EXELON rivastigmine 1.5mg (as hydrogen tartrate) capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rivastigmine hydrogen tartrate, Quantity: 2.4 mg (Equivalent: rivastigmine, Qty 1.5 mg)

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: Gelatin; hypromellose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; iron oxide yellow; microcrystalline cellulose; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; iron oxide red; ethanol absolute; potassium hydroxide; ammonia; Pharmaceutical glaze

Administration route:

Oral

Units in package:

28 capsules, 14 capsules, 56 capsules, 112 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Exelon is indicated for the treatment of patients with mild to moderately severe dementia of the Alzheimer's type.

Product summary:

Visual Identification: Hard capsule with yellow cap/yellow body marked "EXELON 1.5mg" in red, containing off-white to slightly yellow powder.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2000-06-06

Patient Information leaflet

EXELON
®
_Rivastigmine hydrogen tartrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Exelon.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking it against the
benefits they expect it will provide.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT EXELON IS USED
FOR
Exelon is used to treat a condition
called Alzheimer's disease.
Alzheimer's disease is a condition in
which changes in the brain cause
problems with memory, thinking and
behaviour. These problems gradually
become worse with time.
Exelon works by preventing the
breakdown of a chemical in the brain
called acetylcholine. This chemical is
needed to help keep the brain
working properly.
Exelon helps to slow down the
mental decline that happens in people
with Alzheimer's disease and it helps
to improve the ability to cope with
everyday activities. It does not cure
the condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Exelon is only available with a
doctor's prescription. It is not
addictive.
There is not enough information to
recommend this medicine for
children.
BEFORE YOU TAKE
EXELON
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE EXELON IF YOU HAVE HAD
AN ALLERGIC REACTION TO ANY OF THE
FOLLOWIN

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – EXELON
®
RIVASTIGMINE (AS HYDROGEN TARTRATE)
1
NAME OF THE MEDICINE
Rivastigmine as hydrogen tartrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Exelon capsules contain 1.5, 3.0, 4.5 or 6.0 mg rivastigmine as the
hydrogen tartrate salt.
Exelon Oral solution contains rivastigmine hydrogen tartrate
corresponding to rivastigmine base 2
mg/mL.
Excipients with known effect:
Capsules contain sulphites, phenylalanine, tartrazine.
Oral solution contains benzoates and sulphites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Exelon capsule 1.5 mg: Hard capsule with yellow cap/yellow body marked
"EXELON 1.5mg" in red,
containing off-white to slightly yellow powder.
Exelon capsule
3mg: Hard capsule with orange cap/orange body marked with "EXELON 3mg"
in red,
containing off-white to slightly yellow powder.
Exelon capsule
4.5mg: Hard capsule with red cap/red body marked with "EXELON 4.5mg"
in white,
containing off-white to slightly yellow powder.
Exelon capsule
6mg: Hard capsule with red cap/orange body marked with "EXELON 6mg" in
red,
containing off-white to slightly yellow powder.
Exelon Oral liquid solution: clear, yellow solution.
4 CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Exelon is indicated for the treatment of patients with mild to
moderately severe dementia of the
Alzheimer’s type.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The dosage of Exelon shown to be effective in controlled clinical
trials is 6-12 mg/day, given as
twice a day dosing (daily doses of 3 to 6 mg twice daily). There is
evidence from the clinical trials
that doses at the higher end of this range may be more beneficial.
Patients should be individually
titrated to establish the appropriate dosage of Exelon.
2
METHOD OF ADMINISTRATION
Exelon should be administered twice daily with morning and evening
meals. The capsules should
be swallowed whole. The prescribed amount of Exelon Oral solution
should be withdrawn from
the container using the oral dosing syringe