Package Insert: 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

rivastigmina

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4

The active ingredient of Nimvastid is rivastigmina.

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

By blocking these enzymes, Nimvastid allows for an increase in 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 disease, a progressive brain disorder that gradually affects memory, intellectual capacity, and behavior. Capsules and buccal dispersible tablets can also be used for the treatment of dementia in adult patients with Parkinson's disease.

Do not take Nimvastid

• if you are allergic to rivastigmine (the active ingredient in Nimvastid) or to any of the other components of this medication (listed in section 6).
• if you have a skin reaction that extends beyond the size of the patch, if there is a more intense local reaction (such as blisters, increased skin inflammation, swelling) and if there is no improvement within 48 hours after removing the transdermal patch.

If you find yourself in any 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 had any irregular or slow heart rhythm.
• if you have or have had any active stomach ulcer.
• if you have or have had any difficulty urinating.
• if you have or have had any seizures.
• if you have or have had any asthma or severe respiratory disease.
• if you have or have had any kidney function deterioration.
• if you have or have had any liver function deterioration.
• if you suffer from tremors.
• if you have a low body weight.
• if you have gastrointestinal reactions such as dizziness (nausea), vomiting, and diarrhea. You may become dehydrated (loss of a large amount of fluid) if vomiting or diarrhea are prolonged.

If you find yourself in any of these situations, your doctor may consider the need for closer monitoring while you are on treatment.

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 used recently, or may need to use any other medication.

Nimvastid should not be administered at the same time as other medications with similar effects to 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.

If you need to undergo surgery while taking Nimvastid, inform your doctor before any anesthetic is administered, as Nimvastid may exaggerate the effects of some muscle relaxants during anesthesia.

Care should be taken when Nimvastid is used 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 may lead to fainting or loss of consciousness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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 on the fetus. Nimvastid should not be used during pregnancy unless it is clearly necessary.

You should not breastfeed during treatment with Nimvastid.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machinery safely. Nimvastid may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you feel dizzy or drowsy, do not drive, operate machinery, or engage in other tasks that require your attention.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

Starting 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 the 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 monitor 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 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 taken accidental higher doses have experienced dizziness (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. It may also cause a slowing of heart rate and fainting.

If You Forget to Take Nimvastid

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

You may experience side effects more frequently when you start treatment or when your dose is increased. Side effects usually fade away 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 dizziness (nausea), vomiting, diarrhea

Common(may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Abdominal pain
• Restlessness
• Feeling tired or weak
• General feeling of discomfort
• Shakiness or 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 the 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 heart rhythm such as rapid or slow heart rate
• Gastrointestinal bleeding – presents as blood in stools or vomiting blood
• Pancreatitis – symptoms include severe pain in the upper abdomen, often with dizziness (nausea) or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty moving, and muscle weakness

Unknown(cannot be estimated from 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 white of the eyes, abnormal darkening of urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Aggression, feeling of restlessness
• Irregular heart rhythm

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 unease
• Irregular heart rhythm
• 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 rhythm 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 stop urinating properly)

Uncommon(may affect up to 1 in 100 people)

• Hypervigilance (high level of activity, restlessness)

Unknown(cannot be estimated from 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 they may require medical assistance.

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 does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

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

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Nimvastid

• The active ingredient is rivastigmine hydrogen tartrate.

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

• The other components 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 coating.
• The other components 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 coating.

Appearance of the product and contents of the package

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

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

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

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

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

Plastic packaging: available in boxes of 200 or 250 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

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

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:{MM/AAAA}

For detailed information about this medicine, please visit the European Medicines Agency website::http://www.ema.europa.eu/.