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VOLEZE 13.3 MG/24 H TRANSDERMAL PATCH

Active substance(s): RIVASTIGMINE

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170
3

3

3

FRONT

3

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Voleze 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 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.

270

What is in this leaflet:
1. What Voleze is and what it is used for
2. What you need to know before you use Voleze
3. How to use Voleze
4. Possible side effects
5. How to store Voleze
6. Contents of the pack and other information

1.What Voleze is and what it is used for

10

IMPORTANT:
• Take off the previous patch before putting ONE new
patch on.
• Only one patch per day.
• Do not cut the patch into pieces.
• Press the patch firmly in place for at least 30 seconds
using the palm of the hand.
How to start treatment
Your doctor will tell you which Voleze transdermal
patch is most suitable for you.
• Treatment usually starts with Voleze 4.6 mg/24 h*.
• The recommended usual daily dose is Voleze 9.5
mg/24 h*. If well tolerated, the treating physician
may consider increasing the dose to 13.3 mg/24 h.
• Only wear one Voleze patch at a time and replace
the patch with a new one after 24 hours.
* For doses not realisable with this medicinal product
other strengths of this medicinal product are available.
During the course of the treatment your doctor may
adjust the dose to suit your individual needs.
If you have not applied a patch for three days, do not
apply the next one before you have talked to your
doctor. Transdermal patch treatment can be resumed
at the same dose if treatment is not interrupted for
more than three days. Otherwise your doctor will restart
your treatment on Voleze 4.6 mg/24 h.
Where to apply your Voleze transdermal patch
• Before you apply a patch, make sure that your skin is
clean, dry and hairless, free of any powder, oil,
moisturiser or lotion that could keep the patch from
sticking to your skin properly, free of cuts, rashes
and/or irritations.
• Carefully remove any existing patch before putting
on a new one. Having multiple patches on your
body could expose you to an excessive
amount of this medicine which could be
potentially dangerous.
• Apply ONE patch per day to ONLY ONE of the
possible locations shown in the following
diagrams:
- left upper arm or right upper arm
- left upper chest or right upper chest (avoid
breast)
- left upper back or right upper back
- left lower back or right lower back
Every 24 hours take off the previous patch
before putting ONE new patch on to ONLY ONE
of the following possible locations.
Front

143

2. What you need to know before you use Voleze

540

or

or
or

or

4. Possible side effects
Like all medicines, Voleze transdermal patches
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:

or

When changing the patch, you must remove the
previous day’s patch before you 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 the same
skin area 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.
Carefully remove the existing patch before
putting on a new one.

Common (may affect up to 1 in 10 people)
• Loss of appetite
• Feeling dizzy
• Feeling agitated or sleepy
• Urinary incontinence (inability to retain
adequate urine)
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
• Dehydration (losing too much fluid)
• Hyperactivity
(high
level
of
activity,
restlessness)
• Aggression

For patients starting treatment for the first time
and for patients restarting Voleze after treatment
interruption, please begin with the second
picture.
- 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.

Rare (may affect up to 1 in 1,000 people)
• Falling
Very rare (may affect up to 1 in 10,000 people)
• Stiff arms or legs
• Trembling hands

3. How to use Voleze
Always use Voleze transdermal patches exactly as
described in this leaflet and as your doctor has told you.
Check with your doctor, pharmacist or nurse if you are
not sure.

- 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.

Reporting of side effects
If you get any side effects, talk to your doctor and
pharmacist. This includes any possible side effects not
listed in this leaflet.
You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

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 that 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.
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.

6. Contents of the pack and other
information
What Voleze contains
The active substance is rivastigmine.
Each patch releasing 13.3 mg rivastigmine per 24
hours is 15 cm2 and contains 27 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) (80:20)
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 imprinted with black printing ink as follows:
“Rivastigmine” “13.3 mg/24 h”
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 in your
country.

