Exelon 13.3 mg/24 h transdermal patch

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Exelon 4.6 mg/24 h transdermal patch

Exelon 9.5 mg/24 h transdermal patch

Exelon 13.3 mg/24 h transdermal patch

rivastigmine

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Exelon is and what it is used for

The active substance in Exelon is rivastigmine.

Rivastigmine belongs to a group of medicines called cholinesterase inhibitors. In patients with Alzheimer's dementia, certain nerve cells in the brain die, resulting in low levels of the neurotransmitter acetylcholine (a substance that enables nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, Exelon increases the levels of acetylcholine in the brain, helping to reduce the symptoms of Alzheimer'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 behaviour.

2. What you need to know before using Exelon

Do not use 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 ever had an allergic reaction to a similar medicine (carbamate derivatives).
• if you experience a skin reaction that spreads beyond the size of the patch, if you have a more intense local reaction (such as blisters, increasing skin irritation, swelling), or if there is no improvement within 48 hours after removing the transdermal patch.

If any of these situations apply to you, inform your doctor and do not use Exelon transdermal patches.

Warnings and precautions

Talk to your doctor before starting to use Exelon:

• if you have or have ever had an irregular or slow heart rate (pulse).
• if you have or have ever had active stomach ulcer.
• if you have or have ever had difficulties in urinating.
• if you have or have ever had seizures.
• if you have or have ever had asthma or a serious respiratory disease.
• if you suffer from tremors.
• if you have low body weight.
• if you have gastrointestinal reactions such as nausea, vomiting, and diarrhea. You may become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea is prolonged.
• if you have liver problems (hepatic insufficiency).

If any of these situations apply to you, your doctor may consider it necessary to monitor you more closely during treatment.

If you have not used the patches for more than three days, do not apply a new one without first consulting 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 need to take any other medicines.

Exelon may interfere with anticholinergic medicines, some of which are used to relieve stomach cramps or spasms (e.g. dicyclomine), for the treatment of Parkinson's disease (e.g. amantadine), or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).

Exelon transdermal patches must not be administered at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause problems such as stiffness in the limbs and hand tremors.

If you need to undergo surgery while using Exelon transdermal patches, inform your doctor that you are using this medicine, as it may excessively enhance the effects of certain muscle relaxants used during anesthesia.

Caution is advised when using Exelon transdermal patches together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking both medicines together may cause complications such as a decreased heart rate (bradycardia), which may lead to fainting or loss of consciousness.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant, the benefits of using Exelon must be weighed against the potential risks to the fetus. Exelon should not be used during pregnancy unless clearly necessary.

You must not breast-feed during treatment with Exelon transdermal patches.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Exelon transdermal patches may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive or operate machinery, or perform any other tasks requiring your attention.

3. How to use Exelon

Follow exactly the administration instructions for Exelon transdermal patches as given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

IMPORTANT:

• Remove the previous patch before applying a new one.
• One patch per day only.
• Do not cut the patch into pieces.
• Press the patch firmly onto the skin with the palm of your hand for at least 30 seconds.

How to start treatment

Your doctor will determine the most appropriate Exelon transdermal patch dose for you.

• Treatment is usually started with Exelon 4.6 mg/24 h.
• The usual recommended daily dose is Exelon 9.5 mg/24 h. If this dose is well tolerated, your treating doctor may consider increasing the dose to 13.3 mg/24 h.
• Wear only one Exelon patch at a time and replace the patch with a new one every 24 hours.

During treatment, your doctor may adjust the dose according to your individual needs.

If you have not used the patches for more than three days, do not apply a new one without first consulting your doctor. Transdermal patch treatment may be restarted at the same dose if the treatment interruption lasted no more than three days. Otherwise, your doctor will instruct you to restart treatment with Exelon 4.6 mg/24 h.

Exelon may be used with food, drink, and alcohol.

Where to apply your Exelon transdermal patch

• Before applying a patch, make sure the skin is clean, dry, and hair-free, without powders, oils, moisturizers, or lotions that may prevent the patch from adhering properly, and without cuts, redness, or irritation.

• Carefully remove any existing patch before applying a new one. Wearing multiple patches on your body could expose you to an excessive amount of this medication, which could be potentially dangerous.

• Apply only ONE patch per day to ONE of the following areas, as shown in the diagrams below:

• upper left or upper right arm

• upper left or upper right side of the chest (avoiding the breasts in women)

• upper left or upper right side of the back

• lower left or lower right side of the back

Each time the patch is changed, the previous day's patch must be removed before applying the new patch to a different skin site (for example, one day on the right side of the body and the next day on the left side; or one day on the upper part of the body and the next day on the lower part). Wait at least 14 days before applying a new patch to exactly the same skin area again.

How to apply your Exelon transdermal patch

Exelon patches are thin, opaque plastic patches that adhere to the skin. Each patch is kept in a protective pouch until ready to use. Do not open the pouch or remove the patch until the moment of application.

You must wear the patch continuously until it is time to replace it with a new one. When applying a new patch, you may try different areas to find those that are most comfortable for you and where clothing does not rub against the patch.

How to remove your Exelon transdermal patch

Gently pull one edge of the patch to slowly peel it off the skin. If adhesive residue remains on the skin, soak the area with warm water and mild soap or use baby oil to remove it. Do not use alcohol or other solvent liquids (such as nail polish remover or other solvents).

