Memantine Synthon 5 mg + 10 mg + 15 mg + 20 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

MEMANTINEHYDROCHLORIDE 10 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 8,3 mg/stuk ; MEMANTINEHYDROCHLORIDE 15 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 12,5 mg/stuk ; MEMANTINEHYDROCHLORIDE 5 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 4,2 mg/stuk ; MEMANTINEHYDROCHLORIDE 20 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 16,6 mg/stuk

Beschikbaar vanaf:

Synthon B.V. Microweg 22 6545 CM NIJMEGEN

ATC-code:

N06DX01

INN (Algemene Internationale Benaming):

MEMANTINEHYDROCHLORIDE 10 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 8,3 mg/stuk ; MEMANTINEHYDROCHLORIDE 15 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 12,5 mg/stuk ; MEMANTINEHYDROCHLORIDE 5 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 4,2 mg/stuk ; MEMANTINEHYDROCHLORIDE 20 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 16,6 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; 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 (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2013-10-17

Bijsluiter

M1.3.1_03.MMN.hcl.tab.101.04.NL.2697.01
1.3.1
Package Leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE SYNTHON 10 MG, TABLETTEN
MEMANTINE SYNTHON 20 MG, TABLETTEN
MEMANTINE SYNTHON 5 MG + 10 MG +15 MG + 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Memantine Synthon is and what it is used for
2.
What you need to know before you take Memantine Synthon
3.
How to take Memantine Synthon
4.
Possible side effects
5.
How to store Memantine Synthon
6.
Contents of the pack and other information
1.
WHAT MEMANTINE SYNTHON IS AND WHAT IT IS USED FOR
HOW DOES MEMANTINE SYNTHON WORK
Memantine Synthon 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.
Memantine Synthon belongs to a group of medicines called NMDA-receptor
antagonists. Memantine Synthon acts on these NMDA-receptors improving
the transmission of nerve signals and the memory.
WHAT IS MEMANTINE SYNTHON USED FOR
Memantine Synthon is used for the treatment of patients with moderate
to
severe Alzheimer’s disease.
M1.3.1_03.MMN.hcl.tab.101.04.NL.2697.01
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE SYNTHON
DO NOT TAKE MEMANTINE SYNTHON

if you are ALLERGIC TO MEMANTINE HY

Productkenmerken

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M1.3.1_01.MMN.hcl.tab.101.04.NL.2697.01
1
NAME OF THE MEDICINAL PRODUCT
Memantine Synthon 10 mg, tabletten
Memantine Synthon 20 mg, tabletten
Memantine Synthon 5 mg + 10 mg +15 mg + 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).
Each 5 mg film-coated tablet contains 5 mg of memantine hydrochloride
equivalent to 4.15 mg
memantine.
Excipient(s) with known effect: each tablet contains 72.16 mg lactose
(as monohydrate).
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 15 mg film-coated tablet contains 15 mg of memantine
hydrochloride equivalent to 12.46
mg memantine.
Excipient(s) with known effect: each tablet contains 216.48 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.
Yellow, film-coated, oval (8 x 4.5 mm) biconvex tablets, debossed with
‘M9MN 5’ on one side.
White, film