Prospect: Information for the User

Rivastigmina VIR 1.5 mg Hard Capsules EFG

Rivastigmina

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

6. Contents of the pack and additional information

The active ingredient of Rivastigmina VIR is rivastigmina.

Rivastigmina belongs to the group of substances known as cholinesterase inhibitors. In patients with Alzheimer's disease or dementia due to 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). Rivastigmina acts by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, rivastigmina allows an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Rivastigmina VIR 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. The capsules and oral solution can also be used for the treatment of dementia in patients with Parkinson's disease.

Do not take Rivastigmina VIR

• if you are allergic to rivastigmina or other carbamates or to any of the other components of this medication (listed in section 6).

If you are in any of these situations, inform your doctor and do not take Rivastigmina VIR.

Be especially careful with Rivastigmina VIR

Consult your doctor before starting to take Rivastigmina VIR:

• 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 disorder.
• if you have or have had any liver function disorder.
• if you suffer from tremors.
• if you have 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 are in any of these situations, your doctor may consider the need for closer monitoring while you are being treated.

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

Children and Adolescents

Rivastigmina VIR should not be used in pediatric patients for the treatment of Alzheimer's disease.

Other medications and Rivastigmina VIR

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Rivastigmina 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 Rivastigmina VIR, inform your doctor before any anesthetic is administered, as Rivastigmina VIR may exaggerate the effects of some muscle relaxants during anesthesia.

Care should be taken when rivastigmina 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 think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

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

You should not breastfeed during treatment with Rivastigmina VIR.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Starting Treatment

Your doctor will tell you what dose of Rivastigmina VIRyou should 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 can take is 6 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 Rivastigmina VIR 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 Rivastigmina VIR.
• To benefit from your medication, take it every day.
• Take Rivastigmina VIR twice a day (in the morning and at night) with food.
• Swallow the capsule whole with liquid.
• Do not open or crush the capsule.

If You Take More Rivastigmina VIR than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you accidentally take more Rivastigmina VIR than you should, inform your doctor. You may require medical attention.Some people who have taken accidental 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 Rivastigmina VIR

If you forget your dose of Rivastigmina VIR, 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 the use of this medication, ask your doctor or pharmacist.

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

You may experience side effects more frequently when you start treatment or increase your dose. Side effects usually disappear gradually 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.
• Feeling agitated.
• Feeling tired or weak.
• General feeling of discomfort.
• Tremor or feeling of confusion
• Decreased appetite
• Nightmares

Uncommon(may affect up to 1 in 100 people)

• Depression.
• Difficulty sleeping.
• Blackouts 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).
• Problems with your heart rhythm such as rapid or slow heart rhythm.
• Gastrointestinal bleeding – presents as blood in the stool 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

Frequency not known

• Intense vomiting that can cause tearing of part of the digestive tube that connects your mouth to your stomach (esophagus).
• Dehydration (loss of a large amount of fluids).
• Itching
• Liver disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, fatigue, and loss of appetite).
• Aggression, feeling of restlessness.
• Irregular heart rhythm.
• Torticollis (condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side) (frequency not known).

Patients with dementia and 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.
• Blackouts.
• Accidental falls.

Common (may affect up to 1 in 10 people)

• Anxiety.
• Feeling uneasy.
• 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.

Frequency not known

• Torticollis (condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side) .

Other side effects observed with Rivastigmina transdermal patches and 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)

Hyperactivity (high level of activity, restlessness)

Unknown

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

If you experience any of these side effects, consult your doctor, you may need medical assistance

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, website:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Rivastigmina VIR after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

Composition of Rivastigmina VIR capsules

• The active ingredient is rivastigmina(as hydrogen tartrate):

Each hard capsule of Rivastigmina VIR 1.5 mg capsules containsrivastigmina hydrogen tartrate equivalent to 1.5 mg of rivastigmina.

• The other components arecellulose microcrystalline, hydroxypropyl methyl cellulose, colloidal silicon dioxide, magnesium stearate,gelatin, yellow iron oxide (E 172)andtitania dioxide (E 171).

Appearance of the product and content of the container

Rivastigmina VIR 1.5 mg capsules are presented in hard gelatin capsules with a yellow opaque cap and a yellow opaque body with a white powder.

They are packaged in blisters available in three different container sizes(28, 56 or 112 hard capsules).

Some container sizes may not be marketed.

Holder of the Marketing Authorization

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70. Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible for manufacturing

PHARMATHEN,S.A.

Pallini 15351

Attiki

Greece

O

Pharmathen International, S.A

SapesIndustrial Park

Block 5

69300 Rodopi

Greece

O

Hormosan Pharma GmbH

Hanauer Landstraße 139-143

60314 Frankfurt am Main

Germany

This leaflet has been authorized in March 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/