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Nimvastid (rivastigmine) – Package leaflet - N06DA03

Updated on site: 08-Oct-2017

Medication nameNimvastid
ATC CodeN06DA03
Substancerivastigmine
ManufacturerKrka, d.d., Novo mesto

Package leaflet: Information for the user

Nimvastid 1.5 mg hard capsules

Nimvastid 3 mg hard capsules

Nimvastid 4.5 mg hard capsules

Nimvastid 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Nimvastid is and what it is used for

2.What you need to know before you take Nimvastid

3.How to take Nimvastid

4.Possible side effects

5.How to store Nimvastid

6.Contents of the pack and other information

1.What Nimvastid is and what it is used for

The active substance of Nimvastid 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, Nimvastid 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.

Nimvastid 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 Nimvastid

Do not take Nimvastid

-if you are allergic to rivastigmine (the active substance in Nimvastid) or to 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 Nimvastid.

Warnings and precautions

Talk to your doctor before taking Nimvastid:

-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 Nimvastid 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 Nimvastid in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Nimvastid

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

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

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

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

You should not breast-feed during treatment with Nimvastid.

Driving and using machines

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

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 Nimvastid 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 Nimvastid 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 Nimvastid.

To benefit from your medicine, take it every day.

Take Nimvastid 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 Nimvastid than you should

If you accidentally take more Nimvastid than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Nimvastid 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 Nimvastid

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

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

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Feeling dizzy

Loss of appetite

Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea

Common (may affect up to 1 in 10 people)

Anxiety

Sweating

Headache

Heartburn

Weight loss

Stomach pain

Feeling agitated

Feeling tired or weak

Generally feeling unwell

Trembling or feeling confused

Decreased appetite

Nightmares

Uncommon (may affect up to 1 in 100 people)

Depression

Difficulty in sleeping

Fainting or accidentally falling

Changes in how well your liver is working

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

Chest pain

Rash, itching

Fits (seizures)

Ulcers in your stomach or intestine

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

High blood pressure

Urinary tract infection

Seeing things that are not there (hallucinations)

Problems with your heartbeat such as fast or slow heartbeat

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

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

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

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

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

Dehydration (losing too much fluid)

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

Aggression, feeling restless

Uneven heartbeat

Patients with dementia and Parkinson’s disease

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

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

Trembling

Fainting

Accidentally falling

Common (may affect up to 1 in 10 people)

Anxiety

Feeling restless

Slow and fast heartbeat

Difficulty in sleeping

Too much saliva and dehydration

Unusually slow movements or movements you cannot control

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

Uncommon (may affect up to 1 in 100 people)

Uneven heartbeat and poor control of movements

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

Common (may affect up to 1 in 10 people)

Fever

Severe confusion

Urinary incontinence (inability to retain adequate urine)

Uncommon (may affect up to 1 in 100 people)

Hyperactivity (high level of activity, restlessness)

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

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

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

Reporting of side effects

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

5.How to store Nimvastid

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 packaging after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Nimvastid contains

-The active substance is rivastigmine hydrogen tartrate.

Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg or 6 mg rivastigmine.

-The other ingredients for Nimvastid 1.5 mg capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule content, and titanium dioxide (E171), yellow iron oxide (E172) and gelatine in the capsule shell.

-The other ingredients for Nimvastid 3 mg, 4.5 mg and 6 mg capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule content,

and titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and gelatine in the capsule shell.

What Nimvastid looks like and contents of the pack

Nimvastid 1.5 mg hard capsules, which contain a white to almost white powder, have a yellow cap and yellow body.

Nimvastid 3 mg hard capsules, which contain a white to almost white powder, have an orange cap and orange body.

Nimvastid 4.5 mg hard capsules, which contain a white to almost white powder, have a brownish red cap and brownish red body.

Nimvastid 6 mg hard capsules, which contain a white to almost white powder, have a brownish red cap and orange body.

Blister pack (PVC/PVDC/Alu-foil): boxes of 14 (only for 1.5 mg), 28, 30, 56, 60 or 112 hard capsules are available.

HDPE container: boxes of 200 or 250 hard capsules are available. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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

België/Belgique/Belgien

Lietuva

KRKA Belgium, SA.

UAB KRKA Lietuva

Tél/Tel: +32 (0) 489 304 091

Tel: + 370 5 236 27 40

България

Luxembourg/Luxemburg

КРКА България ЕООД

KRKA Belgium, SA.

Teл.: + 359 (02) 962 34 50

Tél/Tel: +32 (0) 489 304 091 (BE)

Česká republika

Magyarország

KRKA ČR, s.r.o.

KRKA Magyarország Kereskedelmi Kft.

