rivastigmine: package leaflet

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.

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, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
- 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.

Caution when Exelon is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

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.

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.

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
- Sleepiness

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

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
- 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
- Seeing things that are not there (hallucinations)
- Depression
- High blood pressure

Uncommon (may affect up to 1 in 100 people)
- Uneven 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 contraction with abnormal bending of the body and head to one side)
- Skin rash

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.

• 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.

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) but these may not all be available in your country.

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

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

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

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

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

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

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

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

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

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00
Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111
Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00
Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570
España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Ísland
Vistor hf.
Sími: +354 535 7000

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

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

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

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

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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

• Take the syringe out of its protective case.
• Push down and turn the child resistant cap to open bottle.

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

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

• 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.

• 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.

• 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
- Sleepiness

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

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
- 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
- Seeing things that are not there (hallucinations)
- Depression
- High blood pressure

Uncommon (may affect up to 1 in 100 people)
- Uneven 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 contraction with abnormal bending of the body and head to one side)
- Skin rash

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 (E211), 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
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
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

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

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

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

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

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

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

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00
Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111
Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00
Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570
España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Ísland
Vistor hf.
Sími: +354 535 7000

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

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

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

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

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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

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.

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, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
- 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.

Caution when Exelon is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

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.

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

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.

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.

Left or right upper arm
Left or right side of chest
Side
Front
Back
Back
Left or right upper back
Left or right lower back
OR
OR
OR
OR

- 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
- Urinary incontinence (inability to retain adequate urine)
- Urinary tract infection
- Anxiety
- Depression
- Confusion
- Headache
- Fainting
- Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
- Heartburn
- Stomach pain
- Rash
- Allergic reaction where the patch was used, such as blisters or inflamed skin
- Feeling tired or weak
- Weight loss
- Fever

Uncommon (may affect up to 1 in 100 people)
- Problems with your heartbeat such as slow heartbeat
- 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 and trembling hands

Not known (frequency cannot be estimated from the available data)
- 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
- Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side)
- Seeing things that are not there (hallucinations)
- Trembling
- Sleepiness
- Rash, itching
- Skin reddening
- Blisters

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
- Feeling restless
- Generally feeling unwell
- Trembling
- 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.

- 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. 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.

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
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
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

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

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

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

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

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

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

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00
Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111
Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00
Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570
España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

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

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

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Ísland
Vistor hf.
Sími: +354 535 7000

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

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

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

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

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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

The active substance of Prometax 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, Prometax 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.

Prometax 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.

Do not take Prometax
- if you are allergic to rivastigmine (the active substance in Prometax) 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 Prometax.

Warnings and precautions
Talk to your doctor before taking Prometax:
- if you have, or have ever had, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
- 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 Prometax 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 Prometax in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Prometax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Prometax should not be given at the same time as other medicines with similar effects to Prometax.
Prometax might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).

Prometax 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 Prometax, tell your doctor before you are given any anaesthetics, because Prometax may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Prometax 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.

Caution when Prometax is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

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 Prometax must be assessed against the possible effects on your unborn child. Prometax should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Prometax.

Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Prometax 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.

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 Prometax 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 Prometax 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 Prometax.
- To benefit from your medicine, take it every day.
- Take Prometax 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 Prometax than you should
If you accidentally take more Prometax than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Prometax 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 Prometax
If you find you have forgotten to take your dose of Prometax, 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.

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
- Sleepiness

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

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
- 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
- Seeing things that are not there (hallucinations)
- Depression
- High blood pressure

Uncommon (may affect up to 1 in 100 people)
- Uneven 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 contraction with abnormal bending of the body and head to one side)
- Skin rash

Other side effects seen with Prometax 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.

• 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.

What Prometax 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 Prometax 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Prometax 3.0 mg capsule contains 3.0 mg of rivastigmine.
Each Prometax 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Prometax 6.0 mg capsule contains 6.0 mg of rivastigmine.

What Prometax looks like and contents of the pack
- Prometax 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on the body.
- Prometax 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 “ENA 713 3 mg” on the body.
- Prometax 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 “ENA 713 4,5 mg” on the body.
- Prometax 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 “ENA 713 6 mg” on the body.
They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) but these may not all be available in your country.

Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain

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

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany

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

België/Belgique/Belgien, България, Česká republika, Danmark, Deutschland, Eesti, Ελλάδα, España, France, Hrvatska, Ireland, Ísland, Italia, Κύπρος, Latvija, Lietuva, Luxembourg/Luxemburg, Magyarország, Malta, Nederland, Norge, Österreich, Polska, Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige Almirall, S.A.
Tél/Tel/Teл./Tlf./Τηλ/Sími/Tel./Tlf/Puh: +34 93 291 30 00

This leaflet was last revised in

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

• Take the syringe out of its protective case.
• Push down and turn the child resistant cap to open bottle.

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

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

• 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.

• 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.

