RIVASTIGMINE KERN PHARMA 2 mg/ml ORAL SOLUTION

2. Before taking Rivastigmine Kern Pharma 2 mg/ml Oral Solution

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

Do not takeRivastigmine Kern Pharma 2 mg/ml Oral Solution

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

Be cautious withRivastigmine Kern Pharma 2 mg/ml Oral Solution

• if you have or have 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 taking this medication,
• 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 taking this medication.

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

Rivastigmine should not be taken at the same time as other medications with similar effects. Rivastigmine may interfere with anticholinergic medications (medications 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 should inform your doctor before taking this medication. It is preferable to avoid using this medication during pregnancy unless it is strictly necessary.

Breastfeeding:

It is not recommended that women taking rivastigmine breastfeed their babies.

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 Kern Pharma 2 mg/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 Kern Pharma 2 mg/ml Oral Solution

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

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 perforated cap, the bottle is inverted, the plunger is pulled until the liquid reaches the mark in mg, 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 medication every day.

Inform your caregiver that you are taking rivastigmine.

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

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Some people who have accidentally taken higher doses have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. It can also cause a slowing of the heart rate and fainting.

If you forget to take Rivastigmine Kern Pharma 2 mg/ml Oral Solution

If you forget a 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.

4. Possible side effects

Like all medications, Rivastigmine Kern Pharma 2 mg/ml Oral Solution can cause side effects, although not everyone will experience them.

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

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): burning sensation, stomach pain, headache, agitation, confusion, weakness, fatigue, sweating, general malaise, weight loss, nightmares, and tremors.

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 (fast or slow heart rate), 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): 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 esophageal rupture (part of the digestive tube that connects the mouth to the stomach).

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 heart rate, excessive saliva, and dehydration (common), irregular heartbeat and loss of movement control (uncommon), Pisa syndrome (frequency not known).

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

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not mentioned in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for human use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rivastigmine Kern Pharma 2 mg/ml Oral Solution

Keep out of the reach and sight of children.

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

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

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 your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Rivastigmine Kern Pharma 2 mg/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 components are sodium benzoate (E-211), water-soluble quinoline yellow (E-104), and purified water.

Appearance of the product and package contents

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

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Industria Química y Farmacéutica Vir, S.A

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

Alcorcón Madrid

This package leaflet was approved in: December 2024

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