Rivastigmine Ababor 2 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivastigmine Ababor 2 mg/ml oral solution EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you

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

Leaflet contents

1. What Rivastigmine Ababor is and what it is used for

2. What you need to know before taking Rivastigmine Ababor

3. How to take Rivastigmine Ababor

4. Possible side effects

5. How to store Rivastigmine Ababor

6. Contents of the pack and other information

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

The active substance is Rivastigmina.

Rivastigmina belongs to a group of substances known as cholinesterase inhibitors.

In patients with Alzheimer's dementia or dementia due to 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). Rivastigmina works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, rivastigmina allows acetylcholine levels to increase in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Rivastigmina Ababor is used to treat adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual capacity, and behavior. It can also be used for the treatment of dementia in adult patients with Parkinson's disease.

2. What you need to know before taking Rivastigmina Ababor

Do not take Rivastigmina Ababor

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

If this applies to you, tell your doctor and stop taking Rivastigmina Ababor.

Warnings and precautions

Talk to your doctor before starting to take Rivastigmina Ababor.

• if you have or have ever had irregular or slow heart rhythm
• if you have or have ever had active stomach ulcer
• if you have or have ever had difficulties in urination
• if you have or have ever had epileptic seizures (fits or convulsions)
• if you have or have ever had asthma or a serious 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 experience gastrointestinal reactions such as nausea, vomiting, and diarrhea. You may become dehydrated (lose a lot of fluid) if vomiting or diarrhea are prolonged

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

If you forget to take Rivastigmina Ababor for more than three days, do not take the next dose until you have consulted with
your doctor.

Children and adolescents

There is no relevant use of Rivastigmina Ababor in the pediatric population for the treatment of Alzheimer's disease.

Taking Rivastigmina Ababor with other medicines

Tell 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 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).

Rivastigmina Ababor should not be taken at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together could cause problems such as rigid limbs and trembling hands.

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

Caution is advised when taking rivastigmine together with beta-blockers (medicines such as atenolol used for hypertension, angina, and other heart conditions). Taking both medicines together could cause problems such as reduced heart rate (bradycardia), leading to fainting or loss of consciousness.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant, the benefits of using Rivastigmina Ababor must be weighed against the potential adverse effects on the fetus.

It is preferable to avoid using Rivastigmina Ababor during pregnancy unless clearly necessary. Inform your doctor if you become pregnant during treatment.

Women receiving treatment with Rivastigmina Ababor must not breastfeed.

Driving and using machines

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

Rivastigmina Ababor may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive, operate machinery, or perform tasks requiring your attention.

Important information about some of the ingredients of Rivastigmina Ababor 2 mg/ml oral solution

One of the excipients in Rivastigmina Ababor oral solution is sodium benzoate. This medicine may be irritating to the skin, eyes, and mucous membranes because it contains benzoic acid.

Rivastigmina Ababor also contains 1.867 mg of sodium per ml of solution, which should be taken into account in the management of patients on low-sodium diets.

3. How to take Rivastigmina Ababor

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Starting treatment

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

? Treatment usually starts with a low dose.

? Your doctor will gradually increase your dose depending on how you respond to treatment.

? The maximum dose that should be taken is 6 mg twice daily.

Your doctor should periodically evaluate whether the desired effects are being achieved. Your doctor will also monitor your weight while you are taking this medicine.

If you have not taken Rivastigmina for more than three days, do not take the next dose until you have spoken with your doctor.

Taking this medicine

? Inform your caregiver that you are taking Rivastigmina Ababor.

? To ensure that your medicine has the desired effect, you must take it every day.

? Rivastigmina Ababor should be taken twice daily with meals (in the morning and in the evening).

How to take this medicine

1. Prepare the bottle and syringe:

? Remove the syringe from its protective case.

? Press and turn the child-resistant cap to open the bottle.

1. Insert the syringe adapter into the opening of the stopper.

3. Insert the syringe into the adapter.

?

? Insert the syringe needle into the opening of the stopper.

1. Fill the syringe.

? Pull back the plunger of the syringe until the liquid reaches the mark corresponding to the dose prescribed by your doctor.

