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VOLEZE 9.5MG/24 H TRANSDERMAL PATCH

Active substance(s): RIVASTIGMINE

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3. How to use Voleze

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Always use this medicine exactly as your doctor
has told you. Check with your doctor or
PACKAGE LEAFLET:
pharmacist if you are not sure.
INFORMATION FOR THE USER
IMPORTANT: Only wear one Voleze patch at a
time. You must remove the previous day’s patch
Voleze 4.6 mg/24 h
before applying a new one. Do not cut the patch
Transdermal Patch
into pieces.
Voleze 9.5 mg/24 h
How to start treatment
Transdermal Patch
Your doctor will tell you which Voleze
transdermal patch is most suitable for you.
Rivastigmine
• Treatment usually starts with Voleze 4.6 mg/24
Read all of this leaflet carefully before you start
h.
using this medicine because it contains • The usual daily dose is Voleze 9.5 mg/24 h.
important information for you.
• Only wear one Voleze patch at a time and
- Keep this leaflet. You may need to read it again.
replace the patch with a new one after 24
- If you have any further questions, ask your
hours.
doctor or pharmacist.
During the course of the treatment your doctor
- This medicine has been prescribed for you, only. may adjust the dose to suit your individual
Do not pass it on to others. It may harm them, needs.
even if their signs of illness are the same as yours. If you have not applied a Voleze patch for
- If you get any side effects talk to your doctor or several days, do not apply the next one before
pharmacist. This includes any possible side you have talked to your doctor.
effects not listed in this leaflet.
Where to apply your Voleze transdermal patch
• Before you apply a patch, make sure that your
What is in this leaflet:
skin is:
1. What Voleze is and what it is used for
- clean, dry and hairless,
2. What you need to know before you use
- free of any powder, oil, moisturiser or lotion
Voleze
that could keep the patch from sticking to
3. How to use Voleze
your skin properly,
4. Possible side effects
free of cuts, rashes and/or irritations.
5. How to store Voleze
• Carefully remove any existing patch
6. Contents of the pack and other
before putting on a new one. Having
information
multiple patches on your body could
expose you to an excessive amount of this
medicine which could be potentially
1.What Voleze is and what it is used for
dangerous.
Rivastigmine belongs to a class of substances • Apply only one patch per day to only one
called cholinesterase inhibitors. Voleze is used
of the following locations, as shown in the
for the treatment of memory disorders in
following diagrams:
patients with Alzheimer’s disease.
- left upper arm or right upper arm
Voleze is indicated in adults.
- left upper chest or right upper chest (avoid
breast)
- left upper back or right upper back
2. What you need to know before you - left lower back or right lower back

use Voleze

540

When changing the patch, apply the new
one to a different location of skin each time
(for example on the right side of your body
one day, then on the left side the next day,
and on your upper body one day, then on
your lower body the next day). Do not apply
a new patch to that same location of skin
twice within 14 days.
How to apply your Voleze transdermal
patch
Voleze patches are thin, translucent, plastic
patches that stick to the skin. Each patch is
sealed in a sachet that protects it until you
are ready to put it on. Do not open the
sachet or remove a patch until just before
you apply it.
- Each patch is sealed in its own protective
sachet. You should only open the sachet
when you are ready to apply the patch.
Cut the sachet along the dotted line with
scissors and remove the patch from the
sachet.

4. Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
You may have side effects more often when
you start your medicine or when your dose is
increased. Usually, the side effects will slowly
go away as your body gets used to the
medicine.
Take off your patch and tell your doctor
straight away, if you notice any of the
following side effects which could become
serious:
Uncommon (may affect up to 1 in 100
people)
• Problems with your heartbeat such as
slow heartbeat
• Seeing things that are not really there
(hallucinations)
• Stomach ulcer

- A protective liner covers the sticky side of
the patch. Peel off one side of the
protective liner and do not touch the sticky
part of the patch with the fingers.

Very rare (may affect up to 1 in 10,000
people)
• Stiff arms or legs
• Trembling hands
Side effects which have been seen since
Voleze patch started to be prescribed
• Allergic reaction where the patch was
used, such as blisters or inflamed skin
• The signs of Parkinson’s disease get worse
- such as tremor, stiffness and shuffling
• Inflammation of the pancreas - signs
include serious upper stomach pain,
often with feeling sick (nausea) or being
sick (vomiting)
• Fast or uneven heartbeat
• High blood pressure
• Fits (seizures)
• Falling
• Dehydration (losing too much fluid)
• Liver disorders (yellow skin, yellowing of
the whites of eyes, abnormal darkening
of the urine or unexplained nausea,
vomiting, tiredness and loss of appetite)
• Changes in tests which show how well
the liver is working
• Aggression, feeling restless

- Put the sticky side of the patch on the
upper or lower back, upper arm or chest
and then peel off the second side of the
protective liner.

