Nimvastid

Package leaflet: Information for the patient

Nimvastid 1.5 mg hard capsules, 3 mg hard capsules, 4.5 mg hard capsules, 6 mg hard capsules

rivastigmine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4. Contents of this leaflet
  1. What Nimvastid is and what it is used for
  2. What you need to know before taking 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

Nimvastid contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances known as cholinesterase inhibitors. In patients with
Alzheimer's dementia or dementia associated with Parkinson's disease, certain brain cells die, resulting
in low levels of acetylcholine (a substance that enables nerve cells to communicate with each other).
Rivastigmine works by inhibiting the enzymes that break down acetylcholine: acetylcholinesterase and
butyrylcholinesterase. By inhibiting these enzymes, Nimvastid increases the levels of acetylcholine in the
brain, thereby improving the symptoms of Alzheimer's disease or dementia associated with Parkinson's
disease.
Nimvastid is used to treat adult patients with mild to moderate Alzheimer's dementia, a progressive
disorder of the central nervous system that gradually affects memory, learning ability, and behaviour.
The hard capsules and orodispersible tablets are also used for the treatment of dementia in adult
patients with Parkinson's disease.

2. What you need to know before taking 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 had a skin reaction while using the patch that spread beyond the area where the patch was applied, or if you experienced a more severe local reaction (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours after removing the patch. If this applies to you, inform your doctor and do not take Nimvastid.

Warnings and precautions
Talk to your doctor before taking Nimvastid:

• if you have or have ever had a heart condition such as irregular or slow heartbeat, prolonged QTc interval, family history of prolonged QTc interval, torsades de pointes, or if you have low levels of potassium or magnesium in your blood.
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures (epileptic fits).
• if you have or have ever had asthma or severe respiratory disorders.
• if you have or have ever had impaired kidney function.
• if you have or have ever had impaired liver function.
• if you suffer from tremors.
• if you are underweight.
• if you experience gastrointestinal disturbances such as nausea, vomiting, and diarrhoea. If vomiting and diarrhoea are persistent, you may become dehydrated (excessive fluid loss). If any of these situations apply to you, your doctor may monitor you more frequently during treatment with this medicine. If you have not taken Nimvastid for more than three days, consult your doctor before resuming treatment.

Children and adolescents
There is no indication for the specific use of Nimvastid in the paediatric population for the treatment of Alzheimer's disease.

Other medicines and Nimvastid
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Nimvastid must not be administered together with other medicines that have similar effects. Nimvastid may interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, for the treatment of Parkinson's disease, or to prevent motion sickness). Nimvastid must not be administered simultaneously with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking these two medicines together may cause adverse effects such as stiffness of the limbs and hand tremors. If you are scheduled for surgery and are being treated with Nimvastid, inform your doctor before receiving anaesthesia, as Nimvastid may enhance the effects of certain muscle relaxants during anaesthesia. Caution is recommended when Nimvastid is taken together with beta-blockers (medicines such as atenolol, used for the treatment of hypertension, angina, and other heart conditions). Taking both medicines together may cause adverse effects such as slowing of the heartbeat (bradycardia), which may lead to fainting or loss of consciousness. Caution is also recommended when Nimvastid is taken together with other medicines that may affect heart rhythm or the heart's electrical system (prolongation of QT interval).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. During pregnancy, the benefits of using Nimvastid must be weighed against the potential risks to the unborn child. Nimvastid must not be used during pregnancy unless strictly necessary.

You must not breastfeed during treatment with Nimvastid.

Driving and using machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Nimvastid may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you feel dizzy or drowsy, do not drive, do not operate machinery, and avoid any other activity requiring alertness.

3. How to take Nimvastid

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.
Starting treatment
Your doctor will tell you what dose of Nimvastid to take.

• Treatment usually starts with a low dose.
• Your doctor will gradually increase the dose based on your response to treatment.
• The highest dose that can be taken is 6.0 mg twice daily.

Your doctor will regularly check whether the medicine is working. Your doctor will also monitor your weight while you are taking this medicine.
If you have not taken Nimvastid for more than three days, consult your doctor before restarting treatment.
Taking the medicine

• Inform anyone caring for you that you are being treated with Nimvastid.
• To benefit from treatment, take the medicine every day.
• Take Nimvastid twice daily, in the morning and evening, with food.
• Swallow the capsules whole with a drink.
• Do not open or break the capsules.

