RIVASTIGMINE VIR 4.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Rivastigmine VIR 4.5 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, pharmacist, or nurse.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Rivastigmine VIR and what is it used for
2. What you need to know before you take Rivastigmine VIR
3. How to take Rivastigmine VIR
4. Possible side effects
5. Storage of Rivastigmine VIR

1. Contents of the pack and further information

1. What is Rivastigmine VIR and what is it used for

The active substance of Rivastigmine VIR is rivastigmine.

Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, causing low levels of the neurotransmitter acetylcholine (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, rivastigmine allows an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

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

2. What you need to know before you take Rivastigmine VIR

Do not take Rivastigmine VIR

• if you are allergic to rivastigmine or other carbamate derivatives or to any of the other ingredients of this medicine (listed in section 6).

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

Be cautious with Rivastigmine VIR

Consult your doctor before starting to take Rivastigmine VIR:

• if you have or have ever had an irregular or slow heart rate (pulse).
• 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 (nausea), vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged.

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

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

Children and Adolescents

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

Other medicines and Rivastigmine VIR

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Rivastigmine 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 Rivastigmine VIR, inform your doctor before you are given any anesthetic, as Rivastigmine VIR may exaggerate the effects of some muscle relaxants during anesthesia.

Caution should be exercised when using rivastigmine 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 can lead to fainting or loss of consciousness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

You should not breastfeed while taking Rivastigmine VIR.

Driving and using machines

Your doctor will inform you if your illness allows you to drive or use machinery safely. Rivastigmine VIR 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 or use machinery or perform other tasks that require your attention.

3. How to take Rivastigmine VIR

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

How to start treatment

Your doctor will indicate what dose of Rivastigmine VIR you should take.

• Normally, treatment starts with a low dose.
• Your doctor will slowly increase the dose depending on how you respond to treatment.
• The highest dose you can take is 6 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 Rivastigmine VIR 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 Rivastigmine VIR.
• To benefit from your medicine, take it every day.
• Take Rivastigmine VIR twice a day (in the morning and at night) with food.
• Swallow the capsule whole with the help of liquid.
• Do not open or crush the capsule.

If you take more Rivastigmine VIR than you should

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

If you accidentally take more Rivastigmine VIR than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken higher doses have suffered from 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 Rivastigmine VIR

If you forget your dose of Rivastigmine VIR, 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 other 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.

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

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

• Feeling of nausea.
• Lack 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.
• 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 (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.

Frequency not known(cannot be estimated from the available data)

• Severe vomiting that can cause a tear in the digestive tract that connects your mouth to your stomach (esophagus).
• Dehydration (loss of a large amount of fluid).
• Itching.
• 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.
• Pisa syndrome (a 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)

• Tremors.
• Fainting.
• Accidental falls.

Common(may affect up to 1 in 10 people)

• Anxiety.
• Feeling of restlessness.
• Fast and slow heart rate.
• Difficulty sleeping.
• Excessive saliva and dehydration.
• Abnormally slow movements or movements that cannot be controlled.
• 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 loss of movement control.

Frequency not known(cannot be estimated from the available data)

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

Other side effects observed in Rivastigmine transdermal patches and that may appear with the hard capsules:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

Hyperactivity (high level of activity, restlessness).

Unknown(frequency 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, consult your doctor, you may need medical attention.

Reporting of side effects

If you experience any side effect, consult your doctor, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines, web: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmine VIR

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

Do not use Rivastigmine VIR after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

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. Contents of the pack and further information

Composition of Rivastigmine VIR capsules

• The active substance is rivastigmine (as hydrogen tartrate):

Each hard capsule of Rivastigmine VIR 4.5 mg contains rivastigmine hydrogen tartrate equivalent to 4.5 mg of rivastigmine.

• The other ingredients are microcrystalline cellulose, hypromellose, colloidal silicon dioxide, magnesium stearate, gelatin, yellow iron oxide (E 172), and titanium dioxide (E 171) and red iron oxide (E 172).

Appearance and packaging of the product

Rivastigmine VIR 4.5 mg hard capsules are presented in hard gelatin capsules with a red opaque cap and a red opaque body with a white powder.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70. Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer

PHARMATHEN, S.A.

Pallini 15351

Attiki

Greece

Or

Pharmathen International, S.A

Sapes Industrial Park

Block 5

69300 Rodopi

Greece

Or

Hormosan Pharma GmbH

Hanauer Landstraße 139-143

60314 Frankfurt am Main

Germany

This leaflet was approved in March 2025

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