PATIENT INFORMATION LEAFLET

Rivastigmina Ortodrol 2 mg/ml Oral Solution EFG

Rivastigmina hydrochloride tartrate

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

The active ingredient of Rivastigmina Ortodrol 2 mg/ml oral solution is rivastigmina.

Rivastigmina belongs to a group of substances called cholinesterase inhibitors.

In patients with Alzheimer's disease or Parkinson's disease-associated dementia, certain nerve cells die in the brain, causing 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. The oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.

Before taking Rivastigmina Ortodrol 2 mg/ml oral solution, it is essential that you read the following information and discuss any questions with your doctor.

Do not takeRivastigmina Ortodrol 2 mg/ml oral solution

• if you are allergic to rivastigmina or to any of the other components of this medication (listed in section 6).
• if you have severe liver problems.

Warnings and precautions

Consult your doctor before starting to use rivastigmina:

• if you have or have had any irregular or slow heart rhythm.or.
• 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 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 Ortodrol 2 mg/ml oral solution should not be used in the pediatric population for the treatment of Alzheimer's disease.

Taking Rivastigmina Ortodrol 2 mg/ml oral solution with other medications

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

Rivastigmina should not be administered at the same time as metoclopramide (a medication used to alleviate or prevent nausea and vomiting). Taking the two medications 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 exacerbate the effects of some muscle relaxants during anesthesia.

Care should be taken when rivastigmina is used with beta blockers (medications such as atenolol used to treat hypertension, angina, and other cardiovascular conditions). Taking the two medications together may cause complications such as a decrease in heart rate (bradycardia) that may lead to fainting or loss of consciousness.

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

Pregnancy, breastfeeding, and fertility

Pregnancy

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

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

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 Ortodrol 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.

Rivastigmina Ortodrol contains sodium benzoate

This medication contains 1 mg of sodium benzoate per ml of solution.

Follow exactly the administration instructions for Rivastigmina Ortodrol 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 inverted, 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 2 times 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 achieve the desired effect, you must take it every day.

Inform your caregiver that you are taking rivastigmina.

This medication 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 medication.

If you take more Rivastigmina Ortodrol 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 medication 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 dizziness.

If you forget to take Rivastigmina Ortodrol 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 medicines, Rivastigmina Ortodrol 2 mg/ml oral solution may cause side effects, although not everyone will experience them.

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

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): anxiety, sweating, headache, heartburn, weight loss, stomach pain, feeling agitated, feeling tired or weak, feeling generally unwell, tremor or feeling confused, decreased appetite, nightmares.

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 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).

Side effects of unknown frequency(cannot be estimated from available data): severe vomiting that may cause esophageal rupture (part of the digestive tube that connects the mouth to the stomach), dehydration (loss of large amounts of fluid), liver disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of urine or unexplained nausea, vomiting, fatigue, and loss of appetite), aggression, feeling restless, irregular heart rhythm, Pisa syndrome (condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side)

Patients with dementia associated with Parkinson's disease experience some side effects more frequently and additional side effects: tremor, fainting, accidental falls (very common), difficulty sleeping, anxiety, restlessness, worsening of Parkinson's disease or development of similar symptoms (muscle stiffness, difficulty moving, and muscle weakness), abnormally slow or uncontrollable movements, slow heart rate, excessive saliva, and dehydration (common), irregular heart rhythm and poor movement control (uncommon), Pisa syndrome (condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side) (unknown).

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

Common: fever, severe confusion, urinary incontinence (inability to stop urinating properly).

Uncommon: hyperactivity (high level of activity, restlessness).

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

If you consider that any of the side effects you experience are 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, pharmacist, or nurse, even if it is a possible 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 about the safety of this medicine.

Keep out of reach and sight of children.

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

No special storage conditions are required. Use Rivastigmina Ortodrol 2 mg/ml oral solution within the month following the first opening of the bottle.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Rivastigmina Ortodrol 2 mg/ml oral solution

• The active ingredient is rivastigmina hydrogentartrate. Each ml contains rivastigmina hydrogentartrate equivalent to 2.0 mg of rivastigmina base.
• The other components are: sodium benzoate, anhydrous citric acid, sodium citrate dihydrate, water-soluble quinoline yellow dye (E104) and purified water.

Appearance of the product and contents of the packaging

Rivastigmina Ortodrol 2 mg/ml oral solution is presented in the form of a transparent, yellow (2.0 mg/ml rivastigmina 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 and responsible for manufacturing

Industria Química y Farmacéutica VIR, S.A

C/ Laguna 66-68-70

Industrial Urtinsa II Industrial Estate

28923 Alcorcón (Madrid)

Spain

This leaflet was approved in January 2025

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