Package Insert: Information for the Patient

Rivastigmina Aristo 13.3 mg/24 h Transdermal Patches EFG

Read this package insert carefully before starting to use this medication, as it contains important information for you.

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

1. What is Rivastigmina Aristo and how is it used

2. What you need to know before starting to use Rivastigmina Aristo

3. How to use Rivastigmina Aristo

4. Possible adverse effects

5. Storage of Rivastigmina Aristo

6. Contents of the package and additional information

The active ingredient of Rivastigmina Aristo is rivastigmina.

Rivastigmina belongs to the group of cholinesterase inhibitors. In patients with Alzheimer's disease, 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.

Rivastigmina Aristo 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.

Do not use Rivastigmina Aristo

• If you are allergic to rivastigmina (the active ingredient in Rivastigmina Aristo) or to any of the other components of this medication (listed in section 6).
• If you have ever had an allergic reaction to a similar medication (carbamate derivatives).
• If you have a skin reaction that extends beyond the size of the patch, if there is a more intense local reaction (such as blisters, increased skin inflammation, swelling) and if there is no improvement within 48 hours after removing the transdermal patch.

Inform your doctor if you find yourself in any of these situations and do not use Rivastigmina Aristo transdermal patches.

Warnings and precautions

Consult your doctor before starting to use Rivastigmina Aristo

• If you have or have had any heart problems such as irregular or slow heart rhythm, prolonged QTc, family history of prolonged QTc, torsades de pointes, or if you have low blood levels of potassium or magnesium.
• 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 suffer from tremors.
• If you have a low body weight.
• If you have gastrointestinal reactions such as dizziness (nausea), dizziness (vomiting), and diarrhea. You may become dehydrated (loss of a large amount of fluid) if vomiting or diarrhea is prolonged.
• If you have liver problems (hepatic insufficiency).

If you find yourself in any of these situations, your doctor may consider the need for closer monitoring while you are being treated.

If you have not used the patches for more than three days, do not apply another one without consulting your doctor first.

Children and adolescents

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

Other medications and Rivastigmina Aristo

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

Rivastigmina may interfere with anticholinergic medications, some of which are medications used to relieve stomach cramps or spasms (e.g. diciclomina), for the treatment of Parkinson's disease (e.g. amantadina) or to prevent motion sickness (e.g. difenhidramina, escopolamina, or meclizina).

Rivastigmina transdermal patches should not be administered at the same time as metoclopramida (a medication used to relieve 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 using this medication, inform your doctor that you are using it, as it may excessively potentiate the effects of some anesthetic muscle relaxants.

Caution should be exercised when using Rivastigmina Aristo transdermal patches together with beta blockers (medications such as atenolol used to treat hypertension, angina, and other heart 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.

Caution should be exercised when using Rivastigmina Aristo together with other medications that may affect heart rhythm or the heart's electrical system (prolongation QT).

Pregnancy, breastfeeding, and fertility

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

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

You should not breastfeed during your treatment with rivastigmina transdermal patches.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machinery safely. Rivastigmina transdermal patches may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive, operate machinery, or perform other tasks that require your attention.

Follow exactly the administration instructions for Rivastigmina Aristo transdermal patches indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

How to start treatment

Your doctor will indicate the most suitable dose of rivastigmina transdermal patch for your case.

• Normally, treatment starts with rivastigmina 4.6 mg/24 h.
• The recommended daily dose is rivastigmina 9.5 mg/24 h. If this dose is well tolerated, your doctor may consider increasing the dose to 13.3 mg/24 h.
• Only wear one transdermal patch at a time and replace the patch with a new one every 24 hours.

Your doctor may adjust the dose during treatment depending on your individual needs.

If you have not used the patches for more than three days, do not apply a new one without consulting your doctor. Treatment with a transdermal patch can be restarted at the same dose if treatment is not interrupted for more than three days. Otherwise, your doctor will have you restart your treatment with rivastigmina 4.6 mg/24 h.

