Axura
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
26-02-2024
Produktets egenskaber
(SPC)
26-02-2024
Offentlige vurderingsrapport
(PAR)
05-01-2012
Aktiv bestanddel:
memantine hydrochloride
Tilgængelig fra:
Merz Pharmaceuticals GmbH
ATC-kode:
N06DX01
INN (International Name):
memantine
Terapeutisk gruppe:
Other anti-dementia drugs
Terapeutisk område:
Alzheimer Disease
Terapeutiske indikationer:
Treatment of patients with moderate to severe Alzheimer's disease.
Produkt oversigt:
Revision: 27
Autorisation status:
Authorised
Autorisation dato:
2002-05-17
Indlægsseddel
52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE USER
AXURA 10 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 for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Axura is and what it is used for
2.
What you need to know before you take Axura
3.
How to take Axura
4.
Possible side effects
5.
How to store Axura
6.
Content of the pack and other information
1.
WHAT AXURA IS AND WHAT IT IS USED FOR
HOW DOES AXURA WORK
Axura contains the active substance memantine hydrochloride.
Axura 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. Axura belongs to a group of
medicines called NMDA-
receptor antagonists. Axura acts on these NMDA-receptors improving the
transmission of nerve
signals and the memory.
WHAT IS AXURA USED FOR
Axura is used for the treatment of patients with moderate to severe
Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AXURA
DO NOT TAKE AXURA
-
if you are allergic (hypersensitive) to memantine hydrochloride or any
of the other ingredients
of Axura tablets (listed in section 6).
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Axura
-
if you have a history of epileptic seizures
-
if you have recently experienced a myocardial infarction (heart
attack), or if you are suffering
from conges
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Axura 10 mg film-coated tablets
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets
Axura 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Axura 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg memantine.
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets
Each filmcoated tablet contains 5 mg of memantine hydrochloride
equivalent to 4.15 mg memantine.
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg memantine.
Each film-coated tablet contains 15 mg of memantine hydrochloride
equivalent to 12.46 mg memantine.
Each film-coated tablet contains 20 mg of memantine hydrochloride
equivalent to 16.62 mg memantine.
Axura 20 mg film-coated tablets
Each film-coated tablet contains 20 mg of memantine hydrochloride
equivalent to 16.62 mg memantine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Axura 10 mg film-coated tablets
Pale yellow to yellow, oval shaped film-coated tablet with breaking
line and engravings "1-0" on one
side and "M M" on the other side.
The tablet can be divided into equal doses.
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets
The 5 mg film-coated tablets are white to off-white, oval-oblong
film-coated tablets with imprint ‘5’ on
one side and imprint ‘MEM’ on the other side.
The 10 mg film-coated tablets are pale yellow to yellow, oval shaped
film-coated tablet with breaking
line and engravings "1-0" on one side and "M M" on the other side. The
tablet can be divided into
equal doses.
The 15 mg film-coated tablets are orange to grey-orange, oval-oblong
film-coated tablets with imprint
‘15’ on one side and imprint ‘MEM’ on the other side.
The 20 mg film-coated tablets are pale red to grey-red, oval-oblong
film-coated tablets with imprint ‘20’
on one side and imprint ‘MEM’ on the other side.
Axura 20 mg film-coated tablets
Pale red to grey-red,
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