Ebixa

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

memantine hydrochloride

Beschikbaar vanaf:

H. Lundbeck A/S

ATC-code:

N06DX01

INN (Algemene Internationale Benaming):

memantine

Therapeutische categorie:

Other anti-dementia drugs

Therapeutisch gebied:

Alzheimer Disease

therapeutische indicaties:

Treatment of patients with moderate to severe Alzheimer's disease.

Product samenvatting:

Revision: 26

Autorisatie-status:

Authorised

Autorisatie datum:

2002-05-15

Bijsluiter

60
B. PACKAGE LEAFLET
61
PACKAGE LEAFLET: INFORMATION FOR THE USER
EBIXA 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 Ebixa is and what it is used for
2.
What you need to know before you take Ebixa
3.
How to take Ebixa
4.
Possible side effects
5.
How to store Ebixa
6.
Contents of the pack and other information
1.
WHAT EBIXA IS AND WHAT IT IS USED FOR
Ebixa contains the active substance memantine hydrochloride. It
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. Ebixa belongs to a group of
medicines called NMDA-
receptor antagonists. Ebixa acts on these NMDA-receptors improving the
transmission of nerve
signals and the memory.
Ebixa is used for the treatment of patients with moderate to severe
Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EBIXA
DO NOT TAKE EBIXA
-
if you are allergic to memantine or any of the other ingredients of
this medicine (listed in
section 6).
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Ebixa:
-
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 pressur

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ebixa 10 mg film-coated tablets
Ebixa 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg
memantine.
Each film-coated tablet contains 20 mg of memantine hydrochloride
equivalent to 16.62 mg
memantine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Ebixa 10 mg film-coated tablets
Pale yellow to yellow, oval shaped film-coated tablets with breaking
line and imprint “1 0” on one
side and “M M” on the other side. The tablet can be divided into
equal doses.
Ebixa 20 mg film-coated tablets
Pale red to grey-red, oval-oblong film-coated tablets with imprint
“20” on one side and “MEM” on the
other side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adult patients with moderate to severe Alzheimer’s
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and
treatment of Alzheimer’s dementia.
Posology
Therapy should only be started if a caregiver is available who will
regularly monitor the intake of the
medicinal product by the patient. Diagnosis should be made according
to current guidelines. The
tolerance and dosing of memantine should be reassessed on a regular
basis, preferably within three
months after start of treatment. Thereafter, the clinical benefit of
memantine and the patient’s
tolerance of treatment should be reassessed on a regular basis
according to current clinical guidelines.
Maintenance treatment can be continued for as long as a therapeutic
benefit is favourable and the
patient tolerates treatment with memantine. Discontinuation of
memantine should be considered when
evidence of a therapeutic effect is no longer present or if the
patient does not tolerate treatment.
_Adults:_
_Dose titration _
The maximum daily dose is 20 mg per day. In order to reduce the