Prometax 9.5mg24hours transdermal patches

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Rivastigmine

Beschikbaar vanaf:

Novartis Pharmaceuticals UK Ltd

ATC-code:

N06DA03

INN (Algemene Internationale Benaming):

Rivastigmine

Dosering:

9.5mg/24hour

farmaceutische vorm:

Transdermal patch

Toedieningsweg:

Transdermal

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04110000; GTIN: 5050650120028

Bijsluiter

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

Productkenmerken

OBJECT 1
PROMETAX 4.6 MG/24 H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 30-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Prometax
®
4.6 mg/24 h transdermal patch
Prometax
®
9.5 mg/24 h transdermal patch
Prometax
®
13.3 mg/24 h transdermal patch
2. Qualitative and quantitative composition
Prometax 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.
Prometax 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.
Prometax 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
Prometax 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 “Prometax”, “4.6
mg/24 h” and “AMCX”.
Prometax 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 “Prometax”, “9.5
mg/24 h” and “BHDI”.
Prometax 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 “Prometax”, “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
t