If you take more Nimvastid than you should
If you accidentally take more Nimvastid than you should, inform your doctor. You may need medical treatment. Some people who have accidentally taken an excessive amount of Nimvastid have experienced nausea, vomiting, diarrhoea, high blood pressure, and hallucinations. A slow heartbeat and fainting may also occur.
If you forget to take Nimvastid
If you realize you have forgotten to take a dose of Nimvastid, wait and take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.
If you have any questions about 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.
Side effects may be more common when you first start taking the medicine or when the dose is increased. Generally, side effects will gradually disappear as your body gets used to the medicine.

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

• Dizziness
• Loss of appetite
• Stomach disturbances such as nausea, vomiting, diarrhoea

Common (may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach ache
• Feeling restless
• Feeling tired or weak
• General feeling of being unwell
• Tremors or confusion
• Loss of appetite
• Nightmares

Uncommon (may affect up to 1 in 100 people)

• Depression
• Sleep disorders
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Rash, itching
• Seizures (epileptic fits)
• Stomach or intestinal ulcer

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

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Heart rhythm disorders, such as fast or slow heartbeat
• Intestinal bleeding – may present as blood in the stool or vomit
• Inflammation of the pancreas – may present as severe pain in the upper stomach, often accompanied by nausea or vomiting
• Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving

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

• Severe vomiting which may lead to rupture of the tube connecting the mouth to the stomach (oesophagus)
• Dehydration (excessive loss of fluids)
• Liver problems (yellowing of the skin and whites of the eyes, dark-coloured urine, unexplained nausea, vomiting, tiredness and loss of appetite)
• Aggression, restlessness
• Irregular heartbeat

Patients with dementia and Parkinson’s disease
These patients experience certain side effects more frequently. They may also experience additional side effects:

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

• Tremors
• Fainting
• Accidental falls

Common (may affect up to 1 in 10 people)

• Anxiety
• Restlessness
• Slow and fast heartbeat
• Sleep disorders
• Excessive salivation and dehydration
• Unusual slowing of movements or uncontrollable movements
• Worsening of Parkinson’s disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving, and muscle weakness

Uncommon (may affect up to 1 in 100 people)

• Irregular heartbeat and poor control of movements

Other side effects observed 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 properly retain 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 reactions at the patch application site, such as blisters or skin inflammation

If you experience any of these symptoms, contact your doctor, as you may require medical attention.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the pack after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 of rivastigmine.
• The excipients of Nimvastid 1.5 mg capsules are, in the capsule core: microcrystalline cellulose, hypromellose, anhydrous colloidal silica, magnesium stearate; in the capsule coating: titanium dioxide (E171), yellow iron oxide (E 172) and gelatin.
• The excipients of Nimvastid 3 mg, 4.5 mg and 6 mg capsules are, in the capsule core: microcrystalline cellulose, hypromellose, anhydrous colloidal silica, magnesium stearate; in the capsule coating: titanium dioxide (E171), yellow iron oxide (E 172), red iron oxide (E 172) and gelatin.

Description of the appearance of Nimvastid and contents of the pack

Nimvastid 1.5 mg hard capsules contain a white to almost white powder and have a yellow cap and a yellow body.
Nimvastid 3 mg hard capsules contain a white to almost white powder and have an orange cap and an orange body.
Nimvastid 4.5 mg hard capsules contain a white to almost white powder and have a brown-red cap and a brown-red body.
Nimvastid 6 mg hard capsules contain a white to almost white powder and have a brown-red cap and an orange body.

They are packaged in blisters (PVC/PVDC, Al-foil) available in cartons containing 14 (only for 1.5 mg), 28, 30, 56, 60 or 112 hard capsules. HDPE bottles: available in packs of 200 or 250 hard capsules. 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Malta
E.J. Busuttil Ltd.
Tel: + 356 21 445 885

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

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

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Package leaflet: information for the patient

Nimvastid 1.5 mg orodispersible tablets, 3 mg orodispersible tablets, 4.5 mg orodispersible tablets, 6 mg orodispersible tablets

rivastigmine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4. Contents of this leaflet
  1. What Nimvastid is and what it is used for
  2. What you need to know before taking Nimvastid
  3. How to take Nimvastid
  4. Possible side effects
  5. How to store Nimvastid
  6. Contents of the pack and other information

7. What Nimvastid is and what it is used for

Nimvastid contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances known as cholinesterase inhibitors. In patients with
Alzheimer's dementia or dementia associated with Parkinson's disease, certain brain cells die, resulting
in low levels of acetylcholine (a substance that enables nerve cells to communicate with each other).
Rivastigmine works by inhibiting the enzymes that break down acetylcholine: acetylcholinesterase and
butyrylcholinesterase. By inhibiting these enzymes, Nimvastid increases acetylcholine levels in the
brain, thereby improving the symptoms of Alzheimer's disease or dementia associated with
Parkinson's disease.
Nimvastid is used to treat adult patients with mild to moderate Alzheimer's dementia, a progressive
disorder of the central nervous system that gradually affects memory, learning ability, and behaviour.
The hard capsules and orodispersible tablets are also used for the treatment of dementia in adult
patients with Parkinson's disease.

2. What you need to know before taking 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 experienced a skin reaction extending beyond the area where the patch was applied, or if you have had a more intense local reaction (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours after removing the patch. If this applies to you, inform your doctor and do not take Nimvastid.

Warnings and precautions
Talk to your doctor before taking Nimvastid:

• if you have or have ever had a heart condition such as irregular or slow heartbeat, prolonged QTc interval, family history of prolonged QTc interval, torsades de pointes, or if you have low levels of potassium or magnesium in your blood.
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures (epileptic fits).
• if you have or have ever had asthma or severe respiratory disorders.
• if you have or have ever had impaired kidney function.
• if you have or have ever had impaired liver function.
• if you suffer from tremors.
• if you are underweight.
• if you experience gastrointestinal disorders such as nausea, vomiting, and diarrhoea. If vomiting and diarrhoea are persistent, you may become dehydrated (excessive loss of fluids). If any of these situations apply to you, your doctor may monitor you more frequently during treatment with this medicine. Children and adolescents There is no indication for the specific use of Nimvastid in the paediatric population for the treatment of Alzheimer's disease. Other medicines and Nimvastid Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Nimvastid should not be administered together with other medicines that have similar effects. Nimvastid may interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, for the treatment of Parkinson's disease, or to prevent motion sickness). Nimvastid should not be taken at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause side effects such as stiffness of limbs and hand tremors. If you are due to undergo surgery and are being treated with Nimvastid, inform your doctor before receiving anaesthesia, as Nimvastid may enhance the effects of certain muscle relaxants during anaesthesia. Caution is advised when taking Nimvastid together with beta-blockers (medicines such as atenolol, used to treat hypertension, angina, and other heart conditions). Taking both medicines together may cause side effects such as slowing of the heartbeat (bradycardia), which may lead to fainting or loss of consciousness. Caution is also advised when taking Nimvastid together with other medicines that may affect heart rhythm or the heart's electrical system (prolongation of QT interval). Pregnancy, breast-feeding and fertility If you are pregnant, think you might be pregnant, planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine. If you are pregnant, the benefits of using Nimvastid must be weighed against the possible risks to the unborn child. Nimvastid should not be used during pregnancy unless strictly necessary.

You must not breast-feed during treatment with Nimvastid.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Nimvastid may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you feel dizzy or drowsy, do not drive, do not use machines, and avoid any other activities requiring alertness.
Nimvastid contains sorbitol (E420)
Nimvastid 1.5 mg orodispersible tablets This medicine contains 0.00525 mg of sorbitol per 1.5 mg orodispersible tablet.
Nimvastid 3 mg orodispersible tablets This medicine contains 0.0105 mg of sorbitol per 3 mg orodispersible tablet.
Nimvastid 4.5 mg orodispersible tablets This medicine contains 0.0 mg of sorbitol per 4.5 mg orodispersible tablet.
Nimvastid 6 mg orodispersible tablets This medicine contains 0.0 mg of sorbitol per 6 mg orodispersible tablet.

3. How to take Nimvastid

Take this medicine exactly as your doctor has instructed you. If you have any doubts,
consult your doctor, pharmacist, or nurse.
Starting treatment
Your doctor will tell you what dose of Nimvastid to take.