Tel: + 420 (0) 221 115 150

Tel.: + 361 (0) 355 8490

Danmark

Malta

KRKA Sverige AB

E.J. Busuttil Ltd.

Tlf: + 46 (0)8 643 67 66 (SE)

Tel: +356 21 445 885

Deutschland

Nederland

TAD Pharma GmbH

KRKA Belgium, SA.

Tel: +32 (0) 489 304 091 (BE)

Eesti

Norge

KRKA, d.d., Novo mesto Eesti filiaal

KRKA Sverige AB

Tel: + 372 (0) 6 671 658

Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα

Österreich

QUALIA PHARMA S.A.

KRKA Pharma GmbH, Wien

Tηλ: +30 (0)210 2832941

Tel: + 43 (0)1 66 24 300

España

Polska

KRKA Farmacéutica, S.L.

KRKA-POLSKA Sp. z o.o.

Tel: + 34 911 61 03 81

Tel.: + 48 (0)22 573 7500

France

Portugal

KRKA France Eurl

KRKA Farmacêutica, Sociedade Unipessoal Lda.

Tél: + 33 (0)1 57 40 82 25

Tel: + 351 (0)21 46 43 650

Hrvatska

România

KRKA - FARMA d.o.o.

KRKA Romania S.R.L., Bucharest

Tel: + 385 1 6312 100

Tel: + 4 021 310 66 05

Ireland

Slovenija

KRKA Pharma Dublin, Ltd.

KRKA, d.d., Novo mesto

Tel: + 353 1 293 91 80

Tel: + 386 (0) 1 47 51 100

Ísland

Slovenská republika

KRKA Sverige AB

KRKA Slovensko, s.r.o.,

Sími: + 46 (0)8 643 67 66 (SE)

Tel: + 421 (0) 2 571 04 501

Italia

Suomi/Finland

KRKA Farmaceutici Milano S.r.l.

KRKA Finland Oy

Tel: + 39 02 3300 8841

Puh/Tel: +358 20 754 5330

Κύπρος

Sverige

Kipa Pharmacal Ltd.

KRKA Sverige AB

Τηλ: + 357 24 651 882

Tel: + 46 (0)8 643 67 66 (SE)

Latvija

United Kingdom

KRKA Latvija SIA

Consilient Health (UK) Ltd.

Tel: + 371 6 733 86 10

Tel: + 44 (0) 203 751 1888

This leaflet was last revised in

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

Package leaflet: Information for the user

Nimvastid 1.5 mg orodispersible tablets

Nimvastid 3 mg orodispersible tablets

Nimvastid 4.5 mg orodispersible tablets

Nimvastid 6 mg orodispersible tablets

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.What Nimvastid is and what it is used for

2.What you need to know before you take Nimvastid

3.How to take Nimvastid

4.Possible side effects

5.How to store Nimvastid

6.Contents of the pack and other information

1. What Nimvastid is and what it is used for

The active substance of Nimvastid 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, Nimvastid 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.

Nimvastid 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 Nimvastid

Do not take Nimvastid

-if you are allergic to rivastigmine (the active substance in Nimvastid) or to 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 Nimvastid.

Warnings and precautions

Talk to your doctor before taking Nimvastid:

-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 Nimvastid 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 Nimvastid in the paediatric population in the treatment of Alzheimer’s disease.

Other medicines and Nimvastid

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

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

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

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

You should not breast-feed during treatment with Nimvastid.

Driving and using machines

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

Nimvastid contains sorbitol E420

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nimvastid

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 Nimvastid 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 Nimvastid 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 Nimvastid.

To benefit from your medicine, take it every day.

Take Nimvastid twice a day, once with your breakfast and once with your evening meal. Your mouth should be empty before taking the tablet.

Nimvastid orodispersible tablets are fragile. They should not be pushed through the foil in the blister pack as this will cause damage to the tablet. Do not handle the tablets with wet hands as the tablets may break up. Remove a tablet from the package as follows:

1.Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it,

2.Pull up the edge of the foil and peel the foil off completely,

3.Tip the tablet out onto your hand.

4.Put the tablet on the tongue as soon as it is removed from the packaging.

In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed without water. The mouth should be empty before placing the tablet on the tongue.

