Memantine Mylan 10 mg/ml, drank

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE

Beschikbaar vanaf:

Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN

ATC-code:

N06DX01

INN (Algemene Internationale Benaming):

MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE

farmaceutische vorm:

Drank

Samenstelling:

KALIUMSORBAAT (E 202) ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; WATER, GEZUIVERD

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Memantine

Autorisatie datum:

2018-12-04

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEMANTINE MYLAN 10 MG/ML, DRANK
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
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.
belongs to a group of medicines called NMDA receptor
antagonists. It acts on these
NMDA-receptors improving the transmission of nerve signals and the
memory.
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 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 myocardial infarction (heart
attack), or if you are suffering from
cong

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Memantine Mylan 10 mg/ml, drank
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of memantine oral solution contains 10 mg of memantine
hydrochloride which is equivalent
to 8.31 mg of memantine.
Each 0.5 ml of solution measured in the dosing pipette delivers 5 mg
of memantine hydrochloride
equivalent to 4.16 mg of memantine. The maximum deliverable dose in
the pipette is 2.0 ml, which
contains 20 mg of memantine hydrochloride equivalent to 16.64 mg of
memantine.
Excipient(s) with known effect
Each ml of contains 100 mg of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear and colourless to light yellowish solution.
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.
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 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 once daily.
In order to reduce the risk of undesirable effects, the maintenance
dose is achieved by upward titration