After removing the patch, wash your hands with soap and water. If you accidentally get the medication in your eyes or if your eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.

Can you wear your Exelon transdermal patch while bathing, swimming, or in the sun?

• Bathing, swimming, or showering should not affect the patch. Make sure it does not partially detach during these activities.

• Do not expose the patch to external sources of heat (e.g., excessive sunlight, sauna, sunbed) for prolonged periods.

What to do if your patch falls off

If your patch falls off, apply a new one for the remainder of that day and change it at your usual time the next day.

When and for how long you should apply your Exelon transdermal patch

• To benefit from your treatment, you must apply a new patch every day, preferably at the same time each day.
• Wear only one Exelon patch at a time and replace the patch with a new one every 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. You may require medical attention. Some people who have accidentally taken excessive oral doses of Exelon have experienced feeling unwell (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. A slowing of heart rate and fainting may also occur.

If you forget to use Exelon

If you realize you forgot to apply a patch, do so as soon as possible. The next day, apply the following patch at your usual time. Do not apply two patches to make up for the missed one.

If you stop using Exelon

Inform your doctor or pharmacist if you discontinue use of the patches.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Exelon transdermal patches may cause adverse effects, although not everyone experiences them.

You may experience adverse effects more frequently when starting treatment or when your dose is increased. Generally, adverse effects will gradually disappear as your body gets used to the medicine.

If you notice any of the following adverse effects, which may be serious, remove the patch and inform your doctor immediately.

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heart rate
• Seeing things that are not really there (hallucinations)
• Stomach ulcer
• Dehydration (loss of large amounts of fluid)
• Hyperactivity (high level of activity, restlessness)
• Aggressiveness

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

• Falls

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

• Stiffness of arms and legs
• Tremor in hands

Not known (frequency cannot be estimated from available data)

• Allergic reaction at the site of patch application, such as blisters or skin inflammation
• Worsening of signs of Parkinson's disease – such as tremor, stiffness, and difficulty moving
• Inflammation of the pancreas – signs include pain in the upper part of the stomach, frequently accompanied by nausea or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Epileptic seizures (convulsions)
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, tiredness, and loss of appetite)
• Changes in blood tests showing liver function
• Feeling of restlessness
• Nightmares

If you notice any of the adverse effects listed above, remove the patch and inform your doctor immediately.

Other adverse effects experienced with Exelon capsules or oral solution and which may also occur with the patches:

Frequent (may affect up to 1 in 10 people)

• Excessive saliva
• Loss of appetite
• Feeling agitated
• General feeling of being unwell
• Tremor or confusion
• Increased sweating

Uncommon (may affect up to 1 in 100 people)

• Irregular heart rhythm (e.g. fast heartbeat)
• Difficulty sleeping
• Accidental falls

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

• Epileptic seizures (convulsions)
• Intestinal ulcer
• Chest pain – likely caused by spasm in the heart

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

• High blood pressure
• Inflammation of the pancreas – signs include severe pain in the upper part of the stomach, frequently with nausea or vomiting
• Gastrointestinal bleeding – manifested as blood in stools or in vomit
• Seeing things that are not there (hallucinations)
• Some people who have experienced severe vomiting have had a tear in part of the digestive tube connecting the mouth to the stomach (esophagus)

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton and on the sachet after CAD/EXP. The expiry date refers to the last day of the month indicated.

• Do not store above 25°C.

• Keep the transdermal patch inside the sachet until use.

• Do not use any patch if it appears damaged or shows signs of tampering.

• After removing a patch, fold it in half with the adhesive side inwards and press together. After placing it back into the original sachet, dispose of the patch safely and ensure it remains out of the reach of children. After removing the patch, avoid touching the eyes and wash hands thoroughly with water and soap. If your household waste is disposed of by incineration, you may discard the patch in your home trash. Otherwise, return used patches to the pharmacy, preferably in the original packaging.

6. Contents of the pack and other information

Composition of Exelon

• The active substance is rivastigmine.

• Exelon 4.6 mg/24 h transdermal patch: Each patch delivers 4.6 mg of rivastigmine over 24 hours, measures 5 cm² and contains 9 mg of rivastigmine.

• Exelon 9.5 mg/24 h transdermal patch: Each patch delivers 9.5 mg of rivastigmine over 24 hours, measures 10 cm² and contains 18 mg of rivastigmine.

• Exelon 13.3 mg/24 h transdermal patch: Each patch delivers 13.3 mg of rivastigmine over 24 hours, measures 15 cm² and contains 27 mg of rivastigmine.

• The other components are lacquered polyethylene terephthalate film, alpha tocopherol, poly(butyl methacrylate, methyl methacrylate), acrylic copolymer, silicone oil, dimethicone, fluoropolymer-coated polyester film.

Appearance of the product and contents of the pack

Thin transdermal patch composed of three layers. The outer layer is beige in colour and marked with:

• «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 sachet contains one transdermal patch.

Exelon 4.6 mg/24 h transdermal patch and Exelon 9.5 mg/24 h transdermal patch are available in packs containing 7, 30 or 42 sachets and multipacks containing 60, 84 or 90 sachets.

Exelon 13.3 mg/24 h transdermal patches are available in packs containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg
Germany

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

Date of the most recent review of this leaflet:

Other sources of information

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