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
Germany: Voleze 13,3mg/24h Stunden
transdermales Pflaster
United Kingdom: Voleze 13.3mg/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 06/2015

Other side effects seen with rivastigmine capsules
or oral solutions and which may occur with the
patch:
Common (may affect up to 1 in 10 people)
• Too much saliva
• Loss of appetite
• Feeling restless
• Generally feeling unwell
• Trembling or feeling confused
• Increased sweating
Uncommon (may affect up to 1 in 100 people)
• Uneven heart rate (e.g. fast heart rate)
• Difficulty sleeping
• Accidental falls
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

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.
(continued overleaf)

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

CLEARLY MARK ANY AMENDMENTS
AND RESUBMIT

tel:
01283 495280

pharmaceuticals ltd

fax:
01283 495290

Approved
for
Print

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4

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Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House,
1st Floor, 85 King William Street, London EC4N 7BL, UK.
Tel:
00 44 (0)1283 495 280
Fax:
00 44 (0)1283 495 290
Email:
medinfo@focuspharma.co.uk

Take off your patch and tell your doctor straight
away, if you notice any of the side effects above.

- 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 for at least 30
seconds using the palm of the hand to make sure that
the edges stick well.

• 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)

Minimum Point Size:

8.5pt

Pantone/
Process Cols Used:

Black

Reason for new version:
v1 New build v2 Minor text amends v3 Pictures changed v4 MAH address change
Caution! We cannot accept responsibility for any errors in this proof after approval. The artwork received has been significantly
adjusted, revised or reset by us from disk or hard copy. Whilst we take extreme care at all times to ensure accuracy, the final
responsibility must be taken by our customer. If you sign this proof you are signifying full approval of design and text.

143

Not known (frequency cannot be estimated from
the available data)
• 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)
• 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
• Feeling restless

code area

70
23
143
8

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
(carbamate
derivatives).
- 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 before using Voleze
- if you have, or have ever had, an irregular
heartbeat.
- if you have, or have ever had, an active
stomach 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.
- if you have gastrointestinal reactions 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 patch for several days,
do not apply the next one before you have talked
to your doctor.
Use in children and adolescents
There is no relevant use of Voleze in the paediatric
population in the treatment of Alzheimer’s disease.
Other medicines and Voleze
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines, including medicines obtained without a
prescription.
Voleze might interfere with anticholinergic medicines
some of which are medicines used to relieve
stomach cramps or spasms (e.g. dicyclomine), to
treat Parkinson’s disease (e.g. amantadine) or to
prevent motion sickness (e.g. diphenhydramine,
scopolamine, or meclizine).
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, drink and alcohol
Voleze can be used with food, drink and alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
If you are pregnant, the benefits of using Voleze
transdermal patches must be assessed against the
possible effects on your unborn child. Voleze
transdermal patches should not be used during
pregnancy unless clearly necessary.
You should not breast-feed during treatment with
Voleze transdermal patches.
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.

or

How to remove your Voleze transdermal patch
Gently pull at one edge of the patch to remove it
slowly from the skin. In case the adhesive residue is left
over on your skin, gently soak the area with warm water
and mild soap or use baby oil to remove it. Alcohol or
other dissolving liquids (nail polish remover or other
solvents) should not be used.
You should wash your hands with soap and water after
removing the patch. In case of contact with eyes or if
the eyes become red after handling the patch, rinse
immediately with plenty of water and seek medical
advice if symptoms do not resolve.
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 any further questions on the use of this
medicine, ask your doctor or pharmacist.

143

or

Back

code area

The active substance of Voleze 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,
Voleze allows levels of acetylcholine to be
increased in the brain, helping to reduce the
symptoms of Alzheimer’s disease.
Voleze 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.

BACK

170
3

3

3

FRONT

3

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Voleze 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 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.

