Exelon: detailed information

Package leaflet: Information for the user

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

rivastigmine
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

What is in this leaflet

What Exelon is and what it is used for
What you need to know before taking Exelon
How to take Exelon
Possible side effects
How to store Exelon
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 known as cholinesterase inhibitors. In patients
with Alzheimer's dementia or dementia associated with Parkinson's disease, certain brain
cells die, resulting in low levels of acetylcholine (a substance that enables nerve cells to
communicate with each other). Rivastigmine works by inhibiting the enzymes that break down acetylcholine:
acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, Exelon increases
the levels of acetylcholine in the brain, thereby improving the symptoms of Alzheimer's disease or
dementia associated with Parkinson's disease.
Exelon is used to treat adult patients with mild to moderate Alzheimer's dementia, 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 substance in Exelon) or to any of the other ingredients of this medicine (listed in section 6).
if you have previously experienced a skin reaction extending beyond the area where the patch was applied, or if you had a more severe local reaction (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours after removing the patch. If this applies to you, inform 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, family history of QTc interval prolongation, torsades de pointes, or if you 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 (epileptic fits).
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 disturbances such as nausea, vomiting, and diarrhea. If vomiting and diarrhea are persistent, you may become dehydrated (excessive loss of fluids). If any of these situations apply to you, your doctor may monitor you more frequently during treatment with this medicine.

If you have not taken Exelon for more than three days, consult your doctor before restarting treatment.
Children and adolescents
There is no established indication for the specific use of Exelon in the pediatric population for the treatment of Alzheimer's disease.
Other medicines and Exelon
Inform 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 may interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, for the treatment of Parkinson's disease, or to prevent motion sickness).
Exelon must not be taken at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause symptoms such as stiffness of the limbs and hand tremors.
If you are undergoing surgery and are being treated with Exelon, inform your doctor before receiving anesthesia, as Exelon may enhance the effects of certain muscle relaxants during anesthesia.
Caution is recommended when Exelon is taken together with beta-blockers (medicines such as atenolol, used to treat hypertension, angina, and other heart conditions). Taking both medicines together may cause symptoms such as slowing of the heartbeat (bradycardia), which may lead to fainting or loss of consciousness.
Caution is also recommended when Exelon is taken together with other medicines that may affect heart rhythm or the heart's electrical system (QT interval prolongation).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, the benefits of using Exelon must be weighed against the possible risks to the unborn child. Exelon should not be used during pregnancy unless strictly necessary.
You must not breastfeed while being treated with Exelon.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Exelon may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you feel dizzy or drowsy, do not drive, do not use machines, and avoid any other activity requiring alertness.

3. How to take Exelon

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor, pharmacist, or nurse.
Starting treatment
Your doctor will tell you what dose of Exelon to take.

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

Your doctor will regularly check whether 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 caring for you that you are being treated with Exelon.
To benefit from treatment, take the medicine every day.
Take Exelon twice daily, 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 require
medical treatment. Some people who accidentally took too much Exelon experienced nausea,
vomiting, diarrhoea, high blood pressure, and hallucinations. Slowing of the heartbeat and fainting may also occur.
If you forget to take Exelon
If you realize you have forgotten to take a dose of Exelon, wait and take the next dose at the
scheduled time. Do not take a double dose to make up for the missed dose.
If you have any questions 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 everyone gets them.
Side effects may be more common when you start taking the medicine or when the dose is increased.
Generally, side effects will gradually disappear as your body gets used to the medicine.

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

Dizziness
Loss of appetite
Stomach disturbances such as nausea or vomiting, diarrhoea

Common (may affect up to 1 in 10 people)

Anxiety
Sweating
Headache
Heartburn
Weight loss
Stomach ache
Restlessness
Feeling tired or weak
General feeling of being unwell
Tremors or confusion
Loss of appetite
Nightmares
Drowsiness

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
Rash, itching
Seizures (epileptic fits)
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 fast or slow heartbeat
Bleeding in the intestine – may present as blood in the stool or vomit
Inflammation of the pancreas – may present as severe pain in the upper abdomen, often accompanied by nausea or vomiting
Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty in moving

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

Severe vomiting which may lead to rupture of the tube connecting the mouth to the stomach (oesophagus)
Dehydration (excessive loss of body fluids)
Liver problems (yellowing of the skin and whites of the eyes, unusually dark urine, or unexplained nausea, vomiting, tiredness and loss of appetite)
Aggression, restlessness
Irregular heartbeat
Pisa syndrome (a condition involving involuntary muscle contractions causing abnormal bending of the body and head to one side)

