RIVASTIGMINA 4.6 MG/24 H Transdermal patch

Зміст інструкції

1. RIVASTIGMINA DOC 4.6 mg/24 hour transdermal patch, 9.5 mg/24 hour transdermal patch
   1. What is RIVASTIGMINA DOC and what is it used for
   2. What you need to know before using RIVASTIGMINA DOC
   3. How to use RIVASTIGMINA DOC
   4. Possible side effects
   5. How to store RIVASTIGMINA DOC
   6. Package Contents and Other Information
2. RIVASTIGMINA DOC 13.3 mg/24 hour transdermal patch
   1. What is RIVASTIGMINA DOC and what is it used for
   2. What you need to know before using RIVASTIGMINA DOC
   3. How to use RIVASTIGMINA DOC
   4. Possible side effects
   5. How to store RIVASTIGMINA DOC
   6. Package Contents and Other Information

RIVASTIGMINA DOC 4.6 mg/24 hour transdermal patch, 9.5 mg/24 hour transdermal patch

Generic medicine

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is RIVASTIGMINA DOC and what is it used for

RIVASTIGMINA DOC contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with
Alzheimer's dementia, some brain cells die, leading to low levels of
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, RIVASTIGMINA DOC increases the levels of acetylcholine in the brain, improving the
symptoms of Alzheimer's disease.
RIVASTIGMINA is used for the treatment of adult patients with Alzheimer's dementia of mild to
moderate degree, a progressive disorder of the central nervous system that gradually affects
memory, learning ability and behavior.

2. What you need to know before using RIVASTIGMINA DOC

Do not use RIVASTIGMINA DOC

• if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6).
• if you have already had an allergic reaction to similar types of medicines (carbamate derivatives).
• if, when using the patch, you have had a skin reaction that extended beyond the area where the patch was applied, if you have had a more intense local reaction (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours of removing the patch.

If this is the case, tell your doctor and do not apply RIVASTIGMINA DOC transdermal patch.

Warnings and precautions
Talk to your doctor before using RIVASTIGMINA DOC

• if you have or have had an irregular or slow heartbeat.
• if you have or have had an active stomach ulcer.
• if you have or have had difficulty urinating.
• if you have or have had seizures.
• if you have or have had asthma or severe respiratory problems.
• if you suffer from tremors.
• if you have a low body weight.
• if you experience gastrointestinal disorders such as nausea, vomiting and diarrhoea. If vomiting and diarrhoea are persistent, you may become dehydrated (excessive fluid loss).
• if you have impaired liver function.

If you recognize yourself in any of these situations, your doctor may visit you more frequently during therapy
with this medicine.
If you have not applied a patch for more than three days, consult your doctor before applying the next one.

Children and adolescents
There is no indication for specific use of RIVASTIGMINA DOC in the pediatric population
in the treatment of Alzheimer's disease.

Other medicines and RIVASTIGMINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
RIVASTIGMINA DOC may interfere with anticholinergic medicines, including medicines used for
relieving stomach cramps or spasms (e.g. dicyclomine), for the treatment of Parkinson's disease (e.g.
amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine or meclizine).
RIVASTIGMINA DOC should not be used at the same time as metoclopramide (a medicine used
to relieve or prevent nausea and vomiting). Using the two medicines together may cause disorders such as stiffness
of the limbs and tremors in the hands.
If you are to undergo surgery and are being treated with RIVASTIGMINA DOC
transdermal patch, tell your doctor before being given anesthesia, as they may increase the effects of some muscle relaxants during anesthesia.
Caution is recommended when RIVASTIGMINA DOC is used together with beta-blockers (medicines
such as atenolol, used for the treatment of hypertension, angina and other heart conditions). Using the
two medicines together may cause disorders such as slowing of the heartbeat (bradycardia) which may
lead to fainting or loss of consciousness.

RIVASTIGMINA DOC with food, drinks and alcohol
RIVASTIGMINA DOC transdermal patch can be used with food, drinks and alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, the benefits of using RIVASTIGMINA DOC transdermal patch must be
weighed against the possible effects on the unborn child.
RIVASTIGMINA DOC should not be used during pregnancy unless strictly necessary.
You should not breastfeed during treatment with RIVASTIGMINA DOC transdermal patch.

