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Exelon (rivastigmine) – Package leaflet - N06DA03

Updated on site: 06-Oct-2017

Medication nameExelon
ATC CodeN06DA03
Substancerivastigmine
ManufacturerNovartis Europharm Ltd

Package leaflet: Information for the user

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

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 further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 Exelon is and what it is used for

The active substance of Exelon is rivastigmine.

Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with

Alzheimer’s dementia or dementia due to Parkinson’s disease, certain nerve cells die in the brain, resulting in 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 levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of

Alzheimer’s disease and dementia associated with Parkinson’s disease.

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

2. What you need to know before you take Exelon

Do not take Exelon

-if you are allergic to rivastigmine (the active substance in Exelon) or any of the other ingredients of this medicine (listed in section 6).

-if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve

within 48 hours after removal of the transdermal patch. If this applies to you, 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, irregular or slow heartbeat.

-if you have, or have ever had, an active stomach ulcer.

-if you have, or have ever had, difficulties in passing urine.

-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 impaired kidney function.

-if you have, or have ever had, impaired liver function.

-if you suffer from trembling.

-if you have a low body weight.

-if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.

If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.

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

Children and adolescents

There is no relevant use of Exelon in the paediatric 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 given at the same time as other medicines with similar effects to Exelon. Exelon might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).

Exelon should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as stiff limbs and trembling hands.

If you have to undergo surgery whilst taking Exelon, tell your doctor before you are given any anaesthetics, because Exelon may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Exelon is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions). Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, the benefits of using Exelon must be assessed against the possible effects on your unborn child. Exelon should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Exelon.

Driving and using machines

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

3.How to take Exelon

Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How to start treatment

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

Treatment usually starts with a low dose.

Your doctor will slowly increase your dose depending on how you respond to treatment.

The highest dose that should be taken is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working for you. Your doctor will also monitor your weight whilst 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 talked to your doctor.

Taking this medicine

Tell 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 evening, with food.

Swallow the capsules whole with a drink.

Do not open or crush 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 attention. Some people who have accidentally taken too much Exelon have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat and fainting may also occur.

If you forget to take Exelon

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

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 medicine or when your dose is increased. Usually, the side effects will slowly go away as your 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 sick (nausea) or being sick (vomiting), diarrhoea

Common (may affect up to 1 in 10 people)

Anxiety

Sweating

Headache

Heartburn

Weight loss

Stomach pain

Feeling agitated

Feeling tired or weak

Generally feeling unwell

Trembling or feeling confused

Decreased appetite

Nightmares

Uncommon (may affect up to 1 in 100 people)

Depression

Difficulty in sleeping

Fainting or accidentally falling

Changes in how well your liver is working

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

Chest pain

Rash, itching

Fits (seizures)

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 are not there (hallucinations)

Problems with your heartbeat such as fast or slow heartbeat

Bleeding in the gut – shows as blood in stools or when being sick

Inflammation of the pancreas – the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)

The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements

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

Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)

Dehydration (losing too much fluid)

Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)

Aggression, feeling restless

Uneven heartbeat

Patients with dementia and Parkinson’s disease

These patients have some side effects more often. They also have some additional side effects:

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

Trembling

Fainting

Accidentally falling

Common (may affect up to 1 in 10 people)

Anxiety

Feeling restless

Slow and fast heartbeat

Difficulty in sleeping

Too much saliva and dehydration

Unusually slow movements or movements you cannot control

The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements and muscle weakness

Uncommon (may affect up to 1 in 100 people)

Uneven heartbeat and poor control of movements

Other side effects seen with Exelon transdermal patches and which may occur with the hard capsules:

Common (may affect up to 1 in 10 people)

Fever

Severe confusion

Urinary incontinence (inability to retain adequate 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 reaction where the patch was used, such as blisters or skin inflammation

If you get any of these side effects, 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 possible side effects not listed in this leaflet. You can also report side effects directly via 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.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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Exelon contains

-The active substance is rivastigmine hydrogen tartrate.

-The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous 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.

What Exelon looks like and contents of the pack

-Exelon 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “EXELON 1,5 mg” on the body.

-Exelon 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “EXELON 3 mg” on the body.

-Exelon 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “EXELON 4,5 mg” on the body.

-Exelon 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “EXELON 6 mg” on the body.

They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country.

Marketing Authorisation holder

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

Manufacturer

Novartis Farmacéutica, S.A.

Planta de Producción

Ronda de Santa Maria 158

E-08210 Barberà del Vallès, Barcelona

Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Novartis Pharma N.V.

