Product Information for the User

Rivastigmina Aristo 9.5mg/24h Transdermal Patch

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

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your pharmacist or nurse.
• 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 pharmacist or nurse, even if they are not listed in this product information.See section 4.

1.What is Rivastigmina Aristo and for what it is 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 of 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, increasing skin inflammation, swelling) and if there is no improvement within 48 hours after removing the transdermal patch.

If you find yourself in any of these situations, inform your doctor 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, QTc prolongation, family history of QTc prolongation, 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 asthma or 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 are 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 on treatment.

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.

Rivastigmina Aristo with other medications

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

Rivastigmina Aristo 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 Aristo transdermal patches 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 stiffness in the limbs and hand tremors.

If you need to undergo surgery while using Rivastigmina Aristo transdermal patches, inform your doctor that you are using them, as they may excessively potentiate the effects of some anesthetic muscle relaxants.

Care should be taken when using Rivastigmina Aristo transdermal patches together with beta blockers (medications such as atenolol used to treat hypertension, angina, and other cardiac conditions). Taking the two medications together may cause complications such as bradycardia (slow heart rate) that may lead to dizziness or loss of consciousness.

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

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 Aristo transdermal patches.

Driving and operating machinery

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

Follow exactly the administration instructions for Rivastigmina transdermal patches indicated by your doctor. If in doubt, consult your doctor, pharmacist, or nurse.

IMPORTANT:

• Remove the previous patch before putting on 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 30 seconds.

How to start treatment

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

• Normally, treatment starts with Rivastigmina Aristo 4.6 mg/24 h.
• The usual recommended daily dose is Rivastigmina Aristo 9.5 mg/24 h. If this dose is well tolerated, your doctor may consider increasing the dose to 13.3 mg/24 h. (The 13.3 mg/24 h dose cannot be achieved with this product. For conditions in which this dose is to be used, consult other rivastigmina products for which 13.3 mg/24 h transdermal patches are available).
• Wear only one transdermal patch at a time and replace the patch with a new one every 24 hours.

During treatment, your doctor may adjust the dose depending on your individual needs.

If you have not used the patches for more than three days, do not put on 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 Aristo 4.6 mg/24 h.

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

Where to place your Rivastigmina Aristo transdermal patch

• Before putting on a patch, make sure the skin is clean, dry, and free of hair, powder, oil, moisturizer, or lotion that may prevent the patch from sticking well to the skin, without cuts, redness, or irritation.
• Remove any existing patch carefully before putting on 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.
• Put on only one patch per day in one of 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

Every 24 hours, remove the previous patch before putting on a new one in only one of the possible areas.

Each time you change the patch, remove the previous patch before putting on a new one in 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). Wait at least 14 days to put a new patch in the same area of the skin.

How to apply your Rivastigmina Aristo transdermal patch

Rivastigmina Aristo patches are thin plastic patches, beige in color, and stick to the skin. Each patch is in a protective envelope that protects it until it is to be put on. Do not open the envelope or remove the patch until it is time to put it on.

If this helps, you can write on the patch, for example, the day of the week, with a fine-pointed red pen.

You must wear the patch continuously until it is time to change it for a new one. When putting on 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 your Rivastigmina Aristo transdermal patch

Gently pull one of the edges of the patch to slowly remove it 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 your Rivastigmina Aristo transdermal patch when bathing, swimming, or exposing yourself to the sun?

• Bathing, swimming, or showering should not affect the patch. Make sure it does not come loose while you are doing 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, put on a new one for the rest of the day and change it the next day at the usual time.

When and for how long should you wear your Rivastigmina Aristo transdermal patch?

• To benefit from your treatment, you must put on a new patch every day, preferably at the same time.
• Wear only one Rivastigmina Aristo patch at a time and replace the patch with a new one every 24 hours.

If you use more Rivastigmina Aristo than you should

If you accidentally put on more than one patch, remove all the 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 orally have had a feeling of discomfort (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. A slowing of heart rate and fainting may also occur.

If you forget to use Rivastigmina Aristo

If you realize you have forgotten to put on a patch, put it on immediately. The next day, put on the next patch at the usual time. Do not put on 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Aristo Rivastigmina 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. Generally, side effects will slowly disappear 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 the 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 nausea or vomiting
• Irregular heart rhythm or rapid heart rate
• High blood pressure
• Seizures (convulsions)
• Liver disorders (yellowing of the skin, yellowing of the whites 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 rivastigmina 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 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 nauseated (vomiting) have had a tear in the tube that connects their mouth to their stomach (esophagus)

Reporting 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 overwrap after CAD/EXP. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• Store the transdermal patch inside the overwrap 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 inward and press. After placing it in the original overwrap, ensure that it is out of the reach of children. After removing the patch, do not touch your eyes, and wash your hands thoroughly with water and soap. If your household waste is disposed of by incineration, you can dispose of the patch in your household waste. If not, take the used patches to the pharmacy, preferably in the original packaging.

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.

Rivastigmina Aristo 9.5mg/24h transdermal patch:

Each transdermal patch releases 9.5mg of rivastigmina in 24hours, measures 9.2cm2and contains 13.8mg of rivastigmina.

• The other components are:

Matrix:

Backing layer:

Release liner:

Orange printing ink

Appearance of the product and contents of the package

Each transdermal patch is a thin patch The outer layer is a brown color printed in orange with:

Each package contains one transdermal patch. Each patch is protected by a cover. The patches are available in packages containing 7, 30 or 42 patches, and in multi-packages containing 60, 84 or 90 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

Bluepharma Indústria Farmaceutica, S.A.

Sao Martinho do Bispo

3045-016 Coimbra

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

GermanyDemelora 9.5 mg/24 Stunden transdermales Pflaster
SpainRivastigmina Aristo 9.5 mg/24 h Transdermal Patches

FranceRivastigmine Arrow 9.5mg/24 heures, device transdermique

ItalyDemelora

NetherlandsRivastigmine Aurobindo 9.5 mg/24 uur, plaster for transdermal use

PortugalRivastigmina Bluepharma

Last revision date of this leaflet:Februaryof2025

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