• 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 Prometax than you should
If you accidentally take more Prometax than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Prometax 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 Prometax
If you find you have forgotten to take your dose of Prometax, 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
- Sleepiness

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

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
- 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
- Seeing things that are not there (hallucinations)
- Depression
- High blood pressure

Uncommon (may affect up to 1 in 100 people)
- Uneven 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 contraction with abnormal bending of the body and head to one side)
- Skin rash

Other side effects seen with Prometax 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 Prometax

• 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 Prometax 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 Prometax 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 (E211), citric acid, sodium citrate, quinoline yellow WS dye (E104) and purified water.

What Prometax looks like and contents of the pack
Prometax 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
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain

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

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany

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

België/Belgique/Belgien, България, Česká republika, Danmark, Deutschland, Eesti, Ελλάδα, España, France, Hrvatska, Ireland, Ísland, Italia, Κύπρος, Latvija, Lietuva, Luxembourg/Luxemburg, Magyarország, Malta, Nederland, Norge, Österreich, Polska, Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige Almirall, S.A.
Tél/Tel/Teл./Tlf./Τηλ/Sími/Tel./Tlf/Puh: +34 93 291 30 00

This leaflet was last revised in

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

The active substance of Prometax 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, Prometax allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease.

Prometax 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.

Do not use Prometax
- if you are allergic to rivastigmine (the active substance in Prometax) 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 Prometax transdermal patches.

Warnings and precautions
Talk to your doctor before using Prometax:
- if you have, or have ever had, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
- 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 Prometax in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Prometax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Prometax 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).

Prometax 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 Prometax transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Prometax 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.

Caution when Prometax is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

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 Prometax must be assessed against the possible effects on your unborn child. Prometax should not be used during pregnancy unless clearly necessary.

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

Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Prometax 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.

Always use Prometax 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 Prometax transdermal patch is most suitable for you.
- Treatment usually starts with Prometax 4.6 mg/24 h.
- The recommended usual daily dose is Prometax 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 Prometax 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 Prometax

Prometax can be used with food, drink and alcohol.

Where to apply your Prometax 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.

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 Prometax transdermal patch
Prometax 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 Prometax 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.

Left or right upper back
Left or right lower back
Left or right upper arm
Left or right side of chest
OR
OR
OR
OR
Side
Front
Back
Back

- 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 Prometax 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 Prometax 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 Prometax transdermal patch
- To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
- Only wear one Prometax patch at a time and replace the patch with a new one after 24 hours.

If you use more Prometax 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 Prometax 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 Prometax
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 Prometax
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, Prometax 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
- Urinary incontinence (inability to retain adequate urine)
- Urinary tract infection
- Anxiety
- Depression
- Confusion
- Headache
- Fainting
- Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
- Heartburn
- Stomach pain
- Rash
- Allergic reaction where patch was used, such as blisters or inflamed skin
- Feeling tired or weak
- Weight loss
- Fever

Uncommon (may affect up to 1 in 100 people)
- Problems with your heartbeat such as slow heartbeat
- 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 and trembling hands

Not known (frequency cannot be estimated from the available data)
- 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
- Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side)
- Seeing things that are not really there (hallucinations)
- Trembling
- Sleepiness
- Rash, itching
- Skin reddening
- Blisters

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

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

Common (may affect up to 1 in 10 people)
- Too much saliva
- Feeling restless
- Generally feeling unwell
- Trembling
- 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.

- 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. 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.

What Prometax contains
- The active substance is rivastigmine.
- Prometax 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.
- Prometax 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.
- Prometax 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 Prometax 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:
- “Prometax”, “4.6 mg/24 h” and “AMCX”,
- “Prometax”, “9.5 mg/24 h” and “BHDI”,
- “Prometax”, “13.3 mg/24 h” and “CNFU”.

One transdermal patch is sealed in one sachet. The 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
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain

Manufacturer
LTS Lohmann Therapie- Systeme AG
Lohmannstrasse 2
56626 Andernach
Germany

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

België/Belgique/Belgien, България, Česká republika, Danmark, Deutschland, Eesti, Ελλάδα, España, France, Hrvatska, Ireland, Ísland, Italia, Κύπρος, Latvija, Lietuva, Luxembourg/Luxemburg, Magyarország, Malta, Nederland, Norge, Österreich, Polska, Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige Almirall, S.A.
Tél/Tel/Teл./Tlf./Τηλ/Sími/Tel./Tlf/Puh: +34 93 291 30 00

This leaflet was last revised in

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu

The active substance of Rivastigmine 1 A Pharma is rivastigmine.

Rivastigmine 1 A Pharma 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, Rivastigmine 1 A Pharma 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.

Rivastigmine 1 A Pharma 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.

Do not take Rivastigmine 1 A Pharma
- if you are allergic to rivastigmine (the active substance of Rivastigmine 1 A Pharma) or any of the other ingredients of this medicine (listed in section 6).
- if you have had a previous skin reaction suggestive of allergic contact dermatitis with rivastigmine.

If this applies to you, tell your doctor and do not take Rivastigmine 1 A Pharma.

