Memantine Accord

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

memantine hydrochloride

Saatavilla:

Accord Healthcare S.L.U.

ATC-koodi:

N06DX01

INN (Kansainvälinen yleisnimi):

memantine

Terapeuttinen ryhmä:

Other anti-dementia drugs

Terapeuttinen alue:

Alzheimer Disease

Käyttöaiheet:

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

Tuoteyhteenveto:

Revision: 7

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-12-03

Pakkausseloste

52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Memantine Accord
3.
How to take Memantine Accord
4.
Possible side effects
5.
How to store Memantine Accord
6.
Contents of the pack and other information
1.
WHAT MEMANTINE ACCORD IS AND WHAT IT IS USED FOR
HOW DOES MEMANTINE ACCORD WORK
Memantine Accord contains the active substance memantine
hydrochloride.
Memantine Accordbelongs 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 Accord belongs to
a group of medicines called
NMDA-receptor antagonists. Memantine Accord acts on these
NMDA-receptors improving the
transmission of nerve signals and the memory.
WHAT IS MEMANTINE ACCORD USED FOR
Memantine Accordis used for the treatment of patients with moderate to
severe Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE ACCORD
DO NOT TAKE MEMANTINE ACCORD:
-
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 Memantine Accor

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Memantine Accord 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.
Excipientwith known effect: each film coated tablet contains 183.13 mg
lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, oblong, coated and scored tablet, debossed with “MT”
divided by the score on one side and
"10" divided by the score 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
_ _
Posology
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 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