Driving and using machines
Your doctor will tell you if your condition allows you to drive and use machines safely. RIVASTIGMINA DOC transdermal patch can cause fainting or severe confusion. If you
feel faint or confused, do not drive, use machines and do not perform any other activity that
requires vigilance.

3. How to use RIVASTIGMINA DOC

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor,
pharmacist or nurse.

IMPORTANT:

• Remove the patch from the previous day before applying a NEW one.
• Only one patch per day.
• Do not cut the patch into pieces.
• Press the patch firmly with the palm of your hand for at least 30 seconds.

How to start treatment
The doctor will tell you which RIVASTIGMINA DOC transdermal patch is most suitable for you.

• Treatment usually starts with RIVASTIGMINA DOC 4.6 mg/24 hours.
• The recommended normal daily dose is RIVASTIGMINA DOC 9.5 mg/24 hours. If well tolerated, the doctor may consider increasing the dose to 13.3 mg/24 hours.
• Apply only one RIVASTIGMINA DOC patch at a time and replace the patch with a new one every 24 hours.

During treatment, the doctor may vary the dose to adjust it to your individual needs.
If you have not applied a patch for more than three days, do not apply the next one before consulting your
doctor. Treatment with the transdermal patches can be resumed at the same dose if therapy has not been
interrupted for more than 3 days; alternatively, the doctor will start treatment again with
RIVASTIGMINA DOC 4.6 mg/24 hours.

Where to apply RIVASTIGMINA DOC transdermal patch

• Before applying a patch, make sure that the skin is:
• clean, dry and hairless,
• free of dust, oils, moisturizers, or lotions that may prevent the patch from adhering correctly to the skin, which must be without cuts, rashes and/or irritations.
• Carefully remove any patch before applying a new one.Having more patches on the skin could expose it to an excessive amount of medicine which could be potentially dangerous.
• Apply ONLY ONEpatch per day on ONEof the possible sites, highlighted in the figures below:
• upper left arm orupper right arm
• upper left chest orupper right chest ( avoid the breast)
• upper left back orupper right back
• lower left back orlower right back

Every 24 hours remove the previous patch before placing a NEW ONE on ONE of the following
possible sites.

When changing the patch, you must remove the patch from the previous day before applying a new one
each time in a different place (for example, on the right side of the body one day and on the left side the
next day, on the upper part of the body one day and on the lower part the next day). Do not
apply a new patch to the same place for a second time before 14 days have elapsed.

How to apply RIVASTIGMINA DOC transdermal patch
RIVASTIGMINA DOC patches are thin, translucent, plastic material that sticks to the skin. Each
patch is sealed in a sachet that protects it until it is used. Do not open the sachet or
remove the patch until just before application.
Carefully remove any patch already present before applying a new one.

For patients starting treatment for the first time and for patients resuming treatment with
RIVASTIGMINA DOC after an interruption, please follow the instructions below next to the
second image.

• Each patch is sealed in its 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 film covers the adhesive side of the patch. Peel off one side of the protective film and do not touch the adhesive part of the patch with your fingers.

• Place the adhesive side of the patch on the upper or lower back, upper arm or chest, then remove the second side of the protective film.

• Press the patch firmly with the palm of your hand for at least 30 seconds, making sure that the edges adhere well.

If it helps, you can write on the patch, for example, the day of the week, with a fine ballpoint pen.
The patch should be worn continuously, until it is time to replace it with a new one. If you wish,
when applying a new patch you can try different points to find those that are more comfortable for you and
where clothes do not rub against the patch.

How to remove RIVASTIGMINA DOC transdermal patch
Gently lift a corner of the patch to remove it slowly from the skin. If any adhesive residue remains on the skin, gently wash the area thoroughly with
lukewarm water and mild soap, or use baby oil to remove it. Alcohol or other
solvents (to remove nail polish or other types) should not be used.
After removing the patch, wash your hands with soap and water. If your eyes come into contact with it or your eyes become
red after handling the patch, rinse immediately with plenty of water and consult a
doctor if symptoms do not improve.