Warnings and precautions
Talk to your doctor before taking Rivastigmine 1 A Pharma
- if you have, or have ever had a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
- 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 Rivastigmine 1 A Pharma 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 Rivastigmine 1 A Pharma in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Rivastigmine 1 A Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Rivastigmine 1 A Pharma should not be given at the same time as other medicines with similar effects to Rivastigmine 1 A Pharma. Rivastigmine 1 A Pharma might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).

Rivastigmine 1 A Pharma 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 Rivastigmine 1 A Pharma, you should tell your doctor before you are given any anaesthetics, because Rivastigmine 1 A Pharma may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Rivastigmine 1 A Pharma 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.

Caution when Rivastigmine 1 A Pharma is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

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 Rivastigmine 1 A Pharma must be assessed against the possible effects on your unborn child. Rivastigmine 1 A Pharma should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Rivastigmine 1 A Pharma.

Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Rivastigmine 1 A Pharma 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.

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 Rivastigmine 1 A Pharma 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 Rivastigmine 1 A Pharma 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 Rivastigmine 1 A Pharma.

To benefit from your medicine, take it every day.

Take Rivastigmine 1 A Pharma 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 Rivastigmine 1 A Pharma than you should
If you accidentally take more Rivastigmine 1 A Pharma than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine 1 A Pharma 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 Rivastigmine 1 A Pharma
If you find you have forgotten to take your dose of Rivastigmine 1 A Pharma, 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.

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

Sleepiness

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

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  Seeing things that are not there (hallucinations)  Depression  High blood pressure

Uncommon (may affect up to 1 in 100 people)

Uneven 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 contraction with abnormal bending of the body and head to one side)  Skin rash

Other side effects seen with 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.

Keep this medicine out of the sight and reach of children.

Do not use Rivastigmine 1 A Pharma after the expiry date which is stated on the blister, bottle and 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.

What Rivastigmine 1 A Pharma contains
- The active substance is rivastigmine.
- The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide , red iron oxide , titanium dioxide and shellac.

Each Rivastigmine 1 A Pharma 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Rivastigmine 1 A Pharma 3 mg capsule contains 3 mg of rivastigmine.
Each Rivastigmine 1 A Pharma 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Rivastigmine 1 A Pharma 6 mg capsule contains 6 mg of rivastigmine.

What Rivastigmine 1 A Pharma looks like and contents of the pack
- Rivastigmine 1 A Pharma 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint “RIV 1.5 mg” on the body.

• Rivastigmine 1 A Pharma 3 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “RIV 3 mg” on the body.

• Rivastigmine 1 A Pharma 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 “RIV 4.5 mg” on the body.

• Rivastigmine 1 A Pharma 6 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “RIV 6 mg” on the body.

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

Marketing Authorisation Holder
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany

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

Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany

Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1, Barleben,
Saxony-Anhalt, 39179,
Germany

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

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: + 32 2 722 97 97

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel: + 32 2 722 97 97

България
Сандоз България КЧТ
Teл.: + 359 2 970 47 47
Magyarország
Sandoz Hungária Kft.
Bartók Béla út 43-47
H-1114 Budapest
Tel.: + 36 1 430 2890
E-mail: info.hungary@sandoz.com

Česká republika
Sandoz s.r.o.
Tel: +420 234 142 222
Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126

Danmark
Sandoz A/S
Tlf.: + 45 63 95 10 00

Nederland
Sandoz BV
Hospitaaldreef 29,
NL-1315 RC Almere
Tel: +31 36 5241600
E-mail: info.sandoz-nl@sandoz.com

Deutschland
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany
Tel: +49 8024 908-3030
E-mail: medwiss@1apharma.com

Norge
Sandoz A/S
Tlf: + 45 63 95 10 00

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 6652400

Österreich
Hexal GmbH
Jakov-Lind-Straße 5, Top 3.05
A-1020 Wien
Austria
Tel: +43 (0)1 480 56 03

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ
Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp.z o.o.
ul. Domaniewska 50 C
PL-02-672 Warszawa
Tel: + 48 22 549 15 00

España
Sandoz Farmacéutica, S.A
Centro Empresarial Parque Norte, Edificio Roble
C/ Serrano Galvache Nº 56,
28033 Madrid
Tel: +34 900 456 856 registros.spain@sandoz.com
Portugal
Sandoz Farmacêutica, Lda.
Tel: +351 21 196 40 00

France
Sandoz SAS
Tél: + 33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Ireland
Rowex Ltd.
Newtown
IE-Bantry Co. Cork
P75 V009
Tel: +353 27 50077
Email: patient.safety.ireland@sandoz.net

Slovenija
Lek Pharmaceuticals d.d.
Verovškova 57
SI-1526 Ljubljana
Tel: + 386 1 5802111
E-mail: info.lek@sandoz.com

Ísland
Sandoz A/S
Simi : + 45 63 95 10 00

Slovenská republika
Sandoz d.d. - organizačná zložka
Žižkova 22B
SK-811 02 Bratislava
Tel: +421 2 48 200 600

Italia
Sandoz S.p.A.
Tel: + 39 02 812 806 96

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
(Ελλάδα)
Τηλ: +30 216 600 5000

Sverige
Sandoz A/S

Tel: +45 63 95 10 00

Latvija
Sandoz d.d. Latvia filiāle
K.Valdemāra Str. 33 – 29
LV-1010 Riga
Tel: + 371 67892006

Lietuva
Sandoz Pharmaceuticals d.d. filialas
Tel: + 370 5 2636037

Hrvatska
Sandoz d.o.o.
Maksimirska 120
10 000 Zagreb
Tel: +38512353111
E-mail: upit.croatia@sandoz.com

This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency (EMA) website:http:/www.ema.europa.eu


Take the syringe out of its protective case.

