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg of mycophenolate mofetil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Lavender coloured, film coated biconvex tablet plain on both the
sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mycolat 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 Mycolat should be initiated and maintained by
appropriately qualified transplant specialists.
Posology
_Use in renal transplant_
Adults
Oral Mycolat 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).
Mycolat 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 mofetil should be initiated within 5 days following
transplantation. The recommended dose in cardiac
transplant patients is 1.5 g admini