Package Insert: Information for the User

Rivastigmina Kern Pharma 2 mg/ml Oral Solution EFG

Rivastigmina (hydrogen tartrate)

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

• If you consider that any of the adverse effects you are experiencing is severe or if you notice any effect not mentioned in this package insert, inform your doctor or pharmacist.

Rivastigmina belongs to a group of substances called cholinesterase inhibitors.

Rivastigmina is used for the treatment of memory disorders in patients with Alzheimer's disease.

Rivastigmina is used for the treatment of dementia in patients with Parkinson's disease.

Before taking Rivastigmina 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 takeRivastigmina Kern Pharma 2 mg/ml oral solution

• if you are allergic (hypersensitive) to rivastigmina or to any of the other components of Rivastigmina Kern Pharma 2 mg/ml oral solution,
• if you have severe liver problems.

Be especially careful withRivastigmina Kern Pharma 2 mg/ml oral solution

• if you have or have had any time kidney or liver function abnormalities, irregular or slow heart rhythm, active stomach ulcer, 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 a low body weight,
• if you suffer from tremors.

If you find yourself in any of these situations, your doctor may consider the need for closer monitoring while you are being treated.

Rivastigmina Kern Pharma 2 mg/ml oral solution is not recommended for use in children or adolescents (under 18 years old).

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.

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

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

Pregnancy and breastfeeding

Pregnancy:

If you are pregnant, think you may be pregnant, or become pregnant while being treated, you must 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 being treated with rivastigmina breastfeed their children.

Driving and operating machinery

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

Follow exactly the administration instructions for Rivastigmina Kern Pharma 2 mg/ml oral solution as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

The syringe is inserted into the perforated cap, the bottle is turned upside down, 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.

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

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

Inform your caregiver that you are taking rivastigmina.

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

If you take more Rivastigmina Kern Pharma 2 mg/ml oral solution than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 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. It may also cause a slowing of heart rate and fainting.

If you forget to take Rivastigmina Kern Pharma 2 mg/ml oral solution

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

Like all medications, Rivastigmina Kern Pharma 2 mg/ml oral solution may

produce side effects, although not everyone will experience them.

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

The frequencies of 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): heartburn, stomach pain, headache, restlessness, confusion, weakness, fatigue, sweating, general discomfort, weight loss, nightmares, and tremors.

Uncommon(affect between 1 and 10 in 1,000 patients): patients have reported depression, difficulty sleeping, changes in liver function, fainting or accidental falls.

Rare(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(affect fewer than 1 in 10,000 patients): patients have experienced gastrointestinal bleeding (blood in stool or vomit), urinary tract infection, pancreatitis (severe pain in the upper 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).

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

Patients with Parkinson's disease-associated dementia experience some side effects more frequently and 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 uncontrollable movements, slow heart rate, excessive saliva, and dehydration (common), irregular heart rhythm, and poor movement control (uncommon), Pisa syndrome (a condition involving involuntary muscle contraction and abnormal tilting of the body and head to one side, unknown).

If these symptoms occur, contact your doctor as they may require medical assistance.

If you consider any of the side effects you experience to be severe or if you notice any side effects not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use Rivastigmina Kern Pharma 2 mg/ml oral solution after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required. Use Rivastigmina Kern Pharma 2 mg/ml oral solution within one month after the first opening of the bottle.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Rivastigmina 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 dye (E-104) and purified water.

Appearance of the Product and Contents of the Package

Rivastigmina Kern Pharma 2 mg/ml Oral Solution is presented in the form of a transparent, yellow (2.0 mg/ml rivastigmine base) solution of 120 ml in amber glass bottles with a child-resistant closure. Along with the oral solution, a syringe for oral dosing is included.

Holder of the Marketing Authorization

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for Manufacturing

Industria Química y Farmacéutica Vir, S.A

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

Alcorcón Madrid

This leaflet has been approved in: December 2024

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