Push down and turn the child resistant cap to open bottle.

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

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


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.


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.


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 Rivastigmine 1 A Pharma than you should
If you accidentally take more Rivastigmine 1 A Pharma than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine 1 A Pharma 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 Rivastigmine 1 A Pharma
If you find you have forgotten to take your dose of Rivastigmine 1 A Pharma, 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

Sleepiness

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

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  Seeing things that are not there (hallucinations)  Depression  High blood pressure

Uncommon (may affect up to 1 in 100 people)

Uneven 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 contraction with abnormal bending of the body and head to one side)  Skin rash

Other side effects seen with 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 Rivastigmine 1 A Pharma

Keep this medicine out of the sight and reach of children.

Do not use Rivastigmine 1 A Pharma after the expiry date which is stated on the bottle and 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 Rivastigmine 1 A Pharma 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.
Content of the pack and other information

What Rivastigmine 1 A Pharma contains
- The active substance is rivastigmine. 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 Rivastigmine 1 A Pharma looks like and contents of the pack
Rivastigmine 1 A Pharma 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
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany

Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany

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

Salutas Pharma Gmbh
Otto-Von-Guericke-Allee 1, Barleben,
Saxony-Anhalt, 39179,
Germany

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

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: + 32 2 722 97 97

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel: + 32 2 722 97 97

България
Сандоз България КЧТ
Teл.: + 359 2 970 47 47 v

Magyarország
Sandoz Hungária Kft.
Bartók Béla út 43-47
H-1114 Budapest
Tel.: + 36 1 430 2890
E-mail: info.hungary@sandoz.com

Česká republika
Sandoz s.r.o.
Tel: +420 234 142 222
Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126

Danmark
Sandoz A/S
Tlf.: + 45 63 95 10 00

Nederland
Sandoz BV
Hospitaaldreef 29,
NL-1315 RC Almere
Tel: +31 36 5241600
E-mail: info.sandoz-nl@sandoz.com

Deutschland
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany
Tel: +49 8024 908-3030
E-mail: medwiss@1apharma.com

Norge
Sandoz A/S
Tlf: + 45 63 95 10 00

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 6652400

Österreich
1A Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
A-1020 Wien
Austria
Tel: +43 (0)1 480 56 03

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ
Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp.z o.o.
ul. Domaniewska 50 C
PL-02-672 Warszawa
Tel: + 48 22 549 15 00

España
Sandoz Farmacéutica, S.A
Centro Empresarial Parque Norte, Edificio Roble
C/ Serrano Galvache Nº 56,
28033 Madrid
Tel: +34 900 456 856 registros.spain@sandoz.com

Portugal
Sandoz Farmacêutica, Lda.
Tel: +351 21 196 40 00

France
Sandoz SAS
Tél: + 33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Ireland
Rowex Ltd.
Newtown
IE-Bantry Co. Cork
P75 V009
Tel: +353 27 50077
Email: patient.safety.ireland@sandoz.net

Slovenija
Lek Pharmaceuticals d.d.
Verovškova 57
SI-1526 Ljubljana
Tel: + 386 1 5802111
E-mail: info.lek@sandoz.com

Ísland
Sandoz A/S
Sími: + 45 63 95 10 00

Slovenská republika
Sandoz d.d. - organizačná zložka
Žižkova 22B
SK-811 02 Bratislava
Tel: +421 2 48 200 600

Italia
Sandoz S.p.A.
Tel: + 39 02 812 806 96

Suomi/Finland
Sandoz A/S
Puh/Tel: + 358 10 6133 400

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
(Ελλάδα)
Τηλ: +30 216 600 5000

Sverige
Sandoz A/S
Tel: + 45 63 95 10 00

Latvija
Sandoz d.d. Latvia filiāle
K.Valdemāra Str. 33 – 29
LV-1010 Riga
Tel: + 371 67892006

Lietuva
Sandoz Pharmaceuticals d.d. filialas
Tel: + 370 5 2636037

Hrvatska
Sandoz d.o.o.
Maksimirska 120
10 000 Zagreb
Tel: +38512353111
E-mail: upit.croatia@sandoz.com

This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http:/www.ema.europa.eu

The active substance of Rivastigmine HEXAL 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, Rivastigmine 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.

Rivastigmine HEXAL 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.

