RIVASTIGMINE SANDOZ 4.6 MG/24 HOURS TRANSDERMAL PATCH

Active substance: RIVASTIGMINE

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Package leaflet: Information for the patient
Rivastigmine Sandoz 4.6 mg/24 h transdermal patch (brand name to be agreed prior to marketing)
Rivastigmine Sandoz 9.5 mg/24 h transdermal patch (brand name to be agreed prior to marketing)
rivastigmine
Read all of this leaflet carefully before you start using this medicine.
- 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. Do not pass it on to others. It may harm them, even
if their symptoms of illness are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
What is in this leaflet
1. What Rivastigmine is and what it is used for
2. What you need to know before you use Rivastigmine
3. How to use Rivastigmine
4. Possible side effects
5. How to store Rivastigmine
6. Contents of the pack and other information

1. What Rivastigmine is and what it is used for
The active substance of Rivastigmine 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.
Rivastigmine 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 Rivastigmine
Do not use Rivastigmine
if you are allergic to rivastigmine (the active substance in 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 derivates).
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 Rivastigmine transdermal patches.
Warnings and precautions
Talk to your doctor before using Rivastigmine:
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.
Use in children and adolescents
There is no relevant use of Rivastigmine in the paediatric population in the treatment of Alzheimer’s
disease.
Other medicines and Rivastigmine
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.
Rivastigmine 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 Rivastigmine transdermal patches, tell your doctor that
you are using them because they may exaggerate the effects of some muscle relaxants during
anaesthesia.
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 Rivastigmine transdermal patches must be assessed against
the possible effects on your unborn child. Rivastigmine should not be used during pregnancy unless
clearly necessary.
You should not breast-feed during treatment with Rivastigmine transdermal patches.

Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Rivastigmine 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 Rivastigmine
Always use Rivastigmine 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 Rivastigmine transdermal patch is most suitable for you.
 Treatment usually starts with Rivastigmine 4.6 mg/24 h.
 The recommended usual daily dose is Rivastigmine 9.5 mg/24 h. If well tolerated, the treating
physician 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, please
refer to other rivastigmine products for which transdermal patches of the 13.3 mg/24 h strength
are available).
 Only wear one Rivastigmine 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
Rivastigmine 4.6 mg/24 h.
Rivastigmine can be used with food, drink and alcohol.
Where to apply your Rivastigmine 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 following 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.

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.
How to apply your Rivastigmine transdermal patch
Rivastigmine 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 Rivastigmine 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.

-

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 Rivastigmine 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 Rivastigmine 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 Rivastigmine transdermal patch

To benefit from treatment, you must apply a new patch every day, preferably at the same time
of day.
 Only wear one Rivastigmine patch at a time and replace the patch with a new one after
24 hours.
If you use more Rivastigmine 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
heartbeat and fainting may also occur.
If you forget to use Rivastigmine
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 Rivastigmine
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, Rivastigmine 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 to 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)

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
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 capsules or oral solution 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)
If you get any side effects, talk to your doctor ,pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
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: www.mhra.gov.uk/yellowcard.
By reporting side affects you can help provide more information on the safety of this medicine

5.

How to store Rivastigmine




Keep this medicine out of the sight and reach of children.
Do not use Rivastigmine after the expiry date, which is stated on the carton and sachet. The
expiry date refers to the last day of the month.
Do not store above 25°C.
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
themtogether. 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.

Contents of the pack and other information

What Rivastigmine contains
The active substance is rivastigmine.
Rivastigmine 4.6 mg/24 h transdermal patches: Each patch releases 4.6 mg of
rivastigmine per 24 hours is 5 cm2 and contains 9 mg of rivastigmine.
Rivastigmine 9.5 mg/24 h transdermal patches: Each patch releases 9.5 mg of
rivastigmine per 24 hours is 10 cm2 and contains 18 mg of rivastigmine.
The other ingredients are: polyethylene terephthalate film lacquered, all-rac-α Tocopherol,
poly(butylmethacrylate, methyl-methacrylate) copolymer (3:1), acrylic copolymer, silicone ,
dimeticone, polyester film fluoropolymer-coated, resin, pigments, organic polymers/resins.
What Rivastigmine looks like and contents of the pack
Rivastigmine 4.6 mg/24 h transdermal patches

Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The
outside of the backing layer is beige and labelled with “RIV”, 4.6 mg/24 h”
Rivastigmine 9.5 mg/24 h transdermal patches

Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The
outside of the backing layer is beige and labelled with “RIV”, 9.5mg/24 h”
One transdermal patch is sealed in one sachet. The patches are available in packs containing 7, 30,
60 (2 packs of 30), 90 (3 packs of 30) sachets. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,

Manufacturer
Novartis Pharma GmbH,
Roonstrasse 25,
D-90429 Nürnberg
Germany
Hexal AG
Industriestrasse 25,
83607 Holzkirchen
Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
39179 Barleben
Germany
Lek Pharmaceuticals d.d
Verovškova 57,
1526 Ljubljana
Slovenia
This leaflet was last revised in November 2013

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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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