Can RIVASTIGMINA DOC transdermal patch be applied while bathing, swimming, or
sunbathing?

• Bathing, swimming or showering should not interfere with the patch. Make sure the patch does not come off during these activities.
• Do not expose the patch to external heat sources (e.g. excessive sunlight, sauna, solarium) for long periods of time.

What to do if a patch comes off
If a patch comes off, apply a new one for the rest of the day, then replace the patch the next day at the usual time.

When and for how long to apply RIVASTIGMINA DOC transdermal patch

• To benefit from treatment, you must apply a new patch every day, preferably at the same time.
• Apply only one patch at a time and replace it with a new one after 24 hours.

If you use more RIVASTIGMINA DOC than you should
If you accidentally apply more than one patch, remove all patches from the skin and inform the doctor that you have applied
more than one patch by mistake. You may need medical attention. Some people who have accidentally taken
an excessive amount of rivastigmine have experienced nausea, vomiting, diarrhea, high blood pressure and hallucinations. Slowing of the heartbeat and fainting can also occur.

If you forget to use RIVASTIGMINA DOC
If you realize you have forgotten to apply a patch, apply one immediately. You can apply the
next patch the following day at the scheduled time. Do not apply two patches to make up for the one
forgotten.

If you stop using RIVASTIGMINA DOC
If you stop using the patch, inform your doctor or pharmacist.
If you have any doubts about using 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.
Side effects may be more frequent when you start using the medicine or when you
increase the dose. Generally side effects will slowly disappear as the body gets
used to the medicine.

Remove the patch and immediately inform your doctor if you notice that any of the following side
effects becomes serious:
Common(may affect up to 1 in 10 people)

• Loss of appetite
• Feeling dizzy
• Feeling agitated or drowsy
• Urinary incontinence (inability to adequately control urination)

Uncommon(may affect up to 1 in 100 people)

• Heartbeat disturbances such as slow heartbeat
• Seeing things that are not really there (hallucinations)
• Stomach ulcer
• Dehydration (excessive fluid loss)
• Hyperactivity (high level of activity, restlessness)
• Aggression

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

• - Falls

Very rare(may affect up to 1 in 10,000 people)

• Stiffness in the arms or legs
• Tremors in the hands

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

• - Allergic reactions at the patch application site, such as blisters or inflamed skin
• - Symptoms of Parkinson's disease worsen - such as tremor, rigidity and shuffling gait
• - Inflammation of the pancreas - manifests as severe pain in the upper abdomen, often accompanied by nausea or vomiting
• - Fast or irregular heartbeat
• - High blood pressure
• - Convulsions (seizures)
• - Liver disorders (yellowing of the skin and whites of the eyes, abnormally dark urine or unexplained nausea, vomiting, fatigue and loss of appetite)
• - Changes in test values indicating how your liver is working
• - Feeling restless
• Nightmares

Remove the patch and immediately inform your doctor if you notice the occurrence of any of the
side effects described above.

Other side effects observed with capsules or oral solution containing rivastigmine and which
may occur with the patch:
Common(may affect up to 1 in 10 people)

• Excessive salivation
• Loss of appetite
• Feeling restless
• General feeling of discomfort
• Tremors or confusion
• Increased sweating

Uncommon(may affect up to 1 in 100 people)

• Irregular heartbeat (e.g. fast heartbeat)
• Sleep disturbances
• Accidental falls

Rare(may affect up to 1 in 1000 people)

• Convulsions (seizures)
• Ulcer in the intestine
• Chest pain - this may be caused by cardiac spasm

Very rare(may affect up to 1 in 10000 people)

• High blood pressure
• Inflammation of the pancreas - manifests as severe pain in the upper abdomen, often accompanied by nausea or vomiting
• Bleeding in the intestine - manifests as blood in the stool or vomit
• Seeing things that are not there (hallucinations)
• In some people who have had severe vomiting, rupture of the tract connecting the mouth to the stomach (esophagus) has occurred.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store RIVASTIGMINA DOC