If you take more Nimvastid than you should

If you accidentally take more Nimvastid than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Nimvastid 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 Nimvastid

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Feeling dizzy

Loss of appetite

Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea

Common (may affect up to 1 in 10 people)

Anxiety

Sweating

Headache

Heartburn

Weight loss

Stomach pain

Feeling agitated

Feeling tired or weak

Generally feeling unwell

Trembling or feeling confused

Decreased appetite

Nightmares

Uncommon (may affect up to 1 in 100 people)

Depression

Difficulty in sleeping

Fainting or accidentally falling

Changes in how well your liver is working

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

Chest pain

Rash, itching

Fits (seizures)

Ulcers in your stomach or intestine

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

High blood pressure

Urinary tract infection

Seeing things that are not there (hallucinations)

Problems with your heartbeat such as fast or slow heartbeat

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

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

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

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

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

your stomach (oesophagus)

Dehydration (losing too much fluid)

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

Aggression, feeling restless

Uneven heartbeat

Patients with dementia and Parkinson’s disease

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

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

Trembling

Fainting

Accidentally falling

Common (may affect up to 1 in 10 people)

Anxiety

Feeling restless

Slow and fast heartbeat

Difficulty in sleeping

Too much saliva and dehydration

Unusually slow movements or movements you cannot control

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

Uncommon (may affect up to 1 in 100 people)

Uneven heartbeat and poor control of movements

Other side effects seen with rivastigmine transdermal patches and which may occur with the orodispersible tablets:

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 Nimvastid

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 packaging after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Nimvastid contains

-The active substance is rivastigmine hydrogen tartrate.

Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg,

4.5 mg or 6 mg rivastigmine.

-The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, spearmint flavour (peppermint oil, maize maltodextrin), peppermint flavour (maltodextrine, gum arabic, sorbitol E420, corn mint oil, L-menthol), crospovidone, calcium silicate, magnesium stearate.

What Nimvastid looks like and contents of the pack

Orodispersible tablets are round and white tablets.

14 x 1 (only for 1.5 mg), 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 tablet in OPA/Alu/PVC foil film and PET/Alu peel off foil perforated unit dose blister packs are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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

België/Belgique/Belgien

Lietuva

KRKA Belgium, SA.

UAB KRKA Lietuva

Tél/Tel: +32 (0) 489 304 091

Tel: + 370 5 236 27 40

България

Luxembourg/Luxemburg

КРКА България ЕООД

KRKA Belgium, SA.

Teл.: + 359 (02) 962 34 50

Tél/Tel: +32 (0) 489 304 091 (BE)

Česká republika

Magyarország

KRKA ČR, s.r.o.

KRKA Magyarország Kereskedelmi Kft.

Tel: + 420 (0) 221 115 150

Tel.: + 361 (0) 355 8490

Danmark

Malta

KRKA Sverige AB

E.J. Busuttil Ltd.

Tlf: + 46 (0)8 643 67 66 (SE)

Tel: +356 21 445 885

Deutschland

Nederland

TAD Pharma GmbH

KRKA Belgium, SA.

Tel: +32 (0) 489 304 091 (BE)

Eesti

Norge

KRKA, d.d., Novo mesto Eesti filiaal

KRKA Sverige AB

Tel: + 372 (0) 6 671 658

Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα

Österreich

QUALIA PHARMA S.A.

KRKA Pharma GmbH, Wien

Tηλ: +30 (0)210 2832941

Tel: + 43 (0)1 66 24 300

España

Polska

KRKA Farmacéutica, S.L.

KRKA-POLSKA Sp. z o.o.

Tel: + 34 911 61 03 81

Tel.: + 48 (0)22 573 7500

France

Portugal

KRKA France Eurl

KRKA Farmacêutica, Sociedade Unipessoal Lda.

Tél: + 33 (0)1 57 40 82 25

Tel: + 351 (0)21 46 43 650

Hrvatska

România

KRKA - FARMA d.o.o.

KRKA Romania S.R.L., Bucharest

Tel: + 385 1 6312 100

Tel: + 4 021 310 66 05

Ireland

Slovenija

KRKA Pharma Dublin, Ltd.

KRKA, d.d., Novo mesto

Tel: + 353 1 293 91 80

Tel: + 386 (0) 1 47 51 100

Ísland

Slovenská republika

KRKA Sverige AB

KRKA Slovensko, s.r.o.,

Sími: + 46 (0)8 643 67 66 (SE)

Tel: + 421 (0) 2 571 04 501

Italia

Suomi/Finland

KRKA Farmaceutici Milano S.r.l.

KRKA Finland Oy

Tel: + 39 02 3300 8841

Puh/Tel: +358 20 754 5330

Κύπρος

Sverige

Kipa Pharmacal Ltd.

KRKA Sverige AB

Τηλ: + 357 24 651 882

Tel: + 46 (0)8 643 67 66 (SE)

Latvija

United Kingdom

KRKA Latvija SIA

Consilient Health (UK) Ltd.

Tel: + 371 6 733 86 10

Tel: + 44 (0) 203 751 1888

This leaflet was last revised in

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

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