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EMERPAND 4.6MG/24H TRANSDERMAL PATCHES

Active substance(s): RIVASTIGMINE

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

Package leaflet: Information for the user

Emerpand 4.6mg/24h, 9.5mg/24h and
13.3mg/24h Transdermal Patches
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,
pharmacist or nurse.
•  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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

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

What Emerpand is and what it is used for
The active substance of Emerpand is rivastigmine.
Rivastigmine belongs to a class of substances
called cholinesterase inhibitors. In patients with
Alzheimer’s dementia, certain nerve cells die in the

Emerpand 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
Emerpand
Do not use Emerpand
• 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
Emerpand Transdermal Patches.

Warnings and precautions

Talk to your doctor before using Emerpand:
• 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.

Pregnancy, breast-feeding and fertility

If any of these apply to you, your doctor may need
to monitor you more closely while you are on this
medicine.

If you are pregnant, the benefits of using Emerpand
Transdermal Patches must be assessed against the
possible effects on your unborn child. Emerpand should
not be used during pregnancy unless clearly necessary.

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 have not applied a patch for more than three
days, do not apply the next one before you have talked
to your doctor.

You should not breast-feed during treatment with
Emerpand Transdermal Patches.

Driving and using machines

Children and adolescents

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

There is no relevant use of Emerpand in the paediatric
population in the treatment of Alzheimer’s disease.

Other medicines and Emerpand

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Emerpand contains butylated hydroxytoluene

Emerpand 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).

May cause local skin reactions (e.g. contact dermatitis),
or irritation to the eyes and mucous membranes.
3

How to use Emerpand

• Only wear one Emerpand 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 more than 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 Emerpand
4.6mg/24h.

Where to apply your Emerpand 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.
•C
 arefully 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:

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.

If you have to undergo surgery whilst using Emerpand
Transdermal Patches, tell your doctor that you are using
them because they may exaggerate the effects of some
muscle relaxants during anaesthesia.

Every 24 hours take off the previous patch before
putting ONE new patch on to ONLY ONE of the
following possible locations.

Rivastigmine (Emerpand) All Strengths Transdermal Patches PIL - UK

Proof Round

4

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0370

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
16.12.16
19.01.17
S.Anson

Dimensions:
170 x 680
Min Body Text Size: 9pts
Supplier:
Lavipharm

Date sent:
16.12.16 + 11.01.17
Date received: 13.01.17

• left upper back or right upper back

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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

Carefully remove the existing patch before putting on a
new one.

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

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

• left lower back or right lower back

• Each patch is sealed in its own
protective sachet.
You should only open the
sachet when you are ready to
apply the patch.
Tear the sachet open where
indicated and remove the patch
from the sachet. The sachet can
be torn open in two places.

Your doctor will tell you which Emerpand Transdermal
Patch is most suitable for you.
• Treatment usually starts with Emerpand 4.6mg/24h.
• The recommended daily dose is Emerpand 9.5mg/24h.
If well tolerated, the treating physician may consider
increasing the dose to 13.3mg/24h.

approved for print/date

Emerpand Patches are transparent to 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.

• left upper arm or right upper arm

How to start treatment

Caution when Emerpand Patch is given together with
beta-blockers (medicines such as atenolol used to treat
hypertension, angina, and other heart conditions).
Taking the two medicines together could cause
problems such as slowing of the heartbeat (bradycardia)
leading to fainting or loss of consciousness.

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 Emerpand Transdermal
Patch

Emerpand can be used with food, drink and alcohol.

Always use this medicine exactly as your doctor has told
you. Check with your doctor, pharmacist or nurse if you
are not sure.

Emerpand Patch should not be given at the same
time as metoclopramide (a medicine used to relieve
or prevent nausea and vomiting). Taking the two
medicines together could cause problems such as stiff
limbs and trembling hands.

• left upper chest or right upper chest (avoid breast)

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 Emerpand Transdermal
Patch

If you forget to use Emerpand

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.

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 Emerpand Transdermal
Patch when you are bathing, swimming, or in
the sun?

•B
 athing, swimming or showering should not affect the
patch. Make sure the patch does not loosen during
these activities.
•D
 o 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
Emerpand Transdermal Patch

• To benefit from treatment, you must apply a new patch
every day, preferably at the same time of day.
•O
 nly wear one Emerpand Patch at a time and replace
the patch with a new one after 24 hours.

If you use more Emerpand 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 Emerpand have
experienced feeling sick (nausea), being sick (vomiting),
diarrhoea, high blood pressure and hallucinations.
Slow heartbeat and fainting may also occur.

If you stop using Emerpand

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
• Anxiety
• Depression
• Urinary incontinence (inability to retain adequate
urine)
• Urinary tract infection
• Headache
• Fainting
• Weight decrease
• Fever
• Weakness
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

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)
• Falling

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)
• Stiff arms or legs
• Trembling hands

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)

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

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, Website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5

Other side effects seen with Rivastigmine
Capsules or Oral Solution and which may occur
with the patch:

How to store Emerpand
• 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.
• 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.

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

• 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

Proof Round

4

UK-Eire-Artwork-Support@Actavis.com

Item no:

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.

Contents of the pack and other information

This leaflet was last revised in January 2017.

What Emerpand contains

If you would like a
leaflet with a larger text,
please contact
01271 385257.

• The active substance is rivastigmine.
• Emerpand 4.6mg/24h Transdermal Patches: Each
patch releases 4.6mg of rivastigmine per 24 hours,
is 5cm2 and contains 9.0mg of rivastigmine.
• Emerpand 9.5mg/24h Transdermal Patches: Each
patch releases 9.5mg of rivastigmine per 24 hours,
is 10.0cm2 and contains 18.0mg of rivastigmine.
• Emerpand 13.3mg/24h Transdermal Patches: Each
patch releases 13.3mg of rivastigmine per 24 hours,
is 15.0cm2 and contains 27.0mg of rivastigmine.
• The other ingredients are butyl acrylate, methyl
methacrylate, styrene alpha methylstyrene, adipic
acid ditridecyl ester, butylated hydroxytoluene (E321),
2-ethylhexyl acrylate and t-Octyl acrylamide.

What Emerpand looks like and contents of the
pack

The patch is comprised of three layers: a backing film, an
adhesive layer, and a square protective release liner. The
backing layer is a translucent low-density polyethylene
(LDPE) material printed with the text “RIV4.6”, “RIV9.5”
and “RIV13.3” in a repeating pattern. The polyester
(PET) release liner, which is removed prior to patch
application, is translucent and coated with silicone.

BBBA0370

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
16.12.16
19.01.17
S.Anson

Dimensions:
170 x 680
Min Body Text Size: 9pts
Supplier:
Lavipharm

Date sent:
16.12.16 + 11.01.17
Date received: 13.01.17

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Lavipharm SA.
Agias Marinas str.,
Paiania Attiki,
T 59, 19002,
Greece

Actavis, Barnstaple, EX32 8NS, UK
BBBA0370

Rivastigmine (Emerpand) All Strengths Transdermal Patches PIL - UK
approved for print/date

One transdermal patch is sealed in one sachet. The
patches are available in packs containing 30 sachets.

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

+ 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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