ACCOCEPT 360 (Mycophenolic Acid Gastro Resistant Tablets 360 mg)

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

MYCOPHENOLIC ACID (AS SODIUM SALT)

Disponible des:

ACCORD HEALTHCARE SDN.BHD.

Designació comuna internacional (DCI):

MYCOPHENOLIC ACID (AS SODIUM SALT)

Unidades en paquete:

10 x 10’s Tablets; 5 x 10s Tablets; 12 x 10’s Tablets

Fabricat per:

INTAS PHARMACEUTICALS LIMITED

Informació per a l'usuari

Consumer Medication Information Leaflet (RiMUP)
ACCOCEPT 180 (Mycophenolic Acid Gastro Resistant
Tablets 180 mg)
ACCOCEPT 360 (Mycophenolic Acid Gastro Resistant
Tablets 360 mg)
Mycophenolate Sodium Equivalent to Mycophenolic Acid (180 mg and 360
mg)
P a g e 1 | 4
What is in this leaflet
1.
What Accocept tablets are used for
2.
How Accocept tablets works
3.
Before you use Accocept tablets
4.
How to use Accocept tablets
5.
While you are using Accocept
tablets
6.
Side effects
7.
Storage and disposal of Accocept
tablets
8.
Product description.
9.
Manufacturer and product
registration holder
10.
Date of revision
What Accocept tablets are used for
Accocept tablets are used to stop the
body’s immune system from rejecting a
kidney transplant. It is used together
with other medicines containing
ciclosporin and corticosteroids.
How Accocept tablets works
Accocept tablets contains a substance
called mycophenolic acid.
This belongs to a group of medicines
called immuno suppressants.
These medicines help to reduce
rejecting a kidney transplant along with
other medicines containing ciclosporin
and corticosteroids
Before you use Accocept tablets
-
When you must not take it
Do not take Accocept tablets
 if you are allergic to Mycophenolic
acid, Mycophenolate sodium,
Mycophenolate Mofetil or any of the
other ingredients of this medicine
 If you are pregnant.
 If you are breast-feeding.
 If you are a woman of child bearing
potential and you are not using highly
effective contraception methods.
If any of the above apply to you, tell
your doctor without taking Accocept
tablets.
-
Before you start to take it
Talk to your doctor or pharmacist
before taking Accocept tablets if:
 You have or have ever had serious
digestive problems, such as stomach
ulcer.
 You have a rare hereditary enzyme
deficiency of hypoxanthine-guanine
phosphoribosyl-transferase (HGPRT)
such as Lesch-Nyhan or Kelley-
Seegmiller syndrome.
-
Taking other medicines
Tell your doctor or pharmacist if you
are taking, have recently taken or might
take

Fitxa tècnica

Package Insert
ACCOCEPT 180 & 360
(Mycophenolic Acid Gastro Resistant Tablets 180 mg and 360 mg)
Name and strength of active ingredient
Accocept 180
Mycophenolate Sodium Ph. Eur. 192.350 mg equivalent to Mycophenolic
Acid 180 mg
Accocept 360
Mycophenolate Sodium Ph. Eur. 384.700 mg equivalent to Mycophenolic
Acid 360 mg
Product Description
Accocept 180
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.
Accocept 360
Peach colored, oblong shaped, biconvex, enteric-coated tablets
imprinted with M2 on one side
with black ink and plain on the other side.
Pharmacological Properties
Pharmacodynamic Properties
Mechanism of action:
Mycophenolic acid (MPA) is a potent, selective, uncompetitive and
reversible inhibitor of
inosine monophosphate dehydrogenase, and therefore inhibits the de
novo pathway of guanosine
nucleotide
synthesis
without
incorporation
into
DNA.
Because
T
and
B-lymphocytes
are
critically dependent for their proliferation on de novo synthesis of
purines whereas other cell
types can utilize salvage pathways, MPA has more potent cytostatic
effects on lymphocytes than
on other cells.
Pharmacokinetic Properties
Absorption
Following oral administration, mycophenolate sodium is extensively
absorbed. Consistent with
its enteric coated design, the time to maximal concentration (T
max
) of MPA was approximately
1.5-2 hours. Approximately 10% of all morning pharmacokinetic profiles
showed a delayed T
max
,
sometimes up to several hours, without any expected impact on 24
hour/daily MPA exposure.
In stable renal transplant patients on ciclosporin based
immunosuppression, the gastrointestinal
absorption of MPA was 93% and the absolute bioavailability was 72%.
Mycophenolic acid
gastro-resistant tablets pharmacokinetics are dose proportional and
linear over the studied dose
range of 180 to 2,160 mg.
The effect of food on Mycophenolic acid gastro-resistant tablets may
lead to an absorption
overlap from one dose interva