Marixino (previously Maruxa)
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
08-12-2021
Valmisteyhteenveto
(SPC)
08-12-2021
Julkisesta arviointikertomuksesta
(PAR)
22-08-2013
Aktiivinen ainesosa:
memantine hydrochloride
Saatavilla:
KRKA, d.d.
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: 8
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2013-04-28
Pakkausseloste
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MARIXINO 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 Marixino is and what it is used for
2.
What you need to know before you take Marixino
3.
How to take Marixino
4.
Possible side effects
5.
How to store Marixino
6.
Contents of the pack and other information
1.
WHAT MARIXINO IS AND WHAT IT IS USED FOR
Marixino 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. Marixino belongs to
a group of medicines called NMDA-receptor antagonists. Marixino acts
on these NMDA-receptors
improving the transmission of nerve signals and the memory.
Marixino is used for the treatment of patients with moderate to severe
Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MARIXINO
DO NOT TAKE MARIXINO
-
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 Marixino:
-
if you have a history of epileptic seizures
-
if you have recently experienced a myocardial infarction (heart
attack), or if you are suffering
from congestive heart failure or from an unc
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Marixino 10 mg film-coated tablets
Marixino 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Marixino 10 mg film-coated tablets
Each film-coated tablet contains 10 mg memantine hydrochloride
equivalent to 8.31 mg memantine.
Marixino 20 mg film-coated tablets
Each film-coated tablet contains 20 mg memantine hydrochloride
equivalent to 16.62 mg memantine.
Excipient with known effect: lactose monohydrate
_Marixino 10 mg film-coated tablets_
Each film-coated tablet contains 51.45 mg lactose monohydrate.
_Marixino 20 mg film-coated tablets_
Each film-coated tablet contains 102.90 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Marixino 10 mg film-coated tablets
White, oval, biconvex film-coated tablet, scored on one side (tablet
length: 12.2–12.9 mm, thickness:
3.5–4.5 mm). The tablet can be divided into equal doses.
Marixino 20 mg film-coated tablets
White, oval, biconvex film-coated tablet (tablet length: 15.7–16.4
mm, thickness: 4.7–5.7 mm).
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
3
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
patien
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