EMERPAND 9.5 mg/24 hours Transdermal Patch

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

RIVASTIGMINE

Доступна с:

Actavis Group PTC ehf

код АТС:

N06DA03

ИНН (Международная Имя):

RIVASTIGMINE

дозировка:

9.5 mg/24 hours

Фармацевтическая форма:

Transdermal Patch

Тип рецепта:

Product subject to prescription which may not be renewed (A)

Терапевтические области:

Anticholinesterases

Статус Авторизация:

Authorised

Дата Авторизация:

2015-01-09

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
EMERPAND 4.6MG/24H, 9.5MG/24H AND
13.3MG/24H TRANSDERMAL PATCHES
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).
•
if you have ever had an allergic reaction to a similar
type of medicine (carbamate de

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emerpand 9.5mg/24h Transdermal Patches
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch
Circular matrix transdermal patches of active surface area 10cm
2
. 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 "RIV9.5” 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
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