Memxa 10mg Tablet

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

MEMANTINE HYDROCHLORIDE

Verfügbar ab:

MEDISPEC (M) SDN.BHD

INN (Internationale Bezeichnung):

MEMANTINE HYDROCHLORIDE

Einheiten im Paket:

10 x 3tablet Tablets

Hergestellt von:

UNISON LABORATORIES CO.LTD

Gebrauchsinformation

MEMXA 10MG TABLET
Memantine hydrochloride 10mg eq. to Memantine 8.31mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_MEMXA 10mg Tablet_
is used
for
2.
How
_MEMXA 10mg Tablet_
works
3.
Before
you
use
_MEMXA _
_10mg _
_Tablet_
4.
How to use
_MEMXA 10mg Tablet_
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
_MEMXA _
_10mg Tablet_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT _MEMXA 10MG TABLET_
IS USED FOR
_MEMXA _
_10 _
belongs
to
a
group
of
medicines
known
as
anti-dementia
medicines.
_MEMXA 10_
is used for the treatment of
patients
with
moderate
to
severe
Alzheimer’s disease.
HOW _MEMXA 10MG TABLET_
WORKS
Memory loss in Alzheimer’s disease is
due to a disturbance of message signals
in the brain. The brain contains so-called
N-methyl-D-aspartate
(NMDA)-
receptors
that
are
involved
in
transmitting nerve signals important in
learning
and
memory.
_MEMXA _
_10_
belongs to a group of medicines called
NMDA-receptor
antagonists.
_MEMXA _
_10_
acts
on
these
NMDA-receptors
improving
the
transmission
of
nerve
signals and the memory.
BEFORE YOU USE _MEMXA 10MG TABLET_
-
_When you must not use it _
If you are allergic (Hypersensitive) to
Memantine hydrochloride or any of the
other ingredients of this medicine (listed
in
_Ingredients)._
_Pregnancy and breast-feeding _
Ask
your
doctor or
pharmacist
before
taking any medicine.
Tell your doctor if you are pregnant or
planning to become pregnant. The use of
Memantine
in
pregnant
women
is
not
recommended.
Women
taking
_MEMXA _
_10mg _
_Tablet_
should not breast-feed.
_Children and adolescents _
_MEMXA _
_10mg _
_Tablet_
is
not
recommended
for
children
and
adolescents under the age of 18 years.
_ _
-
_Before you start to use it _
Talk to your doctor or pharmacist before
taking
_MEMXA 10mg Tablet_
:
•
If you have a history of epileptic
seizures
•
If you have recently experienced a
myocardial infarction (heart attack),
or
if
you
are
suffering
from
congestive heart fai

Fachinformation

FRONT
28.5 cm.
16.5 cm.
PRODUCT DESCRIPTION:
White, centrally tapered, oblong, biconvex, film coated tablet with
engraved MMT on one side and scored on the other
MECHANISM OF ACTION:
_PHARMACOLOGY_
There is increasing evidence that malfunctioning of glutamatergic
neurotransmission, in particular at NMDA-receptors, contributes to
both expression of symptoms and disease progression in
neurodegenerative dementia.
Memantine is a voltage-dependent, moderate-affinity uncompetitive
NMDA-receptor antagonist. It modulates the effects of
pathologically elevated tonic levels of glutamate that may lead to
neuronal dysfunction.
_PHARMACOKINETICS_
Absorption
Memantine has an absolute bioavailability of approximately 100%. t
max
is between 3 and 8 hours. There is no indication that food
influences the absorption of Memantine.
Distribution
Daily doses of 20 mg lead to steady-state plasma concentrations of
Memantine ranging from 70-150 ng/mL (0.5-1 μmol) with large
interindividual variations. When daily doses of 5-30 mg were
administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was
calculated. The volume of distribution is around 10 L/Kg. About 45% of
Memantine is bound to plasma-proteins.
Biotransformation
In man, about 80% of the circulating Memantine-related material is
present as the parent compound. Main human metabolites
are N-3,5-dimethyl-gludantan, the isomeric mixture of 4-and
6-hydroxy-memantine, and 1-nitroso-3,5-dimethyl-adamantane.
None of these metabolites exhibit NMDA-antagonistic activity. No
cytochrome P 450 catalyzed metabolism has been detected
_in vitro._
_ _
Elimination
Memantine is eliminated in a monoexponential manner with a terminal
t½ of 60-100 hours. In volunteers with normal kidney
function, total clearance (Cl
tot
) amounts to 170 mL/min/1.73 m
2
and part of total renal clearance is achieved by tubular secretion.
Renal handling also involves tubular reabsorption, probably mediated
by cation transport proteins. The renal elimination rate
of Memantine under alkaline urine conditions may b