NIMVASTID 6 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 the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Nimvastid and what is it used for

The active ingredient in 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 to treat 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 to treat dementia in adult patients with Parkinson's disease.

2. What you need to know before taking Nimvastid

Do not take Nimvastid

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 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 Medications and Nimvastid

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Nimvastid should not be administered at the same time as other medications with similar effects to those of Nimvastid. Nimvastid may interfere with anticholinergic medications (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 medication used to relieve or prevent nausea and vomiting). Taking the two medications 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.

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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 it is clearly necessary.

You should not breastfeed during treatment with Nimvastid.

Driving and Using Machines

Your doctor will inform you if your condition 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 the administration instructions of this medication exactly as indicated by your doctor. If you are in doubt, consult your doctor, pharmacist, or nurse again.

How to Start Treatment

Your doctor will indicate what dose of Nimvastid you should 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 medication is working for you. Your doctor will also check your weight while you are taking this medication.

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 Medication

• Inform your caregiver that you are taking Nimvastid.
• To benefit from your medication, take it every day.
• Take Nimvastid twice a day (in the morning and at night), with meals.
• Swallow the capsule whole with the help of a 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 require 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 the forgotten doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

You may have side effects more frequently when starting your treatment or when your dose is increased. Generally, side effects will slowly disappear as your body gets used to the medication.

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 fatigue or weakness
• Feeling of general discomfort
• Tremor 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 (convulsions)
• 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 can cause a tear in the 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)

• Tremor
• 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 Appear with Hard Capsules:

Common(may affect up to 1 in 10 people)

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

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 at the patch application site, such as blisters or skin inflammation

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Nimvastid

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This 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: available in boxes of 200 or 250 hard capsules.

Only some pack sizes may be marketed.

Marketing authorization 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 authorization 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/.