Patient Information Leaflet

Rivastigmina Ababor 2 mg/ml Oral Solution EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you

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

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

2. What you need to know before you start taking Rivastigmina Ababor

3. How to take Rivastigmina Ababor

4. Possible side effects

5. Storage of Rivastigmina Ababor

6. Contents and additional information

The active ingredient is Rivastigmina.

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

In patients with Alzheimer's disease or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (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 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 for the treatment in adult patients with mild to moderately severe Alzheimer's disease, 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..

Do not take Rivastigmina Ababor

- if you are allergic to rivastigmina or to any of the other ingredients of this medication (listed in section 6).

If this happens, tell your doctor and stop taking Rivastigmina Ababor.

Warnings and precautions

Consult your doctor before starting to take Rivastigmina Ababor.

- if you have or have had any irregular or slow heart rhythm

- if you have or have had any active stomach ulcer

- if you have or have had any difficulty urinating

- if you have or have had any seizures (attacks or convulsions)

- if you have or have had any asthma or severe respiratory disease

- if you have or have had any kidney function impairment

- if you have or have had any liver function impairment

- if you suffer from tremors

- if you have a low body weight

- if you experience gastrointestinal reactions such as nausea, vomiting, and diarrhea. You may become dehydrated (lose a lot of liquid) if vomiting or diarrhea are 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 forgot to take Rivastigmina Ababor for more than three days, do not take the next dose until you consult 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.

Use of Rivastigmina Ababor with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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 stomach spasms, to treat Parkinson's disease, or to prevent motion sickness).

Rivastigmina Ababor should not be administered at the same time as metoclopramide (a medication used to relieve or prevent nausea and vomiting). Taking the two medications together may cause problems such as stiff limbs and shaky hands.

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

Caution should be exercised when taking rivastigmina with beta-blockers (medications such as atenolol used for hypertension, angina, and other heart conditions). Taking the two medications together may cause problems such as decreased heart rate (bradycardia) leading to fainting or loss of consciousness.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant, it is necessary to evaluate the benefits of using Rivastigmina Ababor against the possible adverse effects on the fetus.

It is preferable to avoid the use of Rivastigmina Ababor during pregnancy, unless it is clearly necessary. Inform your doctor if you become pregnant during treatment.

Women taking Rivastigmina Ababor should not 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 tells you it is safe to do so.

Rivastigmina Ababor 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, operate machinery, or perform tasks that require your attention.

Important information about one of the components of Rivastigmina Ababor 2 mg/ml oral solution

One of the excipients in Rivastigmina Ababor oral solution is sodium benzoate. This medication 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 treatment of patients with low-sodium diets.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

How to start treatment

Your doctor will tell you which dose of Rivastigmina you should take

?The treatment normally starts with a low dose

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

?The maximum dose you should take is 6 mg twice a day

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

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 medication

?Inform your caregiver that you are taking Rivastigmina Ababor.

?To achieve the desired effect, you must take it every day

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

How to take this medication

1. Prepare the bottle and syringe:

?Remove the syringe from its protective cover

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

2. Insert the syringe adapter into the bottle opening

3. Insert the syringe into the adapter

?

?Insert the syringe needle into the stopper opening.

4. Fill the syringe

?Pull the plunger of the syringe until the liquid reaches the dose mark prescribed by your doctor

5. Remove bubbles

?Remove large bubbles with alternating movements of the plunger.

?A couple of 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.

6. Take your medicine

?Take the dose directly from the syringe.

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

7. After using the syringe

?Clean the outside of the syringe and adapter with a clean cloth.

?Then, return the syringe to its protective cover.

?Put the child-resistant closure on the bottle to close it.

If you take more Rivastigmina Ababor 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 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 fainting.

If you forget to take Rivastigmina Ababor

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

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

Like all medicines, this medicine 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.

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

- Restlessness

- Feeling of fatigue or weakness

- General discomfort

- Trembling or feeling of 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 1000 people)

- Chest pain

- Skin rash

- Seizures (attacks 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)

- Gastrointestinal bleeding (blood in stool or vomit)

- Pancreatitis (severe pain in the upper stomach, often accompanied by nausea and vomiting)

- Worsening of Parkinson's disease or development of similar symptoms (muscle stiffness, difficulty moving, and muscle weakness)

Frequency not known:(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 (excessive loss of fluid)

- Liver problems (yellow skin, yellowing of the white of the eyes, abnormal darkening of urine, or nausea, vomiting, fatigue, and abnormal loss of appetite)

- Aggression, feeling of restlessness

- Irregular heartbeat

• Pisa syndrome (condition involving involuntary muscle contraction and abnormal inclination of the body and head to one side)

Patients with dementia associated with Parkinson's disease

These patients experience some side effects more frequently as well as additional side effects:

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

- Trembling

- Fainting

- Accidental falls

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

- Anxiety

- Restlessness

- Irregular heartbeat

- Difficulty sleeping

- Excessive saliva and dehydration

- Abnormally slow or uncontrolled movements

- Worsening of Parkinson's disease or development of similar symptoms (muscle stiffness, difficulty moving, and muscle weakness)

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

- Irregular heartbeat and poor movement control

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

• Pisa syndrome (condition involving involuntary muscle contraction and abnormal inclination of the body and head to one side)

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

Common:

- Fever

- Severe confusion

- Urinary incontinence (inability to retain urine properly)

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

- Hyperactivity (elevated level of activity, restlessness)

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

Allergic reaction where the patch was used, such as blisters or skin inflammation.

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

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://notificaram.es By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not refrigerate.

Keep the packaging in an upright position.

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

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

- The active ingredient is hydrogen tartrate of rivastigmina equivalent to 2.0 mg of rivastigmina base.

- The other components are: sodium benzoate (E211), citric acid monohydrate (E330), sodium citrate (E331), water-soluble quinoline yellow (E104), purified water.

Appearance of the product and content of the container

Rivastigmina Ababor 2mg/ml oral solution is presented in the form of a transparent, yellow (2.0 mg/ml rivastigmina base) solution of 50 or 120 ml in amber type III glass bottles with a child-resistant closure. Along with the oral solution, a syringe for oral dosing and a syringe adapter in a plastic tube are included.

Holder of the Marketing Authorization

Ababor Pharmaceuticals, S.L.

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

28290- Las Rozas. Spain

Responsible for manufacturing

Pharmanel Pharmaceuticals SA

60th km of Athens – Lamia Highway,

GR 320 09

Greece

And

Pharmathen SA

Dervenakion 6

Pallini 15351

Attiki, Greece

This leaflet has been authorized in September 2015

Last revision date of this leaflet: January 2025

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