Rivastigmine Aristo 9.5 mg/24 h transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivastigmina Aristo 9.5 mg/24 h transdermal patches EFG

Read the entire leaflet carefully before you start using 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, ask 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 may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Rivastigmina Aristo is and what it is used for
2. What you need to know before using Rivastigmina Aristo
3. How to use Rivastigmina Aristo
4. Possible side effects
5. How to store Rivastigmina Aristo
6. Contents of the pack and other information

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

The active substance in Rivastigmina Aristo is rivastigmine.

Rivastigmine belongs to the group of drugs known as cholinesterase inhibitors. In patients with Alzheimer's dementia, 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 inhibiting the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, rivastigmine increases acetylcholine levels in the brain, thereby helping to reduce the symptoms of Alzheimer's disease.

Rivastigmina Aristo 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.

2. What you need to know before using Rivastigmina Aristo

Do not use Rivastigmina Aristo

• if you are allergic to rivastigmine (the active substance in Rivastigmina Aristo) or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction to a similar medicine (carbamate derivatives).
• if you develop a skin reaction that spreads beyond the size of the patch, if there is 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 any of these situations apply to you, inform your doctor and do not use Rivastigmina Aristo transdermal patches.

Warnings and precautions

Talk to your doctor before starting to use Rivastigmina Aristo:

• 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 in urination.
• if you have or have ever had seizures.
• if you have or have ever had asthma or a serious respiratory disease.
• if you experience tremors.
• if you have low body weight.
• if you experience gastrointestinal reactions such as feeling dizzy (nausea), dizziness (vomiting), or diarrhea. You may become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea is prolonged.
• if you have liver problems (hepatic insufficiency).

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

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

Children and adolescents

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

Rivastigmina Aristo with other medicines

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

Rivastigmina Aristo may interfere with anticholinergic medicines, some of which are used to relieve stomach cramps or spasms (e.g. dicyclomine), for the treatment of Parkinson's disease (e.g. amantadine), or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).

Rivastigmina Aristo transdermal patches must 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 using Rivastigmina Aristo transdermal patches, inform your doctor that you are using this medicine, as it may excessively enhance the effects of certain muscle relaxants used during anesthesia.

Caution is advised when using Rivastigmina Aristo transdermal patches 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 decreased heart rate (bradycardia), which may lead to fainting or loss of consciousness.

Caution is advised when using Rivastigmina Aristo 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 Rivastigmina Aristo must be weighed against the potential risks to the fetus. Rivastigmina Aristo must not be used during pregnancy unless clearly necessary.

You must not breastfeed during treatment with Rivastigmina Aristo transdermal patches.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Rivastigmina Aristo transdermal patches may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive, operate machinery, or perform any other tasks requiring your attention.

3. How to use Rivastigmina Aristo

Follow exactly the instructions for the administration of Rivastigmine transdermal patches as given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse.

IMPORTANT:

• Remove the previous patch before applying ONE new patch.
• One patch only per day.
• Do not cut the patch into pieces.
• Press the patch firmly onto the skin with the palm of your hand for at least 30 seconds.

How to start treatment

Your doctor will determine the most appropriate dose of Rivastigmine transdermal patch for your individual case.

• Treatment is usually started 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 treating physician 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 under which this dose should be used, please refer to other rivastigmine products for which transdermal patches delivering 13.3 mg/24 h 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 according to your individual needs.

If you have not used the patches for more than three days, do not apply a new one without first consulting your doctor. Transdermal patch treatment may be restarted at the same dose if the treatment interruption was no longer than three days. Otherwise, your doctor will instruct you to restart treatment with
Rivastigmina Aristo 4.6 mg/24 h. Rivastigmina Aristo transdermal patch can be used with food, drink, and alcohol.

Where to apply your Rivastigmina Aristo transdermal patch

• Before applying a patch, ensure the skin is clean, dry, and hair-free, without powders, oils, moisturizers, or lotions that may prevent the patch from adhering properly to the skin, and without cuts, redness, or irritation.

• Carefully remove any existing patch before applying a new one. Wearing multiple patches on your body could expose you to an excessive amount of this medication, which could be potentially dangerous.

• Apply ONLY ONE patch per day to ONE of the following areas, as shown in the diagrams below:

• 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 applying ONE new patch to ONLY ONE of the following possible sites.

Each time you change the patch, remove the patch from the previous day before applying the new patch to a different skin site (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 before applying a new patch to exactly the same skin area again.

How to apply your Rivastigmina Aristo transdermal patch

Rivastigmina Aristo patches are thin, plastic, cinnamon-colored patches that adhere to the skin. Each patch is contained in a protective pouch until ready for use. Do not open the pouch or remove the patch until the time of application.

If this helps, you can write on the patch, for example the day of the week, using a fine-tipped rounded pen.

You must wear the patch continuously until it is time to replace it with a new one. When applying a new patch, you may try different areas to find those that are most comfortable for you and where clothing does not rub against the patch.

How to remove your Rivastigmina Aristo transdermal patch

Gently pull one edge of the patch to slowly peel it off the skin. If adhesive residue remains 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 solvent liquids (such as nail polish remover or other solvents).

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

Can you wear your Rivastigmina Aristo transdermal patch while bathing, swimming, or being exposed to sunlight?

• Bathing, swimming, or showering should not affect the patch. Make sure it does not partially detach during these activities.
• Do not expose the patch to external heat sources (e.g., excessive sunlight, sauna, sunbed) for prolonged periods.