- Then press the patch firmly in place with the
hand to make sure that the edges stick well.

Take off your patch and tell your doctor straight
away, if you notice any of the side effects
above.
Other side effects seen with capsules or oral
solutions containing rivastigmine and which
may occur with the patch:

If it helps you, you may write, for example, the
day of the week, on the patch with a thin ball
point pen.
The patch should be worn continuously until it is
time to replace it with a new one. You may wish
to experiment with different locations when
applying a new patch, to find ones that are
most comfortable for you and where clothing
will not rub on the patch.

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Datum
Bearb. 10.12.2012
Gepr. 10.12.2012
Norm

Name

Benennung

Schulze

Kunde Klocke Verpackungs-Service GmbH 111693
pharmaceuticals ltd

Decor Area Leaflet

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5. How to store Voleze

Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date, which is stated on the carton and
sachet after ‘EXP’. The expiry date refers to
the last day of the month.
Store in the original package in order to
protect from light.
Keep the transdermal patch in the sachet
until use.
This medicinal product does not require any
special temperature storage conditions.
Do not use any patch that is damaged or
shows signs of tampering.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment (see “How to
dispose of your Voleze transdermal patch”
above).

fax:
01283 495290

What Voleze contains
The active substance is rivastigmine.
Voleze 4.6 mg/24 h transdermal patches:
Each patch releases 4.6 mg rivastigmine per
24 hours is 5 cm2 and contains 9 mg
rivastigmine.
Voleze 9.5 mg/24 h transdermal patches:
Each patch releases 9.5 mg rivastigmine per
24 hours is 10 cm2 and contains 18 mg
rivastigmine.
The other ingredients are:
Film: Polyester film
Fluoro-coated polyester film
Drug matrix: Acrylic adhesive, Acrylates
copolymer poly(butyl
methacrylat-co-methyl methacrylat)
Adhesive matrix: Silicone adhesive
Printing ink: Black printing ink
What Voleze looks like and contents of the pack
Each transdermal patch is a thin patch
consisting of three layers. The outer layer is
translucent, white and black-printed with
the following:
- Voleze 4.6 mg/24 h Transdermal Patches:
“Rivastigmine”, “4.6 mg/24 h”
- Voleze 9.5 mg/24 h Transdermal Patches:
“Rivastigmine”, “9.5 mg/24h”
One transdermal patch is packed in one
child-resistant and heat-sealed sachet. The
patches are available in packs containing
7, 10, 30, 60 and 90 sachets and in
multipacks containing 60 (2 x 30) and 90 (3 x
30) sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Unit 5,
Faraday Court, Burton upon Trent, DE14 2WX,
UK
Tel:
00 44 (0)1283 495 280
Fax:
00 44 (0)1283 495 290
Email:
medinfo@focuspharma.co.uk
Manufacturer
Laboratoires Plasto Santé, 42 rue de Longvic,
21300 Chenôve, France
This medicinal product is authorised in the
Member States of the EEA under the following
names:
3411-001-002
Germany: Voleze 4,6mg/24h Stunden
transdermates Pflaster / Voleze 9,5mg/24h
Stunden transdermates Pflaster
United Kingdom: Voleze 4.6mg/24h Transdermal
Patch/Voleze 9.5mg/24h Transdermal Patch

For information in large print, audio CD or
Braille please telephone
00 44 (0)1283 495 280 or email
medinfo@focuspharma.co.uk.
This leaflet was last revised in 07/2013

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Voleze 4.6mg & 9.5mg
/24h Transdermal - PIL
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Rivastigmine_PIL

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Laboratoires Plasto Santé

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6. Contents of the pack and other
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tel:
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Unit 5 Faraday Court, First Avenue, Centrum 100,
Burton upon Trent, Staffordshire DE14 2WX.

size: 540x170mm
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Artikel Nr.

Very rare (may affect up to 1 in 10,000 people)
• High blood pressure
• Inflammation of the pancreas - the signs
include serious upper stomach pain, often
with feeling sick (nausea) or being sick
(vomiting)
• Bleeding in the gut - shows as blood in stools or
when being sick
• Seeing
things
that
are
not
there
(hallucinations)
• Some people who have been violently sick
have had tearing of the tube that connects
your mouth with your stomach (oesophagus)
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.

Common (may affect up to 1 in 10 people)
• Too much saliva
• Loss of appetite
• Feeling restless
• Feeling agitated or sleepy

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Alte Zchng. Nr. :

Material

1:1

Rare (may affect up to 1 in 1,000 people)
• Fits (seizures)
• Ulcer in the intestine
• Chest pain - this may be caused by heart
spasm

Very common (may affect more than 1 in 10
people)
• Feeling dizzy

(continued overleaf)

Projekt-Nr.

