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ELUDEN 9.5 MG/24H TRANSDERMAL PATCH

Active substance(s): RIVASTIGMINE

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Package leaflet: Information for the patient

Eluden 4.6 mg/24 h transdermal patch
Eluden 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 Eluden is and what it is used for
2. What you need to know before you use Eluden
3. How to use Eluden
4. Possible side effects
5. How to store Eluden
6. Contents of the pack and other information
1. What Eluden is and what it is used for
The active substance of Eluden 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.

• Only wear one Eluden at a time and replace the patch with a new one after
24 hours.
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 or more, do not apply the next one
before you have talked to your doctor as you may be more likely to experience side
effects. Treatment can be resumed with the same strength patch if you have not
applied patches for up to three days. Otherwise your doctor may recommend you
continue your treatment with Eluden 4.6 mg/24 h.
Where to apply Eluden
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 following locations shown in the
following diagram:
* 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.

Eluden 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 Eluden
Do not use Eluden
• if you are allergic to rivastigmine (the active substance in Eluden) 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 was 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 Eluden.
Warnings and precautions
Talk to your doctor or pharmacist before using Eluden
• if you have, or have ever had, an irregular heartbeat.
• if you have, or have ever had an active stomach.
• if you have, or have ever had, difficulties in passing urine.
• if you have, 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 or kidney function.
If any of these apply to you, your doctor may need to monitor you more closely while
you are on this medicine.

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 chest or
upper back one day, then on your lower back the next day). Do not apply a new patch
to that same location of skin twice within 14 days.
How to apply Eluden
Eluden patches are thin, tan coloured, 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 from the sachet until just before you apply it.
Carefully remove the existing patch before putting
on a new one.
For patients starting treatment for the first time
and for patients restarting rivastigmine after
treatment interruption, please begin with the
second picture.

Other medicines and Eluden
Please tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Eluden might interfere with anticholinergic medicines (medicines that may cause side
effects such as dry mouth or blurred vision) some of which are medicines used to relieve
stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson’s disease (e.g. amantadine),
to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).

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 at both scissors marks, but not
further than the indicated line. Tear the sachet to
open. Do not cut the entire length of the sachet in
order to avoid damaging of the patch.

If you have to undergo surgery whilst using Eluden transdermal patches, tell your
doctor that you are using them, as you may need to stop them because they may
exaggerate the effects of some muscle relaxants during anaesthesia.
Pregnancy and breast-feeding
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 Eluden must be assessed against the
possible effects on your unborn child. Eluden should not be used during pregnancy
unless clearly necessary.

Remove the patch from the sachet.
Remove the cover sheet from the top, skincoloured side of the patch and discard it.
A protective liner covers the sticky side of the
patch.
Peel off one side of the protective liner but do not
touch the sticky part of the patch with the fingers.

You should not breast-feed during treatment with Eluden.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines
safely. Eluden 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.
3. How to use Eluden



Always use this medicine exactly as described in this leaflet and as your doctor has
told you. Check with your doctor or pharmacist if you are not sure.
IMPORTANT:
• Take off the previous patch before putting ONE new patch on.
• Only wear one Eluden 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 Eluden transdermal patch is most suitable for you.
• Treatment usually starts with one Eluden 4.6 mg/24 h.
• The recommended usual daily dose is one Eluden 9.5 mg/24 h. If your condition
does not improve after at least 6 months, your doctor may consider increasing the
dose to 13.3 mg/24 h (the 13.3 mg/24 h dose strength cannot be achieved with this
product. For conditions where this strength
should be used. Ask your pharmacist for
advice).

TEXT FREE AREA
FOR LAETUS CODE

Put the sticky side of the patch on the upper or
lower back or 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.

If it helps you, you may write, for example, the day of the week, on the patch with a
thin ball point pen.

Other side effects seen with rivastigmine capsules or oral solution and which may
occur with the patch:

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 (choosing from those
highlighted above) when applying a new patch, to find ones that are most
comfortable for you and where clothing will not rub on the patch.