Patients with dementia and Parkinson’s disease
These patients more frequently experience certain side effects. They may also experience additional side effects:
Very common (may affect more than 1 in 10 people)

Tremors
Accidental falls

Common (may affect up to 1 in 10 people)

Anxiety
Restlessness
Slow and fast heartbeat
Sleep disorders
Excessive salivation and dehydration
Unusual slowing of movements or uncontrollable movements
Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty in moving and muscle weakness
Seeing things that are not there (hallucinations)
Depression
High blood pressure

Uncommon (may affect up to 1 in 100 people)

Irregular heartbeat and poor movement control
Low blood pressure

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

Pisa syndrome (a condition involving involuntary muscle contractions causing abnormal bending of the body and head to one side)
Rash

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

Fever
Severe confusion
Urinary incontinence (inability to properly 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 require medical assistance.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via 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 carton after Exp.. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine 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 Exelon contains

The active substance 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 the appearance of Exelon and contents of the pack

Exelon 1.5 mg hard capsules, containing a powder from almost white to slightly yellow, with a yellow cap and yellow body, and red print “EXELON 1.5 mg” on the body.
Exelon 3.0 mg hard capsules, containing a powder from almost white to slightly yellow, with an orange cap and orange body, and red print “EXELON 3 mg” on the body.
Exelon 4.5 mg hard capsules, containing a powder from almost white to slightly yellow, with a red cap and red body, and white print “EXELON 4.5 mg” on the body.
Exelon 6.0 mg hard capsules, containing a powder from almost white to slightly yellow, with a red cap and orange body, and red print “EXELON 6 mg” on the body.

Exelon hard capsules are packed in blisters available in three different cartons (28, 56 or 112 capsules), although not all pack sizes may be marketed.

Marketing Authorization 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

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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/

Package leaflet: information for the user

Exelon 2 mg/ml oral solution

rivastigmine
Please read this entire leaflet carefully before taking this medicine because 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Exelon is and what it is used for
What you need to know before taking Exelon
How to take Exelon
Possible side effects
How to store Exelon
Contents of the pack and other information

1. What Exelon is and what it is used for

Exelon contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances known as cholinesterase inhibitors. In patients
with Alzheimer's dementia or dementia associated with Parkinson's disease, certain brain
cells die, resulting in low levels of acetylcholine (a substance that enables nerve cells to
communicate with each other). Rivastigmine works by inhibiting the enzymes that break down acetylcholine:
acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, Exelon increases
acetylcholine levels in the brain, thereby improving the symptoms of Alzheimer's disease or
Parkinson's disease dementia.
Exelon is used to treat adult patients with mild to moderate Alzheimer's dementia, 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 to treat 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 substance in Exelon) or to any of the other ingredients of this medicine (listed in section 6).
if you have experienced a skin reaction that spread beyond the area where the patch was applied, or if you had a more intense local reaction (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours after removing the patch. If this applies to you, inform 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 QTc interval, a family history of QTc prolongation,
torsade de pointes, or if you 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 (epileptic fits).
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 have a low body weight.
if you experience gastrointestinal disturbances such as nausea, vomiting, and diarrhea. If vomiting and diarrhea are persistent, you may become dehydrated (excessive loss of fluids). If any of these apply to you, your doctor may need to monitor you more frequently during treatment with this medicine.

If you have not taken Exelon for more than three days, consult your doctor before restarting treatment.
Children and adolescents
There is no indication for the use of Exelon in the pediatric population for the treatment of Alzheimer's disease.
Other medicines and Exelon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Exelon must not be taken together with other medicines that have similar effects. Exelon may interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, for the treatment of Parkinson's disease, or to prevent motion sickness).
Exelon must not be taken at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause side effects such as stiffness of the limbs and hand tremors.
If you are scheduled for surgery and are being treated with Exelon, inform your doctor before receiving anesthesia, as Exelon may enhance the effects of certain muscle relaxants during anesthesia.
Caution is recommended when Exelon is taken together with beta-blockers (medicines such as atenolol, used to treat high blood pressure, angina, and other heart conditions). Taking both medicines together may cause side effects such as slowing of the heartbeat (bradycardia), which may lead to fainting or loss of consciousness.
Caution is also recommended when Exelon is taken together with other medicines that may affect heart rhythm or the heart's electrical system (prolongation of the QT interval).
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy, the benefits of using Exelon must be weighed against the possible risks to the unborn child. Exelon must not be used during pregnancy unless strictly necessary.
You must not breastfeed while being treated with Exelon.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Exelon may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you feel dizzy or drowsy, do not drive, operate machinery, or perform any activity requiring alertness.
Exelon contains sodium benzoate (E211) and sodium
One of the inactive ingredients in Exelon oral solution is sodium benzoate (E211). Benzoic acid is mildly 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 exactly as your doctor has instructed. If you have any doubts, consult your doctor, pharmacist, or nurse.
Starting treatment
Your doctor will tell you what 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 daily.