Uncommon (may affect up to 1 in 100 people)
• Uneven heart rate (e.g. fast heart rate)
• Difficulty sleeping
• Accidental falls

Minimum Point Size:

9.7pt

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Black

Reason for new version:
v1 New PIL created for alternative manufacturer (Laboratoires Plasto Santé)
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Do not use Voleze
- 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.
- if you have a skin reaction spreading
beyond the patch size, if there is a more
intense local reaction (such as blisters,
increasing skin inflammation, swelling)
and if it does not improve within 48 hours
after removal of the transdermal patch.
If this applies to you, tell your doctor and do
not apply Voleze transdermal patches.
Warnings and precautions
Talk to your doctor or pharmacist before
using Voleze
- if you have, or have ever had, an irregular
heartbeat.
- if you have, or have ever had, an active
stomach or duodenal ulcer.
- if you have, or have ever had, difficulties
in passing urine.
- if you have, or have ever had, seizures.
- if you have, or have ever had, asthma or
a severe respiratory disease.
- if you suffer from trembling.
- if you have a low body weight (less than
50 kg).
- if you have gastrointestinal reaction such
as feeling sick (nausea), being sick
(vomiting) and diarrhoea. You may
become dehydrated (losing too much
fluid) if vomiting or diarrhoea are
prolonged.
- if you have impaired liver function.
If any of these apply to you, your doctor may
need to monitor you more closely while you
are on this medicine.
If you have not applied a Voleze patch for
several days, do not apply the next one
before you have talked to your doctor.
The use of Voleze in children and adolescents
(age below 18 years) is not recommended.
Other medicines and Voleze
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Voleze might interfere with anticholinergic
medicines (medicines used to relieve
stomach cramps or spasms, to treat
Parkinson’s disease or to prevent travel sickness).
If you have to undergo surgery whilst using
Voleze transdermal patches, tell your doctor that
you are using them because they may
exaggerate the effects of some muscle relaxants
during anaesthesia.
Voleze with food and drink
Food or drink do not affect the use of Voleze
transdermal patches because rivastigmine
enters the bloodstream through the skin.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or planning to
become pregnant. If you are pregnant, the
benefits of using Voleze transdermal patches must
be assessed against the possible effects on your
unborn child.
You should not breast-feed during treatment with
Voleze transdermal patches.
Ask your doctor or pharmacist for advice before
using this medicine.
Driving and using machines
Your doctor will tell you whether your illness allows
you to drive vehicles and use machines safely.
Voleze transdermal patches may cause fainting
or severe confusion. If you feel faint or confused
do not drive, use machines or perform any other
tasks that require your attention.

• Generally feeling unwell
• Trembling or feeling confused
• Increased sweating

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How to remove your Voleze transdermal patch
Gently pull at one edge of the patch to remove
it completely from the skin.
How to dispose of your Voleze transdermal
patch
After removing a patch, fold it in half with the
sticky sides on the inside and press them
together.
Return the used patch to its sachet and dispose
of it in such a way that children cannot handle
it. Do not touch your eyes with your fingers and
wash your hands with soap and water after
removing the patch.
If your community burns domestic rubbish, you
can dispose of the patch with your domestic
rubbish. Otherwise, return used patches to a
pharmacy, preferably in the original packaging.
Can you wear your Voleze transdermal patch
when you are bathing, swimming, or in the sun?
• Bathing, swimming or showering should not
affect the patch. Make sure the patch does
not loosen during these activities.
• Do not expose the patch to any external heat
sources (e.g. excessive sunlight, saunas,
solarium) for long periods of time.
What to do if a patch falls off
If a patch falls off, apply a new one for the rest
of the day, then replace it at the same time as
usual the next day.
When and for how long to apply your Voleze
transdermal patch
• To benefit from treatment, you must
apply a new patch every day, preferably
at the same time of day.
• Only wear one Voleze patch at a time
and replace the patch with a new one
after 24 hours.
If you use more Voleze than you should
If you accidentally apply more than one
patch, remove all the patches from your
skin, then inform your doctor that you have
accidentally applied more than one patch.
You may require medical attention. Some
people who have accidentally taken too
much rivastigmine have experienced
feeling sick (nausea), being sick (vomiting),
diarrhoea, high blood pressure and
hallucinations. Slow heart beat and fainting
may also occur.
If you forget to use Voleze
If you find you have forgotten to apply a
patch, apply one immediately. You may
apply the next patch at the usual time the
next day. Do not apply two patches to
make up for the one that you missed.
If you stop using Voleze
Tell your doctor or pharmacist if you stop
using the patch.
If you have not applied a Voleze patch for
several days, do not apply the next one
before you have talked to your doctor.
If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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