If you experience the following, stop using rivastigmine patches and tell your doctor
immediately or go to the casualty department of your nearest hospital:

How to remove Eluden
Gently pull at one edge of the patch to remove it slowly from the skin. In case
adhesive residue is left over on your skin, gently soak the area with warm water and
mild soap or use baby oil to help remove it. Alcohol or other dissolving liquids (nail
polish remover or other solvents) should not be used.
Washing your hands
You should wash your hands with soap and water after removing or applying a 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 Eluden 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 Eluden
• To benefit from treatment, you must apply a new patch every day, preferably at the
same time of day.
• Only wear one Eluden patch at a time and replace the patch with a new one after
24 hours.
Use in children and adolescents
There is no relevant use of Eluden in the paediatric population in the treatment of
Alzheimer’s disease.
If you use more Eluden 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 used 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 Eluden
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 Eluden
Tell your doctor or pharmacist if you stop using the patch.
If you have not applied a patch for three days or more, do not apply the next one
before you have talked to your doctor as you may be more likely to experience side
effects.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
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)
• stomach ulcer
Not known (frequency cannot be estimated from the available data)
• fits (seizures)
• the signs of Parkinson’s disease get worse – such as tremor, stiffness and shuffling
• liver disorders (you may notice yellowing of the skin, whites of the eyes, abnormal
darkening of the urine or unexplained nausea, vomiting, tiredness and loss of
appetite)
• inflammation of the pancreas – signs include serious upper stomach pain, often
with feeling sick (nausea) or being sick (vomiting)
• allergic reaction where the patch was used, such as blisters or inflamed skin
• fast or uneven heartbeat
Other side effects include:

Rare (may affect up to 1 in 1,000 people)
• chest pain - this may be caused by heart spasm
• ulcer in the intestine
Very rare (may affect up to 1 in 10,000 people)
• bleeding in the gut – shows as blood in stools or when being sick
• some people who have been violently sick have had tearing of the tube that
connects your mouth with your stomach (oesophagus)
Common (may affect up to 1 in 10 people):
• too much saliva
• generally feeling unwell
• trembling or feeling confused
• increased sweating
Uncommon (may affect up to 1 in 100 people):
• difficulty sleeping
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Eluden
• 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.
• This medicinal product does not require any special storage conditions.
• Keep the transdermal patch in the sachet until use.
• 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.
• 
Do not throw away any medicines via wastewater or household waste, if your
community doesn’t burn domestic rubbish. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Eluden contains
• The active substance is rivastigmine.
• Eluden 4.6 mg/24 h transdermal patches: Each patch releases 4.6 mg of
rivastigmine per 24 hours is 4.6 cm2 and contains 6.9 mg of rivastigmine.
• Eluden 9.5 mg/24 h transdermal patches: Each patch releases 9.5 mg of
rivastigmine per 24 hours is 9.2 cm2 and contains 13.8 mg of rivastigmine.
• The other ingredients are:
Matrix:
* poly [(2-ethylhexyl)acrylate,vinylacetate]
* medium- and high molecular weight polyisobutene
* silica, colloidal anhydrous
* paraffin, light liquid
Backing liner:
* polyethylene/thermoplastic resin/aluminium coated polyester film
Release liner:
* polyester film, fluoropolymer-coated
Orange printing ink
What Eluden looks like and contents of the pack
Each transdermal patch is a thin patch. The outer layer is tan coloured and printed
with an orange printing ink as following:
• 'RIV-TDS 4.6 mg/24 h'
• 'RIV-TDS 9.5 mg/24 h'
One transdermal patch is sealed in one sachet. The patches are available in packs
containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire EN6 1TL United Kingdom
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., Mylan Utca 1. Komarom 2900 Hungary

Common (may affect up to 1 in 10 people)
• Lack or loss of appetite
• feeling dizzy
• feeling agitated or tired
• urinary incontinence (inability to retain adequate urine)
• feeling anxious
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)
• dehydration (losing too much fluid)
• hyperactivity (high level of activity, restlessness)
• aggression
Rare (may affect up to 1 in 1,000 people):
• falls
Very rare (may affect up to 1 in 10,000 people):
• stiff arms or legs
• trembling hands
Not known (frequency cannot be estimated from the available data)
• high blood pressure
• changes in tests which show how well the liver is working
• feeling restless

This leaflet was last revised in: 09/2014 460883

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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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