Novartis Pharma Services Inc.

Tél/Tel: +32 2 246 16 11

Tel: +370 5 269 16 50

България

Luxembourg/Luxemburg

Novartis Pharma Services Inc.

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. Pharma

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 26 37 82 111

Eesti

Norge

Novartis Pharma Services Inc.

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

United Kingdom

Novartis Pharma Services Inc.

Novartis Pharmaceuticals UK Ltd.

Tel: +371 67 887 070

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

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

Package leaflet: Information for the user

Exelon 2 mg/ml oral solution rivastigmine

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 further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 Exelon is and what it is used for

The active substance of Exelon is rivastigmine.

Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with

Alzheimer’s dementia or dementia due to Parkinson’s disease, certain nerve cells die in the brain, resulting in 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 levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of

Alzheimer’s disease and dementia associated with Parkinson’s disease.

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

2. What you need to know before you take Exelon

Do not take Exelon

-if you are allergic to rivastigmine (the active substance in Exelon) or any of the other ingredients of this medicine (listed in section 6).

-if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve

within 48 hours after removal of the transdermal patch. If this applies to you, 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, irregular or slow heartbeat.

-if you have, or have ever had, an active stomach ulcer.

-if you have, or have ever had, difficulties in passing urine.

-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 impaired kidney function.

-if you have, or have ever had, impaired liver function.

-if you suffer from trembling.

-if you have a low body weight.

-if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.

If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.

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

Children and adolescents

There is no relevant use of Exelon in the paediatric 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 given at the same time as other medicines with similar effects to Exelon. Exelon might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).

Exelon should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as such as stiff limbs and trembling hands.

If you have to undergo surgery whilst taking Exelon, tell your doctor before you are given any anaesthetics, because Exelon may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Exelon is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, the benefits of using Exelon must be assessed against the possible effects on your unborn child. Exelon should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Exelon.

Driving and using machines

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

Important information about some of the ingredients of Exelon

One of the inactive ingredients in Exelon oral solution is sodium benzoate. Benzoic acid is a mild irritant to the skin, eyes and mucous membranes.

3. How to take Exelon

Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How to start treatment

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

Treatment usually starts with a low dose.

Your doctor will slowly increase your dose depending on how you respond to the treatment.

The highest dose that should be taken is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working for you. Your doctor will also monitor your weight whilst 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 talked to your doctor.

Taking this medicine

Tell 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 evening, with food.

How to use this medicine

1.Preparing the bottle and syringe

Take the syringe out of its protective case.

Push down and turn the child resistant cap to open bottle.

2.Attaching the syringe to the bottle

Push the nozzle of the syringe into the hole in the white stopper.

3.Filling the syringe

Pull the plunger upwards until it reaches the right mark for the dose that your doctor has prescribed.

4.Removing bubbles

Push down and pull up the plunger a few times to get rid of any large bubbles.

A few tiny bubbles are not important and will not affect your dose in any way.

Check the dose is still correct.

Then, remove the syringe from the bottle.

5.Taking your medicine

Swallow your medicine straight from the syringe.

You can also mix your medicine with water in a small glass. Stir and drink all of the mixture.

6.After using the syringe

Wipe the outside of the syringe with a clean tissue.

Then, put the syringe back in its protective case.

Put the child resistant cap back on the bottle 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 require medical attention. Some people who have accidentally taken too much Exelon have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat and fainting may also occur.

If you forget to take Exelon

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

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 medicine or when your dose is increased. Usually, the side effects will slowly go away as your 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 sick (nausea) or being sick (vomiting), diarrhoea

Common (may affect up to 1 in 10 people)

Anxiety

Sweating

Headache

Heartburn

Weight loss

Stomach pain

Feeling agitated

Feeling tired or weak

Generally feeling unwell

Trembling or feeling confused

Decreased appetite

Nightmares

Uncommon (may affect up to 1 in 100 people)

Depression

Difficulty in sleeping

Fainting or accidentally falling

Changes in how well your liver is working

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

Chest pain

Rash, itching

Fits (seizures)

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 are not there (hallucinations)

Problems with your heartbeat such as fast or slow heartbeat

Bleeding in the gut – shows as blood in stools or when being sick

Inflammation of the pancreas – the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)

The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements

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

Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)

Dehydration (losing too much fluid)

Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)

Aggression, feeling restless

Uneven heartbeat

Patients with dementia and Parkinson’s disease

These patients have some side effects more often. They also have some additional side effects:

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

Trembling

Fainting

Accidentally falling

Common (may affect up to 1 in 10 people)

