Rivastigmina Combix 2 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivastigmina Combix 2 mg/ml oral solution EFG

Rivastigmine hydrogen tartrate

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Rivastigmina Combix is and what it is used for
2. What you need to know before taking Rivastigmina Combix
3. How to take Rivastigmina Combix
4. Possible adverse effects
5. How to store Rivastigmina Combix
6. Contents of the pack and other information

1. What Rivastigmina Combix is and what it is used for

The active substance in Rivastigmina Combix is rivastigmine.

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

Rivastigmine is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability, and behavior. The capsules and oral solution may also be used for the treatment of dementia in adult patients with Parkinson's disease.

2. What you need to know before starting to take Rivastigmina Combix

Do not take Rivastigmina Combix

• if you are allergic to rivastigmine (the active substance in Rivastigmina Combix) or to any of the other ingredients of this medicine (listed in section 6).
• if you experience a skin reaction that spreads beyond the size of the patch, if you have a more intense local reaction (such as blisters, increasing skin inflammation, swelling), or 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 rivastigmine.

Warnings and precautions

Talk to your doctor before starting Rivastigmina:

• if you have or have ever had heart problems such as irregular or slow heartbeat (pulse), QTc prolongation, family history of QTc prolongation, torsade de pointes, or if you have low blood levels of potassium or magnesium.
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulties with urination.
• if you have or have ever had seizures.
• if you have or have ever had asthma or a serious respiratory disease.
• if you have or have ever had (impairment of) kidney function.
• if you have or have ever had (impairment of) liver function.
• if you suffer from tremors.
• if you have low body weight.
• if you experience gastrointestinal reactions such as feeling sick (nausea), vomiting, and diarrhea. You may become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea are prolonged.

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

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

Other medicines and Rivastigmina Combix

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

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

Rivastigmine should not be administered at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause problems such as stiffness in the limbs and hand tremors.

If you need to undergo surgery while taking rivastigmine, inform your doctor before receiving any anesthetic, as rivastigmine may intensify the effects of certain muscle relaxants used during anesthesia.

Caution is advised when using rivastigmine together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking both medicines together may cause complications such as a decrease in heart rate (bradycardia), which may lead to fainting or loss of consciousness.

Caution is advised when using rivastigmine together with other medicines that may affect heart rhythm or the heart's electrical system (QT prolongation).

Pregnancy, breastfeeding, and fertility

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

If you are pregnant, the benefits of using rivastigmine must be weighed against the potential risks to the fetus. Rivastigmine should not be used during pregnancy unless clearly necessary.

You should not breastfeed while being treated with rivastigmine.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Rivastigmine may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you feel dizzy or sleepy, do not drive or operate machinery or perform any other tasks requiring your attention.

Rivastigmina Combix contains sodium benzoate (E211) and sodium

One of the inactive ingredients in Rivastigmina Combix oral solution is sodium benzoate (E211). Benzoic acid is slightly irritating to the skin, eyes, and mucous membranes. This medicine contains 3 mg of sodium benzoate (E211) in each 3 ml of oral solution.

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

3. How to take Rivastigmina Combix

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Starting treatment

Your doctor will tell you what dose of rivastigmine you should take.

• Treatment is usually started at a low dose.
• Your doctor will slowly increase your dose depending on how you respond to treatment.
• The highest dose you will take is 6.0 mg twice daily.

Your doctor will regularly monitor whether the medicine is working for you. Your doctor will also monitor your weight 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.

Taking this medicine

• Inform your caregiver that you are taking rivastigmine.
• To benefit from your medicine, take it every day.
• Take rivastigmine twice daily (in the morning and at night), with meals.

For accurate dosing, the packaging contains an oral syringe graduated in mg. Using this syringe, draw the prescribed amount of rivastigmine from the bottle.

Insert the syringe into the pierced stopper, invert the bottle, pull the plunger until the liquid reaches the mark in mg, return the bottle to its upright position, and remove the syringe.

The syringe should be cleaned and dried after each use.

Each dose of rivastigmine may be taken directly from the syringe.

If you take more Rivastigmina Combix than you should

If you accidentally take more rivastigmine than you should, inform your doctor. You may require medical attention.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, stating the medicine and the amount taken. Some people who have accidentally taken higher doses have experienced dizziness (nausea), vomiting, diarrhoea, high blood pressure, and hallucinations. Slowing of the heart rate and fainting may also occur.

If you forget to take Rivastigmina Combix

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 missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You may experience adverse effects more frequently when starting treatment or when your dose is increased. Generally, adverse effects will gradually disappear as your body gets used to the medicine.

Very common (may affect more than 1 in 10 people)

• Dizziness
• Loss of appetite
• Stomach problems such as nausea, vomiting, diarrhoea

Common (may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling restless
• Feeling tired or weak
• General feeling of discomfort
• Tremor or confusion
• Decreased appetite
• Nightmares

Uncommon (may affect up to 1 in 100 people)

• Depression
• Difficulty sleeping
• Fainting or accidental falls
• Changes in liver function

Rare (may affect up to 1 in 1,000 people)

• Chest pain
• Skin rash, itching
• Epileptic seizures (convulsions)
• Ulcers in the stomach or intestine

Very rare (may affect up to 1 in 10,000 people)

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Problems with your heart rhythm such as fast or slow heartbeat
• Gastrointestinal bleeding – shown as blood in stools or vomiting blood
• Inflammation of the pancreas – symptoms include severe pain in the upper stomach, often with nausea or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty performing movements

Not known (cannot be estimated from available data):

• Severe vomiting which may cause tearing of part of the digestive tract connecting your mouth to your stomach (oesophagus)

• Dehydration (loss of large amounts of fluid)

• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, tiredness and loss of appetite)

• Aggression, feeling of restlessness

• Irregular heartbeat

• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)

Patients with dementia or Parkinson's disease

These patients experience some adverse effects more frequently and may also have additional adverse effects:

Very common (may affect more than 1 in 10 people)

• Tremor
• Fainting
• Accidental falls

Common (may affect up to 1 in 10 people)

• Anxiety
• Feeling of restlessness
• Slow and fast heart rate
• Difficulty sleeping
• Excessive salivation and dehydration
• Abnormally slow movements or uncontrollable movements
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty performing movements, and muscle weakness

Uncommon (may affect up to 1 in 100 people)

• Irregular heartbeat and poor movement control

Not known (cannot be estimated from available data)

• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)

Other adverse effects observed with rivastigmine transdermal patches and which may also occur with the oral solution:

Common (may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to properly control urination)

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

Not known (cannot be estimated from available data)

• Allergic reaction at the site where the patch was applied, such as blisters or skin inflammation

If you experience any of these adverse effects, contact your doctor, as medical attention may be required.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmina Combix

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

Do not use Rivastigmina Combix after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required. Use Rivastigmina Combix within one month after first opening the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmina Combix

• The active substance is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate equivalent to 2.0 mg of rivastigmine base.
• The other components are sodium benzoate (E211), quinoline yellow water-soluble dye (E104), and purified water.

Appearance of the medicine and contents of the pack

Rivastigmina Combix oral solution is presented as a clear, yellow solution (2.0 mg/ml rivastigmine base) in 120 ml amber glass bottles with child-resistant closure. An oral dosing syringe is included with the oral solution.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Date of the most recent revision of this leaflet: January 2025

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