Rivastigmine Vir 1.5 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivastigmine VIR 1.5 mg hard capsules EFG

Rivastigmine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet Contents:

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

2. What you need to know before taking Rivastigmine VIR

3. How to take Rivastigmine VIR

4. Possible side effects

5. How to store Rivastigmine VIR

6. Contents of the pack and other information

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

The active substance of Rivastigmina VIR is rivastigmine.

Rivastigmine belongs to a group of substances known as cholinesterase inhibitors. In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells in the brain die, resulting in low levels of the neurotransmitter acetylcholine (a substance that enables nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, rivastigmine increases the levels of acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Rivastigmina VIR is used to treat adult patients with mild to moderately severe Alzheimer's dementia, 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.

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

Do not take Rivastigmine VIR

• if you are allergic to rivastigmine, to 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.

Take special care 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 active stomach ulcer.
• if you have or have ever had difficulties in urination.
• if you have or have ever had seizures.
• if you have or have ever had asthma or a serious respiratory disease.
• if you have or have ever had impaired kidney function.
• if you have or have ever had impaired liver function.
• if you suffer from tremors.
• if you have low body weight.
• if you experience gastrointestinal reactions such as nausea, vomiting, and diarrhea. You could become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea are prolonged.

If you are in any of these situations, your doctor may consider closer monitoring while you are on treatment.

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

Other medicines and Rivastigmine VIR

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

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

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

If you need to undergo surgery while taking Rivastigmine VIR, inform your doctor before any anesthetic is administered, as Rivastigmine VIR may enhance the effects of certain muscle relaxants used during anesthesia.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

If you are pregnant, the benefits of using Rivastigmine VIR must be weighed against the potential risks to the fetus. Rivastigmine VIR must not be used during pregnancy unless clearly necessary.

You must not breastfeed during treatment with Rivastigmine VIR.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Rivastigmine VIR may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you feel dizzy or drowsy, do not drive or operate machinery or perform any other tasks requiring your attention.

3. How to take Rivastigmina VIR

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Starting treatment

Your doctor will tell you what dose of Rivastigmina VIR you should take.

• Treatment is usually started at a low dose.
• Your doctor will slowly increase your dose depending on how you respond to treatment.
• The highest dose you may take is 6 mg twice daily.

Your doctor will regularly monitor whether the medicine is working for you. Your doctor will also monitor your weight while you are taking this medicine.

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 medicine

• Inform your caregiver that you are taking Rivastigmina VIR.
• To benefit from your medicine, take it every day.
• Take Rivastigmina VIR twice daily (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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine 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 accidentally taken higher doses have experienced dizziness (nausea), vomiting, diarrhoea, high blood pressure, and hallucinations. Slowing of the heart rate and fainting may also occur.

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 forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You may experience adverse effects more frequently when starting treatment or when your dose is increased. Generally, adverse effects will gradually disappear 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 nausea, vomiting, diarrhoea.

Common (may affect up to 1 in 10 people)

• Anxiety.
• Sweating.
• Headache.
• Heartburn.
• Weight loss.
• Stomach pain.
• Restlessness.
• Feeling of tiredness or weakness.
• Feeling generally unwell.
• Tremor 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.
• Epileptic 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 do not exist (hallucinations).
• Problems with heart rhythm such as fast or slow heartbeat.
• Gastrointestinal bleeding – manifested as blood in stools or in vomit.
• Inflammation of the pancreas – signs include severe pain in the upper abdomen, often with nausea or vomiting.
• Worsening of signs of Parkinson’s disease or development of similar symptoms – such as muscle rigidity, difficulty performing movements.

Frequency not known (cannot be estimated from available data)

• Severe vomiting which may cause tearing of part of the digestive tract connecting the mouth to the stomach (oesophagus).
• Dehydration (loss of large amounts of fluids).
• Itching.
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, tiredness and loss of appetite).
• Aggression, feeling of restlessness.
• Irregular heartbeat.
• Pisa syndrome (a condition involving involuntary muscle contractions 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 adverse effects more frequently and also have some additional adverse 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.
• Slow and fast heartbeat.
• Difficulty sleeping.
• Excessive salivation and dehydration.
• Abnormally slow movements or uncontrolled movements.
• Worsening of signs of Parkinson’s disease or development of similar symptoms – such as muscle rigidity, difficulty performing movements and muscle weakness.

Uncommon (may affect up to 1 in 100 people)

• Irregular heartbeat and impaired movement control.

Frequency not known (cannot be estimated from available data)

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

Other adverse effects observed with Rivastigmine transdermal patches and which may also occur 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 (frequency cannot be estimated from available data)

• Allergic reaction at the site of patch application, such as blisters or skin inflammation.

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

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at: www.notificaRAM.es.

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

5. Storage of Rivastigmina VIR

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

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmine VIR capsules

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

Each hard capsule of Rivastigmine VIR 1.5 mg contains rivastigmine hydrogen tartrate equivalent to 1.5 mg of rivastigmine.

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

Appearance of the medicine and contents of the pack

Rivastigmine VIR 1.5 mg capsules are presented as hard gelatin capsules with an opaque yellow cap and opaque yellow body containing whitish powder.

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

Some pack sizes may not 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 patient information leaflet was approved in March 2025

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