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MEMANTINE HYDROCHLORIDE 5 MG / 10 MG / 15 MG / 20 MG FILM-COATED TABLETS INITIATION PACK

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MEMANTINE HYDROCHLORIDE INITIATION PACK
PACKAGE�LEAFLET:�INFORMATION�FOR�THE�USER
Memantine�hydrochloride�5�mg�/�10�mg�/�15�mg�/�20�mg�film-coated�tablets�initiation�pack
7�tablets�of�Memantine�hydrochloride�5�mg�film-coated�tablets
7�tablets�of�Memantine�hydrochloride�10�mg�film-coated�tablets
7�tablets�of�Memantine�hydrochloride�15�mg�film-coated�tablets
7�tablets�of�Memantine�hydrochloride�20�mg�film-coated�tablets
Memantine�hydrochloride
Read�all�of�this�leaflet�carefully�before�you�start�taking�this�medicine�because�it�contains�important�
information�for�you
-�Keep�this�leaflet.�You�may�need�to�read�it�again.
-�If�you�have�any�further�questions,�ask�your�doctor�or�pharmacist.
-�This�medicine�has�been�prescribed�only�for�you.�Do�not�pass�it�on�to�others.�It�may�harm�them,�even�if�their�signs�of�
illness�are�the�same�as�yours.
-�If�any�of�the�side�effects�gets�serious,�or�if�you�notice�any�side�effects�not�listed�in�this�leaflet,�please�tell�your�doctor�
or�pharmacist.
In�this�leaflet
1.�What�Memantine�hydrochloride�is�and�what�it�is�used�for
2.�What�you�need�to�know�before�you�take�Memantine�hydrochloride
3.�How�to�take�Memantine�hydrochloride
4.�Possible�side�effects
5.�How�to�store�Memantine�hydrochloride
6.�Content�of�the�pack�and�other�information
1.�WHAT�MEMANTINE�HYDROCHLORIDE�IS�AND�WHAT�IT�IS�USED�FOR
How�does�Memantine�hydrochloride�work
Memantine�hydrochloride�belongs�to�a�group�of�medicines�known�as�anti-dementia�medicines.
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.�Memantine�hydrochloride�belongs�to�a�group�of�medicines�called�NMDA-receptor�antagonists.�
Memantine� hydrochloride� acts� on� these� NMDA-receptors� improving� the� transmission� of� nerve� signals� and� the�
memory.
What�is�Memantine�hydrochloride�used�for
Memantine�hydrochloride�is�used�for�the�treatment�of�patients�with�moderate�to�severe�Alzheimer’s�disease.
2.�WHAT�YOU�NEED�TO�KNOW�BEFORE�YOU�TAKE�MEMANTINE�HYDROCHLORIDE
Do�not�take�Memantine�hydrochloride
-� if� you� are� allergic� to� memantine� hydrochloride� or� any� of� the� other� ingredients� of� Memantine� hydrochloride�
film-coated�tablets�(see�section�6).
Warnings�and�precautions
-�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�
failure�or�from�an�uncontrolled�hypertension�(high�blood�pressure).
In�these�situations�the�treatment�should�be�carefully�supervised,�and�the�clinical�benefit�of�Memantine�hydrochloride�
reassessed�by�your�doctor�on�a�regular�basis.
If�you�suffer�from�renal�impairment�(kidney�problems),�your�doctor�should�closely�monitor�your�kidney�function�and�
if�necessary�adapt�the�memantine�doses�accordingly.
The�use�of�medicinal�products�called�amantadine�(for�the�treatment�of�Parkinson’s�disease),�ketamine�(a�substance�
generally�used�as�an�anaesthetic),�dextromethorphan�(generally�used�to�treat�cough)�and�other�NMDA-antagonists�at�
