Mementor TABLETS 10 MG

国家: 马来西亚

语言: 英文

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

有效成分:

MEMANTINE HYDROCHLORIDE

可用日期:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN（国际名称）:

MEMANTINE HYDROCHLORIDE

每包单位数:

10tablet Tablets; 30tablet Tablets; 60tablet Tablets; 100tablet Tablets

厂商:

TORRENT PHARMACEUTICALS LTD

资料单张

MEMENTOR TABLETS
Memantine Hydrochloride 10 mg
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1.
What Mementor
is used for
2.
How Mementor works
3.
Before you use Mementor
4.
How to use Mementor
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Mementor
8.
Product Description
9.
Manufacturer
10. Product Registration Holder
11. Date of revision
WHAT MEMENTOR IS USED FOR?
Mementor contains Memantine
Hydrochloride. It is used for
treatment of patients with moderate
to severe Alzheimer’s disease.
HOW MEMENTOR WORKS
Memantine Hydrochloride belongs to
a group of medicines known as anti-
dementia medicines. Memory loss in
Azheimer’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. Memantine
Hydrochloride belongs to group of
medicines called NMDA- receptor
antagonists. Mementor acts on these
NMDA-receptors improving the
transmission of nerve signals and
memory.
BEFORE YOU USE MEMENTOR
_When you must not use it_
If you are allergic (hypersensitive) to
Memantine hydrochloride, or any
other ingredients of mementor film-
coated tablets
_Before you start to use it_
_Talk to your doctor or pharmacist_
_before taking Memantor_
- If you have a history epileptic
seizures
-
If you have recently experienced a
myocardial infarction (heart attack),
or if you are suffering from
congestive heart failure or from an
uncontrolled hypertension (high
blood pressure).In these situations
the treatment should be carefully
supervised, and the clinical benefit
of Mementor reassessed by your
doctor on a regular basis.
If you suffer from renal impairment
(kidney problem), your doctor should
closely monitor your kidney function
and if necessary adapt the Mementor
doses accordingly.
The use of medicinal products called
amantadine (for the treatment of
Parkinson’s disease), ketamine (a
substance generally used as an
anaesthetic), d

产品特点

Proposed Prescribing Information
For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory
MEMENTOR TABLETS 10 MG
MEMANTINE HYDROCHLORIDE TABLETS
BRAND OR PRODUCT NAME
MEMENTOR TABLETS 10 MG
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each film coated tablet contains:
10 mg Memantine Hydrochloride equivalent to 8.31 mg Memantine
Colours: Titanium Dioxide
PRODUCT DESCRIPTION
White to off white colored, oval shaped, biconvex, bevel edged, film
coated tablets, debossed
‘10’ on one side and breakline on other side.
DOSAGE FORM
Film coated tablet
PHARMACODYNAMICS / PHARMACOKINETICS
PHARMACODYNAMICS
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 to 150 ng/ml (0.5-1 μmol) with large inter-individual
variations. When daily
doses of 5 to 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:_ It is reported that 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 catalysed metabolism has been reported