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 pack and on the sachet after Exp. The
expiry date refers to the last day of that month.
Store in the original packaging to protect from light.
Store the transdermal patch in the sachet until the time of use.
This medicine does not require any particular storage temperature.
Do not use the patch if it is damaged or if you notice signs of tampering.
After removing a patch, fold it in half with the adhesive sides inwards and press them together. Put the
used patch back in its original sachet and dispose of it in a way that children cannot touch it. Do not
touch your eyes with your fingers and wash your hands with water and soap after removing the patch. If your local
waste disposal service incinerates household waste, you can dispose of the patch with household waste. Alternatively, return the used patches
to the pharmacy, preferably in the original packaging.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What RIVASTIGMINA DOC contains
The active ingredient is rivastigmine.

• RIVASTIGMINA DOC 4.6 mg/24 hours transdermal patch: each 5 cm patch releases 4.6 mg of rivastigmine in 24 hours and contains 9 mg of rivastigmine.
• RIVASTIGMINA DOC 9.5 mg/24 hours transdermal patch: each 10 cm patch releases 9.5 mg of rivastigmine in 24 hours and contains 18 mg of rivastigmine.

The other ingredients are:

Film:polyester film
fluoro-coated polyester film

Active ingredient matrix:acrylic adhesive
acrylic copolymer poly(butyl methacrylate-co-methyl) methacrylate (80:20)

Adhesive matrix:silicone adhesive

Inkblack printing ink

Description of the appearance of RIVASTIGMINA DOC and package contents
Each transdermal patch is a thin patch consisting of three layers. The outer layer is translucent, white and
bears printed with black ink:

• RIVASTIGMINA DOC 4.6 mg/24 hours transdermal patch: “Rivastigmine”, “4.6 mg/24 h”.
• RIVASTIGMINA DOC 9.5 mg/24 hours transdermal patch: “Rivastigmine”, “9.5 mg/24 h”.

Each transdermal patch is packaged in a child-resistant heat-sealed sachet. The patches are
available in packs containing 7, 10, 30, 60 or 90 sachets and in multiple packs containing 60 (2 x

• 30) or 90 (3 x 30) sachets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.

Manufacturer responsible for batch release
Eurofins PHAST GmbH - Kardinal-Wendel-Strasse 16 - 66424 Homburg – Germany.

RIVASTIGMINA DOC 13.3 mg/24 hour transdermal patch

Generic medicine

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is RIVASTIGMINA DOC and what is it used for

RIVASTIGMINA DOC contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with
Alzheimer's dementia, some brain cells die, leading to low levels of 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
RIVASTIGMINA DOC increases the levels of acetylcholine in the brain, improving the symptoms of
Alzheimer's disease.
RIVASTIGMINA is used for the treatment of adult patients with Alzheimer's dementia of mild to moderate
severity, a progressive disorder of the central nervous system that gradually affects
memory, learning ability and behavior.

2. What you need to know before using RIVASTIGMINA DOC

Do not use RIVASTIGMINA DOC

• if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6).
• if you have already had an allergic reaction to similar types of medicines (carbamate derivatives).
• if when using the patch you have had a skin reaction that extended beyond the area where the patch was applied, if you have had a more intense local reaction (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours of removing the patch.

If this is the case, tell your doctor and do not apply RIVASTIGMINA DOC transdermal patch.

Warnings and precautions
Talk to your doctor before using RIVASTIGMINA DOC

• if you have or have had a heart condition such as irregular or slow heartbeat, prolongation of the QTc interval, a family history of prolongation of the QTc interval, torsade de pointes, or have low levels of potassium or magnesium in your blood.
• if you have or have had an active stomach ulcer.
• if you have or have had difficulty urinating.
• if you have or have had convulsions (seizures).
• if you have or have had asthma or severe respiratory disorders.
• if you suffer from tremors.
• if you have a low body weight
• if you experience gastrointestinal disorders such as nausea, vomiting and diarrhea. If vomiting and diarrhea are persistent you may become dehydrated (excessive fluid loss).
• if you have impaired liver function.