the�same�time�should�be�avoided.
Children�and�adolescents
Memantine�hydrochloride�is�not�recommended�for�children�and�adolescents�under�the�age�of�18�years.
Other�medicines�and�Memantine�hydrochloride
Please�tell�your�doctor�or�pharmacist�if�you�are�taking�or�have�recently�taken�any�other�medicines,�including�medicines�
obtained�without�a�prescription.
In�particular,�Memantine�hydrochloride�may�change�the�effects�of�the�following�medicines�and�their�dose�may�need�to�
be�adjusted�by�your�doctor:
amantadine,�ketamine,�dextromethorphan
dantrolene,�baclofen
cimetidine,�ranitidine,�procainamide,�quinidine,�quinine,�nicotine
hydrochlorothiazide�(or�any�combination�with�hydrochlorothiazide)
anticholinergics�(substances�generally�used�to�treat�movement�disorders�or�intestinal�cramps)
anticonvulsants�(substances�used�to�prevent�and�relieve�seizures)
barbiturates�(substances�generally�used�to�induce�sleep)
dopaminergic�agonists�(substances�such�as�L-dopa,�bromocriptine)
neuroleptics�(substances�used�in�the�treatment�of�mental�disorders)
oral�anticoagulants
If�you�go�into�hospital,�let�your�doctor�know�that�you�are�taking�Memantine�hydrochloride.
Memantine�hydrochloride�with�food�and�drink
You�should�inform�your�doctor�if�you�have�recently�changed�or�intend�to�change�your�diet�substantially�(e.g.�from�
normal�diet�to�strict�vegetarian�diet)�or�if�you�are�suffering�from�states�of�renal�tubulary�acidosis�(RTA,�an�excess�of�
acid-forming� substances� in� the� blood� due� to� renal� dysfunction� (poor� kidney� function))� or� severe� infections� of� the�
urinary�tract�(structure�that�carries�urine),�as�your�doctor�may�need�to�adjust�the�dose�of�your�medicine.
Pregnancy�and�breast-feeding
Ask�your�doctor�or�pharmacist�for�advice�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�Memantine�hydrochloride�should�not�breast-feed.
Driving�and�using�machines
Your�doctor�will�tell�you�whether�your�illness�allows�you�to�drive�and�to�use�machines�safely.
Also,�Memantine�hydrochloride�may�change�your�reactivity,�making�driving�or�operating�machinery�inappropriate.
3.�HOW�TO�TAKE�MEMANTINE�HYDROCHLORIDE
The�Memantine�hydrochloride�treatment�initiation�pack�is�only�to�be�used�for�the�beginning�of�the�treatment�with�
Memantine�hydrochloride.
Always�take�Memantine�hydrochloride�exactly�as�your�doctor�has�told�you.�You�should�check�with�your�doctor�or�
pharmacist�if�you�are�not�sure.
Dosage
The�recommended�treatment�dose�of�20�mg�per�day�is�achieved�by�a�gradual�increase�of�the�Memantine�hydrochloride�
dose�during�the�first�3�weeks�of�treatment.�The�treatment�scheme�is�also�indicated�on�the�treatment�initiation�pack.�Take�
one�tablet�once�a�day.
Week�1�(day�1-7):
Take�one�5�mg�tablet�once�a�day�(white,�oval,�biconvex)�for�7�days.
Week�2�(day�8-14):
Take�one�10�mg�tablet�once�a�day�(white,�biconvex,�two-side�scored)�for�7�days.
Week�3�(day�15-21):
Take�one�15�mg�tablet�once�a�day�(light�brown,�oval,�biconvex)�for�7�days.
Week�4�(day�22-28):
Take�one�20�mg�tablet�per�day�(pink,�oval,�biconvex)�for�7�days.
Week�1
Week�2
Week�3
Week�4�and�beyond

