MACMENTA 10 (MEMANTINE HYDROCHLORIDE 10MG FILM-COATED TABLETS)

Country: Malaysia

Language: English

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

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

SYNERRV SDN BHD

INN (International Name):

MEMANTINE HYDROCHLORIDE

Units in package:

4 x 14 Tablets

Manufactured by:

Macleods Pharmaceuticals Limited

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
MACMENTA 10 (MEMANTINE HYDROCHLORIDE 10MG
FILM-COATED TABLETS)
MACMENTA 20 (MEMANTINE HYDROCHLORIDE 20 MG
FILM-COATED TABLETS)
Memantine hydrochloride tablets (10 mg, 20 mg)
WHAT IS IN THIS LEAFLET
1.
What
_Macmenta _
is use for
2.
How
_Macmenta _
works
_3._
_ _
Before you use
_Macmenta _
_4._
_ _
How to use
_Macmenta _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_Macmenta _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _MACMENTA _IS USED FOR
_Macmenta _
contains the active
substance memantine hydrochloride. It
belongs to a group of medicines known
as anti- dementia medicines.
_Macmenta _
is used for the treatment of patients
with moderate to severe Alzheimer’s
disease.
HOW _MACMENTA _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.
_Macmenta _
belongs to a group of medicines called
NMDA-receptor antagonists.
_Macmenta _
acts on these NMDA-
receptors improving the transmission
of nerve signals and the memory.
BEFORE YOU USE _MACMENTA _
-
_When you must not use it _
•
if you are allergic to memantine or
any of the other ingredients of this
medicine.
_Pregnancy and lactation _
Do not take
_Macmenta _
if you are
pregnant, trying to get pregnant or think
you may be pregnant. If you get
pregnant while taking
_Macmenta_
, stop
taking it immediately and contact your
doctor.
The use of memantine in pregnant
women is not recommended.
Do not take
_Macmenta _
if you are
breast- feeding. Women taking
_Macmenta _
should not breast-feed. Ask
your doctor or pharmacist for advice
before taking any medicine.
-
_Before you start use it _
Talk to your doctor or pharmacist
before taking
_Macmenta_
:
•
if you have recently experienced a
myocardial infarction (heart
attack), or if you are suffering

Summary of Product characteristics

MACMENTA 10 (MEMANTINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS)
MACMENTA 20 (MEMANTINE HYDROCHLORIDE 20 MG FILM-COATED TABLETS)
MACLEODS PHARMACEUTICALS LTD.
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A LABORATORY
MACMENTA 10 (MEMANTINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS)
MACMENTA 20 (MEMANTINE HYDROCHLORIDE 20 MG FILM-COATED TABLETS)
COMPOSITION:
Each tablet contains:
MACMENTA 10: Memantine hydrochloride ….…10mg (equivalent to 8.31mg
Memantine)
MACMENTA 20: Memantine hydrochloride ….…20mg (equivalent to
16.62mg
Memantine)
DESCRIPTION:
MACMENTA 10: White to off white, capsule shape, film coated tablet
debossed with
“CL29” on one side and breakline on both sides (12.1 ± 0.3 x 5.1
± 0.3)
MACMENTA 20: Brown colour, capsule shape, film coated tablet debossed
with “CL30”
on one side and plain on both sides (14.6 ± 0.3 x 7.1± 0.3)
PHARMACOLOGICAL ACTION:
PHARMACOKINETICS:
Absorption
Memantine has an absolute bioavailability of approximately 100%. Tmax
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 interindividual
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.
MACMENTA 10 (MEMANTINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS)
MACMENTA 20 (MEMANTINE HYDROCHLORIDE 20 MG FILM-COATED TABLETS)
MACLEODS PHARMACEUTICALS LTD.
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
catalysed
metabolism has been detected in vi