Xapimant 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 8,3 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

N06DX01

INN (Algemene Internationale Benaming):

MEMANTINEHYDROCHLORIDE 10 mg/stuk SAMENSTELLING overeenkomend met ; MEMANTINE 8,3 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 3000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 3000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Memantine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOL 3000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

Sandoz B.V.
Page 1/10
Xapimant 10 mg/ 20 mg, filmomhulde tabletten
RVG 112085, 12086
1313-v6
1.3.1.3 Bijsluiter
February 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XAPIMANT 10 MG, FILMOMHULDE TABLETTEN
XAPIMANT 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 [nationally completed name] is and what it is used for
2. What you need to know before you take [nationally completed name]
3. How to take [nationally completed name]
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1. WHAT
[
NATIONALLY COMPLETED NAME]
IS AND WHAT IT IS USED FOR
_ _
HOW DOES [NATIONALLY COMPLETED NAME] WORK
[Nationally completed name] 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. [Nationally completed name]
belongs to a group of
medicines called NMDA-receptor antagonists. [Nationally completed
name] acts on these NMDA-
receptors improving the transmission of nerve signals and the memory.
WHAT IS [NATIONALLY COMPLETED NAME] USED FOR
[Nationally completed] name is used for the treatment of patients with
moderate to severe
Alzheimer’s disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
_ _
DO NOT TAKE [NATIONALLY COMP

Productkenmerken

Sandoz B.V.
Page 1/12
Xapimant 10 mg/ 20 mg, filmomhulde tabletten
RVG 112085, 12086
1311-v3
1.3.1.1 Samenvatting van de
Productkenmerken
februari 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xapimant 10 mg, filmomhulde tabletten
Xapimant 20 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of memantine hydrochloride which is
equivalent to 8.31 mg of
memantine.
Excipients with known effect
Each tablet contains 126 mg of lactose (as monohydrate).
Each tablet contains 20 mg of memantine hydrochloride which is
equivalent to 16.62 mg of
memantine.
Excipients with known effect
Each tablet contains 230.5 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
FILM-COATED TABLET
_10 mg film-coated tablets: _
White, oval shape (6.1 x 11.6 mm) with a breaking line on both sides.
The tablet can be divided into equal doses.
_20 mg film-coated tablets: _
Brown-red, of round shape (diameter 11.1 mm) with two crossed breaking
lines on one side.
The tablet can be divided into equal quarters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of patients with moderate to severe Alzheimer's disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sandoz B.V.
Page 2/12
Xapimant 10 mg/ 20 mg, filmomhulde tabletten
RVG 112085, 12086
1311-v3
1.3.1.1 Samenvatting van de
Productkenmerken
februari 2020
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 cl