Leaflet: information for the user

Rivastigmina cinfa 2 mg/ml oral solutionEFG

Rivastigmina hidrogenotartrate

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

The active ingredient of Rivastigmina cinfa is rivastigmina.

Rivastigmina belongs to the group of substances known as cholinesterase inhibitors. In patients with Alzheimer's disease or Parkinson's disease-associated dementia, certain nerve cells die in the brain, resulting in low levels of acetylcholine neurotransmitters (a substance that allows nerve cells to communicate with each other). Rivastigmina acts by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, rivastigmina allows an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Rivastigmina is used for the treatment of adult patients with mild to moderately severe Alzheimer's disease, a progressive brain disorder that gradually affects memory, intellectual capacity, and behavior. It can also be used for the treatment of dementia in adult patients with Parkinson's disease.

Do not take Rivastigmina cinfa

• if you are allergic to rivastigmina or any of the other ingredients of this medicine (listed in section 6).
• if you have a skin reaction that extends beyond the size of the patch, if there is a more intense local reaction (such as blisters, increased skin inflammation, swelling) and 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 rivastigmina.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rivastigmina cinfa.

• if you have or have had any heart problems such as irregular or slow heart rhythm, prolonged QTc, family history of prolonged QTc, torsades de pointes, or if you have low blood levels of potassium or magnesium.
• if you have or have had any active stomach ulcers.
• if you have or have had any difficulty urinating.
• if you have or have had any seizures.
• if you have or have had any asthma or severe respiratory disease.
• if you have or have had any kidney function deterioration.
• if you have or have had any liver function deterioration.
• if you suffer from tremors.
• if you have a low body weight.
• if you have gastrointestinal reactions such as dizziness (nausea), vomiting, and diarrhea. You may become dehydrated (loss of a large amount of fluid) if vomiting or diarrhea is prolonged.

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

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

Children and adolescents

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

Other medicines and Rivastigmina cinfa

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

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

Rivastigmina 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.

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

Care should be taken when rivastigmina is used 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 may lead to fainting or loss of consciousness.

Care should be taken when rivastigmina is used with other medicines that may affect heart rhythm or the heart's electrical system (prolongation QT).

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

If you are pregnant, the benefits of using rivastigmina must be weighed against the possible adverse effects on the fetus. Rivastigmina should not be taken during pregnancy unless it is clearly necessary.

Breastfeeding:

You should not breastfeed during treatment with rivastigmina.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so. Rivastigmina 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 operate machinery.

Rivastigmina cinfa contains benzoate sodium (E-211).

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

Rivastigmina cinfa contains sodium.

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

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

How to Start Treatment

Your doctor will tell you what dose of rivastigmina 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 monitor your weight while you are taking this medication.

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

For an exact dose, the containers have an oral syringe graduated. Using this syringe, extract the prescribed amount of rivastigmina from the bottle.

The syringe is inserted into the perforated stopper, the bottle is turned upside down, and the plunger is pulled until the liquid reaches the mg 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 rivastigmina can be taken directly from the syringe.

If You Take More Rivastigmina cinfa 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 medication and the amount ingested.

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

If You Forget to Take Rivastigmina cinfa

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

You may experience side effects more frequently when you start treatment or when your dose is increased. Side effects usually disappear gradually as your body gets used to the medicine.

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

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

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

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling agitated
• Feeling tired or weak
• General feeling of discomfort
• Shakiness or feeling confused
• Loss of 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
• Cutaneous rash, itching
• Seizures (convulsions)
• 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)
• Problems with heart rhythm such as rapid or slow heart rate
• Gastrointestinal bleeding - presents as blood in the stool or vomiting blood
• Pancreatitis - symptoms include severe pain in the upper abdomen, often with dizziness (nausea) or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms such as muscle stiffness, difficulty moving, and muscle weakness

Frequency not known(cannot be estimated from available data)

• Syndrome of Pisa (condition involving involuntary muscle contraction and abnormal inclination of the body and head to one side)
• Intense vomiting that may cause tearing of part of the digestive tube that connects your mouth to your stomach (esophagus)
• Dehydration (loss of a large amount of fluid)
• Liver disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Aggression, feeling restless
• 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)

• Tremor
• Fainting
• Accidental falls

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

• Anxiety
• Feeling uneasy
• Irregular heart rhythm
• Difficulty sleeping
• Excessive saliva and dehydration
• Abnormally slow or uncontrolled movements
• 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 heart rhythm and loss of movement control

Frequency not known(cannot be estimated from available data)

• Syndrome of Pisa (condition involving involuntary muscle contraction and abnormal inclination of the body and head to one side)

Other side effects observed in rivastigmine transdermal patches and that may appear with oral solution:

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

• Fever
• Severe confusion
• Urinary incontinence (inability to stop urinating properly)

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

Frequency not known(cannot be estimated from available data)

• Allergic reaction 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 assistance.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use :https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated. Use Rivastigmina 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 drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rivastigmina cinfa

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

Appearance of the product and contents of the packaging

It is presented in the form of a transparent and yellowish aqueous solution.

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization of marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Industria Química y Farmacéutica Vir, S.A

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

28923 Alcorcón (Madrid) - Spain

Last review date of this leaflet: April 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. 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