Memantine Merz

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

memantine hydrochloride

זמין מ:

Merz Pharmaceuticals GmbH  

קוד ATC:

N06DX01

INN (שם בינלאומי):

memantine hydrochloride

קבוצה תרפויטית:

Other anti-dementia drugs

איזור תרפויטי:

Alzheimer Disease

סממני תרפויטית:

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

leaflet_short:

Revision: 7

מצב אישור:

Authorised

תאריך אישור:

2012-11-22

עלון מידע

69
B. PACKAGE LEAFLET
70
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE MERZ 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 Merz is and what it is used for
2.
What you need to know before you take Memantine Merz
3.
How to take Memantine Merz
4.
Possible side effects
5.
How to store Memantine Merz
6.
Content of the pack and other information
1.
WHAT MEMANTINE MERZ IS AND WHAT IT IS USED FOR
HOW DOES MEMANTINE MERZ WORK
Memantine Merz contains the active substance memantine hydrochloride.
Memantine Merz 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 Merz belongs to a
group of medicines called
NMDA-receptor antagonists. Memantine Merz acts on these NMDA-receptors
improving the
transmission of nerve signals and the memory.
WHAT IS MEMANTINE MERZ USED FOR
Memantine Merz is used for the treatment of patients with moderate to
severe Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE MERZ
DO NOT TAKE MEMANTINE MERZ
-
if you are allergic (hypersensitive) to memantine hydrochloride or any
of the other ingredients
of Memantine Merz tablets (listed in section 6).
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Memantine Merz
-
if

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Memantine Merz 10 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.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pale yellow to yellow, oval shaped film-coated tablet with breaking
line and engravings "1-0" on one
side and "M M" on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of 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 per day. In order to reduce the risk
of undesirable effects the
maintenance dose is achieved by upward titration of 5 mg per week over
the first 3 weeks as follows:
Week 1 (day 1-7):
The patient should take half a 10 mg film-coated tablet (5 mg) per day
for 7 days.
Week 2 (day 8-14):
The patient should take one 10 mg film-coated tablet (10 mg) per d