B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Rivastigmine HEXAL 1.5 mg hard capsules Rivastigmine HEXAL 3 mg hard capsules Rivastigmine HEXAL 4.5 mg hard capsules Rivastigmine HEXAL 6 mg hard capsules rivastigmine

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

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

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

What is in this leaflet

• 1. What Rivastigmine HEXAL is and what it is used for

• 2. What you need to know before you take Rivastigmine HEXAL

• 3. How to take Rivastigmine HEXAL

• 4. Possible side effects

• 5. How to store Rivastigmine HEXAL

• 6. Contents of the pack and other information

1. What Rivastigmine HEXAL is and what it is used for

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.

2. What you need to know before you take Rivastigmine HEXAL

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, irregular or slow heartbeat.

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

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

• – if you have, or have ever had, seizures.

• – if you have, or have ever had, asthma or severe respiratory disease.

• – if you have, or have ever had impaired kidney function.

• – if you have, or have ever had, impaired liver function.

• – if you suffer from trembling.

• – if you have a low body weight.

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

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

If you have not taken 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.

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.

3. How to take Rivastigmine HEXAL

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 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.

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
• 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

Common (may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Slow and fast heartbeat
• Difficulty in sleeping
• Too much saliva and dehydration
• Unusually slow movements or movements you cannot control
• The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles,

difficulty in carrying out movements and muscle weakness

Uncommon (may affect up to 1 in 100 people)

• Uneven heartbeat and poor control of movements

Other side effects seen with 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 or pharmacist. 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 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.

• 6. Content of the pack and other information

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) and plastic bottles of 250 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

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

België/Belgiqu­e/Belgien	Luxembourg/Lu­xemburg
Sandoz N.V.	Hexal AG
Telecom Gardens, Medialaan 40	Industriestraße 25
B-1800 Vilvoorde	D-83607 Holzkirchen
Tél/Tel: + 32 (0)2 722 97 97	Tel: + 49 8024 908 0

E-mail:

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency (EMA) website:

Package leaflet: Information for the patient

Rivastigmine HEXAL 2 mg/ml oral solution rivastigmine

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

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

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

What is in this leaflet

• 1. What Rivastigmine HEXAL is and what it is used for

• 2. What you need to know before you take Rivastigmine HEXAL

• 3. How to take Rivastigmine HEXAL

• 4. Possible side effects

• 5. How to store Rivastigmine HEXAL

• 6. Contents of the pack and other information

1. What Rivastigmine HEXAL is and what it is used for

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 HEXAL 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.

2. What you need to know before you take Rivastigmine HEXAL

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, irregular or slow heartbeat.

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

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

• – if you have, or have ever had, seizures.

• – if you have, or have ever had, asthma or severe respiratory disease.

• – if you have, or have ever had impaired kidney function.

• – if you have, or have ever had impaired liver function.

• – if you suffer from trembling.

• – if you have a low body weight.

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

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

If you have not taken 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.

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.

Rivastigmine HEXAL contains benzoate salt and sodium

This medicine contains 1 mg sodium benzoate in each ml of oral solution.

This medicine contains less than 1 mmol (23 mg) sodium in each ml of oral solution, that is to say essentially ‘sodium-free’.

3. How to take Rivastigmine HEXAL

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 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 the treatment.
• The highest dose that should be taken is 6.0 mg (corresponding to 3 ml) 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.

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.

How to use this medicine

Preparing the bottle and syringe

Take the syringe out of its protective case.

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

• 2. Attaching the syringe to the bottle

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

• 3. Filling the syringe

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

Removing bubbles

Push down and pull up the plunger a few times to get rid of any large bubbles. A few tiny bubbles are not important and will not affect your dose in any way. Check the dose is still correct.

Then, remove the syringe from the bottle.

Taking your medicine

Swallow your medicine straight from the syringe.

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

After using the syringe

Wipe the outside of the syringe with a clean tissue.

Then, put the syringe back in its protective case.

Put the child resistant cap back on the bottle to close it.

If you take more 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
• 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

Common (may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Slow and fast heartbeat
• Difficulty in sleeping
• Too much saliva and dehydration
• Unusually slow movements or movements you cannot control
• The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements and muscle weakness

Uncommon (may affect up to 1 in 100 people)

• Uneven heartbeat and poor control of movements

Other side effects seen with 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 or pharmacist. 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 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) and plastic bottles of 250 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

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

België/Belgiqu­e/Belgien	Luxembourg/Lu­xemburg
Sandoz N.V.	Hexal AG
Telecom Gardens, Medialaan 40	Industriestraße 25
B-1800 Vilvoorde	D-83607 Holzkirchen
Tél/Tel: + 32 (0)2 722 97 97	Tel: + 49 8024 908 0

E-mail:

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency (EMA) website:

Package leaflet: Information for the patient

Rivastigmine HEXAL 2 mg/ml oral solution rivastigmine

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

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

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

What is in this leaflet

• 1. What Rivastigmine HEXAL is and what it is used for

• 2. What you need to know before you take Rivastigmine HEXAL

• 3. How to take Rivastigmine HEXAL

• 4. Possible side effects

• 5. How to store Rivastigmine HEXAL

• 6. Contents of the pack and other information

1. What Rivastigmine HEXAL is and what it is used for

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 HEXAL 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.

2. What you need to know before you take Rivastigmine HEXAL

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, irregular or slow heartbeat.

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

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

• – if you have, or have ever had, seizures.

• – if you have, or have ever had, asthma or severe respiratory disease.

• – if you have, or have ever had impaired kidney function.

• – if you have, or have ever had impaired liver function.

• – if you suffer from trembling.

• – if you have a low body weight.

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

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

If you have not taken 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.

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.

Rivastigmine HEXAL contains benzoate salt and sodium

This medicine contains 1 mg sodium benzoate in each ml of oral solution.

This medicine contains less than 1 mmol (23 mg) sodium in each ml of oral solution, that is to say essentially ‘sodium-free’.

3. How to take Rivastigmine HEXAL

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 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 the treatment.
• The highest dose that should be taken is 6.0 mg (corresponding to 3 ml) 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.

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.

Preparing the bottle and syringe

Take the syringe out of its protective case.

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

• 2. Attaching the syringe to the bottle

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

• 3. Filling the syringe

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

Removing bubbles

Push down and pull up the plunger a few times to get rid of any large bubbles. A few tiny bubbles are not important and will not affect your dose in any way. Check the dose is still correct.

Then, remove the syringe from the bottle.

Taking your medicine

Swallow your medicine straight from the syringe.

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

After using the syringe

Wipe the outside of the syringe with a clean tissue.

Then, put the syringe back in its protective case.

Put the child resistant cap back on the bottle to close it.

If you take more 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
• 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

Common (may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Slow and fast heartbeat
• Difficulty in sleeping
• Too much saliva and dehydration
• Unusually slow movements or movements you cannot control
• The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements and muscle weakness

Uncommon (may affect up to 1 in 100 people)

• Uneven heartbeat and poor control of movements

Other side effects seen with 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 or pharmacist. 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”