If you recognize yourself in any of these situations, your doctor may visit you more frequently during therapy
with this medicine.
If you have not applied a patch for more than three days, consult your doctor before applying the next one.

Children and adolescents
There is no indication for specific use of RIVASTIGMINA DOC in the pediatric population
in the treatment of Alzheimer's disease.

Other medicines and RIVASTIGMINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
RIVASTIGMINA DOC can interfere with anticholinergic medicines including medicines used for
relieving stomach cramps or spasms (e.g. dicyclomine), for the treatment of Parkinson's disease (e.g.
amantadine) or to prevent travel sickness (e.g. diphenhydramine, scopolamine or meclizine).
RIVASTIGMINA DOC should not be administered simultaneously with metoclopramide (a
medicine used to relieve or prevent nausea and vomiting). Using the two medicines together may cause
disorders such as stiffness of the limbs and tremors in the hands.
If you are to undergo surgery and are being treated with RIVASTIGMINA DOC transdermal
patch, tell your doctor before being given anesthesia, as they may increase
the effects of some muscle relaxants during anesthesia.
Caution is recommended when RIVASTIGMINA DOC is taken together with beta blockers (medicines
such as atenolol, used for the treatment of hypertension, angina and other heart conditions). Using the
two medicines together may cause disorders such as slowing of the heartbeat (bradycardia) which may
lead to fainting or loss of consciousness.
Caution is recommended when RIVASTIGMINA DOC is taken together with other medicines that
can affect heart rhythm or the heart's electrical system (prolongation of the QT interval).

RIVASTIGMINA DOC with food, drinks and alcohol
RIVASTIGMINA DOC transdermal patch can be used with food, drinks and alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, the benefits of using RIVASTIGMINA DOC transdermal patch must be
weighed against the possible effects on the unborn child. RIVASTIGMINA DOC should not be used in
pregnancy unless strictly necessary.
You should not breastfeed during treatment with RIVASTIGMINA DOC transdermal patch.

Driving and using machines
Your doctor will tell you if your condition allows you to drive and use machines safely. RIVASTIGMINA DOC
transdermal patch can cause fainting or severe confusion. If you
feel faint or confused, do not drive, use machines and do not perform any other activity that
requires vigilance.

3. How to use RIVASTIGMINA DOC

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor,
pharmacist or nurse.

IMPORTANT:

• Remove the patch from the previous day before applying a NEW one.
• Only one patch per day.
• Do not cut the patch into pieces.
• Press the patch firmly with the palm of your hand for at least 30 seconds.

How to start treatment
The doctor will tell you which RIVASTIGMINA DOC transdermal patch is most suitable for you.

• Treatment usually starts with RIVASTIGMINA DOC 4.6 mg/24 hours.
• The recommended normal daily dose is RIVASTIGMINA DOC 9.5 mg/24 hours. If well tolerated, the doctor may consider increasing the dose to 13.3 mg/24 hours.
• Apply only one RIVASTIGMINA DOC patch at a time and replace the patch with a new one every 24 hours.

During treatment, the doctor may vary the dose to adjust it to your individual needs.
If you have not applied a patch for more than three days, do not apply the next one before consulting your
doctor. Treatment with the transdermal patches can be resumed at the same dose if therapy has not been
interrupted for more than 3 days; alternatively, the doctor will start treatment again with
RIVASTIGMINA DOC 4.6 mg/24 hours.

Where to apply RIVASTIGMINA DOC transdermal patch

• Before applying a patch, make sure that the skin is:
• clean, dry and hairless,
• free of dust, oils, moisturizers, or lotions that may prevent the patch from adhering correctly to the skin, which must be without cuts, rashes and/or irritation.
• Carefully remove any patch before applying a new one.Having more patches on the skin could expose it to an excessive amount of medicine which could be potentially dangerous.
• Apply ONLY ONEpatch per day on ONLY ONEof the possible sites, highlighted in the figures below:
• upper left arm orupper right arm
• upper left chest orupper right chest ( avoid the breast)
• upper left back orupper right back
• lower left back orlower right back

Every 24 hours remove the previous patch before placing a NEW ONE on ONLY ONE of the following
possible sites.

