Ebixa

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Memantine hydrochloride

Tilgjengelig fra:

Lundbeck Australia Pty Ltd

Klasse:

Medicine Registered

Informasjon til brukeren

EBIXA
®

_(EE-BIC-SA)_
_Memantine hydrochloride (meh-MAN-teen high-dro-CLOR-ride)_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet contains answers to some
common questions about Ebixa.
It does not contain all the information
that is known about Ebixa. It does
not take the place of talking to your
doctor or pharmacist.
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 EBIXA IS USED FOR
Ebixa 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.
Ebixa belongs to a group of
medicines called N-methyl-D-
aspartate (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.
Ebixa should improve your thinking
capacity and your ability to
remember.
Your doctor, however, may prescribe
Ebixa 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.
Ebixa is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE EBIXA 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 shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips, tongue or
other parts of the body, or rash,
itching or hives on the skin.
DO NOT TAKE EBIXA IF YOU HAVE A
SEIZURE DISORDER OR ANY HISTORY OF
SEIZURES (FITS OR EPILEPSY).
DO NOT TAKE IT AFTER THE EXPIRY DATE
PRINTED ON THE PACK.
If you take it after th

Preparatomtale

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PRODUCT INFORMATION 

EBIXA
®
 FILM-COATED TABLETS 

NAME OF THE MEDICINE 

Memantine hydrochloride 

Chemical name:  
1-amino-3, 5-dimethyl-adamantane hydrochloride 

CAS number:  
19982-08-2 (free base) 
4110-52-1 (hydrochloride salt) 

Molecular formula:  
C
12
H
21
N.HCl  

Molecular weight:  
215.77 

Structural formula:  

DESCRIPTION 

Memantine hydrochloride is a colourless crystalline substance with a bitter taste.  The 
solubility of memantine hydrochloride in water at room temperature is about 3.5%.  No 
polymorphic forms have been detected. 

Ebixa  10  mg  tablets  are  pale  yellow  to  yellow,  oval  shaped  film-coated  tablets  with 
break line and engravings ‘M’ on both parts right and left of the break line and on the 
other side, ‘1’ left and ‘0’ right of the break line. They contain the following excipients: 
microcrystalline  cellulose,  croscarmellose  sodium,  hypromellose,  iron  oxide  yellow, 
macrogol 400, magnesium stearate, colloidal anhydrous silica and titanium dioxide. 

Ebixa  20  mg  tablets  are  pink  to  grey-red  oval  biconvex  film-
coated  tablets  with  ’20’ 
embossed  on  one  side  and  ‘MEM’  on  the  other  side.    They  contain  the  following 
excipients:,

microcrystalline cellulose croscarmellose sodium, hypromellose, iron oxide 
red CI77491, iron oxide yellow CI77492, macrogol 400, magnesium stearate, colloidal 
anhydrous silica and titanium dioxide. 

NH
3
+
Cl
-
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_Page 2 of 14 _
PHARMACOLOGY 

Pharmacological actions 

There is increasing evidence that malfunctioning of glutamatergic neurotransmission, 
in  particular  at  N-methyl-D-aspartate  (NMDA)  receptors,  contribut