Memantine Mylan

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

memantine hydrochloride

Dostupné z:

Mylan Pharmaceuticals Limited

ATC kód:

N06DX01

INN (Medzinárodný Name):

memantine

Terapeutické skupiny:

Other anti-dementia drugs, Psychoanaleptics,

Terapeutické oblasti:

Alzheimer Disease

Terapeutické indikácie:

Treatment of patients with moderate to severe Alzheimer’s disease.

Prehľad produktov:

Revision: 10

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2013-04-21

Príbalový leták

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEMANTINE MYLAN 10 MG FILM-COATED TABLETS
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 Mylan is and what it is used for
2.
What you need to know before you take Memantine Mylan
3.
How to take Memantine Mylan
4.
Possible side effects
5.
How to store Memantine Mylan
6.
Contents of the pack and other information
1.
WHAT MEMANTINE MYLAN IS AND WHAT IT IS USED FOR
Memantine Mylan contains the active substance memantine. 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 Mylan belongs to a
group of medicines called
NMDA-receptor antagonists. Memantine Mylan acts on these
NMDA-receptors improving the
transmission of nerve signals and the memory.
Memantine Mylan is used for the treatment of patients with moderate to
severe Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE MYLAN
DO NOT TAKE MEMANTINE MYLAN:
-
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 Memantine Mylan
-
if you have a history of epileptic seizures
-
if you have recently experienced a myocardial infarction (heart

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Memantine Mylan 10 mg film-coated tablets
Memantine Mylan 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 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.
Memantine Mylan 10 mg film-coated tablets
A dark yellow film-coated, tapered oblong shaped, biconvex tablet
debossed with “ME” on the left of
the score and “10” on the right of the score on one side of the
tablet and a score on the other side.
The tablet can be divided into equal doses.
Memantine Mylan 20 mg film-coated tablets
A red film-coated, oval, biconvex, bevelled edge tablet debossed with
“ME” on one side of the tablet
and “20” on the other side.
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
p