Rivastigmine Sandoz Transdermal Patch 13.3mg/24hours

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RIVASTIGMINE

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC code:

N06DA03

INN (International Name):

RIVASTIGMINE 13.3 mg/24 h

Pharmaceutical form:

TRANSDERMAL PATCH

Composition:

RIVASTIGMINE 13.3 mg/24 h

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2016-02-04

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RIVASTIGMINE SANDOZ
13.3 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 only. Do not pass it on to
others. It may harm them,
even if their symptoms 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 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 this medicine (listed in

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivastigmine Sandoz 13.3 mg/24 h transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[13.3 mg]
Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours.
Each transdermal patch
of 15
cm2 contains 27 mg of rivastigmine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch
[13.3 mg]
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.
Page 2 of 19
Posology
TRANSDERMAL PATCHES
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
*
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 as long as
the patient continues to demonstrate therapeutic benefit. If well
tolerated and