Marixino 10 mg film-coated tablets

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

MEMANTINE HYDROCHLORIDE

Dostupné z:

PAHANG PHARMACY SDN. BHD.

INN (Medzinárodný Name):

MEMANTINE HYDROCHLORIDE

Počet v balení:

56 Tablets

Výrobca:

KRKA, d.d., Novo mesto

Príbalový leták

MARIXINO
Memantine hydrochloride film-coated tablets (10 mg)
_ _
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What _Marixino_ is use for
2.
How _Marixino_ works
3.
Before you use _Marixino_
4.
How to use _Marixino_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Marixino_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _MARIXINO_
IS
USED
FOR
_Marixino_ contains the active substance
memantine hydrochloride. It belongs to
a group of medicines known as anti-
dementia medicines.
_Marixino_ is used for the treatment of
patients with moderate to severe
Alzheimer’s disease.
HOW _MARIXINO_
WORKS
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.
BEFORE YOU USE
_MARIXINO_
_ _
-
_When you must not use it _

if you are allergic to memantine or
any of the other ingredients of this
medicine.
_Pregnancy and lactation _
Do not take _Marixino _if you are
pregnant, trying to get pregnant or think
you may be pregnant. If you get
pregnant while taking _Marixino_, stop
taking it immediately and contact your
doctor.
The use of memantine in pregnant
women is not recommended.
Do not take _Marixino_ if you are breast-
feeding. Women taking _Marixino_
should not breast-feed. Ask your doctor
or pharmacist for advice before taking
any medicine._ _
_ _
-
_Before you start use it _
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 uncontrolled hypertension
(high blood press

Súhrn charakteristických

1.3.1
Memantine hydrochloride
SPC, Labeling and Package Leaflet
MY
SmPCPIL132273_1
14.05.2019 – Updated: 14.05.2019
Page 1 of 7
MARIXINO
_Memantine hydrochloride_
NAME OF THE MEDICINAL PRODUCT
Marixino 10 mg film-coated tablets
COMPOSITION
Each film-coated tablet contains 10 mg memantine hydrochloride.
PRODUCT DESCRIPTION
White, oval shaped, biconvex film-coated tablets scored on one side.
The tablet can be divided into equal doses.
THERAPEUTIC INDICATIONS
Treatment of adult patients with moderate to severe Alzheimer's
disease.
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 daily. 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):
1.3.1
Memantine hydrochloride
SPC, Labeling and Package Leaflet
MY
SmPCPIL132273_1
14.05.2019 – Updated: 14.05.2019
Page 2 of 7
The patient should take one 10 mg film-coated tablet (10 mg) per day