RIVASTIGMINE VIR 2 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Rivastigmine VIR 2 mg/ml Oral Solution EFG

Rivastigmine Hydrogen Tartrate

Read the entire package leaflet carefully before starting to take the medicine.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the Package Leaflet

1. What is Rivastigmine VIR 2 mg/ml Oral Solution and what is it used for
2. Before taking Rivastigmine VIR 2 mg/ml Oral Solution
3. How to take Rivastigmine VIR 2 mg/ml Oral Solution
4. Possible side effects
5. Storage of Rivastigmine VIR 2 mg/ml Oral Solution
6. Further information

1. What is Rivastigmine VIR 2 mg/ml Oral Solution and what is it used for

Rivastigmine belongs to a group of substances called cholinesterase inhibitors.

Rivastigmine is used to treat memory disorders in patients with Alzheimer's disease.

Rivastigmine is used to treat dementia in patients with Parkinson's disease.

2. Before taking Rivastigmine VIR 2 mg/ml Oral Solution

Before taking Rivastigmine VIR 2mg/ml Oral Solution, it is important that you read the following information and discuss any doubts with your doctor.

Do not takeRivastigmine VIR 2mg/ml Oral Solution

• if you are allergic (hypersensitive) to rivastigmine or any of the other components of Rivastigmine VIR 2mg/ml Oral Solution.
• if you have severe liver problems.

Be particularly careful withRivastigmine VIR 2mg/ml Oral Solution

• if you have or have ever had kidney or liver function disorders, irregular or slow heart rhythm, active stomach ulcers, asthma, or severe respiratory disease, difficulty urinating, or epileptic seizures (attacks or convulsions), your doctor may need to monitor you more closely while you are being treated.
• if you experience gastrointestinal reactions such as nausea and vomiting.
• if you have low body weight.
• if you suffer from tremors.

If you are in any of these situations, your doctor may consider it necessary to perform closer monitoring while you are being treated.

Rivastigmine VIR 2mg/ml Oral Solution is not recommended for use in children or adolescents (under 18 years of age).

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

In case you need to undergo surgery while taking rivastigmine, inform your doctor before any anesthetic is administered, as rivastigmine may enhance the effects of some muscle relaxants during anesthesia.

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

Pregnancy and breastfeeding

Pregnancy:

If you are pregnant, think you may be pregnant, or become pregnant during treatment, you must inform your doctor before taking this medicine. It is preferable to avoid using this medicine during pregnancy unless it is strictly necessary.

Breastfeeding:

It is not recommended that women being treated with rivastigmine breastfeed their children.

Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not perform these activities unless your doctor indicates that it is safe to do so. Rivastigmine VIR 2mg/ml Oral Solution may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or use machines.

3. How to take Rivastigmine VIR 2 mg/ml Oral Solution

Follow the administration instructions of Rivastigmine VIR 2mg/ml Oral Solution exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

For exact dosing, the containers come with a graduated oral syringe. Using this syringe, extract the prescribed amount of rivastigmine from the bottle.

The syringe is inserted into the pierced cap, the bottle is inverted, the plunger is pulled until the liquid reaches the ml mark, the bottle is returned to its initial position, and the syringe is removed.

The syringe should be cleaned and dried after each use.

Each dose of rivastigmine can be taken directly from the syringe.

Rivastigmine should be taken twice a day with meals (in the morning and at night).

Your doctor will indicate what dose of rivastigmine you should take, starting treatment with a low dose and gradually increasing it depending on how you respond to treatment. The maximum dose that should be taken is 6 mg twice a day. If you have not taken rivastigmine for several days, do not take the next dose until you have spoken with your doctor. To achieve the desired effect, you should take this medicine every day.

Inform your caregiver that you are taking rivastigmine.

This medicine should only be prescribed by a specialist, and your doctor should periodically evaluate whether it has the desired effects. Your doctor will monitor your weight while you are taking this medicine.

If you take more Rivastigmine VIR 2mg/ml Oral Solution than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. 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 Rivastigmine VIR 2mg/ml Oral Solution

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

4. Possible side effects

Like all medicines, Rivastigmine VIR 2mg/ml Oral Solution can cause side effects, although not everyone gets them.

The tendency to notice side effects is more frequent when starting to take your medicine or when increasing the dose. The side effects will disappear gradually as your body gets used to the medicine.

The frequencies of the side effects are:

Very common side effects(affect more than 1 in 10 patients): dizziness, nausea, vomiting, diarrhea, and loss of appetite.

Common side effects(affect between 1 and 10 in 100 patients): anxiety, sweating, headache, stomach burning, 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 side effects(affect between 1 and 10 in 1,000 patients), patients have reported depression, difficulty sleeping, changes in liver function, fainting or accidental falls.

Rare side effects(affect between 1 and 10 in 10,000 patients), patients have experienced chest pain, epileptic seizures (attacks or convulsions), skin rash, gastric and intestinal ulcers.

Very rare side effects(affect less than 1 in 10,000 patients), patients have experienced gastrointestinal bleeding (blood in the stool or when vomiting), urinary tract infection, pancreatitis (severe pain in the upper part of the stomach, often accompanied by nausea and vomiting), heart rhythm problems (rapid or slow heartbeat), high blood pressure, hallucinations, worsening of Parkinson's disease or development of similar symptoms (muscle stiffness, difficulty moving).

Frequency not known(cannot be estimated from the available data): severe vomiting that can cause esophageal rupture (part of the digestive tube that connects the mouth to the stomach), Pisa Syndrome (a condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side) (frequency not known).

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Patients with dementia associated with Parkinson's disease experience some side effects more frequently, as well as additional side effects: tremors (very common), difficulty sleeping, anxiety, restlessness, worsening of Parkinson's disease or development of similar symptoms (muscle stiffness, difficulty moving), abnormally slow or uncontrolled movements, slow heartbeat, excessive saliva, and dehydration (common), irregular heartbeat and loss of movement control (uncommon), Pisa Syndrome (a condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side) (frequency not known).

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If these symptoms occur, contact your doctor, as you may need medical attention.

Reporting of side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmine VIR 2 mg/ml Oral Solution

Keep out of the reach and sight of children.

Do not use Rivastigmine VIR 2mg/ml Oral Solution after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required. Use Rivastigmine VIR 2mg/ml Oral Solution within a month of opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of Rivastigmine VIR 2mg/ml Oral Solution

• The active ingredient is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate equivalent to 2.0 mg of rivastigmine base.
• The other ingredients are sodium benzoate, water-soluble quinoline yellow (E104), and purified water.

Appearance of the product and packaging contents

Rivastigmine VIR 2mg/ml Oral Solution is presented as a clear, yellow solution (2.0 mg/ml rivastigmine base) in 120 ml amber glass bottles with a child-resistant closure. The oral solution comes with a dosing syringe.

Marketing Authorization Holder and Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of the last revision of this package leaflet: January 2025

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