Do not take Rivastigmine HEXAL
- if you are allergic to rivastigmine (the active substance in Rivastigmine HEXAL) or any of the other ingredients of this medicine (listed in section 6).
- if you have had a previous skin reaction suggestive of allergic contact dermatitis with rivastigmine.

If this applies to you, tell your doctor and do not take Rivastigmine HEXAL.

Warnings and precautions
Talk to your doctor before taking Rivastigmine HEXAL
- if you have, or have ever had, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
- 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 Rivastigmine HEXAL 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 Rivastigmine HEXAL in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Rivastigmine HEXAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Rivastigmine Hexal should not be given at the same time as other medicines with similar effects to Rivastigmine HEXAL. Rivastigmine HEXAL might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).

Rivastigmine Hexal 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 Rivastigmine HEXAL, tell your doctor before you are given any anaesthetics, because Rivastigmine HEXAL may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Rivastigmine HEXAL 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.

Caution when Rivastigmine HEXAL is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

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 Rivastigmine HEXAL must be assessed against the possible effects on your unborn child. Rivastigmine HEXAL should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Rivastigmine HEXAL.

Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Rivastigmine HEXAL 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.

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 Rivastigmine HEXAL 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 Rivastigmine HEXAL 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 Rivastigmine HEXAL.

To benefit from your medicine, take it every day.

Take Rivastigmine HEXAL 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 Rivastigmine HEXAL than you should
If you accidentally take more Rivastigmine HEXAL than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine HEXAL 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 Rivastigmine HEXAL
If you find you have forgotten to take your dose of Rivastigmine HEXAL, 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.

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

Sleepiness

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

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  Seeing things that are not there (hallucinations)  Depression  High blood pressure

Uncommon (may affect up to 1 in 100 people)

Uneven 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 contraction with abnormal bending of the body and head to one side)  Skin rash

Other side effects seen with 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.

Keep this medicine out of the sight and reach of children.

Do not use Rivastigmine HEXAL after the expiry date which is stated on the blister, bottle label and 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.

What Rivastigmine HEXAL contains
- The active substance is rivastigmine.
- The other ingredients are: hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide red iron oxide, titanium dioxide, and shellac.

Each Rivastigmine HEXAL 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Rivastigmine HEXAL 3 mg capsule contains 3 mg of rivastigmine.
Each Rivastigmine HEXAL 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Rivastigmine HEXAL 6 mg capsule contains 6 mg of rivastigmine.

What Rivastigmine HEXAL looks like and contents of the pack
- Rivastigmine HEXAL 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint “RIV 1.5 mg” on the body.

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

• Rivastigmine HEXAL 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 “RIV 4.5 mg” on the body.

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

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

Marketing Authorisation Holder
HEXAL AG
Industriestraße 25
D-83607 Holzkirchen
Germany

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

Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany

Salutas Pharma Gmbh
Otto-Von-Guericke-Allee 1, Barleben,
Saxony-Anhalt, 39179,
Germany

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

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel.: + 32 2 722 97 97

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel: + 32 2 722 97 97

България
Сандоз България КЧТ
Teл.: + 359 2 970 47 47
Magyarország
Sandoz Hungária Kft.k
Bartók Béla út 43-47
H-1114 Budapest
Tel.: + 36 1 430 2890
E-mail: info.hungary@sandoz.com

Česká republika
Sandoz s.r.o.
Tel: +420 234 142 222
Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126
Danmark
Sandoz A/S
Tlf.: + 45 63 95 10 00

Nederland
Sandoz BV
Hospitaaldreef 29,
NL-1315 RC Almere
Tel: +31 36 5241600E-mail: info.sandoz- nl@sandoz.com

Deutschland
Hexal AG
Industriestraße 25
D-83607 Holzkirchen
Tel: + 49 8024 908 0
E-mail: service@hexal.com

Norge
Sandoz A/S

Tlf: + 45 63 95 10 00

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 6652400

Österreich
Hexal GmbH
Jakov-Lind-Straße 5, Top 3.05
A-1020 Wien
Tel: + 43 (0)1 486 96 22

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ
Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp.z o.o.
ul. Domaniewska 50 C
PL-02-672 Warszawa
Tel: + 48 22 549 15 00

España
Sandoz Farmacéutica, S.A
Centro Empresarial Parque Norte, Edificio Roble
C/ Serrano Galvache Nº 56,
28033 Madrid
Tel: +34 900 456 856 registros.spain@sandoz.com

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 196 40 00

France
Sandoz SAS
Tél: + 33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL

Tel: +40 21 407 51 60

Ireland
Rowex Ltd.
Newtown
IE-Bantry Co. Cork
P75 V009
Tel: +353 27 50077
Email: patient.safety.ireland@sandoz.net

Slovenija
Lek Pharmaceuticals d.d.
Verovškova 57
SI-1526 Ljubljana
Tel: + 386 1 5802111
E-mail: info.lek@sandoz.com

Ísland
Sandoz A/S

Simi: + 45 63 95 10 00

Slovenská republika
Sandoz d.d. - organizačná zložka
Žižkova 22B
SK-811 02 Bratislava
Tel: +421 2 48 200 600