Rivastigmina transdermal patches can be used with food, drink, and alcohol.

Where to place yourrivastigmina transdermal patch

• Before applying a patch, ensure that the skin is clean, dry, and free of hair, powders, oils, moisturizers, or lotions that may prevent the patch from adhering well to the skin, without cuts, redness, or irritation.
• Remove the existing patch carefully before applying a new one.The wearing of multiple patches on your body may expose you to an excessive amount of this medication, which could be potentially hazardous.
• Apply only one patch per day toONEof the possible areas as shown in the following diagrams:

• upper left or upper right arm
• upper left or upper right chest(avoiding breasts in women)
• upper left or upper right back
• lower left or lower right back

Each time you change the patch, remove the previous patch before applying a new one to a different area of the skin (for example, one day on the right side of the body and the next day on the left side; or one day on the upper part of the body and the next day on the lower part). Do not apply a new patch to the same area of skin for at least 14 days.

How to apply yourrivastigmina transdermal patch

Rivastigmina patches are thin, brown, and adhere to the skin. Each patch is found in a protective envelope that protects it until it is applied. Do not open the envelope or remove the patch until you are ready to apply it.

IMPORTANT:

• Remove the previous patch before applying a new one.
• Only one patch per day.
• Do not cut the patch into pieces.
• Press the patch firmly against the skin with the palm of your hand for at least 30seconds.

You can write on the patch, for example, the day of the week, with a fine-tip red pen.

You must wear the patch continuously until you change it for a new one. When applying a new patch, you can try different areas to find the ones that are most comfortable and where clothing does not rub against the patch.

How to remove yourrivastigmina transdermal patch

Gently pull one of the edges of the patch to remove it slowly from the skin. If there are any remaining adhesive residues on the skin, soak the area with warm water and mild soap or use baby oil to remove it. Do not use alcohol or other solvents (nail polish removers or other solvents).

After removing the patch, wash your hands with soap and water. If you come into contact with your eyes or if your eyes become red after handling the patch, wash immediately with plenty of water and seek medical advice if the symptoms do not resolve.

Can you wear yourrivastigmina transdermal patch when bathing, swimming, or exposing yourself to the sun?

• Bathing, swimming, or showering should not affect the patch. Ensure that it does not come loose partially while performing these activities.
• Do not expose the patch to an external heat source (e.g. excessive sunlight, sauna, solarium) for long periods of time.

What to do if a patch falls off

If a patch falls off, apply a new one for the rest of the day and change it the next day at the usual time.

How long and when to wear yourrivastigmina transdermal patch

• To benefit from your treatment, you must apply a new patch every day, preferably at the same time.
• Wear only one rivastigmina patch at a time and replace the patch with a new one every24hours.

If you use moreRivastigmina Aristo than you should

If you accidentally applied more than one patch, remove all patches from the skin and inform your doctor or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount taken). You may need medical attention. Some people who have taken accidentally high doses of rivastigmina have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. They may also experience a slowing of heart rate and dizziness.

If you forget to use Rivastigmina Aristo

If you realize you have forgotten to apply a patch, apply it immediately. The next day, apply the next patch at the usual time. Do not apply two patches to compensate for the one you forgot.

If you interrupt treatment with Rivastigmina Aristo

Inform your doctor or pharmacist if you stop using the patches.

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

Like all medications, rivastigmine transdermal patches may cause side effects, although not everyone will experience them.

You may experience side effects more frequently when you start treatment or when your dose is increased. Side effects usually fade away as your body gets used to the medication.