Anxiety

Feeling restless

Slow and fast heartbeat

Difficulty in sleeping

Too much saliva and dehydration

Unusually slow movements or movements you cannot control

The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements and muscle weakness

Uncommon (may affect up to 1 in 100 people)

Uneven heartbeat and poor control of movements

Other side effects seen with Exelon transdermal patches and which may occur with the oral solution:

Common (may affect up to 1 in 10 people)

Fever

Severe confusion

Urinary incontinence (inability to retain adequate 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 reaction where the patch was used, such as blisters or skin inflammation

If you get any of these side effects, 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 possible side effects not listed in this leaflet. You can also report side effects directly via 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. 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 of opening the bottle.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Exelon contains

-The active substance is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg.

-The other ingredients are sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye (E104) and purified water.

What Exelon looks like and contents of the pack

Exelon oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug. The oral solution is packaged with an oral dosing syringe in a plastic tube container.

Marketing Authorisation holder

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Novartis Pharma N.V.

Novartis Pharma Services Inc.

Tél/Tel: +32 2 246 16 11

Tel: +370 5 269 16 50

България

Luxembourg/Luxemburg

Novartis Pharma Services Inc.

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. Pharma

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 26 37 82 111

Eesti

Norge

Novartis Pharma Services Inc.

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

United Kingdom

Novartis Pharma Services Inc.

Novartis Pharmaceuticals UK Ltd.

Tel: +371 67 887 070

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

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

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. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Exelon is and what it is used for

2.What you need to know before you use Exelon

3.How to use Exelon

4.Possible side 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 of Exelon is rivastigmine.

Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with

Alzheimer’s dementia, certain nerve cells die in the brain, resulting in 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 levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease.

Exelon is used for the treatment of 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 you use Exelon

Do not use Exelon

-if you are allergic to rivastigmine (the active substance in Exelon) or any of the other ingredients of this medicine (listed in section 6).

-if you have ever had an allergic reaction to a similar type of medicine (carbamate derivatives).

-if you have a skin reaction spreading beyond the patch size, if there is a more intense local

reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch.

If this applies to you, 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, an irregular or slow heartbeat.

-if you have, or have ever had, an active stomach ulcer.

-if you have, or have ever had, difficulties in passing urine.

-if you have, or have ever had, seizures.

-if you have, or have ever had, asthma or a severe respiratory disease.

-if you suffer from trembling.

-if you have a low body weight.

-if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.

-if you have impaired liver function.

If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.

If you have not applied a patch for more than three days, do not apply the next one before you have talked to your doctor.

Children and adolescents

There is no relevant use of Exelon in the paediatric 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 might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson’s disease (e.g. amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).

Exelon Patch should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as stiff limbs and trembling hands.

If you have to undergo surgery whilst using Exelon transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Exelon Patch is given together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, the benefits of using Exelon must be assessed against the possible effects on your unborn child. Exelon should not be used during pregnancy unless clearly necessary.

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

Driving and using machines

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Exelon transdermal patches may cause fainting or severe confusion. If you feel faint or confused do not drive, use machines or perform any other tasks that require your attention.

3.How to use Exelon

Always use Exelon transdermal patches exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

IMPORTANT:

Take off the previous patch before putting ONE new patch on.

Only one patch per day.

Do not cut the patch into pieces.

Press the patch firmly in place for at least 30 seconds using the palm of the hand.

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 h.

The recommended usual daily dose is Exelon 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h.

Only wear one Exelon patch at a time and replace the patch with a new one after 24 hours. During the course of the treatment your doctor may adjust the dose to suit your individual needs.

If you have not applied a patch for more than three days, do not apply the next one before you have talked to your doctor. Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days. Otherwise your doctor will restart your treatment on Exelon

4.6 mg/24 h.

Exelon can be used with food, drink and alcohol.

Where to apply your Exelon transdermal patch

Before you apply a patch, make sure that your skin is clean, dry and hairless, free of any powder, oil, moisturiser or lotion that could keep the patch from sticking to your skin properly, free of cuts, rashes and/or irritations.

Carefully remove any existing patch before putting on a new one. Having multiple patches on your body could expose you to an excessive amount of this medicine which could be potentially dangerous.

Apply ONE patch per day to ONLY ONE of the possible locations shown in the following diagrams:

-left upper arm or right upper arm

-left upper chest or right upper chest (avoid breast)

-left upper back or right upper back

-left lower back or right lower back

Every 24 hours take off the previous patch before putting ONE new patch on to ONLY ONE of the following possible locations.

