RIVASTIGMINE TEVA 9.5 mg/24 hours Transdermal Patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RIVASTIGMINE BASE

Available from:

Teva Pharma B.V.

ATC code:

N06DA03

INN (International Name):

RIVASTIGMINE BASE

Dosage:

9.5 mg/24 hours

Pharmaceutical form:

Transdermal Patch

Prescription type:

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

Therapeutic area:

Anticholinesterases

Authorization status:

Authorised

Authorization date:

2013-08-23

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivastigmine Teva 9.5mg/24h Transdermal Patches
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each transdermal patch releases 9.5 mg rivastigmine per 24 hours.
Each transdermal patch of 10 cm
2
contains 18 mg rivastigmine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch
The drug product is a three-layer matrix transdermal roundshaped patch
consisting of backing film, drug (acrylic)
matrix containing drug substance, adhesive (silicone) matrix and
furthermore a rectangular release liner.
The outside of the backing layer is translucent, white and
black-printed as follows;
“Rivastigmine, 9.5 mg/24 h”
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 should be
continued for as long as the patient continues to
TRANSDERMAL PATCHES
RIVASTIGMINE_ IN VIVO_
RELEASE RATES PER 24 H
Rivastigmine Teva 4.6 mg/24 h
4.6 mg
Rivastigmine Teva 9.5 mg/24 h
9.5 mg
Rivastigmine Teva 13.3 mg/24 h
13.3 mg
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