Rivastigmine Sandoz 9.5mg/24 hours Transdermal Patch

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Rivastigmine

Verfügbar ab:

Rowex Ltd

ATC-Code:

N06DA; N06DA03

INN (Internationale Bezeichnung):

Rivastigmine

Dosierung:

9.5 milligram(s)/24 hours

Darreichungsform:

Transdermal patch

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Anticholinesterases; rivastigmine

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2013-12-20

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Rivastigmine Sandoz 4.6 mg/24 h transdermal patch
Rivastigmine Sandoz 9.5 mg/24 h transdermal patch
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. Do not pass it on to
others. It may harm them, even
if their symptoms of illness are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1. What
Rivastigmine Sandoz
is and what it is used for
2. What you need to know before you use
Rivastigmine Sandoz
3. How to use Rivastigmine Sandoz
4. Possible side effects
5. How to store
Rivastigmine Sandoz
6. Contents of the pack and other information
1.
WHAT RIVASTIGMINE SANDOZ IS AND WHAT IT IS USED FOR
_ _
The active substance of Rivastigmine Sandoz 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, Rivastigmine Sandoz
allows levels of
acetylcholine to be increased in the brain, helping to reduce the
symptoms of Alzheimer’s disease.
Rivastigmine Sandoz is used for the treatment of adult patients with
mild to moderately severe
Alzheimer’s dementia, a progressive brain disorder that gradually
affects memory, intellectual ability
and behaviour.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RIVASTIGMINE SANDOZ
DO NOT USE RIVASTIGMINE SANDOZ
-
if you are allergic to rivastigmine (the active substance in
Rivastigmine Sandoz
or any of the
other ingredients of th

Fachinformation

Health Products Regulatory Authority
03 November 2020
CRN009W0J
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivastigmine Sandoz 9.5mg/24 hours Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Each transdermal patch of 10 cm2contains 18 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. The outside of the backing layer is
beige and labelled with “RIV”,9.5 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 PATCHES
RIVASTIGMINE_ IN VIVO_ RELEASE RATES PER 24 H
Rivastagmine Sandoz 4.6 mg/24 h
4.6 mg
Rivastigmine Sandoz 9.5 mg/24 h
9.5 mg
Rivastigmine 13.3 mg/24 h*
13.3 mg
*The 13.3 mg/24 h dose strength cannot be achieved with this product.
For conditions where this strength should be used,
please refer to other rivastigmine products for which transdermal
patches of the 13.3 mg/24 h strength 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 dos