Italia
Sandoz S.p.A.
Tel: + 39 02 812 806 96

Suomi/Finland
Sandoz A/S

Puh/Tel: + 358 10 6133 400

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
(Ελλάδα)
Τηλ: +30 216 600 5000
Sverige
Sandoz A/S

Tel: + 45 63 95 10 00

Latvija
Sandoz d.d. Latvia filiāle
K.Valdemāra Str. 33 – 29
LV-1010 Riga
Tel: + 371 67892006

Lietuva
Sandoz Pharmaceuticals d.d. filialas
Tel: + 370 5 2636037

Hrvatska
Sandoz d.o.o.
Maksimirska 120
10 000 Zagreb
Tel: +38512353111
E-mail: upit.croatia@sandoz.com

This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu/


Take the syringe out of its protective case.

Push down and turn the child resistant cap to open bottle.

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

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


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.


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.


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 Rivastigmine HEXAL than you should
If you accidentally take more Rivastigmine HEXAL than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine HEXAL 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 Rivastigmine HEXAL
If you find you have forgotten to take your dose of Rivastigmine HEXAL, 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

Sleepiness

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

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  Seeing things that are not there (hallucinations)  Depression  High blood pressure

Uncommon (may affect up to 1 in 100 people)

Uneven 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 contraction with abnormal bending of the body and head to one side)  Skin rash

Other side effects seen with 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 RIVASTIGMINE HEXAL

Keep this medicine out of the sight and reach of children.

Do not use Rivastigmine HEXAL after the expiry date which is stated on the bottle label and 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 Rivastigmine HEXAL 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.
Content of the pack and other information

What Rivastigmine HEXAL contains
- The active substance is rivastigmine. 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. See section 2 “Rivastigmine Hexal contains benzoate salt and sodium”

What Rivastigmine HEXAL looks like and contents of the pack
Rivastigmine HEXAL 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
HEXAL AG
Industriestraße 25
D-83607 Holzkirchen
Germany

Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany

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

Salutas Pharma Gmbh
Otto-Von-Guericke-Allee 1, Barleben,
Saxony-Anhalt, 39179,
Germany

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

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel,: + 32 2 722 97 97

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel: + 32 2 722 97 97

България
Сандоз България КЧТ
Teл.: + 359 2 970 47 47
Magyarország
Sandoz Hungária Kft.
Bartók Béla út 43-47
H-1114 Budapest
Tel.: + 36 1 430 2890
E-mail: info.hungary@sandoz.com

Česká republika
Sandoz s.r.o.
Tel: +420 234 142 222
Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126
Danmark
Sandoz A/S
Tlf.: + 45 63 95 10 00

Nederland
Sandoz BV
Hospitaaldreef 29,
NL-1315 RC Almere
Tel: +31 36 5241600 E-mail: info.sandoz- nl@sandoz.com

Deutschland
Hexal AG
Industriestraße 25
D-83607 Holzkirchen
Tel: + 49 8024 908 0
E-mail: service@hexal.com
Norge
Sandoz A/S
Tlf: + 45 63 95 10 00

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 6652400

Österreich
HEXAL Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
A-1020 Wien
Tel: + 43 (0)1 486 96 22
Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ
Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp.z o.o.
ul. Domaniewska 50 C
PL-02-672 Warszawa
Tel: + 48 22 549 15 00

España
Sandoz Farmacéutica, S.A
Centro Empresarial Parque Norte, Edificio Roble
C/ Serrano Galvache Nº 56,
28033 Madrid
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica, Lda.
Tel: +351 21 196 40 00

France
Sandoz SAS
Tél: + 33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Ireland
Rowex Ltd.
Newtown
IE-Bantry Co. Cork
P75 V009
Tel: +353 27 50077
Email: patient.safety.ireland@sandoz.net

Slovenija
Lek Pharmaceuticals d.d.
Verovškova 57
SI-1526 Ljubljana
Tel: + 386 1 5802111
E-mail: info.lek@sandoz.com

Ísland
Sandoz A/S
Simi: + 45 63 95 10 00

Slovenská republika
Sandoz d.d. - organizačná zložka
Žižkova 22B
SK-811 02 Bratislava
Tel: +421 2 48 200 600

Italia
Sandoz S.p.A.

Tel: + 39 02 812 806 96

Suomi/Finland
Sandoz A/S
Puh/Tel: + 358 10 6133 400

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
(Ελλάδα)
Τηλ: +30 216 600 5000
Sverige
Sandoz A/S
Tel: + 45 63 95 10 00

Latvija
Sandoz d.d. Latvia filiāle
K.Valdemāra Str. 33 – 29
LV-1010 Riga
Tel: + 371 67892006

Lietuva
Sandoz Pharmaceuticals d.d. filialas
Tel: + 370 5 2636037

Hrvatska
Sandoz d.o.o.
Maksimirska 120
10 000 Zagreb
Tel: +38512353111
E-mail: upit.croatia@sandoz.com

This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu/

The active substance of Rivastigmine Sandoz 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, Rivastigmine Sandoz 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.

