EXELON 1.5 mg Hard capsules

Зміст інструкції

1. Exelon 1.5 mg hard capsules, 3.0 mg hard capsules, 4.5 mg hard capsules, 6.0 mg hard capsules
   1. What is Exelon and what is it used for
   2. What you need to know before taking Exelon
   3. How to take Exelon
   4. Possible side effects
   5. How to store Exelon
   6. Package contents and other information
2. Exelon 2 mg/ml oral solution
   1. What is Exelon and what is it used for
   2. What you need to know before taking Exelon
   3. How to take Exelon
   4. Possible side effects
   5. How to store Exelon
   6. Contents of the pack and other information
3. Exelon 4.6 mg/24 hour transdermal patch, 9.5 mg/24 hour transdermal patch, 13.3 mg/24 hour transdermal patch
   1. What is Exelon and what is it used for
   2. What you need to know before using Exelon
   3. How to use Exelon
   4. Possible side effects
   5. How to store Exelon
   6. Package contents and other information

Exelon 1.5 mg hard capsules, 3.0 mg hard capsules, 4.5 mg hard capsules, 6.0 mg hard capsules

rivastigmine

Read this leaflet carefully before you start taking this medicine asit 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 their symptoms are the same as yours, as it could 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 Exelon is and what it is used for
• 2. What you need to know before you take Exelon
• 3. How to take Exelon
• 4. Possible side effects
• 5. How to store Exelon
• 6. Contents of the pack and other information

1. What is Exelon and what is it used for

Exelon contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients
with Alzheimer's dementia or dementia associated with Parkinson's disease, 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, Exelon increases the levels of
acetylcholine in the brain, improving the symptoms of Alzheimer's disease or dementia associated
with Parkinson's disease.
Exelon 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. The hard capsules and oral solution are also
used for the treatment of dementia in adult patients with Parkinson's disease.

2. What you need to know before taking Exelon

Do not take Exelon

• if you are allergic to rivastigmine (the active ingredient of Exelon) or to any of the other ingredients of this medicine (listed in section 6).
• if when using the patch you have had a skin reaction that spread beyond the area where the patch was applied, if you have had a local reaction more intense (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 take Exelon.

Warnings and precautions
Talk to your doctor before taking Exelon:

• if you have or have ever had a heart condition such as irregular or slow heartbeat, QTc interval prolongation, a family history of QTc interval prolongation, torsade de pointes, or have low levels of potassium or magnesium in your blood.
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures (convulsions).
• if you have or have ever had asthma or severe respiratory disorders.
• if you have or have ever had impaired kidney function.
• if you have or have ever had impaired liver function.
• if you suffer from tremors.
• if you are underweight.
• 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 recognize yourself in any of these situations, your doctor may visit you more frequently during therapy with this medicine.

If you have not taken Exelon for more than three days, consult your doctor before resuming treatment.

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

Other medicines and Exelon
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Exelon must not be administered together with other medicines that have similar effects. Exelon can
interfere with anticholinergic medicines (medicines used to relieve cramps or spasms in the
stomach, for the treatment of Parkinson's disease or to prevent travel sickness).
Exelon must not be administered simultaneously with metoclopramide (a medicine used
to relieve or prevent nausea and vomiting). Taking the two medicines together may cause disorders
such as rigidity of the limbs and tremor of the hands.
If you are to undergo surgery and are being treated with Exelon, tell your doctor before
being given anesthesia, as Exelon may increase the effects of some muscle relaxants
during anesthesia.
Caution is recommended when Exelon is taken together with beta-blockers (medicines such as
atenolol, used for the treatment of hypertension, angina and other heart diseases). Taking
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 Exelon is taken together with other medicines that can
affect the heart rhythm or the electrical system of the heart (QT interval prolongation).

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 taking this medicine.
If you are pregnant, the benefits of using Exelon must be weighed against the possible
effects on the unborn child. Exelon should not be used during pregnancy unless strictly necessary.
You should not breastfeed during treatment with Exelon.

Driving and using machines
Your doctor will tell you if your illness allows you to drive and use machines safely. Exelon may cause dizziness and drowsiness, especially at the beginning of treatment or when
you increase the dose. If you feel dizzy or sleepy, do not drive, do not use machines and do not perform
any other activity that requires vigilance.

3. How to take Exelon

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor, pharmacist or nurse.

