RIVASTIGMINE ORTODROL 2 mg/ml ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rivastigmine Ortodrol 2 mg/ml oral solution EFG

Rivastigmine hydrogen tartrate

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Rivastigmine Ortodrol 2 mg/ml oral solution is and what it is used for
2. Before taking Rivastigmine Ortodrol 2 mg/ml oral solution
3. How to take Rivastigmine Ortodrol 2 mg/ml oral solution
4. Possible side effects
5. Storage of Rivastigmine Ortodrol 2 mg/ml oral solution
6. Further information

1. What Rivastigmine Ortodrol 2 mg/ml oral solution is and what it is used for

The active substance in Rivastigmine Ortodrol 2 mg/ml oral solution is rivastigmine.

Rivastigmine belongs to a group of substances called cholinesterase inhibitors.

In patients with Alzheimer's dementia or dementia associated with Parkinson's disease, certain nerve cells die in the brain, causing low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, rivastigmine allows an increase in 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 disease, a progressive brain disorder that gradually affects memory, intellectual ability, and behavior. The oral solution can also be used to treat dementia in adult patients with Parkinson's disease.

2. What you need to know before taking Rivastigmine Ortodrol 2 mg/ml oral solution

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

Do not takeRivastigmine Ortodrol 2 mg/ml oral solution

• if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver problems.

Warnings and precautions

Consult your doctor before starting to use rivastigmine:

• if you have or have ever had an irregular or slow heart rate (pulse).
• if you have or have ever had an active stomach ulcer.
• If you have or have ever had difficulty 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 kidney function impairment.
• If you have or have ever had liver function impairment.
• If you suffer from tremors.
• If you have low body weight.
• If you have gastrointestinal reactions such as a feeling of nausea, vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged.

If you are in any of these situations, your doctor may consider it necessary to monitor you more closely 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.

Children and adolescents

Rivastigmine Ortodrol 2 mg/ml oral solution should not be used in the pediatric population for the treatment of Alzheimer's disease.

Taking Rivastigmine Ortodrol 2 mg/ml oral solution with other medicines

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

Rivastigmine 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.

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

Caution should be exercised when using rivastigmine with beta-blockers (medicines such as atenolol used to treat high blood pressure, angina, and other heart conditions). Taking the two medicines together may cause complications such as a decrease in heart rate (bradycardia) that can lead to fainting or loss of consciousness.

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

You should not breastfeed while taking rivastigmine.

Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not carry out these activities unless your doctor tells you it is safe to do so. Rivastigmine 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 use machines.

Rivastigmine Ortodrol contains sodium benzoate

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

3. How to take Rivastigmine Ortodrol 2 mg/ml oral solution

Follow the instructions for administration of Rivastigmine Ortodrol 2 mg/ml oral solution exactly as indicated by your doctor. Ask your doctor or pharmacist if you have any doubts.

For exact dosing, the packs contain an oral syringe graduated. Using this syringe, extract the prescribed amount of rivastigmine from the bottle.

The syringe is inserted into the pierced 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 in the evening).

Your doctor will tell you what dose of rivastigmine to take, starting 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 to your doctor. To get the effect of your medicine, you should take it every day.

Tell your caregiver that you are taking rivastigmine.

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

If you take more Rivastigmine 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, telephone 91 562 04 20, indicating the medicine and the amount taken. Some people who have taken accidentally higher doses have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. There may also be a slowing of the heart rate and fainting.

If you forget to take Rivastigmine Ortodrol 2 mg/ml oral solution

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.

4. Possible side effects

Like all medicines, Rivastigmine Ortodrol 2 mg/ml oral solution can cause side effects, although not everybody gets them.

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

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): anxiety, sweating, headache, stomach burning, weight loss, stomach pain, feeling of agitation, feeling of fatigue or weakness, feeling of general discomfort, tremor or feeling of confusion, 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 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).

Side effects with unknown frequency(cannot be estimated from the available data): severe vomiting that can cause esophageal rupture (part of the digestive tube that connects the mouth to the stomach), dehydration (loss of a large amount of fluid), liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormal darkening of urine or unexplained nausea, vomiting, fatigue, and loss of appetite), aggression, feeling of restlessness, irregular heart rate, torticollis (a 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, as well as 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 uncontrolled movements, slow heart rate, excessive saliva, and dehydration (common), irregular heart rate, and loss of movement control (uncommon), torticollis (a 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 the oral solution:

Common: fever, severe confusion, urinary incontinence (inability to properly hold urine).

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmine Ortodrol 2 mg/ml oral solution

Keep out of the reach and sight of children.

Do not use Rivastigmine Ortodrol 2 mg/ml oral solution after the expiry date stated on the pack. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Rivastigmine Ortodrol 2 mg/ml oral solution

• The active substance is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate equivalent to 2.0 mg of rivastigmine base.
• The other ingredients are: sodium benzoate, anhydrous citric acid, sodium citrate dihydrate, water-soluble quinoline yellow (E104), and purified water.

Appearance of the product and pack contents

Rivastigmine Ortodrol 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 a child-resistant closure. An oral syringe for dosing is included with the oral solution.

Marketing Authorization Holder and manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70

Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

This leaflet was approved in January 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/