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RIVAMYLAN 9.5 MG / 24 HOURS TRANSDERMAL PATCH

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Package leaflet: Information for the user
Rivamylan 4.6 mg / 24 hours transdermal patch
Rivamylan 9.5 mg / 24 hours 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 Rivamylan is and what it is used for
2.
What you need to know before you use Rivamylan
3.
How to use Rivamylan
4.
Possible side effects
5.
How to store Rivamylan
6.
Contents of the pack and other information
1.

What Rivamylan is and what it is used for

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

Do not use Rivamylan:
- if you are allergic to rivastigmine (the active substance in Rivamylan) 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 Rivamylan transdermal patches.

1

Warnings and precautions
Talk to your doctor before using Rivamylan:
- 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.
Children and adolescents
There is no relevant use of Rivamylan in the paediatric population in the treatment of
Alzheimer’s disease.
Other medicines and Rivamylan
Tell your doctor or pharmacist if you are using, have recently used or might use any other
medicines, including medicines obtained without a prescription.
Rivamylan 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 Rivamylan transdermal patches, tell your doctor
that you are using them because they may exaggerate the effects of some muscle relaxants
during anaesthesia.
Rivamylan with food, drink and alcohol
Rivamylan 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 Rivamylan must be assessed against the possible
effects on your unborn child. Rivamylan should not be used during pregnancy unless clearly
necessary.
You should not breast-feed during treatment with Rivamylan transdermal patches.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines
safely.

2

Rivamylan 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.
3.
How to use Rivamylan
Always use this medicine exactly 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 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 Rivamylan transdermal patch is most suitable for you.
 Treatment usually starts with Rivamylan 4.6 mg / 24 hours.
 The recommended usual daily dose is Rivamylan 9.5 mg / 24 hours. If well tolerated,
the treating physician may consider increasing the dose to 13.3 mg / 24 hours *
 Only wear one Rivamylan patch at a time and replace the patch with a new one after
24 hours.
* The 13.3 mg / 24 hours 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 hours strength 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 Rivamylan 4.6 mg / 24 hours.
Where to apply your Rivamylan 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

3

Every 24 hours take off the previous patch before putting one
new patch on to only one of the following possible locations

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 Rivamylan transdermal patch
Rivamylan patches are thin, opaque, 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.
For patients starting treatment for the first time and for
patients restarting Rivamylan 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.

4

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.

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.
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.
How to remove your Rivamylan 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 Rivamylan 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 Rivamylan transdermal patch
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To benefit from treatment, you must apply a new patch every day, preferably at the
same time of day.
Only wear one Rivamylan patch at a time and replace the patch with a new one after
24 hours.

If you use more Rivamylan 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 Rivamylan have
experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and
hallucinations. Slow heartbeat and fainting may also occur.
If you forget to use Rivamylan
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 Rivamylan
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.
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:
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
 Stomach ulcer
 Dehydration (losing too much fluid)
 Hyperactivity (high level of activity, restlessness)
 Aggression
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
Not known (frequency cannot be estimated from the available data)
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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 the 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
Seeing things that are not really there (hallucinations)

Take off your patch and tell your doctor straight away, if you notice any of the side effects
above.
Other side effects seen with Rivastigmine Mylan capsules and which may occur with the
patch:
Common (may affect up to 1 in 10 people)
 Somnolence
 Generally feeling unwell
 Trembling or feeling confused
 Increased sweating
Rare (may affect up to 1 in 1,000 people)
 Ulcer in the intestine
 Chest pain – this may be caused by heart spasm
Very rare (may affect up to 1 in 10,000 people)
 Bleeding in the gut – shows as blood in stools or when being sick
Not known (frequency cannot be estimated from the available data)
 Some people who have been violently sick have had tearing of the tube that connects
your mouth with your stomach (oesophagus)
Reporting of side effects
If you get any side effects, talk to your doctor or 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: http://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 Rivamylan

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.
Do not store above 25°C.
7

Keep the transdermal patch in the sachet until use.
Do not use this medicine if you notice that it 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.
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.
6.

Contents of the pack and other information

What Rivamylan contains
Rivamylan 4.6 mg / 24 hours transdermal patch:
 The active substance is rivastigmine. Each patch releasing 4.6 mg of rivastigmine per
24 hours is 5 cm2 and contains 9 mg of rivastigmine.
 The other ingredients are:
Backing film with imprint: polyethylene/polyester film
Medicinal product matrix: acrylic adhesive, poly(butylmethacrylate,
methylmethacrylate)
Adhesive matrix: dimethicone, silicone adhesive
Release liner: fluoropolymer-coated polyester film
Rivamylan 9.5 mg / 24 hours transdermal patch:
 The active substance is rivastigmine. Each patch releasing 9.5 mg of rivastigmine per
24 hours is 10 cm2 and contains 18 mg of rivastigmine.
 The other ingredients are:
Backing film with imprint: polyethylene/polyester film
Medicinal product matrix: acrylic adhesive, poly(butylmethacrylate,
methylmethacrylate)
Adhesive matrix: dimethicone, silicone adhesive
Release liner: fluoropolymer coated polyester film
What Rivamylan looks like and contents of the pack
Rivamylan 4.6 mg / 24 hours transdermal patch:
Transdermal patch.
Thin, opaque/ peach-coloured /impermeable, plastic round-shaped patch with imprint on the
backing film “Rivamylan 4.6 mg / 24 hours” individually packaged in a sealed child resistant
sachet. The sticky translucent adhesive side is stuck to the skin after removal of the protective
covering consisting of a clear to slightly hazy oversized release liner that is slit and has small
dimples surrounding the patch and a clear to slightly hazy oversized underlay.
Rivamylan 9.5 mg / 24 hours transdermal patch:
Transdermal patch.
Thin, opaque/ peach-coloured /impermeable, plastic round-shaped patch with imprint on the
backing film “Rivamylan 9.5 mg / 24 hours” individually packaged in a sealed child resistant
8

sachet. The sticky translucent adhesive side is stuck to the skin after removal of the protective
covering consisting of a clear to slightly hazy oversized release liner that is slit and has small
dimples surrounding the patch and a clear to slightly hazy oversized underlay.

Available in packs containing 7, 30, 60 and 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
This leaflet was last revised in 03/2015.

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