How to start treatment
Your doctor will tell you which dose of Exelon to take.

• Treatment generally starts with a low dose.
• Your doctor will slowly increase the dose based on your response to treatment.
• The highest dose that can be taken is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working. Your doctor will also monitor your
weight while you are taking this medicine.
If you have not taken Exelon for more than three days, consult your doctor before resuming treatment.

Taking the medicine

• Inform the person who is taking care of you that you are being treated with Exelon.
• To benefit from the treatment, take the medicine every day.
• Take Exelon twice a day, in the morning and in the evening, with food.
• Swallow the capsules whole with a drink.
• Do not open or break the capsules.

If you take more Exelon than you should
If you accidentally take more Exelon than you should, inform your doctor. You may need medical
care. Some people who have accidentally taken an excessive amount of Exelon have
experienced nausea, vomiting, diarrhea, high blood pressure and hallucinations. Slowing of the
heartbeat and fainting can also occur.

If you forget to take Exelon
If you discover that you have forgotten to take your dose of Exelon, wait and take the next dose
at the scheduled time. Do not take a double dose to make up for a missed dose.
If you have any doubts about 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.
Side effects may be more frequent when you start taking the medicine or when
you increase the dose. Generally, side effects will gradually disappear as the
body gets used to the medicine.

Very common(may affect more than 1 in 10 people)

• Feeling dizzy
• Loss of appetite
• Stomach problems such as feeling nauseous, vomiting, diarrhoea

Common(may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling restless
• Feeling tired or weak
• General feeling of being unwell
• Tremors or feeling confused
• Loss of appetite
• Nightmares

Uncommon(may affect up to 1 in 100 people)

• Depression
• Sleep disorders
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Skin rash, itching
• Convulsions (seizures)
• Stomach or intestinal ulcer

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

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Heart rhythm disorders, such as a fast or slow heartbeat
• Bleeding from the intestine - this manifests with the presence of blood in the stool or vomit
• Inflammation of the pancreas - this manifests with severe pain in the upper part of the stomach, often accompanied by nausea or vomiting
• The signs of Parkinson's disease worsen or symptoms similar to it develop - such as muscle stiffness, difficulty performing movements

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

• Severe vomiting that can lead to rupture of the tract connecting the mouth to the stomach (esophagus)
• Dehydration (excessive fluid loss)
• Liver disorders (yellowing of the skin and the white of the eye, abnormally dark urine or unexplained nausea, vomiting, fatigue and loss of appetite)
• Aggression, feeling restless
• Irregular heartbeat
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Patients with dementia and Parkinson's disease
These patients more frequently experience some side effects. They also experience some
additional side effects:

Very common(may affect more than 1 in 10 people)

• Tremors
• Fainting
• Accidental falls

Common(may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Fast and slow heartbeat
• Sleep disorders
• Excessive salivation and dehydration
• Unusual slowing of movements or movements that cannot be controlled
• The signs of Parkinson's disease worsen or symptoms similar to it develop - such as muscle stiffness, difficulty performing movements and muscle weakness

Uncommon(may affect up to 1 in 100 people)

• Irregular heartbeat and poor control of movements

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

• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Other side effects observed with Exelon transdermal patches and that may occur with
the capsules:
Common(may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to adequately retain urine)

Uncommon(may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

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

• Allergic reactions at the patch application site, such as blisters or skin inflammation If you experience any of these symptoms, contact your doctor as you may need medical assistance.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system
detailed in Appendix V. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Exelon

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the pack after Exp.. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.

6. Package contents and other information

What Exelon contains

• The active ingredient is rivastigmine hydrogen tartrate.
• The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, precipitated silica, gelatin, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171) and shellac.

Each Exelon 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Exelon 3.0 mg capsule contains 3.0 mg of rivastigmine.
Each Exelon 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Exelon 6.0 mg capsule contains 6.0 mg of rivastigmine.

