RIVASTIGMINE CINFA 2 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Rivastigmine Cinfa 2 mg/ml Oral SolutionEFG

Rivastigmine Hydrogen Tartrate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Rivastigmine Cinfa and what is it used for
2. What you need to know before taking Rivastigmine Cinfa
3. How to take Rivastigmine Cinfa
4. Possible side effects
5. Storage of Rivastigmine Cinfa
6. Package Contents and Additional Information

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

The active ingredient of Rivastigmine Cinfa is rivastigmine.

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

Rivastigmine is used to treat adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability, and behavior. It can also be used to treat dementia in adult patients with Parkinson's disease.

2. What you need to know before taking Rivastigmine Cinfa

Do not take Rivastigmine Cinfa

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

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Rivastigmine Cinfa.

• If you have or have ever had any heart problems, such as irregular or slow heart rhythm, QTc prolongation, family history of QTc prolongation, torsades de pointes, or if you have low blood potassium or magnesium levels.
• 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 dizziness (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 for more than three days, do not take the next dose until you have consulted your doctor.

Children and Adolescents

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

Other Medications and Rivastigmine Cinfa

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

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

Rivastigmine 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.

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

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

Caution should be exercised when using rivastigmine with other medications that may affect heart rate or the heart's electrical system (QT prolongation).

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

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

Breastfeeding:

You should not breastfeed during treatment with rivastigmine.

Driving and Using Machines

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

Rivastigmine Cinfa contains Sodium Benzoate (E-211).

This medication contains 1 mg of sodium benzoate (E-211) per ml.

Rivastigmine Cinfa contains Sodium.

This medication contains less than 1 mmol of sodium (23 mg) per ml; this is, essentially "sodium-free".

3. How to take Rivastigmine Cinfa

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

How to start treatment

Your doctor will indicate what dose of rivastigmine you should take.

• Normally, treatment starts with a low dose.
• Your doctor will gradually increase the dose depending on how you respond to treatment.
• The highest dose you should take is 6 mg twice a day.

Your doctor will regularly check if the medication is working for you. Your doctor will also check your weight while you are taking this medication.

If you have not taken rivastigmine 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 rivastigmine.
• To benefit from your medication, take it every day.
• Take rivastigmine twice a day (in the morning and at night), with meals.

For exact dosing, the packages contain 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, and the plunger is pulled until the liquid reaches the mark in mg.

The bottle is returned to its original 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.

If you take more Rivastigmine Cinfa 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.

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 Cinfa

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.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Very common side effects(may affect more than 1 in 10 patients)

• Dizziness
• Lack of appetite
• Stomach problems such as nausea, vomiting, diarrhea

Common side effects(may affect up to 1 in 10 patients)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling of agitation
• Feeling of fatigue or weakness
• Feeling of general malaise
• Tremors or feeling of confusion
• Decreased appetite
• Nightmares

Uncommon side effects(may affect up to 1 in 100 patients)

• Depression
• Difficulty sleeping
• Fainting or accidental falls
• Changes in liver function

Rare side effects(may affect up to 1 in 1,000 patients)

• Chest pain
• Skin rash, itching
• Seizures
• Ulcers in the stomach or intestine

Very rare side effects(may affect up to 1 in 10,000 patients)

• High blood pressure
• Urinary tract infection
• Seeing things that do not exist (hallucinations)
• Heart rhythm 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 available data)

• Pisa syndrome (a condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side)
• Severe vomiting that can cause tearing of part of the digestive tube that connects the mouth to the stomach (esophagus)
• Dehydration (loss of a large amount of fluid)
• 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 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 side effects(may affect more than 1 in 10 patients)

• Tremors
• Fainting
• Accidental falls

Common side effects(may affect up to 1 in 10 patients)

• Anxiety
• Feeling of restlessness
• Fast or 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 side effects(may affect up to 1 in 100 patients)

• Irregular heartbeat and loss of movement control

Frequency not known(cannot be estimated from 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 occur with the oral solution:

Common side effects(may affect up to 1 in 10 patients)

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

Uncommon side effects(may affect up to 1 in 100 patients)

• Hyperactivity (high level of activity, restlessness)

Frequency not known(cannot be estimated from available data)

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

If you experience any of these symptoms, contact your doctor, as you may require medical attention.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rivastigmine Cinfa

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

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated. Use Rivastigmine Cinfa oral solution in the month following the first opening of the bottle.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rivastigmine Cinfa

• The active ingredient is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate equivalent to 2 mg of rivastigmine base.
• The other ingredients are: sodium benzoate (E-211), water-soluble quinoline yellow (E-104), and purified water.

Appearance of the Product and Package Contents

It is presented in the form of a clear, yellow aqueous solution.

It is presented in amber glass bottles with a child-resistant closure. A dosing syringe is included with the oral solution.

Each package contains a bottle with 120 ml of oral solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Industria Química y Farmacéutica Vir, S.A.

C/ Laguna 66-68-70, Pol. Industrial Urtinsa II.

28923 Alcorcón (Madrid) - Spain

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

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71816/P_71816.html

QR code to: https://cima.aemps.es/cima/dochtml/p/71816/P_71816.html