If you notice any of the following serious side effects, remove the patch and immediately inform your doctor:

Frequent(may affect up to 1 in 10people)

• Loss of appetite
• Sensation of dizziness
• Sensation of agitation or numbness
• Urinary incontinence (inability to stop urinating properly)

Infrequent(may affect up to 1 in 100people)

• Problems with your heart rhythm, such as slow heart rate
• Seeing things that are not really there (hallucinations)
• Stomach ulcer
• Dehydration (loss of a large amount of fluid)
• Hyperactivity (high level of activity, restlessness)
• Aggression
  

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

• Falls

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

• Rigidity of arms and legs
• Tremor in the hands

Unknown(cannot be estimated from available data)

• Allergic reaction where the patch was applied, such as blisters or skin inflammation
• Worsening of Parkinson's disease symptoms – such as tremor, rigidity, and difficulty moving
• Pisa syndrome (condition involving involuntary muscle contraction and abnormal tilting of the body and head to one side)
• Pancreatitis – symptoms include upper stomach pain, often accompanied by dizziness (nausea or vomiting)
• Irregular heart rhythm or rapid heart rate
• High blood pressure
• Seizures (convulsions)
• Liver disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Changes in liver function tests
• Sensation of anxiety
• Nightmares

If you notice any of the side effects listed above, remove the patch and immediately inform your doctor.

Other side effects experienced with rivastigmine capsules or oral solution and that may occur with patches:

Frequent(may affect up to 1 in 10people)

• Excessive saliva
• Loss of appetite
• Sensation of agitation
• Sensation of general discomfort
• Tremor or sensation of confusion
• Increased sweating

InfrequentFrequent(may affect up to 1 in 100people)

• Irregular heart rhythm (e.g., rapid heart rate)
• Difficulty sleeping
• Accidental falls

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

• Seizures (convulsions)
• Ulcer in the intestine
• Chest pain– likely caused by a heart spasm

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

• High blood pressure
• Pancreatitis – symptoms include severe upper stomach pain, often accompanied by dizziness (nausea or vomiting)
• Gastrointestinal bleeding – manifests as blood in the stool or vomiting blood
• Seeing things that are not really there (hallucinations)
• Some people who have been severely ill have had a tear in the esophagus (the tube that connects the mouth to the stomach)

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side 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, website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box and on the pouch after CAD. The expiration date is the last day of the month indicated.
• Store the transdermal patch inside the pouch until use.
• Do not use any patch if you observe that it is damaged or shows signs of manipulation.
• After removing a patch, fold it in half with the adhesive side inwards and press. After placing it in the original pouch, dispose of it. After removing the patch, do not touch your eyes, and wash your hands thoroughly with water and soap.

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

Composition of Rivastigmina Aristo

The active ingredient isrivastigmina.

Each patch releases 13.3 mg of rivastigmina in 24hours, measures 12.8cm2and contains 19.2mg of rivastigmina.

The other components are

Backing layer: aluminum-coated polyester resin thermoplastic/polyethylene film

Active layer: poly [(2-ethylhexyl) acrylate, vinyl acetate]

Adhesive matrix: medium and high molecular weight polyisobutene, anhydrous colloidal silica, light liquid paraffin

Release layer: polyester film coated with fluoropolymer

Orange printing ink

Appearance of the product and contents of the package

Thin, circular transdermal patch. The outer layer is orange and bears the imprint in orange ink: "RIV-TDS 13.3 mg/24 h".

Each package contains one transdermal patch.

Rivastigmina Aristo 13.3 mg/24 h transdermal patches EFG are available in packages containing 7 or 30 patches and in multi-packages containing 60 (2x30) or 90 (3x30) patches.

Only some package sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

c/ Solana, 26

28850– Torrejon de Ardoz

Spain

Responsible for manufacturing

Luye Pharma AG

Am Windfeld, 35

83714 Miesbach, Germany

Or

Bluepharma Indústria Farmaceutica, S.A.

Sao Martinho do Bispo

3045-016 Coimbra

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

GermanyDemelora 13.3 mg/24 Stunden Transdermales Pflaster
SpainRivastigmina Aristo 13.3 mg/24 h transdermal patches EFG

ItalyDemelora Demelora 13.3 mg/24 h

NetherlandsRivastigmine Aurobindo 13.3 mg/24 hr, Plaster for transdermal use

PortugalRivastigmina Bluepharma

Last review date of this leaflet:February2025

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