Description of Exelon and package contents

• Exelon 1.5 mg hard capsules, containing a nearly white to slightly yellow powder, have a yellow cap and a yellow body, with the red inscription “EXELON 1.5 mg” on the body.
• Exelon 3.0 mg hard capsules, containing a nearly white to slightly yellow powder, have an orange cap and an orange body, with the red inscription “EXELON 3 mg” on the body.
• Exelon 4.5 mg hard capsules, containing a nearly white to slightly yellow powder, have a red cap and a red body, with the white inscription “EXELON 4.5 mg” on the body.
• Exelon 6.0 mg hard capsules, containing a nearly white to slightly yellow powder, have a red cap and an orange body, with the red inscription “EXELON 6 mg” on the body. Exelon hard capsules are packaged in blisters available in three different packs (28, 56 or 112 capsules), but not all pack sizes may be marketed.

Marketing authorisation holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
For further information on this medicine, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu/

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Exelon 2 mg/ml oral solution

rivastigmine

Read this leaflet carefully before you start taking this medicine becauseit 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 their symptoms are the same as yours, as it could 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 Exelon is and what it is used for
• 2. What you need to know before you take Exelon
• 3. How to take Exelon
• 4. Possible side effects
• 5. How to store Exelon
• 6. Contents of the pack and other information

1. What is Exelon and what is it used for

Exelon contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients
with Alzheimer's dementia or dementia associated with Parkinson's disease, some brain cells
die, resulting in 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, Exelon increases levels of
acetylcholine in the brain, improving the symptoms of Alzheimer's disease or dementia associated
with Parkinson's disease.
Exelon 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 behaviour. The hard capsules and oral solution are also
used for the treatment of dementia in adult patients with Parkinson's disease.

2. What you need to know before taking Exelon

Do not take Exelon

• if you are allergic to rivastigmine (the active ingredient of Exelon) or to any of the other ingredients of this medicine (listed in section 6).
• 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 local reaction more intense (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 take Exelon.

Warnings and precautions
Talk to your doctor before taking Exelon:

• if you have or have ever had a heart condition such as irregular or slow heartbeat, prolongation of the QT interval, a family history of prolongation of the QT interval, torsades de pointes, or have a low level of potassium or magnesium in the blood.
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures (convulsions).
• if you have or have ever had asthma or severe respiratory disorders.
• if you have or have ever had impaired kidney function.
• if you have or have ever had impaired liver function.
• if you suffer from tremors.
• if you weigh little.
• if you experience gastrointestinal disorders such as nausea, vomiting and diarrhoea. If vomiting and diarrhoea are persistent you may become dehydrated (excessive loss of fluids). 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 taken Exelon for more than three days, consult your doctor before resuming treatment.

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

Other medicines and Exelon
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Exelon must not be administered together with other medicines that have similar effects. Exelon can
interfere with anticholinergic medicines (medicines used to relieve cramps or spasms in the
stomach, for the treatment of Parkinson's disease or to prevent travel sickness).
Exelon must not be administered at the same time as metoclopramide (a medicine used
to relieve or prevent nausea and vomiting). Taking the two medicines together may cause disorders
such as rigidity of the limbs and tremor of the hands.
If you are to undergo surgery and are taking Exelon, tell your doctor before
being subjected to anesthesia, as Exelon may increase the effects of some muscle relaxants
during anesthesia.
Caution is recommended when Exelon is taken together with beta-blockers (medicines such as
atenolol, used for the treatment of hypertension, angina and other heart diseases). Taking
the two medicines together may cause disorders such as slowing of the heartbeat (bradycardia) that
can lead to fainting or loss of consciousness.
Caution is recommended when Exelon is taken together with other medicines that can
affect the heart rhythm or the electrical system of the heart (prolongation of the QT interval).

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 taking this medicine.
If you are pregnant, the benefits of using Exelon must be weighed against the possible
effects on the unborn child. Exelon should not be used during pregnancy unless strictly necessary.
You should not breastfeed during treatment with Exelon.

Driving and using machines
Your doctor will tell you if your condition allows you to drive and use machines safely. Exelon may cause dizziness and drowsiness, especially at the beginning of treatment or when
you increase the dose. If you feel dizzy or sleepy, do not drive, do not use machines and do not perform
any other activity that requires vigilance.

Exelon contains sodium benzoate (E211) and sodium
One of the inactive ingredients of Exelon oral solution is sodium benzoate (E211). Benzoic acid is
weakly irritating to the skin, eyes and mucous membranes. This medicine contains 3 mg of sodium
benzoate (E211) per 3 ml of oral solution.
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially ‘sodium
free’.

3. How to take Exelon

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor, pharmacist, or nurse.

