Marbodin 20 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

N06DX01

INN (Algemene Internationale Benaming):

MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Memantine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2013-11-11

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
MARBODIN 20 MG FILMOMHULDE TABLETTEN
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 __ is and what it is used for
2.
What you need to know before you take __
3.
How to take __
4.
Possible side effects
5.
How to store __
6.
Contents of the pack and other information
1.
WHAT __ IS AND WHAT IT IS USED FOR
HOW DOES __ WORK
__ 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. __ belongs to a
group of medicines called NMDA-receptor antagonists. __
acts on these NMDA-
receptors improving the transmission of nerve signals and the memory.
WHAT IS __ USED FOR
__ is used for the treatment of patients with moderate
to severe Alzheimer’s
disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE __
DO NOT TAKE __
•
if you are allergic to memantine hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking _._
•
if you have a history of epileptic seizures
•
if you have recently experienced a myocardia

Productkenmerken

_Ver. 03 _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Marbodin 20 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Pink, oval, biconvex, 13.5 mm – 7.3 mm, film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of patients with moderate to severe Alzheimer’s disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and
treatment of Alzheimer’s dementia. 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 risk
of undesirable effects,
the maintenance dose is achieved by upward titration of 5 mg per week
over the first 3 weeks
as follows. For up-titration other tablet strengths are available.
Week 1 (day 1-7):
The patient should take one 5 mg film-coated tablet per day for 7
days.
Week 2 (day 8-14):
The patient should take one 10 mg film-coated tablet per day for 7
days.
_Ver. 03 _
Week 3 (day 15-21):
The patient should take one 15 mg film