Rivamensa Patch 10

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RIVASTIGMINE

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

RIVASTIGMINE

Unit dalam pakej:

30pieces Pieces

Dikeluarkan oleh:

DaeHwa Pharmaceutical Co.Ltd

Risalah maklumat

RIVAMENSA PATCH 5
RIVAMENSA PATCH 10
Rivastigmine (9mg, 18mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_RIVAMENSA Patch _
is used for
2.
How
_RIVAMENSA Patch _
works
3.
Before you use
_RIVAMENSA Patch_
4.
How to use
_RIVAMENSA Patch_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_RIVAMENSA_
_ _
_Patch_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _RIVAMENSA PATCH _IS USED FOR
Treatment of patients with mild to
moderately severe dementia of the
Alzheimer type and severe dementia of
the Alzheimer's type.
Treatment of patients with mild to
moderately severe dementia associated
with Parkinson's disease.
HOW _RIVAMENSA PATCH _WORKS
Rivastigmine improves the function of
nerve cells in the brain. It works by
preventing the breakdown of a chemical
called acetylcholine. People with
dementia usually have lower levels of
this chemical, which is important for the
processes of memory, thinking, and
reasoning.
BEFORE YOU USE _RIVAMENSA PATCH_
-
_When you must not use it _
- if you are allergic to rivastigmine or
any of the other ingredients of this
medicine.
- if you have ever had an allergic
reaction to a similar type of medicine
(carbamate derivatives).
- if you have a skin reaction spreading
beyond the patch size, if there is a
more intense local reaction (such as
blisters, increasing skin inflammation,
swelling) and if it does not improve
within 48 hours after removal of the
transdermal patch.
If this applies to you, tell your doctor
and do not apply RIVAMENSA Patch.
-
_Pregnancy and breast-feeding _
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine.
RIVAMENSA should not be used during
pregnancy unless clearly necessary.
You should not breast-feed during
treatment with RIVAMENSA Patch.
-
_Before you start to use it _
Talk to your doctor before using
RIVAMENSA:
- if you have, or have ever had,

Ciri produk

PROPOSED PACKAGE INSERT
PRODUCT NAME
RIVAMENSA PATCH 10
RIVAMENSA PATCH 5
NAME AND STRENGTH OF ACTIVE INGREDIENT(S)
RIVAMENSA PATCH 10
: 18mg as Rivastigmine
RIVAMENSA PATCH 5
: 9mg as Rivastigmine
PRODUCT DESCRIPTION
Appearance of Rivamensa patch is as follows per each dose.
Rivamensa patch 5 (9mg as rivastigmine) : Transdermal patch of
semi-transparent square shape with
rounded corners in patch size of 5cm
2
.
Rivamensa patch 10 (18mg as rivastigmine) : Transdermal patch of
semi-transparent square shape
with rounded corners in patch size of 10cm
2
.
PHARMACODYNAMICS
_Mechanism of Action:_ Pathological changes in dementia eg,
Alzheimer's disease involve cholinergic
neuronal pathways that project from the basal forebrain to the
cerebral cortex and hippocampus.
These pathways are known to be involved in attention, learning and
memory, and other cognitive
processes.
Rivastigmine,
a
brain-selective
acetyl-
and
butyryl-cholinesterase
inhibitor
of
the
carbamate type, is thought to facilitate cholinergic neurotransmission
by slowing the degradation of
acetylcholine released by functionally intact cholinergic neurons.
Data from animal studies indicate
that rivastigmine selectively increases the availability of
acetylcholine in the cortex and hippocampus.
Thus,
Rivastigmine may have
an
ameliorative
effect on
cholinergic-mediated cognitive
deficits
associated with Alzheimer's disease and with Parkinson's disease. In
addition, there is some evidence
that cholinesterase inhibition could slow the formation of
amyloidogenic β-amyloid-precursor protein
(APP) fragments, and thus of amyloid plaques, which are one of the
main pathological features of
Alzheimer's disease.
PHARMACOKINETICS
_Absorption_: Absorption of rivastigmine from Rivastigmine patches is
slow. After the first dose,
detectable plasma concentrations are observed after a lag time of
0.5-1 hr. Concentrations then rise
slowly and typically after 8 hrs reach levels close to maximum,
although maximum values (Cmax) are
often reached at later times (10-16 hrs). After t