How to start treatment
Your doctor will tell you which dose of Exelon to take.

• Treatment usually starts with a low dose.
• Your doctor will slowly increase the dose based on your response to treatment.
• The highest dose that can be taken is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working. Your doctor will also monitor your weight while you are taking this medicine.
If you have not taken Exelon for more than three days, consult your doctor before restarting treatment.

Taking the medicine

• Inform the person who is taking care of you that you are being treated with Exelon.
• To benefit from the treatment, take the medicine every day.
• Take Exelon twice a day, in the morning and in the evening, with food.

How to use this medicine

• 1. Preparing the vial and syringe
• Remove the syringe from the protective tube.
• To open the vial, press and rotate the safety cap.

• 2. Inserting the syringe into the vial

• Push the syringe nozzle into the hole of the white seal.

• 3. Filling the syringe
• Raise the plunger until you reach the mark corresponding to the dose your doctor has prescribed.

• 4. Removing bubbles
• Push and pull the plunger several times to eliminate any large bubbles.
• Some small bubbles are not a concern and do not affect the correct dosage in any way.
• Verify that the dose is still correct.
• Then remove the syringe from the vial.

• 5. Taking the medicine
• Drink the medicine directly from the syringe.
• It is also possible to mix the medicine in a glass with a little water. Stir and drink the entire mixture.

• 6. After using the syringe
• Rub the outside of the syringe with a clean paper towel.
• Then put the syringe back in the protective tube.
• Put the safety cap back on the vial to close it.

If you take more Exelon than you should
If you accidentally take more Exelon than you should, inform your doctor. You may need
medical attention. Some people who have accidentally taken an excessive amount of Exelon have
experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. Slowing of the
heartbeat and fainting can also occur.

If you forget to take Exelon
If you discover that you have forgotten to take your dose of Exelon, wait and take the next dose
at the scheduled time. Do not take a double dose to make up for a missed dose. 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 everyone will experience them.
Side effects may be more frequent when you start taking the medicine or when
you increase the dose. Generally, side effects will gradually disappear as the
body gets used to the medicine.

Very common(may affect more than 1 in 10 people)

• Feeling of dizziness
• Loss of appetite
• Stomach discomfort such as feeling of nausea, vomiting, diarrhea

Common(may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling of agitation
• Feeling of tiredness or weakness
• General feeling of discomfort
• Tremors or feeling of confusion
• Loss of appetite
• Nightmares

Uncommon(may affect up to 1 in 100 people)

• Depression
• Sleep disturbances
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Skin rash, itching
• Convulsions (seizures)
• Ulcer in the stomach or intestine

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

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Heart rhythm disorders, such as fast or slow heartbeat
• Bleeding from the intestine - manifested by the presence of blood in the stool or vomit
• Inflammation of the pancreas - manifested by severe pain in the upper part of the stomach, often accompanied by feeling of nausea or vomiting
• The signs of Parkinson's disease worsen or symptoms similar to those develop - such as muscle stiffness, difficulty performing movements

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

• Severe vomiting that can lead to rupture of the tract connecting the mouth to the stomach (esophagus)
• Dehydration (excessive fluid loss)
• Liver disorders (yellowing of the skin and the white of the eye, abnormally dark discoloration of the urine or unexplained nausea, vomiting, fatigue and loss of appetite)
• Aggression, feeling of restlessness
• Irregular heartbeat
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Patients with dementia and Parkinson's disease
These patients more frequently experience some side effects. They also experience some
additional side effects:

Very common(may affect more than 1 in 10 people)

• Tremors
• Fainting
• Accidental falls

Common(may affect up to 1 in 10 people)

• Anxiety
• Feeling of restlessness
• Fast and slow heartbeat
• Sleep disturbances
• Excessive salivation and dehydration
• Unusual slowing of movements or movements that cannot be controlled
• The signs of Parkinson's disease worsen or symptoms similar to those develop - such as muscle stiffness, difficulty performing movements and muscle weakness

Uncommon(may affect up to 1 in 100 people)

• Irregular heartbeat and poor control of movements

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

• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Other side effects observed with Exelon transdermal patches and that may occur with
the oral solution:
Common(may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to adequately retain urine)

Uncommon(may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

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

• Allergic reactions at the patch application site, such as blisters or skin inflammation If any of these symptoms occur, contact your doctor as you may need medical assistance.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system detailed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Exelon

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the pack after Exp. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C. Do not refrigerate or freeze.
• Store in an upright position.
• Use Exelon oral solution within 1 month of opening the bottle.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Exelon contains

• The active ingredient is rivastigmine hydrogen tartrate. Each ml contains an amount of rivastigmine hydrogen tartrate corresponding to 2.0 mg of rivastigmine base.
• The other ingredients are sodium benzoate (E211), citric acid, sodium citrate, quinoline yellow colourant (E104) and purified water.

