EXELON 1.5MG CAPSULES

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

RIVASTIGMINE HYDROGEN TARTRATE

זמין מ:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (שם בינלאומי):

RIVASTIGMINE HYDROGEN TARTRATE

יחידות באריזה:

28 Capsule Capsules

תוצרת:

Siegfried Barbera, S.L.

עלון מידע

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
EXELON
® CAPSULES
_ _
Rivastigmine (1.5mg, 3.0mg, 4.5mg, 6.0mg)
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
11. Serial number
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 any of these apply to you, do not
take Exelon, and tell your doctor.
_- Before you start to use it _
Follow all the doctor’s instructions
carefully. They may differ from the
general information contained in this
leaflet.
Warning and precautions

If you experience gastro-
intestinal reactions such as
nausea (feeling sick), vomiting

מאפייני מוצר

Novartis
Business Use Only
Page 2
Malaysian Package Leaflet
12 Dec 2022
Exelon hard capsules
EXELON
®
Brain-selective cholinesterase inhibitor.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Hard capsules
Certain dosage strengths may not be available in all countries.
ACTIVE SUBSTANCE
Each hard gelatin capsule contain rivastigmine hydrogen tartrate
corresponding to 1.5, 3.0, 4.5
or 6.0 mg rivastigmine base.
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
CAPSULE
CONTENT:
microcrystalline
cellulose;
magnesium
stearate;
hypromellose;
silica,
colloidal anhydrous.
CAPSULES SHELL:
gelatin; titanium dioxide (E 171); iron oxide, yellow (E 172);
printing ink,
based on iron oxide, red (E 172) and shellac.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Treatment of patients with mild to moderately severe dementia of the
Alzheimer type, also
termed probable Alzheimer’s Disease or Alzheimer’s Disease.
Treatment of patients with mild to moderately severe dementia
associated with Parkinson’s
disease.
Novartis
Business Use Only
Page 3
Malaysian Package Leaflet
12 Dec 2022
Exelon hard capsules
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
INITIAL DOSE
1.5 mg twice a day.
DOSE TITRATION
The starting dose is 1.5 mg twice a day. If this dose is well
tolerated after a minimum of two
weeks of treatment, the dose may be increased to 3 mg twice a day.
Subsequent increases to 4.5
mg and then 6 mg twice a day should also be based on good tolerability
of the current dose and
may be considered after a minimum of two weeks’ treatment at that
dose level.
If adverse eff