Front

OR

 

OR

 

OR

 

OR

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Back

OR

OR

OR

 

When changing the patch, you must remove the previous day’s patch before you apply the new one to a different location of skin each time (for example on the right side of your body one day, then on the left side the next day, and on your upper body one day, then on your lower body the next day). Do not apply a new patch to the same skin area twice within 14 days.

How to apply your Exelon transdermal patch

Exelon patches are thin, opaque, plastic patches that stick to the skin. Each patch is sealed in a sachet that protects it until you are ready to put it on. Do not open the sachet or remove a patch until just before you apply it.

Carefully remove the existing patch before putting on a new one.

For patients starting treatment for the first time and for patients restarting Exelon after treatment interruption, please begin with the second picture.

-Each patch is sealed in its own protective sachet.

You should only open the sachet when you are ready to apply the patch.

Cut the sachet along the dotted line with scissors and remove the patch from the sachet.

-A protective liner covers the sticky side of the patch.

Peel off one side of the protective liner and do not touch the sticky part of the patch with the fingers.

-Put the sticky side of the patch on the upper or lower back, upper arm or chest and then peel off the second side of the protective liner.

-Then press the patch firmly in place for at least 30 seconds using the palm of the hand to make sure that the edges stick well.

If it helps you, you may write, for example, the day of the week, on the patch with a thin ball point pen.

The patch should be worn continuously until it is time to replace it with a new one. You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.

How to remove your Exelon transdermal patch

Gently pull at one edge of the patch to remove it slowly from the skin. In case the adhesive residue is left over on your skin, gently soak the area with warm water and mild soap or use baby oil to remove it. Alcohol or other dissolving liquids (nail polish remover or other solvents) should not be used.

You should wash your hands with soap and water after removing the patch. In case of contact with eyes or if the 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 when you are bathing, swimming, or in the sun?

Bathing, swimming or showering should not affect the patch. Make sure the patch does not loosen during these activities.

Do not expose the patch to any external heat sources (e.g. excessive sunlight, saunas, solarium) for long periods of time.

What to do if a patch falls off

If a patch falls off, apply a new one for the rest of the day, then replace it at the same time as usual the next day.

When and for how long to apply your Exelon transdermal patch

To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.

Only wear one Exelon patch at a time and replace the patch 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 the patches from your skin, then inform your doctor that you have accidentally applied more than one patch. You may require medical attention. Some people who have accidentally taken too much Exelon have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat and fainting may also occur.

If you forget to use Exelon

If you find you have forgotten to apply a patch, apply one immediately. You may apply the next patch at the usual time the next day. Do not apply two patches to make up for the one that you missed.

If you stop using Exelon

Tell your doctor or pharmacist if you stop using the patch.

If you have any further questions on 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 everybody gets them.

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

Take off your patch and tell your doctor straight away, if you notice any of the following side effects which could become serious:

Common (may affect up to 1 in 10 people)

Loss of appetite

Feeling dizzy

Feeling agitated or sleepy

Urinary incontinence (inability to retain adequate urine)

Uncommon (may affect up to 1 in 100 people)

Problems with your heartbeat such as slow heartbeat

Seeing things that are not really there (hallucinations)

Stomach ulcer

Dehydration (losing too much fluid)

Hyperactivity (high level of activity, restlessness)

Aggression

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

Falling

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

Stiff arms or legs

Trembling hands

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

Allergic reaction where the patch was used, such as blisters or inflamed skin

The signs of Parkinson’s disease get worse – such as tremor, stiffness and shuffling

Inflammation of the pancreas – signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)

Fast or uneven heartbeat

High blood pressure

Fits (seizures)

Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)

Changes in tests which show how well the liver is working

Feeling restless

Nightmares

Take off your patch and tell your doctor straight away, if you notice any of the side effects above.

Other side effects seen with Exelon capsules or oral solution and which may occur with the patch:

Common (may affect up to 1 in 10 people)

Too much saliva

Loss of appetite

Feeling restless

Generally feeling unwell

Trembling or feeling confused

Increased sweating

Uncommon (may affect up to 1 in 100 people)

Uneven heart rate (e.g. fast heart rate)

Difficulty sleeping

Accidental falls

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

Fits (seizures)

Ulcer in the intestine

Chest pain – this may be caused by heart spasm

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

High blood pressure

Inflammation of the pancreas – the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)

Bleeding in the gut – shows as blood in stools or when being sick

Seeing things that are not there (hallucinations)

Some people who have been violently sick have had tearing of the tube that connects your mouth with your stomach (oesophagus)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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. 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 and sachet after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Keep the transdermal patch in the sachet until use.