1. Remove air bubbles.

? Remove large air bubbles by moving the plunger back and forth.

? A few small bubbles are not important and do not affect the dose in any way.

? Check that the dose is correct.

? Then remove the syringe from the bottle.

1. Take your medicine.

? Take the dose directly from the syringe.

? You may also mix it with water in a small glass. Stir and drink the mixture completely.

1. After using the syringe.

? Clean the outer part of the syringe and the adapter with a clean tissue.

? Then return the syringe to its protective case.

? Replace the child-resistant cap on the bottle to close it.

If you take more Rivastigmina Ababor than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken.

Some people who have accidentally taken higher doses have experienced nausea, vomiting, diarrhoea, high blood pressure, and hallucinations. A slowing of heart rate and fainting may also occur.

If you forget to take Rivastigmina Ababor

If you forget your dose of Rivastigmina Ababor, 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 may cause adverse effects, although not everyone experiences them.

The likelihood of experiencing adverse effects is higher when starting treatment or increasing the dose. Adverse effects will likely diminish gradually as your body becomes accustomed to the medicine.

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

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

Common: (may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Burning sensation
• Weight loss
• Stomach pain
• Agitation
• Feeling of tiredness or weakness
• General malaise
• 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
• Epileptic seizures (fits or convulsions)
• Gastric and intestinal ulcers

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

• High blood pressure
• Urinary tract infection
• Hallucinations
• Heart rhythm problems (fast or slow heartbeat)
• Gastrointestinal bleeding (blood in stools or vomit)
• Pancreatitis (severe pain in the upper abdomen, often accompanied by nausea and vomiting)
• Worsening of Parkinson's disease or development of similar symptoms (muscle rigidity, difficulty moving)

Frequency not known: (cannot be estimated from available data)

• Severe vomiting that may lead to esophageal rupture (part of the digestive tract connecting the mouth to the stomach)
• Dehydration (excessive fluid loss)
• Liver problems (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine, or nausea, vomiting, fatigue, and unusual loss of appetite)
• Aggression, 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 associated with Parkinson's disease

These patients experience some adverse effects more frequently, as well as 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
• Restlessness
• Slow and fast heart rate
• Difficulty sleeping
• Excessive salivation and dehydration
• Abnormally slow or uncontrolled movements
• Worsening of Parkinson's disease or development of similar symptoms (muscle rigidity, difficulty moving, and muscle weakness)

Uncommon: (may affect up to 1 in 100 people)

• Irregular heartbeat and impaired motor control

Frequency 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)

The following additional adverse reactions have been observed with the use of Rivastigmine transdermal patches, which may also occur with the oral solution:

Common:

• Fever
• Severe confusion
• Urinary incontinence (inability to properly retain urine)

Uncommon: (may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

Frequency 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 these symptoms occur, contact your doctor, as medical attention may be required.

Reporting of adverse effects

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

5. Storage of Rivastigmina Ababor

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not refrigerate.

Keep the container in an upright position.

Use Rivastigmina Ababor 2 mg/ml oral solution within one month after first opening the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, 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

• The active substance is rivastigmine hydrogen tartrate, equivalent to 2.0 mg of rivastigmine base.
• The other components are: sodium benzoate (E211), citric acid monohydrate (E330), sodium citrate (E331), quinoline yellow soluble in water (E104), purified water.

Nature of the product and pack contents

Rivastigmina Ababor 2 mg/ml oral solution is presented as a clear, yellow solution (2.0 mg/ml rivastigmine base) in 50 ml or 120 ml amber glass bottles (Type III) with child-resistant closures. An oral dosing syringe and a syringe adapter in a plastic tube are included with the oral solution.

Marketing Authorization Holder

Ababor Pharmaceuticals, S.L.

Chile, 4 - Building 1 - Office 1 - Las Matas

28290- Las Rozas, Spain

Manufacturer

Pharmanel Pharmaceuticals SA

60th km of Athens – Lamia Highway,

GR 320 09

Greece

And

Pharmathen SA

Dervenakion 6

Pallini 15351

Attica, Greece

This summary of product characteristics was approved in September 2015

Date of the most recent review of this summary: January 2025

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