EXELON 1.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Exelon 1.5mg hard capsules

Exelon 3.0mg hard capsules

Exelon 4.5mg hard capsules

Exelon 6.0mg hard capsules

rivastigmine

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Exelon and what is it used for
2. What you need to know before you start taking Exelon
3. How to take Exelon
4. Possible side effects
5. Storage of Exelon
6. Contents of the pack and further information

1. What is Exelon and what is it used for

The active substance in Exelon is rivastigmine.

Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with Alzheimer's dementia or dementia associated with Parkinson's disease, certain nerve cells die in the brain, causing low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Exelon allows an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Exelon is used to treat adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability, and behavior. The capsules and oral solution can also be used to treat dementia in adult patients with Parkinson's disease.

2. What you need to know before you start taking Exelon

Do not take Exelon

• if you are allergic to rivastigmine (the active substance of Exelon) or any of the other ingredients of this medicine (listed in section 6).
• if you have a skin reaction that spreads beyond the size of the patch, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if there is no improvement within 48 hours after removing the transdermal patch.

If you are in one of these situations, inform your doctor and do not take Exelon.

Warnings and precautions

Talk to your doctor before starting to take Exelon:

• if you have or have ever had an irregular or slow heart rate (pulse).

• 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.
• if you have or have ever had asthma or severe respiratory disease.
• if you have or have ever had kidney function impairment.
• if you have or have ever had liver function impairment.
• if you suffer from tremors.
• if you have low body weight.
• if you have gastrointestinal reactions such as a feeling of nausea, vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged.

If you are in one of these situations, your doctor may consider it necessary to monitor you more closely while you are taking Exelon.

If you have not taken Exelon for more than three days, do not take the next dose until you have consulted your doctor.

Children and adolescents

Exelon should not be used in the pediatric population for 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 at the same time as other medicines with similar effects to those of Exelon. Exelon may interfere with anticholinergic medicines (used to relieve stomach cramps or spasms, for the treatment of Parkinson's disease, or to prevent travel sickness).

Exelon should 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 problems such as stiffness in the limbs and hand tremors.

If you need to undergo surgery while taking Exelon, inform your doctor before you are given any anesthetic, as Exelon may exaggerate the effects of some muscle relaxants during anesthesia.

Caution should be exercised when using Exelon with beta blockers (medicines such as atenolol used to treat high blood pressure, angina, and other heart conditions). Taking the two medicines together may cause complications such as a decrease in heart rate (bradycardia) that can lead to fainting or loss of consciousness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, it is necessary to evaluate the benefits of using Exelon against the possible risks to the fetus. Exelon should not be used during pregnancy unless clearly necessary.

You should not breastfeed while taking Exelon.

Driving and using machines

Your doctor will inform you whether your illness allows you to drive or use machines safely. Exelon may cause dizziness and somnolence, mainly at the start of treatment or when the dose is increased. If you feel dizzy or drowsy, do not drive or use machines, or perform other tasks that require your attention.

3. How to take Exelon

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor, pharmacist, or nurse again.

How to start treatment

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

• Normally, treatment starts with a low dose.
• Your doctor will gradually increase the dose depending on how you respond to treatment.
• The highest dose you should take is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working for you. Your doctor will also check your weight while you are taking this medicine.

If you have not taken Exelon for more than three days, do not take the next dose until you have consulted your doctor.

Taking this medicine

• Inform your caregiver that you are taking Exelon.
• To benefit from your medicine, take it every day.

• Take Exelon twice a day (in the morning and in the evening), with meals.
• Swallow the capsule whole with the help of liquid.
• Do not open or crush the capsule.

If you take more Exelon than you should

If you accidentally take more Exelon than you should, talk to your doctor. You may need medical attention. Some people who have accidentally taken higher doses have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. There may also be a slowing of the heart rate and fainting.

If you forget to take Exelon

If you miss a dose of Exelon, wait and take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you have any further questions on 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.

You may have side effects more often when you start your treatment or when your dose is increased. Generally, side effects will slowly disappear as your body gets used to the medicine.

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

• Nausea
• Loss of appetite
• Stomach problems such as 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
• Feeling of general discomfort
• Tremor or feeling of confusion
• Decreased appetite
• Nightmares

Uncommon(may affect up to 1 in 100 people)

• Depression
• Difficulty sleeping
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Skin rash, itching
• Epileptic seizures (convulsions)
• Ulcers in your stomach or intestine

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

• High blood pressure
• Urinary tract infection
• Seeing things that do not exist (hallucinations)
• Heart rate problems such as fast or slow heart rate
• Gastrointestinal bleeding – appears as blood in the stool or when vomiting
• Pancreatitis – signs include severe pain in the upper abdomen, often with nausea or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving

Not known(cannot be estimated from the available data)

• Severe vomiting that can cause a tear in the tube that connects your mouth to your stomach (esophagus)
• Dehydration (loss of a large amount of fluid)
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormal darkening of urine or unexplained nausea, vomiting, tiredness, and loss of appetite)
• Aggression, feeling of restlessness
• Irregular heart rate

Patients with dementia or Parkinson's disease

These patients experience some side effects more frequently and also have some additional side effects:

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

• Tremor
• Fainting
• Accidental falls

Common(may affect up to 1 in 10 people)

• Anxiety
• Feeling of restlessness
• Fast and slow heart rate
• Difficulty sleeping
• Excessive saliva and dehydration
• Abnormally slow or uncontrolled movements
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving, and muscle weakness

Uncommon(may affect up to 1 in 100 people)

• Irregular heart rate and loss of movement control

Other side effects observed with Exelon transdermal patches and that may appear with hard capsules:

Common(may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to properly control urine)

Uncommon(may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

Not known(cannot be estimated from the available data)

• Allergic reaction where the patch was applied, such as blisters or skin inflammation

If you experience any of these side effects, contact your doctor, as you may need medical attention.

Reporting of side effects

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

5. Storage of 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 pack after EXP. The expiry date is the last day of the month stated.
• Do not store above 30°C.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

Exelon Composition

• The active ingredient is rivastigmine hydrogen tartrate.
• The other components are hypromellose, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, 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.

Product Appearance and Container Contents

• Exelon 1.5 mg hard capsules, contain a white to slightly yellowish powder, have a yellow cap and body with a red printed mark "EXELON 1.5 mg" on the body.
• Exelon 3.0 mg hard capsules, contain a white to slightly yellowish powder, have an orange cap and body with a red printed mark "EXELON 3 mg" on the body.

• Exelon 4.5 mg hard capsules, contain a white to slightly yellowish powder, have a red cap and body with a white printed mark "EXELON 4.5 mg" on the body.
• Exelon 6.0 mg hard capsules, contain a white to slightly yellowish powder, have a red cap and an orange body with a red printed mark "EXELON 6 mg" on the body.

It is packaged in blisters and is available in three different presentations (28, 56 or 112 capsules) and plastic bottles of 250 capsules, not all of which may be available in your country.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica, S.A.

Production Plant

Ronda de Santa Maria 158

E-08210 Barberà del Vallès, Barcelona

Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus:

Other Sources of Information

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu