Alzest 9.5mg/24hours transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rivastigmine

Available from:

Dr Reddy's Laboratories (UK) Ltd

ATC code:

N06DA03

INN (International Name):

Rivastigmine

Dosage:

9.5mg/24hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000; GTIN: 05036072005556

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALZEST 4.6 MG/24 H TRANSDERMAL PATCH
ALZEST 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 or pharmacist.
•
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 or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT ALZEST IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ALZEST
3.
HOW TO USE ALZEST
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ALZEST
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ALZEST IS AND WHAT IT IS USED FOR
The active substance of Alzest 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 allows levels of acetylcholine to
be increased
in the brain, helping to reduce the symptoms of Alzheimer’s disease.
Alzest 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 ALZEST
DO NOT USE ALZEST
•
if you are allergic to rivastigmine (the active substance in Alzest)
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

Summary of Product characteristics

OBJECT 1
ALZEST 9.5MG/24H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 07-Jun-2016 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Alzest 9.5 mg/24 h Transdermal Patch
2. Qualitative and quantitative composition
Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Each transdermal patch of 9.2 cm
2
contains 13.8 mg of rivastigmine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
Each transdermal patch is a thin, matrix-type transdermal patch. The
outside of the backing layer is tan
coloured.
Each patch is printed in orange with “RIV-TDS 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
TRANSDERMAL PATCHES
RIVASTIGMINE _IN VIVO _RELEASE RATES PER 24 H
Alzest 4.6 mg/24 h
4.6 mg
Alzest 9.5 mg/24 h
9.5 mg
Rivastigmine 13.3 mg/24 h*
13.3 mg
*The 13.3 mg/24 h dose strength cannot be achieved with this product.
For conditions where this strength
should be used, please refer to other rivastigmine products for which
transdermal patches of the 13.3
mg/24 h strength are available.
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