When changing the patch, you must remove the patch from the previous day before applying a new one
each time to a different point (for example, on the right side of the body one day and on the left side the
next day, on the upper part of the body one day and on the lower part the next day). Do not
apply a new patch to the same point a second time before 14 days have passed.

How to apply RIVASTIGMINA DOC transdermal patch
RIVASTIGMINA DOC patches are thin, translucent, plastic material that adheres to the skin. Each
patch is sealed in a sachet that protects it until it is used. Do not open the sachet or
remove the patch until just before application.
Carefully remove any patch already present before applying a new one.

For patients starting treatment for the first time and for patients resuming treatment with
RIVASTIGMINA DOC after an interruption, please follow the instructions below next to the
second image.

• Each patch is sealed in its protective sachet. You must open the sachet only 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 film covers the adhesive side of the patch. Peel off one side of the protective film and do not touch the adhesive part of the patch with your fingers.

• Place the adhesive side of the patch on the upper or lower back, upper arm or chest, then remove the second side of the protective film.

• Press the patch firmly with the palm of your hand for at least 30 seconds, making sure that the edges adhere well.

If it helps, you can write on the patch, for example, the day of the week, with a fine ballpoint pen.
The patch should be worn continuously, until it is time to replace it with a new one. If you wish,
when applying a new patch, you can try different points, to find those that are more comfortable for you and
where clothes do not rub against the patch.

How to remove RIVASTIGMINA DOC transdermal patch
Gently lift a corner of the patch to remove it slowly from the skin. If adhesive residue remains on the skin, bathe the area thoroughly but gently with warm water and mild soap, or use baby oil to remove it. Alcohol or other solvents (for removing nail polish or other types) should not be used.
After removing the patch, wash your hands with soap and water. If your eyes come into contact with it or if your eyes become red after handling the patch, rinse immediately with plenty of water and consult a
doctor if symptoms do not subside.

Can RIVASTIGMINA DOC transdermal patch be applied while bathing, swimming, or
sunbathing?

• Bathing, swimming or showering should not interfere with the patch. Make sure the patch does not come off during these activities.
• Do not expose the patch to external heat sources (e.g. excessive sunlight, sauna, solarium) for long periods of time.

What to do if a patch comes off
If a patch comes off, apply a new one for the remainder of the day, then replace the patch the next day at the usual time.

When and for how long to apply RIVASTIGMINA DOC transdermal patch

• To benefit from the treatment, you must apply a new patch every day, preferably at the same time.
• Apply only one patch at a time and replace it with a new one after 24 hours.

If you use more RIVASTIGMINA DOC than you should
If you accidentally apply more than one patch, remove all patches from the skin and inform the doctor that you have accidentally applied more than one patch. You may need medical attention. Some people who have mistakenly taken an excessive amount of rivastigmine have experienced nausea, vomiting, diarrhea, high blood pressure and hallucinations. Slowing of the heartbeat and fainting can also occur.

If you forget to use RIVASTIGMINA DOC
If you realize you have forgotten to apply a patch, apply one immediately. You can apply the next patch at the scheduled time the following day. Do not apply two patches to make up for the one forgotten.

If you stop using RIVASTIGMINA DOC
If you stop treatment with the patch, inform your doctor or pharmacist.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, RIVASTIGMINA DOC transdermal patch may cause side effects
although not everybody gets them.
Side effects may be more frequent when you start using the medicine or when you
increase the dose. Generally side effects will slowly disappear as the body gets
used to the medicine.