If�you�take�more�Memantine�hydrochloride�than�you�should
-�In�general,�taking�too�much�Memantine�hydrochloride�should�not�result�in�any�harm�to�you.�You�may�experience�
increased�symptoms�as�described�in�section�4.�“Possible�side�effects”.
-�If�you�take�a�large�overdose�of�Memantine�hydrochloride,�contact�your�doctor�or�get�medical�advice,�as�you�may�need�
medical�attention.
If�you�forget�to�take�Memantine�hydrochloride
-�If�you�find�you�have�forgotten�to�take�your�dose�of�Memantine�hydrochloride,�wait�and�take�your�next�dose�at�the�usual�
time.
-�Do�not�take�a�double�dose�to�make�up�for�a�forgotten�dose.
If�you�have�any�further�questions�on�the�use�of�this�product,�ask�your�doctor�or�pharmacist.
4.�POSSIBLE�SIDE�EFFECTS
Like�all�medicines,�this�medicine�can�cause�side�effects,�although�not�everybody�gets�them.
In�general,�the�observed�side�effects�are�mild�to�moderate.
Common�(may�affect�up�to�1�in�10�people):
•� Headache,�sleepiness,�constipation,�elevated�liver�function�tests,�dizziness,�balance�disorders,�shortness�of�breath,�
high�blood�pressure�and�drug�hypersensitivity
Uncommon�(may�affect�up�to�1�in�100�people):
•� Tiredness,� fungal� infections,� confusion,� hallucinations,� vomiting,� abnormal� gait,� heart� failure� and� venous� blood�
clotting�(thrombosis/thromboembolism)
Very�Rare�(may�affect�up�to�1�in�10,000�people):
•�Seizures
Not�known�(frequency�cannot�be�estimated�from�the�available�data):
•�Inflammation�of�the�pancreas,�inflammation�of�the�liver�(hepatitis)�and�psychotic�reactions
Alzheimer’s�disease�has�been�associated�with�depression,�suicidal�ideation�and�suicide.�These�events�have�been�reported�
in�patients�treated�with�memantine.
If�any�of�the�side�effects�gets�serious,�or�if�you�notice�any�side�effects�not�listed�in�this�leaflet,�please�tell�your�doctor�or�
pharmacist.
Reporting�of�side�effects
�If�you�get�any�side�effects,�talk�to�your�doctor,�pharmacist�or�nurse.�This�includes�any�possible�side�effects�not�listed�in�
this�leaflet.�You�can�also�report�side�effects�directly�via�the�Yellow�Card�Scheme�at:�www.mhra.gov.uk/yellowcard.
�By�reporting�side�effects�you�can�help�provide�more�information�on�the�safety�of�this�medicine.
5.�HOW�TO�STORE�MEMANTINE�HYDROCHLORIDE�TABLETS
Keep�this�medicine�out�of�the�sight�and�reach�of�children.
Do�not�use�this�medicine�after�the�expiry�date�which�is�stated�on�the�carton�and�the�blister�after�EXP.�The�expiry�date�
refers�to�the�last�day�of�that�month.
This�medicinal�product�does�not�require�any�special�storage�conditions.
Do�not�throw�away�any�medicines�via�wastewater�.�Ask�your�pharmacist�how�to�throw�away�medicines�you�no�longer�
use.�These�measures�will�help�to�protect�the�environment.
6.�CONTENTS�OF�THE�PACK�AND�OTHER�INFORMATION�
What�Memantine�hydrochloride�tablets�contains
The� active� substance� is� memantine� hydrochloride.� Each� film-coated� tablet� contains� 5/10/15/20� mg� memantine�
hydrochloride�equivalent�to�4.15/8.31/12.46/16.62�mg�memantine.
The� other� ingredients� for� Memantine� hydrochloride� 5/10/15� and� 20� mg� film-coated� tablets� are� microcrystalline�
cellulose,�croscarmellose�sodium,�colloidal�silicon�dioxide�and�magnesium�stearate,�all�in�the�tablet�core;�and�polyvinyl�
alcohol,�titanium�dioxide�(E171),�macrogol�3350,�talc�and�additional�for�Memantine�hydrochloride�15�mg�film-coated�
tablets�are�iron�oxide�yellow,�red�and�black�(E172)�and�for�Memantine�hydrochloride�20�mg�film-coated�tablets�are�iron�
oxide�yellow�and�red�(E172),�all�in�the�tablet�coating.
What�Memantine�hydrochloride�tablets�looks�like�and�contents�of�the�pack
Memantine�hydrochloride�5�mg�film-coated�tablets�are�presented�as�white,�oval,�biconvex�film-coated�tablets�
embossed�on�one�side�with�‘5’�and�with�the�dimensions�of�8.1mm�–�4.1mm.
Memantine� hydrochloride� 10� mg� film-coated� tablets� are� presented� as� white,� slim� through� the� middle,� biconvex�
film-coated�tablets�with�breaking�lines�on�both�sides�and�engraving�‘1�0’�on�one�side�and�with�the�dimensions�of�10mm�
–�5.6mm.
The�tablet�can�be�divided�in�equal�doses.
Memantine�hydrochloride�15�mg�film-coated�tablets�are�presented�as�light�brown,�oval,�biconvex�film-coated�tablets�
with�the�dimensions�of�12.3mm�–�6.6mm.
Memantine�hydrochloride�20�mg�film-coated�tablets�are�presented�as�pink,�oval,�biconvex�film-coated�tablets�with�the�
dimensions�of�13.5mm�–�7.3mm.
One�treatment�initiation�pack�contains�28�tablets�in�4�PVC/PE/PVDC/Al-blisters,�with�7�tablets�of�Memantine�5�mg�in,�
7�tablets�of�Memantine�10�mg,�7�tablets�of�Memantine�15�mg�and�7�tablets�of�Memantine�20�mg,�in�a�carton�box.
Marketing�Authorization�Holder
Abdi�Farma,�Unipessoal�Lda.
Quinta�da�Fonte,�Rua�dos�Malhões,
Edifício�D.�Pedro�I
2770�–�071�Paço�de�Arcos,�Portugal
abdifarma@abdiibrahim.com.tr
Manufacturer
GE Pharmaceuticals Ltd.
Industrial Zone, “Chekanitza-South” Area, 2410 Botevgrad Bulgaria
This�medicinal�product�is�authorised�in�the�Member�States�of�the�EEA�under�the�following�names:�
Belgium�(BE)

