Accempa 360 mg maagsapresistente tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

MYCOFENOLAAT NATRIUM SAMENSTELLING overeenkomend met ; MYCOFENOLZUUR

Beschikbaar vanaf:

Teva Nederland B.V.

ATC-code:

L04AA06

INN (Algemene Internationale Benaming):

MYCOPHENOLATE SODIUM COMPOSITION corresponding to ; MYCOFENOLZUUR

farmaceutische vorm:

Maagsapresistente tablet

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Mycophenolic Acid

Autorisatie datum:

2015-02-16

Bijsluiter

Mycophenolic acid, ES/H/0277/001-002, 17.01.18
1
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
ACCEMPA 360 MAAGSAPRESISTENTE TABLETTEN
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.
-
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains a substance called mycophenolic acid. This
belongs to a group of
medicines called immunosuppressants.
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
WARNING
Mycophenolic acid 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
mycophenolic acid 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 . See also further information in this section
under “Warnings and
precautions”, “Pregnancy and breas

Productkenmerken

Mycophenolic acid, ES/H/0277/001-002, 17.01.18
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Accempa 180 mg maagsapresistente tabletten
Accempa 360 mg maagsapresistente tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
180 mg gastro-resistant tablets
Each gastro-resistant tablet contains 180 mg mycophenolic acid (as
mycophenolate sodium).
Excipient with known effect
Each tablet contains 13.9 mg (0.61 mmol) sodium.
360 mg gastro-resistant tablets
Each gastro-resistant tablet contains 360 mg mycophenolic acid (as
mycophenolate sodium).
Excipient 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 gastro-resistant tablets
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 gastro-resistant tablets
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
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 should be initiated and maintained by
appropriately qualified transplant
specialists.
POSOLOGY
Mycophenolic acid, ES/H/0277/001-002, 17.01.18
2
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