Axympa 360mg Gastro-resistant Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MYCOPHENOLIC ACID

Available from:

Teva Pharma B.V. (utrecht) Swensweg 5, 2031 GA Haarlem, Netherlands

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:

Withdrawn

Authorization date:

2013-08-07

Patient Information leaflet

PACKAGE LEAFLET
Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
AXYMPA 360MG GASTRO-RESISTANT TABLETS
Mycophenolic acid
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 or
nurse.
-
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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Axympa is and what it is used for
2.
What you need to know before you take Axympa
3.
How to take Axympa
4.
Possible side effects
5.
How to store Axympa
6.
Contents of the pack and other information
1.
WHAT AXYMPA IS AND WHAT IT IS USED FOR
Axympa contains a substance called mycophenolic acid. This belongs to
a group of medicines
called immunosuppressants.
Axympa 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 AXYMPA
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, breast-feeding and fertility”.
DO NOT TAKE AXYMPA
•
if you are allergic to mycophenolic

Summary of Product characteristics

Page
1
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1
NAME OF THE MEDICINAL PRODUCT
Axympa 180mg gastro-resistant tablets
Axympa 360mg gastro-resistant tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Axympa 180 mg gastro-resistant tablets:
Each gastro-resistant tablet contains 180 mg mycophenolic acid (as
mycophenolate sodium).
Excipient(s) with known effect≥ Each tablet contains 13.9 mg (0.61
mmol) sodium
Axympa 360 mg gastro-resistant tablets:
Each gastro-resistant tablet contains 360 mg mycophenolic acid (as
mycophenolate sodium).
Excipient(s) with known effect≥ Each tablet contains 27.9 mg (1.21
mmol) sodium
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet
180 MG:
Lime Green colored, round shaped, biconvex bevelled edged
enteric-coated tablets imprinted with
M1 on one side with black ink and plain on the other side
Note: Diameter of the tablet is 10.80 ± 0.2 mm
360 MG:
Peach colored, oblong shaped, biconvex, enteric-coated tablets
imprinted with M2 on one side with
black ink and plain on the other side.
Note: Length and Width of the tablet is 17.50 ± 0.2 mm and 10.35 ±
0.2 mm
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Axympa 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 Axympa 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.
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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, Axympa should be initiated within 72 hours following
transplantation.
Paediatric population
Insufficient data are availa