Remove the patch and tell your doctor immediately if you notice any of the following side
effects become serious:
Common(may affect up to 1 in 10 people)

• Loss of appetite
• Feeling dizzy
• Feeling restless or sleepy
• Urinary incontinence (inability to adequately control urination)

Uncommon(may affect up to 1 in 100 people)

• Heartbeat disturbances such as slow heartbeat
• Seeing things that are not really there (hallucinations)
• Stomach ulcer
• Dehydration (excessive fluid loss)
• Hyperactivity (high level of activity, restlessness)
• Aggression

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

• - Falls

Very rare(may affect up to 1 in 10,000 people)

• Stiffness in the arms or legs
• Tremors in the hands

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

• - Allergic reactions at the patch application site, such as blisters or inflamed skin
• - Symptoms of Parkinson's disease worsen - such as tremor, rigidity and shuffling gait
• - Inflammation of the pancreas - manifests with severe pain in the upper abdomen, often accompanied by nausea or vomiting
• - Fast or irregular heartbeat
• - High blood pressure
• - Convulsions (seizures)
• - Liver disorders (yellowing of the skin and whites of the eyes, abnormally dark urine or unexplained nausea, vomiting, fatigue and loss of appetite)
• - Changes in test values indicating how your liver is working
• - Feeling restless
• Nightmares

Remove the patch and tell your doctor immediately if you notice the occurrence of any of the
side effects described above.

Other side effects observed with rivastigmine capsules or oral solution and which may
occur with the patch:
Common(may affect up to 1 in 10 people)

• Excessive salivation
• Loss of appetite
• Feeling restless
• General feeling of unwellness
• Tremors or feeling confused
• Increased sweating

Uncommon(may affect up to 1 in 100 people)

• Irregular heartbeat (e.g. fast heartbeat)
• Sleep disturbances
• Accidental falls

Rare(may affect up to 1 in 1000 people)

• Convulsions (seizures)
• Ulcer in the intestine
• Chest pain - this may be caused by cardiac spasm

Very rare(may affect up to 1 in 10000 people)

• High blood pressure
• Inflammation of the pancreas - manifests with severe pain in the upper abdomen, often accompanied by nausea or vomiting
• Bleeding of the intestine - manifests with the presence of blood in the stool or vomit
• Seeing things that are not there (hallucinations)
• In some people who have had severe vomiting, rupture of the tract connecting the mouth to the stomach (esophagus) has occurred.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store RIVASTIGMINA DOC

• 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 pack and on the sachet after Scad. The expiry date refers to the last day of that month.
• Store in the original packaging to protect from light.
• Store the transdermal patch in the sachet until the time of use.
• This medicine does not require any particular storage temperature.
• Do not use the patch if it is damaged or if you notice signs of tampering.
• After removing a patch, fold it in half with the adhesive sides inwards and press them together. Put the used patch back in its original sachet and dispose of it in a way that children cannot touch it. Do not touch your eyes with your fingers and wash your hands with water and soap after removing the patch. If your municipality incinerates household waste, you can throw the patch with household waste. Alternatively, return the used patches to the pharmacy, preferably in the original packaging.

Do not dispose of any medicine in the drain water and household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help to protect the environment

6. Package Contents and Other Information

What RIVASTIGMINA DOC contains
The active ingredient is rivastigmine.
Each 15 cm patch releases 13.3 mg of rivastigmine in 24 hours and contains 27 mg of rivastigmine.
The other ingredients are:

Film:polyester film
fluoro-coated polyester film

Active ingredient matrix:acrylic adhesive
acrylic copolymer poly(butyl methacrylate-co-methyl) methacrylate (80:20)

Adhesive matrix:silicone adhesive

Inkblack printing ink (containing PET, resins/waxes, carbon black,
additives)

Description of the appearance of RIVASTIGMINA DOC and package contents
Each transdermal patch is a thin patch consisting of three layers. The outer layer is translucent, white and
bears the following printed in black ink:

• RIVASTIGMINA DOC 13.3 mg/24 hour transdermal patch: “Rivastigmine”, “13.3 mg/24 h”.

Each transdermal patch is packaged in a child-resistant heat-sealed sachet. The patches are
available in packs containing 30 sachets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.

Manufacturer:
Eurofins PHAST GmbH - Kardinal-Wendel-Strasse 16 - 66424 Homburg – Germany.