EXELON PATCH 15

Land: Maleisië

Taal: Engels

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

Werkstoffen:

RIVASTIGMINE, BASE

Beschikbaar vanaf:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Algemene Internationale Benaming):

RIVASTIGMINE, BASE

Eenheden in pakket:

30pieces Pieces; 30 Pieces

Geproduceerd door:

LTS LOHMANN THERAPIE-SYSTEM AG

Bijsluiter

EXELON PATCH
®
_Consumer Medication Information Leaflet (RiMUP) _
Rivastigmine
4.6 mg/24 h transdermal patch (Exelon
®
Patch 5)
9.5 mg/24 h transdermal patch (Exelon
®
Patch 10)
13.3 mg/24 h transdermal patch (Exelon
®
Patch 15)
1
WHAT IS IN THIS LEAFLET
1.
What Exelon Patch is used for
2. How Exelon Patch works
3. Before you apply Exelon Patch
4. How to use Exelon Patch
5. While you are using Exelon
Patch
6. Side effects
7. Storage and disposal of Exelon
Patch
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial Number
WHAT EXELON PATCH IS USED FOR
It is used for the treatment of memory
disorders and dementia in patients
with Alzheimer’s disease or with
Parkinson’s disease.
HOW EXELON PATCH WORKS
Exelon belongs to a class of
substances called cholinesterase
inhibitors. The active substance of
Exelon is rivastigmine.
In patients with Alzheimer's dementia
or Parkinson’s disease dementia,
certain nerve cells die in the brain,
resulting in low levels of the
neurotransmitter: acetylcholine (a
substance that allows nerve cells to
communicate with each other).
Rivastigmine works by blocking the
enzymes that break down
acetylcholine: acetylcholinesterase
and butyrylcholinesterase. By
blocking these enzymes, Exelon
allows levels of acetylcholine to be
increased in the brain, helping to
reduce the symptoms of Alzheimer’s
disease or Parkinson’s disease
dementia.
BEFORE YOU APPLY EXELON PATCH
_- When you must not use it _
Do not apply Exelon Patch
•
If you know that you are allergic
(hypersensitive) to rivastigmine
(the active substance in Exelon
Patch) or to any of the other
ingredients listed at the end of
this leaflet,
•
If you have ever had an allergic
reaction to a similar type of
medicine,
•
If you have had a skin reaction
which has spread beyond the
patch size, if there was a more
intense local reaction (such as
blisters, increasing skin
inflammation, swelling) and if it
did not improve within 48 hours
after removal of the transdermal
patch.
If any

Productkenmerken

Novartis
Business Use Only
Page 2
Malaysia Package Leaflet
12 Dec 2022
Exelon Patch
EXELON
® PATCH
Brain-selective cholinesterase inhibitor.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Transdermal patch.
Each patch is a thin, matrix-type transdermal patch consisting of
three layers.
The outside of the backing layer is beige and labelled for each patch
dose as follows:
- for Exelon
®
Patch 5: “AMCX”
- for Exelon
®
Patch 10: “BHDI”
- for Exelon
®
Patch 15: “CNFU”
Certain dosage strengths may not be available in all countries.
ACTIVE SUBSTANCE
•
Each patch of 5 cm
2
contains 9 mg rivastigmine base,
_in vivo_
release rate of 4.6 mg/24
hours.
•
Each patch of 10 cm
2
contains 18 mg rivastigmine base,
_in vivo_
release rate of 9.5 mg/24
hours.
•
Each patch of 15 cm
2
contains 27 mg rivastigmine base,
_in vivo_
release rate of 13.3 mg/24
hours.
EXCIPIENTS
Acrylic
pressure
sensitive
adhesive,
silicone
pressure
sensitive
adhesive,
poly
(butyl-
methacrylate, methyl-methacrylate), polyethylene terephthalate
(backing film), fluoropolymer-
coated polyethylene terephthalate (release liner), silicone oil,
vitamin E.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Treatment of patients with:
•
Mild to moderately severe dementia of the Alzheimer’s type.
•
Severe dementia of the Alzheimer’s type.
•
Mild to moderately severe dementia associated with Parkinson’s
disease.
DOSAGE REGIMEN AND ADMINISTRATION
POSOLOGY
PATCHES
RIVASTIGMINE BASE
DOSE LOAD
RIVASTIGMINE BASE_ IN VIVO_ RELEASE
RATES PER 24 H
Exelon Patch 5
9 mg
4.6 mg
Exelon Patch 10
18 mg
9.5 mg
Exelon Patch 15
27 mg
13.3 mg
Novartis
Business Use Only
Page 3
Malaysia Package Leaflet
12 Dec 2022
Exelon Patch
Mild to moderately severe dementia of the Alzheimer’s type OR ASSOCIATED WITH PARKINSON’S
DISEASE
INITIAL DOSE AND DOSE TITRATION TO THE EFFECTIVE DOSE:
Treatment is started with Exelon Patch 5
once a day. After a minimum of four weeks of treatment and if well
tolerated, this dose should
be increased to Exelon P