Exelon Patch 5 (4.6mg24hr)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Rivastigmine (as base)

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

N06DA03

Dosage:

9mg/5cm2

Pharmaceutical form:

PATCH, EXTENDED RELEASE

Composition:

Rivastigmine (as base) 9mg/5cm2

Administration route:

TRANSDERMAL

Prescription type:

Prescription Only

Manufactured by:

LTS Lohmann Therapie-Systeme AG

Authorization status:

ACTIVE

Authorization date:

2008-04-28

Patient Information leaflet

EXELON


PATCH 
Brain-selective cholinesterase inhibitor 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Transdermal patch.  
Each transdermal 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 as follows: 
With Exelon Patch 5 and “AMCX” 
With Exelon Patch 10 and “BHDI” 
With Exelon Patch 15 and “CNFU”. 
ACTIVE SUBSTANCE  
Each  Exelon  Patch  5  transdermal  patch  releases  4.6mg  of  rivastigmine  per  24  hours.  Each 
transdermal patch of 5 cm
2 
contains 9 mg rivastigmine.  
Each  Exelon  Patch  10  transdermal  patch  releases  9.5mg  of  rivastigmine  per  24  hours.  Each 
transdermal patch of 10 cm
2 
contains 18 mg rivastigmine.  
Each Exelon Patch 15 transdermal patch releases 13.3mg of rivastigmine per 24 hours. Each 
transdermal patch of 15 cm
2 
contains 27 mg rivastigmine. 
EXCIPIENTS 
Backing layer: polyethylene terephthalate film, lacquered 
Medicinal  product  matrix:  alpha-tocopherol,  poly  (butylmethacrylate,  methyl-methacrylate), 
acrylic copolymer 
Adhesive matrix: alpha tocopherol, silicone oil, dimethicone 
Release liner: polyester film, fluoropolymer-coated 
Novartis 

Page 2 
Country-Specific Package Leaflet 
27 May 2014 
Exelon Patch 

INDICATIONS 
PATCH 5, 10 & 15 
Symptomatic treatment of mild to moderately severe, and
severe Alzheimer’s dementia. 
PATCH 5 & 10 
Symptomatic  treatment  of  mild  to  moderate  dementia  associated  with  Parkinson’s  disease.  It  is 
generally  recommended to  those  patients  in  whom  the  administration  of  oral  Exelon  capsules  is 
unsuitable or infeasible.

DOSAGE AND ADMINISTRATION 
Treatment should be initiated and supervised by a physician experienced�

Summary of Product characteristics

Exelon Patch Dec 2022.SIN Page 1 of 25
EXELON

PATCH
Brain-selective cholinesterase inhibitor
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Transdermal patch.
Each transdermal 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
as follows:
-
for Exelon Patch 5; “AMCX”
-
for Exelon Patch 10; “BHDI”
-
for Exelon Patch 15; “CNFU”.
ACTIVE SUBSTANCE
Each Exelon Patch 5 transdermal patch releases 4.6mg of rivastigmine
per 24 hours. Each
transdermal patch of 5 cm
2
contains 9 mg rivastigmine.
Each Exelon Patch 10 transdermal patch releases 9.5mg of rivastigmine
per 24 hours. Each
transdermal patch of 10 cm
2
contains 18 mg rivastigmine.
Each Exelon Patch 15 transdermal patch releases 13.3mg of rivastigmine
per 24 hours. Each
transdermal patch of 15 cm
2
contains 27 mg rivastigmine.
EXCIPIENTS
Backing layer: polyethylene terephthalate film, lacquered
Medicinal product matrix: alpha-tocopherol, poly (butylmethacrylate,
methyl-methacrylate),
acrylic copolymer
Adhesive matrix: alpha tocopherol, silicone oil, dimethicone
Release liner: polyester film, fluoropolymer-coated
Exelon Patch Dec 2022.SIN Page 2 of 25
INDICATIONS
PATCH 5, 10 & 15
Symptomatic treatment of mild to moderately severe, and severe
Alzheimer’s dementia.
PATCH 5 & 10
Symptomatic treatment of mild to moderate dementia associated with
Parkinson’s disease. It is
generally recommended to those patients in whom the administration of
oral Exelon capsules is
unsuitable or infeasible.
DOSAGE REGIMEN AND ADMINISTRATION
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and
treatment
of
Alzheimer’s
dementia.
Diagnosis
should
be
made
according
to
current
guidelines.
Similar
to
any
treatment
initiated
in
patients
with
dementia,
therapy
with
rivastigmine should only be started if a caregiver is available to
regularly administer and
monitor the treatment.
POSOLOGY
PATCHES
RIVASTIGMINE BASE
DOSE LOAD
RIVASTIGMINE BASE_ _