Memantine�Abdi�5�mg�/�10�mg�/�15�mg�/�20�mg�comprimés�pelliculés,�filmtabletten,�
filmomhulde�tabletten�Starter�Pack
7�comprimés,�tabletten�of�Memantine�Abdi�5�mg�comprimés�pelliculés,�filmtabletten,�
filmomhulde�tabletten�
7�comprimés,�tabletten�of�Memantine�Abdi�10�mg�comprimés�pelliculés,�filmtabletten,�
filmomhulde�tabletten�
7�comprimés,�tabletten�of�Memantine�Abdi�15�mg�comprimés�pelliculés,�filmtabletten,�
filmomhulde�tabletten�
7�comprimés,�tabletten�of�Memantine�Abdi�20�mg�comprimés�pelliculés,�filmtabletten,�
filmomhulde�tabletten
Germany�(DE) Memantin�Abdi�Startpackung�5�mg�/�10�mg�/�15�mg�/�20�mg�Filmtabletten
7�tabletten�of�Memantin�Abdi�5�mg�filmtabletten
7�tabletten�of�Memantin�Abdi�10�mg�filmtabletten
7�tabletten�of�Memantin�Abdi�15�mg�filmtabletten
7�tabletten�of�Memantin�Abdi�20�mg�filmtabletten
Hungary�(HU) Memantin�Abdi�5�mg�/�10�mg�/�15�mg�/�20�mg�filmtabletta�kezelés�kezd��csomag
7�tabletta�of�Memantin�Abdi�5�mg�filmtabletta
7�tabletta�of�Memantin�Abdi�10�mg�filmtabletta
7�tabletta�of�Memantin�Abdi�
15�mg�filmtabletta
7�tabletta�of�Memantin�Abdi�
20�mg�filmtabletta
Netherlands
Memantine�Abdi�5�mg�/�10�mg�/�15�mg�/�20�mg�filmomhulde�tabletten�startverpakking�
(NL) �
7�tabletten�of�Memantine�Abdi�5�mg�filmomhulde�tabletten
7�tabletten�of�Memantine�Abdi�10�mg�filmomhulde�tabletten
7�tabletten�of�Memantine�Abdi�15�mg�filmomhulde�tabletten�
7�tabletten�of�Memantine�Abdi�20�mg�filmomhulde�tabletten
Poland�(PL)
Memantyny�Abdi�5�mg�/�10�mg�/�15�mg�/�20�mg�tabletki�powlekane�zestaw�
rozpoczynaj�cy�leczenie
7�tabletki�of�Memantyny�Abdi�5�mg�tabletki�powlekane
7�tabletki�of�Memantyny�Abdi�10�mg�tabletki�powlekane
7�tabletki�of�Memantyny�Abdi�15�mg�tabletki�powlekane
7�tabletki�of�Memantyny�Abdi�20�mg�tabletki�powlekane
This�leaflet�was�last�approved�in�02/2015.

5�mg�tablet�(red�blister)
10�mg�tablet�(black�blister)
15�mg�tablet�(green�blister)
20�mg�tablet�once�a�day�
(blue�blister)

Maintenance�dose
The�recommended�daily�dose�is�20�mg�once�a�day.
For�continuation�of�the�treatment�please�consult�your�doctor.
Dosage�in�patients�with�impaired�kidney�function
If�you�have�impaired�kidney�function,�your�doctor�will�decide�upon�a�dose�that�suits�your�condition.�In�this�case,�
monitoring�of�your�kidney�function�should�be�performed�by�your�doctor�at�specified�intervals.

Duration�of�treatment
Continue�to�take�Memantine�hydrochloride�as�long�as�it�is�of�benefit�to�you.�Your�doctor�should�assess�your�treatment�
on�a�regular�basis.

A20008307/01

Administration
Memantine�hydrochloride�should�be�administered�orally�once�a�day.�To�benefit�from�your�medicine�you�should�take�
it�regularly�every�day�at�the�same�time�of�the�day.�The�tablets�should�be�swallowed�with�some�water.
The�tablets�can�be�taken�with�or�without�food.

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