MEMANTINE RBX memantine hydrochloride 10 mg tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

memantine hydrochloride

Διαθέσιμο από:

Sun Pharma ANZ Pty Ltd

INN (Διεθνής Όνομα):

memantine hydrochloride

Φύλλο οδηγιών χρήσης

MEMANTINE RBX
_MEMANTINE HYDROCHLORIDE 10 & 20 MG TABLETS_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet contains answers to
some common questions about
MEMANTINE RBX.
It does not contain all the
information that is known about
MEMANTINE RBX. It does not
take the place of talking to your
doctor or pharmacist.
This leaflet was last updated on
the date at the end of this leaflet.
More recent information may be
available. The latest Consumer
Medicine Information is available
from
https://www.ebs.tga.gov.au/
and may contain important
information about the medicine
and its use of which you should be
aware.
All medicines have risks and
benefits. Your doctor has weighed
the risk of you using this medicine
against the benefits he/she expects
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT MEMANTINE RBX
IS USED FOR
MEMANTINE RBX is used to
treat moderately severe to severe
Alzheimer's disease (AD). AD can
be described as a general decline
in all areas of mental ability.
MEMANTINE RBX belongs to a
group of medicines called N-
methyl-Daspartate (NMDA)
receptor antagonists. It is thought
to work by protecting NMDA
receptors in the brain against high
levels of the chemical glutamate,
which could be the cause of brain
degeneration.
NMDA receptors are involved in
the transmission of nerve signals
within the brain, e.g. in learning
and memory.
MEMANTINE RBX should
improve your thinking capacity
and your ability to remember.
Your doctor, however, may
prescribe MEMANTINE RBX for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available
with a doctor's prescription.
MEMANTINE RBX is not
addictive.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MEMANTINE RBX
IF YOU ARE ALLERGIC TO IT OR ANY OF
THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Symptoms of an allergic reaction
may include shortn

Αρχείο Π.Χ.Π.

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PRODUCT INFORMATION
MEMANTINE RBX
MEMANTINE HYDROCHLORIDE 10 & 20 MG FILM-COATED TABLETS
NAME OF THE MEDICINE
Memantine hydrochloride
Structural formula:
Molecular formula: C
12
H
21
N.HCl
Chemical name: 1-amino-3, 5-dimethyl-adamantane hydrochloride
Molecular weight: 215.76
CAS number: 19982-08-2 (free base); 4110-52-1 (hydrochloride salt)
DESCRIPTION
Memantine hydrochloride is a white to off-white crystalline powder. It
is soluble in water and
methanol, and insoluble in petroleum ether. Its pKa is 10.27. No
polymorphic forms have been
detected.
Each MEMANTINE RBX tablet contains 10 mg or 20 mg of memantine
hydrochloride. The
inactive ingredients are: microcrystalline cellulose, colloidal
anhydrous silica, croscarmellose
sodium, purified talc and magnesium stearate. In addition, the 10 mg
tablet contains OPADRY
complete film coating system OY-S-58910 WHITE (hypromellose, titanium
dioxide,
macrogol 400 and purified talc; Proprietary ingredient # 11503), and
the 20 mg tablet contains
OPADRY complete film coating system 03B540015 PINK (hypromellose,
titanium dioxide,
macrogol 400, iron oxide red and iron oxide yellow; Proprietary
ingredient # 108462).
PHARMACOLOGY
Pharmacological actions
There is increasing evidence that malfunctioning of glutamatergic
neurotransmission, in
particular at N-methyl-D-aspartate (NMDA) receptors, contributes to
both expression of
symptoms and disease progression in neurodegenerative dementia.
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Memantine is a rapid, strongly voltage-dependent, uncompetitive NMDA
receptor antagonist.
Prolonged increased levels of glutamate in the brain of demented
patients are sufficient to
counter the voltage-dependent block of NMDA receptors by Mg
2+
ions and allow continuous
influx of Ca
2+
ions into cells and ultimately neuronal degeneration. Studies suggest
that
memantine binds more effectively than Mg
2+
ions at the NMDA receptor, and thereby
effectively blocks this prolonged influx of Ca
2+
ions through the NMDA