What to do if your patch falls off

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

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

• To benefit from your treatment, you should apply 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 have accidentally applied more than one patch, remove all patches from the skin and inform your doctor or contact the Toxicology Information Service at telephone: 91 562 04 20 (indicating the medication and the amount administered). You may require medical attention. Some people who have accidentally taken excessively high oral doses of rivastigmine have experienced discomfort (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. Slowing of the heart rate and fainting may also occur.

If you forget to use Rivastigmina Aristo

If you realize you have forgotten to apply a patch, do so immediately. The next day, apply the following patch at your usual time. Do not apply two patches to make up for the missed one.

If you stop using Rivastigmina Aristo

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

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

4. Possible adverse effects

Like all medicines, Rivastigmina Aristo transdermal patches may produce adverse effects, although not everyone experiences 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.

If you notice any of the following adverse effects, which may be serious, remove the patch and contact your doctor immediately:

Frequent (may affect up to 1 in 10 people)

• Loss of appetite
• Dizziness
• Feeling agitated
• Urinary incontinence (inability to properly control urination)
• Urinary tract infection
• Anxiety
• Depression
• Confusion
• Headache
• Fainting
• Stomach problems such as nausea, vomiting, diarrhea
• Indigestion
• Stomach pain
• Rash
• Allergic reaction at the application site, such as blisters or skin swelling
• Feeling tired or weak
• Weight loss
• Fever

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heart rate
• Stomach ulcer
• Dehydration (loss of large amounts of fluid)
• Hyperactivity (high level of activity, restlessness)
• Aggression

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

• Falls

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

• Stiffness of arms and legs, hand tremors

Not known (cannot be estimated from available data)

• Worsening of Parkinson's disease symptoms – such as tremor, stiffness, and difficulty with movement
• Inflammation of the pancreas – symptoms include pain in the upper abdomen, often accompanied by nausea or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Seizures (convulsions)
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, unusually dark urine, or unexplained nausea, vomiting, tiredness, and loss of appetite)
• Changes in liver function tests
• Restlessness
• Nightmares
• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)
• Seeing things that are not there (hallucinations)
• Tremor
• Drowsiness
• Skin rash, itching
• Redness of the skin
• Blisters

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

Other adverse effects reported with rivastigmine capsules or oral solution, which may also occur with the patches:

Frequent (may affect up to 1 in 10 people)

• Excessive saliva
• Feeling agitated
• Feeling generally unwell
• Tremor
• Increased sweating

Uncommon (may affect up to 1 in 100 people)

• Irregular heartbeat (e.g. fast heartbeat)
• Difficulty sleeping
• Accidental falls

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

• Seizures (convulsions)
• Intestinal ulcer
• Chest pain – possibly caused by spasm in the heart

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

• High blood pressure
• Inflammation of the pancreas – symptoms include severe upper abdominal pain, often with nausea or vomiting
• Gastrointestinal bleeding – seen as blood in the stool or vomit
• Seeing things that are not there (hallucinations)
• Some people who have experienced severe vomiting have developed a tear in the tube connecting the mouth to the stomach (esophagus)

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmina Aristo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and on the sachet after CAD/EXP. The expiry date refers to the last day of the month indicated.
• Keep the transdermal patch inside the sachet until ready to use.
• Do not use any patch if it appears damaged or shows signs of tampering.
• After removing a patch, fold it in half with the adhesive side inwards and press together. After placing it back into the original sachet, dispose of it safely and ensure it remains out of children's reach. After removing the patch, avoid touching the eyes and wash your hands thoroughly with water and soap. If your household waste is disposed of by incineration, you may discard the patch in your household waste. Otherwise, return used patches to the pharmacy, preferably in their original packaging.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be taken to the SIGRE Point at your pharmacy. If you are unsure how to dispose of unused medicines or packaging, please consult your pharmacist. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmina Aristo

• The active substance is rivastigmine.

Rivastigmina Aristo 9.5 mg/24 h transdermal patch:

Each transdermal patch releases 9.5 mg of rivastigmine over 24 hours, has a surface area of 9.2 cm², and contains 13.8 mg of rivastigmine.

• The other components are:

Matrix:

• poly[(2-ethylhexyl) acrylate, vinyl acetate]
• medium and high molecular weight polyisobutene
• anhydrous colloidal silica
• fluid paraffin oil

Backing layer:

• polyethylene/thermoplastic resin/polyester laminate with aluminum coating

Release liner:

• fluoropolymer-coated polyester film

Orange printing ink

Nature of the product and contents of the pack

Each transdermal patch is a thin patch. The outer side is beige with orange printing showing:

• "RIV-TDS 9.5 mg/24 h"

Each sachet contains one transdermal patch. Each transdermal patch is protected by a pouch. The patches are available in packs containing 7, 30 or 42 sachets, and in multipacks containing 60 (2x30), 84 (2x42) or 90 (3x30) sachets. Some pack sizes may not be marketed.

Marketing Authorization Holder

Aristo Pharma Iberia, S.L
C/ Solana, 26
28850 – Torrejón de Ardoz
Spain

Manufacturer

Luye Pharma AG
Am Windfeld, 35
83714 Miesbach, Germany

Bluepharma Indústria Farmacêutica, S.A.
São 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:

Germany: Demelora 9.5 mg/24 Stunden transdermales Pflaster
Spain: Rivastigmina Aristo 9.5 mg/24 h Parches transdérmicos
France: Rivastigmine Arrow 9.5 mg/24 heures, dispositif transdermique
Italy: Demelora
Netherlands: Rivastigmine Aurobindo 9.5 mg/24 uur, pleister voor transdermaal gebruik
Portugal: Rivastigmina Bluepharma

Date of the most recent revision of this leaflet: October 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/