Your doctor will regularly check whether 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 caring for you that you are being treated with Exelon.
To benefit from 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

Medical diagram showing a syringe next to a vial, with an arrow indicating the rotation of the cap and the

Preparing the vial and syringe
- Remove the syringe from the protective tube.
- To open the vial, press down and twist the safety cap to remove it.
Inserting the syringe into the vial
- Push the tip of the syringe into the hole in the white seal.

Technical drawing showing a hand removing a syringe from a vial and two illustrations of syringes with arrows indicating movement

Filling the syringe
- Pull back the plunger to the mark corresponding to the dose prescribed by your doctor.
Removing air bubbles
- Push and pull the plunger several times to remove any large air bubbles.
- A few small bubbles are not a concern and will not affect the correct dosage in any way.
- Check that the dose is still correct.
- Then remove the syringe from the vial.

Technical drawing showing a hand inserting a needle with syringe into tissue and a syringe next to an open medicine vial

Taking the medicine
- Drink the medicine directly from the syringe.
- Alternatively, you may mix the medicine in a glass with a small amount of water. Stir and drink all the mixture.
After using the syringe
- Wipe the outside of the syringe with a clean paper towel.
- Then return the syringe to the protective tube.
- Replace the safety cap on the vial to close it.

If you take more Exelon than you should
If you accidentally take more Exelon than prescribed, inform your doctor. You may need medical treatment. Some people who accidentally took too much Exelon experienced nausea, vomiting, diarrhoea, high blood pressure, and hallucinations. Slowing of the heartbeat and fainting may also occur.
If you forget to take Exelon
If you realize you have missed a dose of Exelon, wait and take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult 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 common when you first start taking the medicine or when the dose is increased. Generally, side effects will gradually disappear as your body gets used to the medicine.

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

Dizziness
Loss of appetite
Stomach disturbances such as nausea or vomiting, diarrhoea

Common (may affect up to 1 in 10 people)

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

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
Rash, itching
Seizures (epileptic fits)
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 fast or slow heartbeat
Bleeding in the intestine – may present as blood in the stool or vomit
Inflammation of the pancreas – may present as severe pain in the upper abdomen, often accompanied by nausea or vomiting
Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty in performing movements

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

Severe vomiting which may lead to rupture of the tube connecting the mouth to the stomach (oesophagus)
Dehydration (excessive loss of fluids)
Liver problems (yellowing of the skin and whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, tiredness and loss of appetite)
Aggression, feeling restless
Irregular heartbeat
Pisa syndrome (a condition involving involuntary muscle contractions causing abnormal bending of the body and head to one side)

Patients with dementia and Parkinson’s disease
These patients more frequently experience certain side effects. They may also experience additional side effects:

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

Tremors
Accidental falls

Common (may affect up to 1 in 10 people)

Anxiety
Feeling restless
Slow and fast heartbeat
Sleep disorders
Excessive salivation and dehydration
Unusual slowing of movements or uncontrollable movements
Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty in performing movements and muscle weakness
Seeing things that are not there (hallucinations)
Depression
High blood pressure

Uncommon (may affect up to 1 in 100 people)

Irregular heartbeat and poor control of movements
Low blood pressure

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

Pisa syndrome (a condition involving involuntary muscle contractions causing abnormal bending of the body and head to one side)
Rash

Other side effects observed with Exelon transdermal patches and which may also 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 you experience any of these symptoms, contact your doctor, as you may require medical assistance.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system referred to 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 carton after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate or freeze.
Store in an upright position.
Use Exelon oral solution within 1 month after opening the bottle.
Do not dispose of 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. Pack contents and other information

What Exelon contains

The active substance is rivastigmine hydrogen tartrate. Each ml contains an amount of rivastigmine hydrogen tartrate equivalent to 2.0 mg of rivastigmine base.
The other components are sodium benzoate (E211), citric acid, sodium citrate, quinoline yellow dye (E104), and purified water.

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

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

Manufacturers
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain