NIMVASTID 1.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Nimvastid 1.5 mg Hard Capsules EFG

Nimvastid 3 mg Hard Capsules EFG

Nimvastid 4.5 mg Hard Capsules EFG

Nimvastid 6 mg Hard Capsules EFG

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.

Contents of the pack

1. What is Nimvastid and what is it used for
2. What you need to know before you take Nimvastid
3. How to take Nimvastid
4. Possible side effects
5. Storage of Nimvastid
6. Contents of the pack and other information

1. What is Nimvastid and what is it used for

The active substance of Nimvastid is rivastigmine.

Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with Alzheimer's dementia or dementia associated with Parkinson's disease, certain nerve cells die in the brain, causing low levels of acetylcholine neurotransmitters (a substance that allows nerve cells to communicate with each other). Rivastigmine acts by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.

By blocking these enzymes, Nimvastid allows the increase of acetylcholine 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 behavior. The capsules and orodispersible tablets 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 of Nimvastid) or any of the other ingredients of this medicine (listed in section 6).
• if you have a skin reaction that spreads beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if there is no improvement within 48 hours after removing the transdermal patch.

If you are in one of these situations, inform your doctor and do not take Nimvastid.

Warnings and precautions

Consult your doctor before starting to use Nimvastid:

• if you have or have ever had an irregular or slow heart rate.
• 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.
• if you have or have ever had asthma or severe respiratory disease.
• if you have or have ever had kidney function impairment.
• if you have or have ever had liver function impairment.
• if you suffer from tremors.
• if you have low body weight.
• if you have gastrointestinal reactions such as a feeling of nausea, vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged.

If you are in one of these situations, your doctor may consider it necessary to monitor you more closely while you are being treated.

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

Children and adolescents

Nimvastid should not be used in the pediatric population for the treatment of Alzheimer's disease.

Other medicines and Nimvastid

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Nimvastid should not be administered at the same time as other medicines with similar effects to those of Nimvastid. Nimvastid may interfere with anticholinergic medicines (used to relieve stomach cramps or spasms, for the treatment of Parkinson's disease, or to prevent travel sickness).

Nimvastid should not be administered at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together may cause problems such as stiffness in the limbs and hand tremors.

In case you need to undergo surgery while taking Nimvastid, inform your doctor before you are given any anesthetic, as Nimvastid may exaggerate the effects of some muscle relaxants during anesthesia.

Caution should be exercised when using Nimvastid with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking the two medicines together may cause complications such as a decrease in heart rate (bradycardia) that may lead to fainting or loss of consciousness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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, it is necessary to evaluate the benefits of using Nimvastid against the possible adverse effects for the fetus. Nimvastid should not be used during pregnancy unless clearly necessary.

You should not breastfeed while taking Nimvastid.

Driving and using machines

Your doctor will inform you if your illness allows you to drive or use machinery safely. Nimvastid may cause dizziness and somnolence, mainly at the start of treatment or when the dose is increased. If you feel dizzy or drowsy, do not drive or use machinery, or perform other tasks that require your attention.

3. How to take Nimvastid

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor, pharmacist, or nurse again.

How to start treatment

Your doctor will tell you which dose of Nimvastid to take.

• Normally, treatment starts with a low dose.
• Your doctor will gradually increase the dose depending on how you respond to treatment.
• The highest dose you should take is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working for you. Your doctor will also check your weight while 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 consulted 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 in the evening), with meals.
• Swallow the capsule whole with the help of liquid.
• Do not open or crush the capsule.

If you take more Nimvastid than you should

If you accidentally take more Nimvastid than you should, inform your doctor. You may need medical attention. Some people who have accidentally taken higher doses have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. There may also be a slowing of the heart rate and fainting.

If you forget to take Nimvastid

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

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 frequently when you start your treatment or when your dose is increased. Generally, side effects will slowly disappear as your body gets used to the medicine.

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

• Nausea
• Loss of appetite
• Stomach problems such as nausea, vomiting, diarrhea

Common(may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling of agitation
• Feeling of tiredness or weakness
• Feeling of general discomfort
• Tremors or feeling of confusion
• Decreased appetite
• Nightmares

Uncommon(may affect up to 1 in 100 people)

• Depression
• Difficulty sleeping
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Skin rash, itching
• 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 do not exist (hallucinations)
• Heart rate problems such as fast or slow heart rate
• Gastrointestinal bleeding – manifested as blood in the stool or when vomiting
• Pancreatitis – signs include severe pain in the upper abdomen, often with nausea or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving

Not known(cannot be estimated from the available data)

• Severe vomiting that may cause tearing of part of the digestive tube that connects your mouth to your stomach (esophagus)
• Dehydration (loss of a large amount of fluid)
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormal darkening of urine or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Aggression, feeling of restlessness
• Irregular heart rate

Patients with dementia or Parkinson's disease

These patients experience some side effects more frequently and also have some 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 of restlessness
• Fast or slow heart rate
• Difficulty sleeping
• Excessive saliva and dehydration
• Abnormally slow or uncontrolled 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 heart rate and loss of movement control

Other side effects observed in rivastigmine transdermal patches and that may occur with hard capsules:

Common(may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to stop urine properly)

Uncommon(may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

Not known(cannot be estimated from the available data)

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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. Storage of 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 carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Nimvastid composition

• The active ingredient is rivastigmine hydrogen tartrate.

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

• The other ingredients of Nimvastid 1.5 mg hard capsules are microcrystalline cellulose, hypromellose, anhydrous colloidal silica, magnesium stearate in the capsule content and titanium dioxide (E171), yellow iron oxide (E172) and gelatin in the capsule shell.
• The other ingredients of Nimvastid 3 mg, 4.5 mg and 6 mg hard capsules are microcrystalline cellulose, hypromellose, anhydrous colloidal silica, magnesium stearate in the capsule content and titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and gelatin in the capsule shell.

Product appearance and container contents

Nimvastid 1.5 mg hard capsules contain a white to off-white powder in a capsule with a yellow cap and body.

Nimvastid 3 mg hard capsules contain a white to off-white powder in a capsule with an orange cap and body.

Nimvastid 4.5 mg hard capsules contain a white to off-white powder in a capsule with a reddish-brown cap and body.

Nimvastid 6 mg hard capsules contain a white to off-white powder in a capsule with a reddish-brown cap and an orange body.

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

Plastic containers: boxes of 200 or 250 hard capsules are available.

Only some 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 about this medicinal product, please contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:{MM/AAAA}

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