• Treatment usually starts with a low dose.
• Your doctor will slowly increase the dose based on your response to treatment.
• The highest dose that can be taken is 6.0 mg twice daily.

Your doctor will regularly check whether the medicine is working. Your doctor will also monitor
your weight while you are taking this medicine.
If you have not taken Nimvastid for more than three days, consult your doctor before restarting treatment.
Taking the medicine

• Inform the person caring for you that you are being treated with Nimvastid.
• To benefit from treatment, take the medicine every day.
• Take Nimvastid twice daily with food (in the morning and evening). The tablet should be taken on an empty stomach. The orodispersible tablets of Nimvastid are fragile. They must not be removed from the blister through the aluminium foil as this could damage them. Do not touch the tablets with wet hands, as the tablets may break. To remove the tablet from the packaging:
  1. Hold the blister strip by the edges and separate one blister cavity from the rest of the strip by tearing gently along the perforated line.
  2. Pull and completely remove the foil lid.
  3. Push the tablet out into your hand.
  4. Place the tablet on your tongue immediately after removing it from the packaging.

P $ j1

The tablet will dissolve directly in the mouth within a few seconds and can be swallowed without water.
Your mouth must be empty before placing the tablet on your tongue.
If you take more Nimvastid than you should
If you accidentally take more Nimvastid than you should, inform your doctor. You may need
medical treatment. Some people who accidentally took an excessive amount of Nimvastid have
experienced nausea, vomiting, diarrhoea, high blood pressure, and hallucinations. Slowing of the heartbeat and fainting may also occur.
If you forget to take Nimvastid
If you realize you have forgotten to take a dose of Nimvastid, wait and take the next dose at the
scheduled time. Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects may be more common when you start taking the medicine or when the dose is increased.
Generally, side effects will gradually disappear as your body gets used to the medicine.

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

• Dizziness
• Loss of appetite
• Stomach problems such as nausea, vomiting, diarrhoea

Common (may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach ache
• Feeling restless
• Feeling tired or weak
• General feeling of being unwell
• Tremors or feeling confused
• Loss of appetite
• Nightmares

Uncommon (may affect up to 1 in 100 people)

• Depression
• Sleep disturbances
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Rash, itching
• Seizures (epileptic fits)
• Stomach or intestinal ulcer

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

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Heart rhythm disorders, such as fast or slow heartbeat
• Bleeding in the intestine – may present as blood in the stool or vomit
• Inflammation of the pancreas – may present as severe pain in the upper stomach, often accompanied by nausea or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty performing movements

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

• Severe vomiting which may lead to rupture of the tube connecting the mouth to the stomach (oesophagus)
• Dehydration (excessive loss of fluids)
• Liver problems (yellowing of the skin and whites of the eyes, unusually dark urine, unexplained nausea, vomiting, tiredness and loss of appetite)
• Aggression, feeling restless
• Irregular heartbeat

Patients with dementia and Parkinson's disease
These patients more frequently experience certain side effects. They may also experience additional side effects:

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

• Tremors
• Fainting
• Accidental falls

Common (may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Slow and fast heartbeat
• Sleep disturbances
• Excessive salivation and dehydration
• Unusual slowing of movements or uncontrollable movements
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty performing movements and muscle weakness

Uncommon (may affect up to 1 in 100 people)

• Irregular heartbeat and poor control of movements

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

Common (may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to properly retain 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 reactions at the patch application site, such as blisters or skin inflammation

If you experience any of these symptoms, contact your doctor as you may need medical assistance.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 of rivastigmine.
• The other components are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, peppermint flavour (peppermint oil, corn maltodextrin), peppermint flavour (maltodextrin, gum arabic, sorbitol (E420), peppermint leaf oil, L-menthol), crospovidone, calcium silicate, magnesium stearate. See section 2 “Nimvastid contains sorbitol (E420)”.

Description of the appearance of Nimvastid and package contents
The orodispersible tablets are round and white in colour. Pack sizes containing (only for 1.5 mg): 28 x 1, 30 x 1, 56 x 1, 60 x 1, or 112 x 1 tablets in single-dose perforated blisters (OPA/Al/PVC film and peelable PET/Al foil). 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E.J. Busuttil Ltd.
Tel: +356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: +32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

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

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu