Rivastigmine Sandoz Transdermal Patch 13.3mg/24hours

Land: Malta

Språk: engelska

Källa: Malta Medicines Authority

Aktiva substanser:

RIVASTIGMINE

Tillgänglig från:

1 A Pharma GmbH

ATC-kod:

N06DA03

INN (International namn):

RIVASTIGMINE

Läkemedelsform:

TRANSDERMAL SYSTEM

Sammansättning:

RIVASTIGMINE 13.3 milligram(s)/24 hours

Receptbelagda typ:

POM

Terapiområde:

PSYCHOANALEPTICS

Bemyndigande status:

Authorised

Tillstånd datum:

2016-02-04

Bipacksedel

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Rivastigmine Sandoz 13,3 mg/24 hours Transdermal System
rivastigmine
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
WHAT IS IN THIS LEAFLET
1. What Rivastigmine Sandoz 13,3 mg/24 hours Transdermal System is and
what it is used for
2. What you need to know before you use Rivastigmine Sandoz 13,3 mg/24
hours Transdermal
System
3. How to use Rivastigmine Sandoz 13,3 mg/24 hours Transdermal System
4. Possible side effects
5. How to store Rivastigmine Sandoz 13,3 mg/24 hours Transdermal
System
6. Contents of the pack and other information
1. WHAT RIVASTIGMINE SANDOZ 13,3 MG/24 HOURS TRANSDERMAL SYSTEM IS AND
WHAT IT IS USED
FOR
_ _
The active substance of Rivastigmine Sandoz 13,3 mg/24 hours
Transdermal System is
rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase
inhibitors. 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).
Rivastigmine works by blocking the enzymes that break down
acetylcholine: acetylcholinesterase
and butyrylcholinesterase. By blocking these enzymes, [Nationally
completed name] allows levels
of acetylcholine to be increased in the brain, helping to reduce the
symptoms of Alzheimer’s
disease.
Rivastigmine Sandoz 13,3 mg/24 hours Transdermal System is used for
the treatment of adult
patients with mild to moderately severe Alzheimer’s dementia, a
progressive brain disorder that
gradually affects memory, intell

Produktens egenskaper

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivastigmine Sandoz 13,3 mg/24 h Transdermal System
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours.
Each transdermal patch of 15
cm
2
contains 27 mg of rivastigmine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch
Each transdermal patch is a thin, matrix-type transdermal patch
consisting of three layers.
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 printed with
“RIV 13.3 mg/24 h”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderately severe Alzheimer’s
dementia.
4.2
POSOLOGY AND METHOD OF 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
TRANSDERMAL SYSTEMS
RIVASTIGMINE_ IN VIVO_
RELEASE RATES PER 24 H
Rivastigmine Sandoz
4.6 mg/24 h*
4.6 mg
Rivastigmine Sandoz
9.5 mg/24 h*
9.5 mg
Rivastigmine Sandoz
13.3 mg/24 h
13.3 mg
Page 2 of 15
* For doses not realisable with this medicinal product other strengths
of this medicinal product are
available.
Initial dose
Treatment is started with 4.6 mg/24 h.
Maintenance dose
After a minimum of four weeks of treatment and if well tolerated
according to the treating physician,
the dose of 4.6 mg/ 24 h should be increased to 9.5 mg/24 h, the daily
recommended effective dose,
which should be continued for as long as the patient continues to
demonstrate therapeutic benefit.
Dose escalation
9.5 mg/24 h is the recommended daily effective dose which should be
continued for