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ERASTIG 4.6 MG/24 H TRANSDERMAL PATCH

Active substance(s): RIVASTIGMINE

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TEVA UK Ref: 231-30-57007-E LEA RIVASTIGMINE TRANSD PATCH 4.6-9.5MG/24HR 30 TAB TUK
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02 July 2015

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Package leaflet:
Information for the user

Erastig 4.6 mg/24 h
transdermal patch

Erastig 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, 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 Erastig is and what it is used for
2. What you need to know before you use Erastig
3. How to use Erastig
4. Possible side effects
5. How to store Erastig
6. Contents of the pack and other information

1.

WHAT ERASTIG IS AND WHAT IT IS USED FOR

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

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Erastig
- 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.

Erastig 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 Erastig transdermal patches, tell your doctor
that you are using them because they may exaggerate the effects of some muscle relaxants
during anaesthesia.
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 Erastig transdermal patches must be assessed
against the possible effects on your unborn child. Erastig should not be used during
pregnancy unless clearly necessary.
You should not breast-feed during treatment with Erastig transdermal patches.

Driving and using machines

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

HOW TO USE ERASTIG

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

If you have not applied a Erastig patch for several days, do not apply the next one before you
have talked to your doctor.

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.

Children and adolescents

How to start treatment

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

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

Other medicines and Erastig

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.

Erastig can be used with food, drink and alcohol.

Where to apply your Erastig transdermal patch

Pregnancy, breast-feeding and fertility

3.

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 Erastig 4.6 mg/24 h.

Your doctor will tell you which Erastig transdermal patch is most suitable for you.
• Treatment usually starts with Erastig 4.6 mg/24 h.
• The recommended usual daily dose is Erastig 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 Erastig patch at a time and replace the patch with a new one after 24 hours.

• 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 only one patch per day to only one of the possible locations, as 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

Back

How to apply your Erastig transdermal patch

Erastig 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 “Erastig” 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.

- 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.
Or

Or

Or

Or

Or

Or

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 that same location of skin twice
within 14 days.

- 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.

folding line,
Falzkante

code area
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.
Gently pull at one edge of the patch to remove it completely 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.

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.

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.

Take off your patch and tell your doctor straight away, if you notice any of the
following side effects which could become serious:

Can you wear your Erastig 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 Erastig transdermal patch

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

If you use more Erastig 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 Erastig

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 Erastig

Tell your doctor or pharmacist if you stop using the patch.

Common (may affect up to 1 in 10 people)












Loss of appetite, decreased appetite
Feeling dizzy
Feeling agitated or sleepy
Urinary tract infection
Urinary incontinence (inability to retain adequate urine)
Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea,
indigestion and stomach pain.
Anxiety
Depression
Headache
Fainting
Feeling tired or weak
Fever
Weight loss
Delirium
Rash
A skin reaction where the patch was used, such as redness, rash, swelling, inflammation or
irritation of the skin.

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.

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)

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

• 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).

• 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
• Seeing things that are not really there (hallucinations)
• 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.
Take off your patch and tell your doctor straight away, if you notice any of the side effects
above.

Reporting of side effects

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

Keep the transdermal patch in the sachet until use.

Common (may affect up to 1 in 10 people)

Do not use any patch that is damaged or shows signs of tampering.






Too much saliva
Generally feeling unwell
Trembling or feeling confused
Increased sweating.

5. HOW TO STORE ERASTIG

• Difficulty sleeping.

What Erastig contains

[Erastig 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.
[Erastig 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:

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.

Film: Polyester film
Fluoro-coated polyester film
Drug matrix: Acrylic adhesive, Acrylates copolymer
poly(butyl methacrylat-co-methyl methacrylat)
Adhesive matrix: Silicone adhesive
Printing ink: Black printing ink

Store in the original package in order to protect from light.

What Erastig looks like and contents of the pack

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special temperature storage conditions
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.

Uncommon (may affect up to 1 in 100 people)

6. CONTENT OF THE PACK AND OTHER INFORMATION
The active substance is rivastigmine.

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.

Each transdermal patch is a thin patch consisting of three layers. The outer layer is translucent,
white and black-printed with the following:
[Erastig 4.6 mg/24 h transdermal patch:]
“Rivastigmine”, “4.6 mg/24 h”
[Erastig 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.
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK

Rare (may affect up to 1 in 1,000 people)
• Chest pain - this may be caused by heart spasm.

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

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

This leaflet was last revised in 07/2015
PL 00289/1814
PL 00289/1815

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How to remove your Erastig transdermal patch

4. POSSIBLE SIDE EFFECTS

57007-E
231829.03-GB

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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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