270

What is in this leaflet:
1. What Voleze is and what it is used for
2. What you need to know before you use Voleze
3. How to use Voleze
4. Possible side effects
5. How to store Voleze
6. Contents of the pack and other information

1.What Voleze is and what it is used for

10

IMPORTANT:
• Take off the previous patch before putting ONE new
patch on.
• Only one patch per day.
• Do not cut the patch into pieces.
• Press the patch firmly in place for at least 30 seconds
using the palm of the hand.
How to start treatment
Your doctor will tell you which Voleze transdermal
patch is most suitable for you.
• Treatment usually starts with Voleze 4.6 mg/24 h*.
• The recommended usual daily dose is Voleze 9.5
mg/24 h*. If well tolerated, the treating physician
may consider increasing the dose to 13.3 mg/24 h.
• Only wear one Voleze patch at a time and replace
the patch with a new one after 24 hours.
* For doses not realisable with this medicinal product
other strengths of this medicinal product are available.
During the course of the treatment your doctor may
adjust the dose to suit your individual needs.
If you have not applied a patch for three days, do not
apply the next one before you have talked to your
doctor. Transdermal patch treatment can be resumed
at the same dose if treatment is not interrupted for
more than three days. Otherwise your doctor will restart
your treatment on Voleze 4.6 mg/24 h.
Where to apply your Voleze transdermal patch
• Before you apply a patch, make sure that your skin is
clean, dry and hairless, free of any powder, oil,
moisturiser or lotion that could keep the patch from
sticking to your skin properly, free of cuts, rashes
and/or irritations.
• Carefully remove any existing patch before putting
on a new one. Having multiple patches on your
body could expose you to an excessive
amount of this medicine which could be
potentially dangerous.
• Apply ONE patch per day to ONLY ONE of the
possible locations shown in the following
diagrams:
- left upper arm or right upper arm
- left upper chest or right upper chest (avoid
breast)
- left upper back or right upper back
- left lower back or right lower back
Every 24 hours take off the previous patch
before putting ONE new patch on to ONLY ONE
of the following possible locations.
Front

143

2. What you need to know before you use Voleze

540

or

or
or

or

4. Possible side effects
Like all medicines, Voleze transdermal patches
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:

or

When changing the patch, you must remove the
previous day’s patch before you 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 the same
skin area 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.
Carefully remove the existing patch before
putting on a new one.

Common (may affect up to 1 in 10 people)
• Loss of appetite
• Feeling dizzy
• Feeling agitated or sleepy
• Urinary incontinence (inability to retain
adequate urine)
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
• Dehydration (losing too much fluid)
• Hyperactivity
(high
level
of
activity,
restlessness)
• Aggression

For patients starting treatment for the first time
and for patients restarting Voleze after treatment
interruption, please begin with the second
picture.
- 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.

Very rare (may affect up to 1 in 10,000 people)
• Stiff arms or legs
• Trembling hands

3. How to use Voleze
Always use Voleze transdermal patches exactly as
described in this leaflet and as your doctor has told you.
Check with your doctor, pharmacist or nurse if you are
not sure.

By reporting side effects you can help provide more
information on the safety of this medicine.

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 that 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.
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.

6. Contents of the pack and other
information
What Voleze contains
The active substance is rivastigmine.
Each patch releasing 13.3 mg rivastigmine per 24
hours is 15 cm2 and contains 27 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) (80:20)
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 imprinted with black printing ink as follows:
“Rivastigmine” “13.3 mg/24 h”
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 in your
country.

Manufacturer
PHAST Gesellschaft für Pharmazeutische
Qualitätsstandards mbH, Kardinal-Wendel-Strasse
16, 66424 Homburg, Germany

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 06/2015

Other side effects seen with rivastigmine capsules
or oral solutions and which may occur with the
patch:
Common (may affect up to 1 in 10 people)
• Too much saliva
• Loss of appetite
• Feeling restless
• Generally feeling unwell
• Trembling or feeling confused
• Increased sweating
Uncommon (may affect up to 1 in 100 people)
• Uneven heart rate (e.g. fast heart rate)
• Difficulty sleeping
• Accidental falls
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

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.
(continued overleaf)

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

CLEARLY MARK ANY AMENDMENTS
AND RESUBMIT

tel:
01283 495280

pharmaceuticals ltd

fax:
01283 495290

Approved
for
Print

Amend
&
Resubmit

VERSION

4

01/06/2015

Focus Contact:

Signature: (Proof Reader)

Date:

Signature: (Regulatory)

Date:

Product Description/Component:

Signature: (Marketing)

Date:

Signature: (Braille)

Date:

Voleze 13.3mg 24h Transdermal
- PIL
Market:

File Name:

Part No/Component Code:

UK / English

Rivastigmine_13.3mg_PIL

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10

Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House,
1st Floor, 85 King William Street, London EC4N 7BL, UK.
Tel:
00 44 (0)1283 495 280
Fax:
00 44 (0)1283 495 290
Email:
medinfo@focuspharma.co.uk

Take off your patch and tell your doctor straight
away, if you notice any of the side effects above.

- 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 for at least 30
seconds using the palm of the hand to make sure that
the edges stick well.

Reporting of side effects
If you get any side effects, talk to your doctor and
pharmacist. This includes any possible side effects not
listed in this leaflet.
You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.

Minimum Point Size:

8.5pt

Pantone/
Process Cols Used:

Black

Reason for new version:
v1 New build v2 Minor text amends v3 Pictures changed v4 MAH address change
Caution! We cannot accept responsibility for any errors in this proof after approval. The artwork received has been significantly
adjusted, revised or reset by us from disk or hard copy. Whilst we take extreme care at all times to ensure accuracy, the final
responsibility must be taken by our customer. If you sign this proof you are signifying full approval of design and text.

143

Not known (frequency cannot be estimated from
the available data)
• 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)
• 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
• Feeling restless

- 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.

• 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)

This medicinal product is authorised in the
Member States of the EEA under the following
names:
3411
Germany: Voleze 13,3mg/24h Stunden
transdermales Pflaster
United Kingdom: Voleze 13.3mg/24h Transdermal
Patch

Rare (may affect up to 1 in 1,000 people)
• Falling

code area

70
23
143
8

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
(carbamate
derivatives).
- 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 before using Voleze
- if you have, or have ever had, an irregular
heartbeat.
- if you have, or have ever had, an active
stomach 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.
- if you have gastrointestinal reactions 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 patch for several days,
do not apply the next one before you have talked
to your doctor.
Use in children and adolescents
There is no relevant use of Voleze in the paediatric
population in the treatment of Alzheimer’s disease.
Other medicines and Voleze
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines, including medicines obtained without a
prescription.
Voleze might interfere with anticholinergic medicines
some of which are medicines used to relieve
stomach cramps or spasms (e.g. dicyclomine), to
treat Parkinson’s disease (e.g. amantadine) or to
prevent motion sickness (e.g. diphenhydramine,
scopolamine, or meclizine).
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, drink and alcohol
Voleze can be used with food, drink and alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
If you are pregnant, the benefits of using Voleze
transdermal patches must be assessed against the
possible effects on your unborn child. Voleze
transdermal patches should not be used during
pregnancy unless clearly necessary.
You should not breast-feed during treatment with
Voleze transdermal patches.
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.

or

How to remove your Voleze transdermal patch
Gently pull at one edge of the patch to remove it
slowly from the skin. In case the adhesive residue is left
over on your skin, gently soak the area with warm water
and mild soap or use baby oil to remove it. Alcohol or
other dissolving liquids (nail polish remover or other
solvents) should not be used.
You should wash your hands with soap and water after
removing the patch. In case of contact with eyes or if
the eyes become red after handling the patch, rinse
immediately with plenty of water and seek medical
advice if symptoms do not resolve.
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 any further questions on the use of this
medicine, ask your doctor or pharmacist.

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code area

The active substance of Voleze 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,
Voleze allows levels of acetylcholine to be
increased in the brain, helping to reduce the
symptoms of Alzheimer’s disease.
Voleze 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.

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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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