Rivastigmine CINFA 2 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivastigmina cinfa 2 mg/ml oral solution EFG

Rivastigmine hydrogen tartrate

Read the entire leaflet carefully before you start taking this medicine, because 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Rivastigmina cinfa is and what it is used for
2. What you need to know before taking Rivastigmina cinfa
3. How to take Rivastigmina cinfa
4. Possible side effects
5. How to store Rivastigmina cinfa
6. Contents of the pack and other information

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

The active substance in Rivastigmina cinfa is rivastigmine.

Rivastigmine belongs to a group of medicines called cholinesterase inhibitors. In patients with Alzheimer's dementia or dementia associated with 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 inhibiting 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.

Rivastigmine 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 behaviour. It may also be used to treat dementia in adult patients with Parkinson's disease.

2. What you need to know before starting Rivastigmina cinfa

Do not take Rivastigmina cinfa

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

Talk to your doctor or pharmacist before starting Rivastigmina cinfa.

• If you have or have ever had any heart problems such as irregular or slow heartbeat (pulse), QTc prolongation, family history of QTc prolongation, torsades de pointes, or if you have low blood levels of potassium or magnesium.
• If you have or have ever had an active stomach ulcer.
• If you have or have ever had difficulties urinating.
• If you have or have ever had seizures.
• If you have or have ever had asthma or a severe respiratory disease.
• If you have or have ever had (impairment) of kidney function.
• If you have or have ever had (impairment) of liver function.
• If you suffer from tremors.
• If you have low body weight.
• If you experience gastrointestinal reactions such as dizziness (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 for more than three days, do not take the next dose until you have consulted your doctor.

Children and adolescents

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

Other medicines and Rivastigmina cinfa

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

Rivastigmine should not be administered at the same time as other medicines with similar effects to it. Rivastigmine may interfere with anticholinergic medicines (used to relieve stomach cramps or spasms, to treat 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, inform your doctor before you are given any anesthetic, as rivastigmine may exaggerate the effects of certain muscle relaxants used during anesthesia.

Caution is advised 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.

Caution is advised when using rivastigmine together with other medicines that may affect heart rhythm or the heart's electrical system (QT prolongation).

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

If you are pregnant, the benefits of using rivastigmine must be weighed against the potential adverse effects on the fetus. Rivastigmine should not be taken during pregnancy unless clearly necessary.

Breastfeeding:

You must not breastfeed during treatment with rivastigmine.

Driving and using machines

Your condition may affect your ability to drive or operate machinery, and you should not engage in these activities unless your doctor tells you it is safe to do so. Rivastigmine may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, do not drive or operate machinery.

Rivastigmina cinfa contains sodium benzoate (E-211).

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

Rivastigmina cinfa contains sodium.

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

3. How to take Rivastigmina cinfa

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

Starting treatment

Your doctor will tell you what dose of rivastigmine 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 maximum dose you will take is 6 mg twice a day.

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 rivastigmine 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 rivastigmine.
• To benefit from your medicine, take it every day.
• Take rivastigmine twice a day (in the morning and at night), with meals.

For accurate dosing, the packages contain an oral syringe with graduated markings. Using this syringe, draw up the prescribed amount of rivastigmine from the bottle.

Insert the syringe into the pierced stopper, invert the bottle, and pull the plunger until the liquid reaches the mark in mg.

Return the bottle to its upright position and remove the syringe. The syringe should be cleaned and dried after each use.

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

If you take more Rivastigmina cinfa 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.

Some people who have accidentally taken higher doses have experienced dizziness (nausea), vomiting, diarrhoea, high blood pressure, and hallucinations. Slowing of heart rate and fainting may also occur.

If you forget to take Rivastigmina 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 forgotten doses.

If you have any other 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 becomes accustomed to the medicine.

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

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

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

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling restless
• Feeling tired or weak
• Feeling generally unwell
• Tremor or confusion
• Decreased appetite
• Nightmares

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

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

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

• Chest pain
• Skin rash, itching
• Epileptic seizures (convulsions)
• Ulcers in the stomach or intestine

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

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Problems with heart rhythm such as fast or slow heartbeat
• Gastrointestinal bleeding –表现为 blood in stools or vomit
• Inflammation of the pancreas – signs include severe upper stomach pain, often with nausea or vomiting
• Worsening of signs of Parkinson's disease or development of similar symptoms such as muscle stiffness, difficulty performing movements

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)
• Severe vomiting which may cause tearing of part of the digestive tract connecting the mouth to the stomach (esophagus)
• Dehydration (loss of large amounts of fluid)
• 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 restless
• Irregular heartbeat

Patients with dementia or Parkinson's disease

These patients experience some adverse effects more frequently and may also have additional adverse effects:

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

• Tremor
• Fainting
• Accidental falls

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

• Anxiety
• Feeling restless
• Slow and fast heartbeat
• Difficulty sleeping
• Excessive saliva and dehydration
• Abnormally slow movements or movements that cannot be controlled
• Worsening of signs of Parkinson's disease or development of similar symptoms such as muscle stiffness, difficulty performing movements, and muscle weakness

Uncommon adverse 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 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 the oral solution:

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

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

Uncommon adverse 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 site where the patch was applied, such as blisters or skin inflammation.

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

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmina cinfa

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated. Use Rivastigmina cinfa oral solution within the month following the first opening of the bottle.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to a pharmacy’s SIGRE collection point. 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 Rivastigmina cinfa

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

Appearance of the product and contents of the pack

It is presented as a clear, yellow aqueous solution.

It is supplied in amber glass bottles with child-resistant closures. An oral dosing syringe is included with the oral solution.

Each pack contains one 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 most recent revision of this summary: April 2025

Detailed information about this medicine 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 up-to-date information about this medicine by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (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 link: https://cima.aemps.es/cima/dochtml/p/71816/P_71816.html