Exelon 13.3mg24hours transdermal patches

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

şimdi satın al

Indir Ürün özellikleri (SPC)
21-06-2018

Aktif bileşen:

Rivastigmine

Mevcut itibaren:

Novartis Pharmaceuticals UK Ltd

INN (International Adı):

Rivastigmine

Doz:

13.3mg/24hour

Farmasötik formu:

Transdermal patch

Uygulama yolu:

Transdermal

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: ; GTIN: 5010678905298

Bilgilendirme broşürü

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
EXELON
® 4.6 MG/24 H TRANSDERMAL PATCH
EXELON
® 9.5 MG/24 H TRANSDERMAL PATCH
EXELON
® 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 Exelon is and what it is used for
2.
What you need to know before you use Exelon
3.
How to use Exelon
4.
Possible side effects
5.
How to store Exelon
6.
Contents of the pack and other information
1.
WHAT EXELON IS AND WHAT IT IS USED FOR
The active substance of Exelon 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, Exelon allows levels
of acetylcholine to be
increased in the brain, helping to reduce the symptoms of
Alzheimer’s disease.
Exelon 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 EXELON
DO NOT USE EXELON
-
if you are allergic to rivastigmine (the active substance in Exelon)
or any of the other
ingredients of this medicine (listed in section 6).
-
if you have ever had
                                
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Ürün özellikleri

                                OBJECT 1
EXELON 4.6 MG/24H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 14-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Exelon
®
4.6 mg/24 h transdermal patch
Exelon
®
9.5 mg/24 h transdermal patch
Exelon
®
13.3 mg/24 h transdermal patch
2. Qualitative and quantitative composition
Exelon 4.6 mg/24 h transdermal patch
Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours.
Each transdermal patch of 5 cm
2
contains 9 mg of rivastigmine.
Exelon 9.5 mg/24 h transdermal patch
Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Each transdermal patch of 10 cm
2
contains 18 mg of rivastigmine.
Exelon 13.3 mg/24 h transdermal patch
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
Exelon 4.6 mg/24 h 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 “Exelon”, “4.6
mg/24 h” and “AMCX”.
Exelon 9.5 mg/24 h 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 “Exelon”, “9.5
mg/24 h” and “BHDI”.
Exelon 13.3 mg/24 h 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 “Exelon”, “13.3
mg/24 h” and “CNFU”.
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 patie
                                
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