Rivastigmine Sandoz 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.

Do not take Rivastigmine Sandoz
- if you are allergic to rivastigmine (the active substance of Rivastigmine Sandoz) or any of the other ingredients of this medicine (listed in section 6).
- if you have had a previous skin reaction suggestive of allergic contact dermatitis with rivastigmine.

If this applies to you, tell your doctor and do not take Rivastigmine Sandoz.

Warnings and precautions
Talk to your doctor before taking Rivastigmine Sandoz
- if you have, or have ever had, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
- 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 Rivastigmine Sandoz 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 Rivastigmine Sandoz in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Rivastigmine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Rivastigmine Sandoz should not be given at the same time as other medicines with similar effects to Rivastigmine Sandoz. Rivastigmine Sandoz might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).
Rivastigmine Sandoz 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 Rivastigmine Sandoz, tell your doctor before you are given any anaesthetics, because Rivastigmine Sandoz may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Rivastigmine Sandoz 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.

Caution when Rivastigmine Sandoz is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

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 Rivastigmine Sandoz must be assessed against the possible effects on your unborn child. Rivastigmine Sandoz should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Rivastigmine Sandoz.

Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Rivastigmine Sandoz 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.

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 Rivastigmine Sandoz 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 Rivastigmine Sandoz 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 Rivastigmine Sandoz.

To benefit from your medicine, take it every day.

Take Rivastigmine Sandoz 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 Rivastigmine Sandoz than you should
If you accidentally take more Rivastigmine Sandoz than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine Sandoz 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 Rivastigmine Sandoz
If you find you have forgotten to take your dose of Rivastigmine Sandoz, 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.

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

Sleepiness

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

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  Seeing things that are not there (hallucinations)  Depression  High blood pressure

Uncommon (may affect up to 1 in 100 people)

Uneven 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 contraction with abnormal bending of the body and head to one side)  Skin rash

Other side effects seen with 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.

Keep this medicine out of the sight and reach of children.

Do not use Rivastigmine Sandoz after the expiry date which is stated on the blister, bottle and carton after “EXP”. The expiry date refers to the last day of that month.
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.

Do not store above 30°C.

What Rivastigmine Sandoz contains
- The active substance is rivastigmine.
- The other ingredients are: hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide , red iron oxide , titanium dioxide , and shellac.

Each Rivastigmine Sandoz 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Rivastigmine Sandoz 3 mg capsule contains 3 mg of rivastigmine.
Each Rivastigmine Sandoz 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Rivastigmine Sandoz 6 mg capsule contains 6 mg of rivastigmine.

What Rivastigmine Sandoz looks like and contents of the pack
- Rivastigmine Sandoz 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint “RIV 1.5 mg” on the body.

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

• Rivastigmine Sandoz 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 “RIV 4.5 mg” on the body.

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

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

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl
Austria

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

Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany

Salutas Pharma Gmbh
Otto-Von-Guericke-Allee 1, Barleben,
Saxony-Anhalt, 39179,
Germany

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

België/Belgique/Belgien
Sandoz nv/sa

Tél/Tel.: + 32 2 722 97 97

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel: + 32 2 722 97 97

България
Сандоз България КЧТ
Teл.: + 359 2 970 47 47
Magyarország
Sandoz Hungária Kft.
Bartók Béla út 43-47
H-1114 Budapest
Tel.: + 36 1 430 2890
E-mail: info.hungary@sandoz.com

Česká republika
Sandoz s.r.o.
Tel: +420 234 142 222

Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126=
Danmark
Sandoz A/S
Tlf.: +45 6395 1000

Nederland
Sandoz BV
Hospitaaldreef 29,
NL-1315 RC Almere
Tel: +31 36 5241600
E-mail: info.sandoz-nl@sandoz.com

Deutschland
Hexal AG
Industriestraße 25
D-83607 Holzkirchen
Tel: + 49 8024 908 0
E-mail: service@hexal.com

Norge
Sandoz A/S
Tlf: +45 63 95 10 00

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 6652400

Österreich
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Tel: + 43 (0)53382000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ
Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp.z o.o.
ul. Domaniewska 50 C
PL-02-672 Warszawa
Tel: + 48 22 549 15 00

España
Sandoz Farmacéutica, S.A
Centro Empresarial Parque Norte, Edificio Roble
C/ Serrano Galvache Nº 56,
28033 Madrid
Tel: +34 900 456 856 registros.spain@sandoz.com

Portugal
Sandoz Farmacêutica, Lda.
Tel: +351 21 196 40 00
France
Sandoz SAS
Tél: + 33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21407 51 60

Ireland
Rowex Ltd.
Newtown
Slovenija
Lek Pharmaceuticals d.d.
Verovškova 57

IE-Bantry Co. Cork
P75 V009
Tel: +353 27 50077
Email: patient.safety.ireland@sandoz.net

SI-1526 Ljubljana
Tel: + 386 1 5802111
E-mail: info.lek@sandoz.com

Ísland
Sandoz A/S

Sími : +45 63 95 10 00

Slovenská republika
Sandoz d.d. - organizačná zložka
Žižkova 22B
SK-811 02 Bratislava
Tel: +421 2 48 200 600

