EXELON 6MG CAPSULES

Country: Malaysia

Language: English

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

Active ingredient:

RIVASTIGMINE HYDROGEN TARTRATE

Available from:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

RIVASTIGMINE HYDROGEN TARTRATE

Units in package:

60Capsule Capsules; 28 Capsule Capsules

Manufactured by:

NOVARTIS FARMACEUTICA S.A.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
EXELON
® CAPSULES/ORAL SOLUTION
_ _
Rivastigmine (1.5mg, 3.0mg, 4.5mg, 6.0mg, 2.0mg/ml)
1
WHAT IS IN THIS LEAFLET
1. What Exelon is used for
2. How Exelon works
3. Before you use Exelon
4. How to use Exelon
5. While you are using Exelon
6. Side effects
7. Storage and disposal of Exelon
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT IS EXELON USED FOR
It is used for the treatment of memory
disorders and dementia in people with
Alzheimer’s disease or with
Parkinson’s disease.
HOW EXELON WORKS
Rivastigmine belongs to a class of
substances called cholinesterase
inhibitors.
In individuals with Alzheimer's
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). This
causes changes in the brain and
problems with memory, thinking and
behaviour. These problems gradually
become worse with time.
Exelon works by preventing the
breakdown of acetylcholine. This
chemical is needed to help keep the
brain working properly.
Rivastigmine helps to reduce the
symptoms of Alzheimer's disease, to
slow down the mental decline that
happens in people with this condition,
and helps to improve the ability to
cope with everyday activities. It does
not cure the condition.
BEFORE YOU USE EXELON
_-When you must not use it _
Do not take Exelon
• If you know that you are allergic
(hypersensitive) to rivastigmine (the
active substance in Exelon) 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 this applies to you, tell your doctor
without taking Exelon.
_- Before you start to use it _
Follow all the doctor’s instructions
carefully. They may differ from the
general information contained in this
leaflet.
Take special care with Exelon
• If you experience gastro-intestinal
reactions such as nausea (feeling
sick), vomiti

Summary of Product characteristics

Drug Regulatory Affairs
EXELON

(RIVASTIGMINE)
1.5, 3.0, 4.5 or 6.0 mg hard capsules
MALAYSIAN PACKAGE INSERT (MARCH 2016)
FOR PROMOTIONAL MATERIALS, PLEASE QUOTE THE FOLLOWING:
PI RD 04 MARCH 2016
IPL Creator:
CDS Author(s):
Pedda Reddy
E. Randolph
GLC approval:
6-May-2014 amended 12-Jan-2016
Release date:
04-March-2016
Tracking Number:
2015-PSB/GLC-0798-s
Document status:
Final
Number of pages:
17
Novartis
Page 2
Malaysian Package Leaflet
04 March 2016
Exelon hard capsules
EXELON

Hard capsules.
Brain-selective cholinesterase inhibitor.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Hard capsules.
ACTIVE SUBSTANCE
Exelon hard capsules contain 1.5, 3.0, 4.5 or 6.0 mg rivastigmine (as
the hydrogen tartrate
salt).
Certain dosage strengths may not be available in all countries.
DESCRIPTION
EXELON 1.5 MG :
Colour : Cap-Yellow opaque, Body-Yellow opaque.
Imprint : Red imprint on body, radial “EXELON 1.5mg”
EXELON 3.0 MG :
Colour : Cap-Orange opaque, Body-Orange opaque.
Imprint : Red imprint on body, radial “EXELON 3mg”.
EXELON 4.5 MG :
Colour : Cap-Red opaque, Body-Red opaque.
Imprint : White imprint on body, radial “EXELON 4.5mg’.
EXELON 6.0 MG :
Colour : Cap-Red opaque, Body-Orange opaque.
Imprint : Red imprint on body, radial “EXELON 6mg”.
EXCIPIENTS
1.5 MG CAPSULES
Gelatin; iron oxide, yellow (E 172); magnesium stearate;
methylhydroxypropylcellulose;
microcrystalline cellulose; printing ink, based on iron oxide, red (E
172); silica, colloidal
anhydrous; titanium dioxide (E 171).
3.0 MG AND 6.0 MG CAPSULES
Gelatin;
iron
oxide,
red
(E
172);
iron
oxide,
yellow
(E
172);
magnesium
stearate;
methylhydroxypropylcellulose; microcrystalline cellulose; printing
ink, based on iron oxide,
red (E 172); silica, colloidal anhydrous; titanium dioxide (E 171).
Novartis
Page 3
Malaysian Package Leaflet
04 March 2016
Exelon hard capsules
4.5 MG CAPSULES
Gelatin;
iron
oxide,
red
(E
172);
iron
oxide,
yellow
(E
172);
magnesium
stearate;
methylhydroxypropylcellulose; microcrystalline cellulose; printing
ink, base