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EMPLARIV 4.6 MG/24 H TRANSDERMAL PATCH

Active substance(s): RIVASTIGMINE / RIVASTIGMINE / RIVASTIGMINE

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CONFIDENTIAL
Module 1.3.1.4

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

1.

What is and what it is used for

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

Do not use
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 transdermal patches.

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Warnings and precautions
Talk to your doctor before using
if you have, or have ever had, an irregular or slow 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 in the paediatric population in the treatment of
Alzheimer’s disease.
Other medicines and
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.
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 transdermal patches, tell your doctor
that you are using them because they may exaggerate the effects of some muscle relaxants during
anaesthesia.
with food, drink and alcohol
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 medicine.
If you are pregnant, the benefits of using transdermal patches must be assessed
against the possible effects on your unborn child. transdermal patches should not be
used during pregnancy unless clearly necessary.
You should not breast-feed during treatment with transdermal patches.
Driving and using machines

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Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
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

Always use 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.
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 transdermal patch is most suitable for you.

Treatment usually starts with 4.6 mg/24 h.

The recommended usual daily dose is 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 patch 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, 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 name> 4.6 mg/24 h.
Where to apply your 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.

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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 that same skin area twice within 14 days.
How to apply your transdermal patch
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.

For patients starting treatment for the first time and for patients
restarting 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.

-

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.

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-

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 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 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.

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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 transdermal patch

To benefit from treatment, you must apply a new patch every day, preferably at the same time
of day.

Only wear one patch at a time and replace the patch with a new one after 24
hours.
If you use more 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 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
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
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, 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:
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

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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)

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

Nightmares
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:
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
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)

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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 national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of
this medicine.

5.

How to store

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.

Content of the pack and other information

What contains
The active substance is rivastigmine.
[ 4.6 mg/24 h transdermal patch:]
Each patch releases 4.6 mg rivastigmine per 24 hours is 5 cm2 and contains 9 mg rivastigmine.
[ 9.5 mg/24 h transdermal patch:]
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) (80:20)
Adhesive matrix:
Silicone adhesive
Printing ink:
Black printing ink

What 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 printed with black printing ink as follows:

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[ 4.6 mg/24 h transdermal patch:]
“Rivastigmine”, “4.6 mg/24 h”
[ 9.5 mg/24 h transdermal patch:]
“Rivastigmine”, “9.5 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.
Marketing Authorisation Holder and Manufacturer
[To be completed nationally]
{Name and address}
{tel}
{fax}
{e-mail}
This medicinal product is authorised in the Member States of the EEA under the following
names:
3406-001-002
Germany

EmplaRiv 4,6 mg/24 Stunden transdermales Pflaster
EmplaRiv 9,5 mg/24 Stunden transdermales Pflaster

United Kingdom

EmplaRiv 4.6 mg/24 h Transdermal Patch
EmplaRiv 9.5 mg/24 h Transdermal Patch

This leaflet was last revised in {MM/YYYY}
[To be completed nationally]

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Expand Transcript

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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