Italia
Sandoz S.p. A.
Tel: + 39 02 812 806 96

Suomi/Finland
Sandoz A/S

Puh/Tel: +358 10 6133 400

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
(Ελλάδα)
Τηλ: +30 216 600 5000
Sverige
Sandoz A/S

Tel: +45 63 95 10 00

Latvija
Sandoz d.d. Latvia filiāle
K.Valdemāra Str. 33 – 29
LV-1010 Riga
Tel: + 371 67892006

Lietuva
Sandoz Pharmaceuticals d.d. filialas
Tel: + 370 5 2636037

Hrvatska
Sandoz d.o.o.
Maksimirska 120
10 000 Zagreb
Tel: +38512353111
E-mail: upit.croatia@sandoz.com

This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu


Take the syringe out of its protective case.

Push down and turn the child resistant cap to open bottle.

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

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


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.


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.


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 Rivastigmine Sandoz than you should
If you accidentally take more Rivastigmine Sandoz than you should, inform your doctor . You may require medical attention. Some people who have accidentally taken too much Rivastigmine Sandoz 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 Rivastigmine Sandoz
If you find you have forgotten to take your dose of Rivastigmine Sandoz, 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

Sleepiness

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

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  Seeing things that are not there (hallucinations)  Depression  High blood pressure

Uncommon (may affect up to 1 in 100 people)

Uneven 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 contraction with abnormal bending of the body and head to one side)  Skin rash

Other side effects seen with 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 Rivastigmine Sandoz

Keep this medicine out of the sight and reach of children.

Do not use Rivastigmine Sandoz after the expiry date which is stated on the bottle and 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 Rivastigmine Sandoz 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.
Content of the pack and other information

What Rivastigmine Sandoz contains
- The active substance is rivastigmine. 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 Rivastigmine Sandoz looks like and contents of the pack
Rivastigmine Sandoz 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
Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl
Austria

Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany

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

Salutas Pharma Gmbh
Otto-Von-Guericke-Allee 1, Barleben,
Saxony-Anhalt, 39179,
Germany

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

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel.: + 32 2 722 97 97

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel: + 32 2 722 97 97

България
Сандоз България КЧТ
Teл.: + 359 2 970 47 47
Magyarország
Sandoz Hungária Kft.
Bartók Béla út 43-47
H-1114 Budapest
Tel.: + 36 1 430 2890
E-mail: info.hungary@sandoz.com

Česká republika
Sandoz s.r.o.
Tel: +420 234 142 222
Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126
Danmark
Sandoz A/S

Tlf.: +45 6395 1000

Nederland
Sandoz BV
Hospitaaldreef 29,
NL-1315 RC Almere
Tel: +31 36 5241600
E-mail: info.sandoz-nl@sandoz.com

Deutschland
Hexal AG
Industriestraße 25
D-83607 Holzkirchen
Tel: + 49 8024 908 0
E-mail: service@hexal.com

Norge
Sandoz A/S

Tlf: +45 63 95 10 00

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 6652400

Österreich
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Tel: + 43 (0)53382000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ
Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp.z o.o.
ul. Domaniewska 50 C
PL-02-672 Warszawa
Tel: + 48 22 549 15 00

España
Sandoz Farmacéutica, S.A
Centro Empresarial Parque Norte, Edificio Roble
C/ Serrano Galvache Nº 56,
28033 Madrid
Tel: +34 900 456 856 registros.spain@sandoz.com

Portugal
Sandoz Farmacêutica, Lda.

Tel: +351 21 196 40 00
France
Sandoz SAS
Tél: + 33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Ireland
Rowex Ltd.
Newtown
IE-Bantry Co. Cork
P75 V009
Tel: +353 27 50077
Email: patient.safety.ireland@sandoz.net

Slovenija
Lek Pharmaceuticals d.d.
Verovškova 57
SI-1526 Ljubljana
Tel: + 386 1 5802111
E-mail: info.lek@sandoz.com

Ísland
Sandoz A/S

Sími: +45 63 95 10 00

Slovenská republika
Sandoz d.d. - organizačná zložka
Žižkova 22B
SK-811 02 Bratislava
Tel: +421 2 48 200 600

Italia
Sandoz S.p.A.
Tel: + 39 02 812 806 96

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
(Ελλάδα)
Τηλ: +30 216 600 5000
Sverige
Sandoz A/S
Tel: +45 63 95 10 00

Latvija
Sandoz d.d. Latvia filiāle
K.Valdemāra Str. 33 – 29
LV-1010 Riga
Tel: + 371 67892006

Lietuva
Sandoz Pharmaceuticals d.d. filialas
Tel: + 370 5 2636037
Hrvatska
Sandoz d.o.o.
Maksimirska 120
10 000 Zagreb
Tel: +38512353111
E-mail: upit.croatia@sandoz.com

This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency (EMA) website: https://www.ema.europa.eu/