Description of the appearance of Exelon and contents of the pack
Exelon oral solution is available in an amber glass bottle with a safety cap, seal, measuring tube
and self-aligning piston, containing 50 ml or 120 ml of a clear, yellow solution. The
oral solution is packaged with an oral dosing syringe contained in a plastic tube.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/

Exelon 4.6 mg/24 hour transdermal patch, 9.5 mg/24 hour transdermal patch, 13.3 mg/24 hour transdermal patch

rivastigmina

Read this leaflet carefully before you start to use this medicine becauseit 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 their symptoms are the same as yours, as it could 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 Exelon is and what it is used for
• 2. What you need to know before you take Exelon
• 3. How to take Exelon
• 4. Possible side effects
• 5. How to store Exelon
• 6. Contents of the pack and other information

1. What is Exelon and what is it used for

Exelon contains the active ingredient rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients
with Alzheimer's dementia, some brain cells die, resulting in 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, Exelon increases acetylcholine levels in the brain,
improving the symptoms of Alzheimer's disease.
Exelon 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 Exelon

Do not use Exelon

• if you are allergic to rivastigmine (the active ingredient of Exelon) or to 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 spread 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 Exelon transdermal patches.

Warnings and precautions
Talk to your doctor before using Exelon:

• if you have or have ever had a heart condition such as irregular or slow heartbeat, prolonged QTc interval, a family history of prolonged QTc interval, torsade de pointes, or have a low level of potassium or magnesium in your blood.
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures (convulsions).
• if you have or have ever 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 diarrhoea. If vomiting and diarrhoea are persistent you may become dehydrated (excessive loss of fluids).
• 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 Exelon in the pediatric population in the treatment of Alzheimer's disease.

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

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

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

3. How to use Exelon

Use Exelon transdermal patches always exactly as your doctor has instructed. 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
Your doctor will tell you which Exelon transdermal patch is most suitable for you.

• Treatment usually starts with Exelon 4.6 mg/24 hours.
• The usual recommended daily dose is Exelon 9.5 mg/24 hours. If well tolerated, your doctor may consider increasing the dose to 13.3 mg/24 hours.
• Apply only one Exelon patch at a time and replace the patch with a new one every 24 hours. During treatment, your 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 the therapy has not
been interrupted for more than 3 days; alternatively, your doctor will start the treatment again
with Exelon 4.6 mg/24 hours.
Exelon can be used simultaneously with the intake of food, drinks and alcohol.

Where to apply Exelon transdermal patch

• Before applying a patch, make sure that the skin is clean, dry and hair-free, 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 ONLY ONEof the possible locations 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
ONE new one on ONE of the following possible locations.

Front
O O O O
Back
O
O O
When changing the patch, you must remove the patch from the previous day before applying a
new one each time in a different location (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 location again until 14 days have passed.

How to apply Exelon transdermal patch
Exelon patches are thin, opaque, plastic material that sticks to the skin. Each patch is
sealed in a sachet that protects it until it is time to use it. Do not open the sachet or
remove the patch until just before application.

Carefully remove the patch already present before applying
a new one.
For patients starting treatment for the first time and for
patients resuming treatment with Exelon after
an interruption, please start with the instructions reported 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-point 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 locations to find those that are more
comfortable for you and where clothes do not rub against the patch.

How to remove Exelon transdermal patch
Gently lift one corner of the patch to remove it slowly from the skin. If
adhesive residue remains on the skin, wet the area thoroughly but gently with
lukewarm 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 water and soap. If it comes into contact with your eyes 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 you apply Exelon transdermal patch while bathing, swimming, or sunbathing?

