Emerpand 4.6mg/24hr transdermal patch

Country: Malta

Bahasa: Inggeris

Sumber: Malta Medicines Authority

Bahan aktif:

RIVASTIGMINE

Boleh didapati daripada:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Kod ATC:

N06DA03

INN (Nama Antarabangsa):

RIVASTIGMINE 4.6 mg/24 h

Borang farmaseutikal:

TRANSDERMAL PATCH

Komposisi:

RIVASTIGMINE 4.6 mg/24 h

Jenis preskripsi:

POM

Kawasan terapeutik:

PSYCHOANALEPTICS

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2015-08-03

Risalah maklumat

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PACKAGE LEAFLET
Package leaflet: Information for the user
EMERPAND 4.6 MG/24 H TRANSDERMAL PATCH
EMERPAND 9.5 MG/24 H TRANSDERMAL PATCH
EMERPAND 13.3 MG/24 H TRANSDERMAL PATCH
rivastigmine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Emerpand is and what it is used for
2.
What you need to know before you use Emerpand
3.
How to use Emerpand
4.
Possible side effects
5.
How to store Emerpand
6.
Contents of the pack and other information
1.
WHAT EMERPAND IS AND WHAT IT IS USED FOR
The active substance of Emerpand 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, Emerpand allows levels
of acetylcholine to be increased in the brain, helping to reduce the
symptoms of Alzheimer’s
disease.
Emerpand 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 EMERPAND
DO NOT USE EMERPAND
-
if you are allergic to rivastigmine or any of the other ingredients of
this medicine (listed in
section 6).
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Emerpand 4.6 mg/24 h transdermal patch
Emerpand 9.5 mg/24 h transdermal patch
Emerpand 13.3 mg/24 h transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours.
Each transdermal patch of
5 cm
2
contains 9.0 mg of rivastigmine.
Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Each transdermal patch of
10 cm
2
contains 18.0 mg of rivastigmine.
Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours.
Each transdermal patch of
15 cm
2
contains 27.0 mg of rivastigmine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch
Circular matrix transdermal patches of active surface area 5 cm² 10
cm² and 15 cm². The patch is
comprised of three layers: a backing film, an adhesive layer, and a
square protective release liner.
The backing layer is a translucent low-density polyethylene (LDPE)
material printed with the text
"RIV4.6” “RIV9.5” and “RIV13.3” in a repeating pattern. The
polyester (PET) release liner, which
is removed prior to patch application, is translucent and coated with
silicone.
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
DOSE LOAD
RIVASTIGMINE_ IN VIVO_
RELEASE RATES PER 24 H
Emerpand 4.6 mg/24 h
9.0 mg
4.6 mg
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Emerpand 9.5 mg/24 h
18.0 mg
9.5 mg
Emerpand 13.3 mg/24 h
27.0 mg
13.3 mg
Initial dose
Treatment is started with 4.6