Mantomed 10 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

MEMANTINEHYDROCHLORIDE 10 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 8,31 mg/stuk

Beschikbaar vanaf:

Medochemie Limited Constantinopelstreet 1-10 3011 LIMASSOL (CYPRUS)

ATC-code:

N06DX01

INN (Algemene Internationale Benaming):

MEMANTINEHYDROCHLORIDE 10 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 8,31 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Memantine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2014-10-06

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
MANTOMED 5 MG, FILMOMHULDE TABLETTEN
MANTOMED 10 MG, FILMOMHULDE TABLETTEN
MANTOMED 15 MG, FILMOMHULDE TABLETTEN
MANTOMED 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 Mantomed is and what it is used for
2.
What you need to know before you take Mantomed
3.
How to take Mantomed
4.
Possible side effects
5.
How to store Mantomed
6.
Contents of the pack and other information
1.
WHAT MANTOMED IS AND WHAT IT IS USED FOR
Mantomed 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 belongs to a group
of medicines called
NMDAreceptor antagonists. Memantine acts on these NMDA-receptors
improving the transmission
of nerve signals and the memory.
Mantomed is used for the treatment of patients with moderate to severe
Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MANTOMED
DO NOT TAKE MANTOMED:
•
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 Mantomed
•
if you have a history of epileptic seizures
•
if you have recently exp

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mantomed 5 mg, filmomhulde tabletten
Mantomed 10 mg, filmomhulde tabletten
Mantomed 15 mg, filmomhulde tabletten
Mantomed 20 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated 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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The 5 mg film-coated tablets are: yellow, round, biconvex film coated
tablets with diameter of
nucleus 6mm.
The 10 mg film-coated tablets are: yellow, oblong, biconvex, scored on
both side film coated tablets
with dimensions of nucleus 5.6x11.1mm. The tablet can be divided into
equal doses.
The 15 mg film-coated tablets are: pink, round, biconvex film coated
tablets, with diameter of nucleus
9.5mm
The 20 mg film-coated tablets are: yellow, round, biconvex film coated
tablets with diameter of
nucleus 10.3mm
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.
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 cl