• Bathing, swimming or showering should not interfere with the patch. Make sure the patch does not detach 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 Exelon 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 Exelon than you should
If you accidentally apply more than one patch, remove all patches from the skin and inform your doctor that
you have accidentally applied more than one patch. You may need medical attention. Some people who have
accidentally taken an excessive amount of Exelon have experienced nausea, vomiting,
diarrhea, high blood pressure and hallucinations. Slowing of the heartbeat and
fainting may also occur.

If you forget to use Exelon
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 you forgot.

If you stop using Exelon
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, Exelon transdermal patches can cause side effects, although not everyone will experience them.
Side effects may be more frequent when you start taking the medicine or when
you increase the dose. Generally, side effects will gradually disappear as the
body gets used to the medicine.

Remove the patch and inform your doctor immediately if you notice that any of the following
side effects become severe:
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 based on 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
• Pancreatitis - 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 functioning
• Feeling restless
• Nightmares
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

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

Other side effects observed with Exelon capsules or oral solution and that 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 1,000 people)

• Convulsions (seizures)
• Intestinal ulcer
• Chest pain - this may be caused by cardiac spasm

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

• High blood pressure
• Pancreatitis - manifests as severe pain in the upper abdomen, often accompanied by nausea or vomiting
• Bleeding from 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 listed in Annex V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Exelon

• 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 package and on the sachet after Expiry/EXP. The expiry date refers to the last day of that month.
• Do not store at a temperature above 25°C.
• Store the transdermal patch in the sachet until the time of use.
• Do not use the patch if it is damaged or if it shows signs of tampering.
• After removing a patch, fold it in half with the adhesive sides inwards and press them together. Return the used patch to its original sachet and dispose of it in a way that children cannot reach it. Do not touch your eyes with your fingers and wash your hands with water and soap after removing the patch. Do not dispose of any medicine in the drain or in 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 Exelon contains

• The active ingredient is rivastigmine.
• Exelon 4.6 mg/24 hour transdermal patches: Each 5 cm patch releases 4.6 mg of rivastigmine in 24 hours and contains 9 mg of rivastigmine.
• Exelon 9.5 mg/24 hour transdermal patches: Each 10 cm patch releases 9.5 mg of rivastigmine in 24 hours and contains 18 mg of rivastigmine.
• Exelon 13.3 mg/24 hour transdermal patches: Each 15 cm patch releases 13.3 mg of rivastigmine in 24 hours and contains 27 mg of rivastigmine.
• The other ingredients are lacquered polyethylene terephthalate film, alpha-tocopherol, poly(butyl methacrylate, methyl methacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film, coated with fluoropolymer.

Description of Exelon’s appearance and package contents
Each transdermal patch is thin and consists of three layers. The outer layer is beige and is
marked with one of the following texts:

• “Exelon”, “4.6 mg/24 h” and “AMCX”,
• “Exelon”, “9.5 mg/24 h” and “BHDI”,
• “Exelon”, “13.3 mg/24 h” and “CNFU”

Each transdermal patch is sealed in a sachet.
Exelon 4.6 mg/24 hour transdermal patches and Exelon 9.5 mg/24 hour transdermal patches are available
in packs containing 7, 30 or 42 sachets and in multiple packs containing 60, 84 or 90 sachets.
Exelon 13.3 mg/24 hour transdermal patches are available in packs containing 7 or 30 sachets and
in multiple packs containing 60 or 90 sachets.
Not all pack sizes may be marketed.

Marketing authorisation holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu/

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE
MARKETING AUTHORISATION(S)
Scientific conclusions
Taking into account the evaluation of the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for rivastigmine, the PRAC’s scientific
conclusions are as follows:
Based on literature data suggesting a causal association between rivastigmine and
pleurotonia, with reports of positive response to discontinuation (dechallenge) and/or
reintroduction (rechallenge), including a dose-response relationship in some cases and in view
of a potential class effect, it is recommended to amend the product information of medicines
containing rivastigmine to include the adverse reaction "pleurotonia", also known as Pisa
syndrome.
Having examined the PRAC recommendation, the Committee for Human Medicinal Products
(CHMP) agrees with the overall conclusions and with the justification for the recommendation.

Justification for the variation of the marketing authorisation(s)
Based on the scientific conclusions on rivastigmine, the CHMP considers that the benefit-risk
balance of the medicine containing (medicines containing) rivastigmine remains unchanged
subject to the proposed changes to the product information.
The CHMP recommends the variation of the marketing authorisation(s).