Rivastigmine 3M Health Care Ltd
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
18-09-2014
Charakterystyka produktu
(SPC)
18-09-2014
Sprawozdanie z oceny publicznego
(PAR)
18-09-2014
Składnik aktywny:
rivastigmine
Dostępny od:
3M Health Care Limited
Kod ATC:
N06DA03
INN (International Nazwa):
rivastigmine
Grupa terapeutyczna:
Psychoanaleptics, , Anticholinesterases
Dziedzina terapeutyczna:
Alzheimer Disease
Wskazania:
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Podsumowanie produktu:
Revision: 1
Status autoryzacji:
Withdrawn
Data autoryzacji:
2014-04-03
Ulotka dla pacjenta
39
B. PACKAGE LEAFLET
Medicinal product no longer authorised
40
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVASTIGMINE 3M HEALTH CARE LTD. 4.6 MG/24 H TRANSDERMAL PATCH
RIVASTIGMINE 3M HEALTH CARE LTD. 9.5 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 Rivastigmine 3M Health Care Ltd. is and what it is used for
2.
What you need to know before you use Rivastigmine 3M Health Care Ltd.
3.
How to use Rivastigmine 3M Health Care Ltd.
4.
Possible side effects
5.
How to store Rivastigmine 3M Health Care Ltd.
6.
Contents of the pack and other information
1.
WHAT RIVASTIGMINE 3M HEALTH CARE LTD. IS AND WHAT IT IS USED FOR
The active substance of Rivastigmine 3M Health Care Ltd. 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 3M
Health Care Ltd. allows levels of
acetylcholine to be increased in the brain, helping to reduce the
symptoms of Alzheimer’s disease.
Rivastigmine 3M Health Care Ltd. is used for the treatment of adult
patients with mild to moderately
severe Alzheimer’s dementia, a progressive brain disorder that
gradually affec
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Rivastigmine 3M Health Care Ltd. 4.6 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
4.15 cm
2
contains 7.17 mg of rivastigmine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch
Rectangular patches, approximately 2.5 cm by 1.8 cm with rounded
corners. Each patch consists of a
combination of a removable, transparent, split release liner, a
functional layer containing drug-in-
adhesive (DIA) matrix, and a protective backing layer. The backing
layer is transparent to translucent,
labelled with “R5” in a repeated pattern.
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
Rivastigmine 4.6 mg/24 h
4.6 mg
Rivastigmine 9.5 mg/24 h
9.5 mg
Rivastigmine 13.3 mg/24 h
*
13.3 mg
*
A marketing authorisation for Rivastigmine 3M Health Care Ltd. 13.3
mg/24 h transdermal patch is
currently not available, this presentation may although be available
from other marketing authorisation
holders.
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 a
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