EXELON PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

rivastigmine, Quantity: 27 mg

Dostupné z:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Medzinárodný Name):

Rivastigmine

Forma lieku:

Drug delivery system, transdermal

Zloženie:

Excipient Ingredients: acrylates copolymer; dl-alpha-tocopherol; dimeticone 12500; ethyl acetate; methylated trimethylated silica; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane

Spôsob podávania:

Transdermal

Počet v balení:

30 transdermal drug delivery systems, 7 transdermal drug delivery systems

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

EXELON / PROMETAX is indicated for the treatment of patients with mild, moderate and severe dementia of the Alzheimer's type.

Prehľad produktov:

Visual Identification: Circular 15 cm2 transdermal drug delivery system, backing layer (beige), bi-layer adhesive matrix and an oversized rectangular overlapping release liner with dimples. Patch backing is printed with "CNFU" and "Exelon Patch 15 (rivastigmine)"; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2015-04-07

Príbalový leták

EXELON
® PATCH
_Rivastigmine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Exelon Patch.
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 PATCH IS
USED FOR
Exelon Patch contains rivastigmine
as the active substance. Rivastigmine
belongs to a class of substances
called cholinesterase inhibitors and is
used to treat a condition called
Alzheimer's disease.
In patients 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 Patch works by preventing
the breakdown of a chemical in the
brain called 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
patient's ability to cope with
everyday activities. It does not cure
the condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THI

Súhrn charakteristických

1
AUSTRALIAN PRODUCT INFORMATION –
EXELON
® PATCH (RIVASTIGMINE)
1
NAME OF THE MEDICINE
Rivastigmine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Exelon Patches are available in three strengths:
Exelon® Patch 5: Each patch of 5 cm
2
contains 9 mg rivastigmine.
Exelon® Patch 10: Each patch of 10 cm
2
contains 18 mg rivastigmine.
Exelon® Patch 15: Each patch of 15 cm
2
contains 27 mg rivastigmine.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Exelon Patch is a thin, matrix-type transdermal patch consisting of
three layers, one of which
contains rivastigmine.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Exelon is indicated for the treatment of patients with mild, moderate
and severe dementia of the
Alzheimer’s type.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
INITIAL DOSE AND DOSE TITRATION TO THE EFFECTIVE DOSE
Treatment is started with Exelon Patch 5 once a day.
INCREASE THE DOSE ONLY AFTER A MINIMUM OF 4 WEEKS AT THE PREVIOUS
DOSE, AND ONLY IF THE PREVIOUS
DOSE HAS BEEN WELL TOLERATED. For mild and moderate Alzheimer’s
disease patients continue the
recommended effective dose of Exelon Patch 10 for as long as
therapeutic benefit persists.
Moderate patients can then be increased to the maximum recommended
dose of Exelon Patch 15.
For patients with severe Alzheimer’s disease, after titration up
Exelon Patch 15 may be used. Doses
higher than Exelon Patch 15 confer no appreciable additional benefit,
and are associated with an
increase in the incidence of adverse events.
MAINTENANCE DOSE
_Mild Alzheimer’s Disease _
The effective dosage is Exelon Patch 10 administered once per day;
replace with a new patch every
24 hours.
2
_Moderate Alzheimer’s Disease _
After 4 weeks on Patch 5, if tolerated increase to Patch 10. The
effective dosage is Exelon Patch 10
for as long as therapeutic benefit persists but (after a minimum of 4
weeks) this may be increased to
Exelon Patch 15 administered once per day; replace with a new patch
every 24 hours.
_Severe Alzheime