Myfortic 360mg gastro-resistant Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MYCOPHENOLIC ACID

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

L04AA06

INN (International Name):

MYCOPHENOLIC ACID 360 mg

Pharmaceutical form:

GASTRO-RESISTANT TABLET

Composition:

MYCOPHENOLIC ACID 360 mg

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Authorization status:

Authorised

Authorization date:

2005-05-30

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYFORTIC
® 360 MG GASTRO-RESISTANT TABLETS
mycophenolic acid (as mycophenolate sodium)
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 Myfortic is and what it is used for
2.
What you need to know before you take Myfortic
3.
How to take Myfortic
4.
Possible side effects
5.
How to store Myfortic
6.
Contents of the pack and other information
1.
WHAT MYFORTIC IS AND WHAT IT IS USED FOR
Myfortic contains a substance called mycophenolic acid. This belongs
to a group of medicines called
immunosuppressants.
Myfortic is used to stop the body’s immune system from rejecting a
kidney transplant. It is used together
with other medicines containing ciclosporin and corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYFORTIC
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 MYFORTIC:
-
if you are allergic to mycophenoli

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Myfortic 360 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 360 mg mycophenolic acid (as
mycophenolate sodium).
Excipients with known effect:
Lactose: 90 mg per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet
Pale orange red, film-coated ovaloid tablet, with imprint (debossing)
“CT” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Myfortic is indicated in combination with ciclosporin and
corticosteroids for the prophylaxis of acute
transplant rejection in adult patients receiving allogeneic renal
transplants.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Myfortic should be initiated and maintained by
appropriately qualified transplant specialists.
Posology
The recommended dose is 720 mg administered twice daily (1,440 mg
daily dose). This dose of
mycophenolate sodium corresponds to 1 g mycophenolate mofetil
administered twice daily (2 g daily dose)
in terms of mycophenolic acid (MPA)
content.
For additional information about the corresponding therapeutic doses
of mycophenolate sodium and
mycophenolate mofetil, see sections 4.4 and 5.2.
In
_de novo_
patients, Myfortic should be initiated within 72 hours following
transplantation.
_ _
_Special population _
_Paediatric population _
Insufficient data are available to support the efficacy and safety of
Myfortic in children and adolescents.
_ _
Limited pharmacokinetic data are available for paediatric renal
transplant patients (see section 5.2).
_Older people _
The recommended dose in elderly patients is 720 mg twice daily.
_Patients with renal impairment _
In patients experiencing delayed renal graft function
post-operatively, no dose adjustments are needed (see
section 5.2).
Patients with severe renal impairment (glomerular filtration rate <25
ml
·
min
-1
·
1.73 m
-2
) should be carefully
monitored and the daily dose of Myfortic should not exceed