Memantine easypharm 10 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE

Beschikbaar vanaf:

Easypharm Generika GmbH Millenium Tower, Handelskai 94-96 1200 WIEN (OOSTENRIJK)

ATC-code:

N06DX01

INN (Algemene Internationale Benaming):

MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Memantine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2013-10-17

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE EASYPHARM 10 MG, TABLETTEN
MEMANTINE EASYPHARM 20 MG, 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.
WHAT IS IN THIS LEAFLET
1.
What Memantine easypharm is and what it is used for
2.
What you need to know before you take Memantine easypharm
3.
How to take Memantine easypharm
4.
Possible side effects
5.
How to store Memantine easypharm
6.
Contents of the pack and other information
1.
WHAT MEMANTINE EASYPHARM IS AND WHAT IT IS USED FOR
HOW DOES MEMANTINE EASYPHARM WORK
Memantine easypharm 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 easypharm belongs to a group of medicines called NMDA-
receptor antagonists. Memantine easypharm acts on these NMDA-receptors
improving the transmission of nerve signals and the memory.
WHAT IS MEMANTINE EASYPHARM USED FOR
Memantine easypharm is used for the treatment of patients with
moderate to
severe Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE EASYPHARM
DO NOT TAKE MEMANTINE EASYPHARM

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 Memantine easypharm.
Take special care with

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Memantine easypharm 10 mg, tabletten
Memantine easypharm 20 mg, tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg film-coated tablet contains 10 mg of memantine
hydrochloride
equivalent to 8.31 mg memantine.
Excipient(s) with known effect: each tablet contains 144.32 mg lactose
(as
monohydrate).
Each 20 mg film-coated tablet contains 20 mg of memantine
hydrochloride
equivalent to 16.62 mg memantine.
Excipient(s) with known effect: each tablet contains 288.63 mg lactose
(as
monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated, round (8 mm) biconvex tablets, scored with a wide
pressure-sensitive division mark on one side and debossed with
‘M9MN’ and
‘10’ on the other side.
The tablet can be divided into equal doses.
Pink, film-coated, oval (13.5 x 6.6 mm) biconvex tablets, scored with
a wide
pressure-sensitive division mark on one side and debossed with ‘M9MN
20’
on the other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of 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. 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. Discontinuati