Do not use any patch that is damaged or shows signs of tampering.

After removing a patch, fold it in half with the sticky sides on the inside and press them together. Return the used patch to its sachet and dispose of it in such a way that children cannot handle it. Do not touch your eyes with your fingers and wash your hands with soap and water after removing the patch. If your community burns domestic rubbish, you can dispose of the patch with your domestic rubbish. Otherwise, return used patches to a pharmacy, preferably in the original packaging.

6. Contents of the pack and other information

What Exelon contains

-The active substance is rivastigmine.

-Exelon 4.6 mg/24 h transdermal patches: Each patch releasing 4.6 mg of rivastigmine per 24 hours is 5 cm2 and contains 9 mg of rivastigmine.

-Exelon 9.5 mg/24 h transdermal patches: Each patch releasing 9.5 mg of rivastigmine per 24 hours is 10 cm2 and contains 18 mg of rivastigmine.

-Exelon 13.3 mg/24 h transdermal patches: Each patch releasing 13.3 mg of rivastigmine per 24 hours is 15 cm2 and contains 27 mg of rivastigmine.

-The other ingredients are polyethylene terephthalate film lacquered, alpha-tocopherol, poly(butylmethacrylate, methylmethacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymer-coated.

What Exelon looks like and contents of the pack

Each transdermal patch is a thin patch consisting of three layers. The outer layer is beige and labelled with the following:

-“Exelon”, “4.6 mg/24 h” and “AMCX”,

-“Exelon”, “9.5 mg/24 h” and “BHDI”,

-“Exelon”, “13.3 mg/24 h” and “CNFU”.

One transdermal patch is sealed in one sachet.

Exelon 4.6 mg/24 h transdermal patches and Exelon 9.5 mg/24 h transdermal patches are available in packs containing 7, 30 or 42 sachets and in 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 in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Novartis Pharma N.V.

Novartis Pharma Services Inc.

Tél/Tel: +32 2 246 16 11

Tel: +370 5 269 16 50

България

Luxembourg/Luxemburg

Novartis Pharma Services Inc.

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. Pharma

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 26 37 82 111

Eesti

Norge

Novartis Pharma Services Inc.

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

United Kingdom

Novartis Pharma Services Inc.

Novartis Pharmaceuticals UK Ltd.

Tel: +371 67 887 070

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

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

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION

TO THE TERMS OF THE MARKETING AUTHORISATION

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR for rivastigmine, the scientific conclusions of CHMP are as follows:

Cardiac arrhythmia

Cardiac arrhythmia / bradycardia are listed adverse reactions for rivastigmine.

During the reporting period, 2 cases of torsade de pointe have been reported. Of these 2 cases of torsade de pointes with positive dechallenge after dose reduction or discontinuation of rivastigmine, the causal role of rivastigmine due to its bradycardia-related adverse event could not be ruled out despite the confounding factors in these cases (venlafaxine, tiapride).

Rivastigmine is known to induce bradycardia which constitutes a risk factor of QT prolongation and post-marketing cases of cardiac arrhythmia have been reported with the use of rivastigmine, especially in patients with other risk factors for QTc prolongation / Torsade de pointes (TdP) (concomitant treatments known to induce TdP, relevant cardiac disorders).

Nightmares

During the reporting period 35 cases of nightmares were reported and 324 cumulatively (124 with oral formulations, 176 with patch formulations, 16 with unknown formulation and 4 with oral plus patch formulation). 26 relevant cases with positive dechallenge after discontinuation or dose reduction or positive rechallenge were identified. When documented the temporal relationship between the event onset and the start of rivastigmine indicates a causal relationship.

Due to the scientific literature, the significant proportional reporting ratio (PRR) for nightmares in EudraVigilance, data from clinical trials with oral formulation and post-marketing cases with both formulations, the PRAC agreed to add “nightmares” as adverse reaction in section 4.8 of the SmPC with frequency “not known” for the patch formulation and frequency “common” for oral formulations of rivastigmine-containing medicines.

Therefore, in view of available data regarding cardiac arrhythmia and nightmares, the PRAC considered that changes to the product information were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds recommending the variation to the terms of the Marketing Authorisation

On the basis of the scientific conclusions for rivastigmine the CHMP is of the opinion that the benefit-risk balance of the medicinal products containing rivastigmine is favourable subject to the proposed changes to the product information.

The CHMP recommends that the terms of the Marketing Authorisations should be varied.

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