RIVASTIGMINE ARISTO 13.3 mg/24h TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the Patient

Rivastigmine Aristo 13.3 mg/24 h Transdermal Patches EFG

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

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

Contents of the Package Leaflet

1. What is Rivastigmine Aristo and what is it used for
2. What you need to know before starting to use Rivastigmine Aristo
3. How to use Rivastigmine Aristo
4. Possible side effects
5. Storage of Rivastigmine Aristo
6. Package contents and additional information

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

The active ingredient of Rivastigmine Aristo is rivastigmine.

Rivastigmine belongs to the group of cholinesterase inhibitors. In patients with Alzheimer's dementia, certain nerve cells die in the brain, causing low levels of acetylcholine neurotransmitters (a substance that allows nerve cells to communicate with each other). Rivastigmine acts by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, rivastigmine allows the increase of acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease.

Rivastigmine Aristo is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability, and behavior.

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

Do not use Rivastigmine Aristo

• if you are allergic to rivastigmine (the active ingredient of Rivastigmine 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 patch size, 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 are in any of these situations, inform your doctor and do not use Rivastigmine Aristo transdermal patches.

Warnings and precautions

Consult your doctor before starting to use Rivastigmine Aristo

• if you have or have ever had any heart problems, such as irregular or slow heartbeat, 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 ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures.
• if you have or have ever had asthma or severe respiratory disease.
• if you suffer from tremors.
• if you have low body weight.
• if you have gastrointestinal reactions such as nausea, vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged.
• if you have liver problems (liver failure).

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

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

Children and adolescents

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

Other medications and Rivastigmine Aristo

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

Rivastigmine may interfere with anticholinergic medications, some of which are medications 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).

Rivastigmine 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.

In case you need to undergo surgery while using this medication, inform your doctor that you are using it, as it may potentiate the effects of some muscle relaxants used in anesthesia.

Caution should be exercised when using Rivastigmine Aristo transdermal patches 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 can lead to fainting or loss of consciousness.

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

Pregnancy, breastfeeding, and fertility

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

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

You should not breastfeed while being treated with rivastigmine transdermal patches.

Driving and using machines

Your doctor will inform you if your condition allows you to drive or use machinery safely. Rivastigmine 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.

3. How to use Rivastigmine Aristo

Follow the instructions for administering Rivastigmine Aristo transdermal patches exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist.

How to start treatment

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

• Normally, treatment is started with rivastigmine 4.6 mg/24 h.
• The recommended daily dose is rivastigmine 9.5 mg/24 h. If this dose is well tolerated, the doctor treating you may consider increasing the dose to 13.3 mg/24 h.
• 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 another one without consulting your doctor first. Treatment with the 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 treatment with rivastigmine 4.6 mg/24 h.

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

Where to place your rivastigmine transdermal patch

• Before applying a patch, make sure the skin is clean, dry, and hairless, without powders, oils, moisturizers, or lotions that may prevent the patch from sticking well to the skin, without cuts, redness, or irritation.
• Remove any existing patch carefully 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 onepatch per day to oneof the possible areas shown in the following diagrams:

• upper left orupper right arm
• upper left orupper right chest (avoiding the breasts in women)
• upper left orupper right back
• lower left orlower right back

Each time you change the patch, remove the previous day's patch before applying a new patch to a different area of the skin (e.g., 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 your rivastigmine transdermal patch

Rivastigmine patches are thin, cinnamon-colored, and stick to the skin. Each patch is in a pouch that protects it until you are ready to apply it. Do not open the pouch 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 30 seconds.

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

You should wear the patch continuously until it is time to change it for a new one. When you apply 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 rivastigmine transdermal patch

Gently pull one of the edges of the patch to slowly peel it off the skin. If there are any 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 accidentally get the patch in your eyes or if your eyes become red after handling the patch, rinse them immediately with plenty of water and seek medical advice if the symptoms do not resolve.

Can you wear your rivastigmine 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 peel off partially while performing these activities.
• Do not expose the patch to an external heat source (e.g., excessive sunlight, sauna, solarium) for extended periods.

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.

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

• To benefit from your treatment, you should apply a new patch every day, preferably at the same time.
• Wear only one rivastigmine patch at a time and replace the patch with a new one every 24 hours.

If you use more Rivastigmine Aristo than you should

If you accidentally apply more than one patch, remove all patches from the skin and inform your doctor or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medication and the amount administered). You may need medical attention. Some people who have accidentally taken excessive amounts of rivastigmine have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. A decrease in heart rate and fainting may also occur.

If you forget to use Rivastigmine 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 make up for the one you forgot.

If you interrupt treatment with Rivastigmine Aristo

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

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

4. Possible Adverse Effects

Like all medicines, rivastigmine transdermal patches can cause adverse effects, although not all people will experience them.

You may have adverse effects more frequently when starting your treatment or when your dose is increased. Generally, the adverse effects will slowly disappear as your body gets used to the medicine.

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

Frequent(may affect up to 1 in 10 people)

• Lack of appetite
• Dizzy sensation
• Sensation of restlessness or numbness
• Urinary incontinence (inability to stop urinating properly)

Infrequent(may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heart rate
• Seeing things that do not really exist (hallucinations)
• Stomach ulcer
• Dehydration (loss of a large amount of fluid)
• Hyperactivity (high level of activity, restlessness)
• Aggressiveness

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

• Falls

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

• Stiffness of the arms and legs
• Tremor in the hands

Unknown(cannot be estimated from the available data)

• Allergic reaction where the patch was applied, such as blisters or skin inflammation
• Worsening of Parkinson's disease symptoms – such as tremor, stiffness, and difficulty moving
• Pisa syndrome (a condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side)
• Pancreatitis – signs include severe pain in the upper part of the stomach, often accompanied by a feeling of dizziness (nausea or vomiting)
• Fast or irregular heart rate
• High blood pressure
• Seizures (convulsions)
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormal darkening of urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Changes in tests that show liver function
• Feeling of restlessness
• Nightmares

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

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

Frequent(may affect up to 1 in 10 people)

• Excessive saliva
• Lack of appetite
• Sensation of restlessness
• Sensation of general discomfort
• Tremor or sensation of confusion
• Increased sweating

Infrequent(may affect up to 1 in 100 people)

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

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

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

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

• High blood pressure
• Pancreatitis – signs include severe pain in the upper part of the stomach, often accompanied by a feeling of dizziness (nausea or vomiting)
• Gastrointestinal bleeding – manifested as blood in the stool or when vomiting
• Seeing things that do not exist (hallucinations)
• Some people who have been severely ill have had a tear in part of the digestive tube that connects their mouth to their stomach (esophagus)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rivastigmine Aristo

• Keep this medicine out of sight and reach of children.
• Do not use this medicine 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 in the pouch until use.
• Do not use any patch if you observe that it is damaged or shows signs of tampering.
• After removing a patch, fold it in half with the adhesive side inward and press. After inserting it into the original pouch, dispose of it. After removing the patch, do not touch your eyes, and wash your hands well with soap and water.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rivastigmine Aristo

The active ingredient is rivastigmine.

Each patch releases 13.3 mg of rivastigmine in 24 hours, measures 12.8 cm2, and contains 19.2 mg of rivastigmine.

The other components are

Supporting layer: aluminum-coated polyethylene/thermoplastic resin/polyester 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: fluoropolymer-coated polyester film

Orange printing ink

Appearance of the Product and Package Contents

Thin, circular transdermal patch. The outer layer is cinnamon-colored and printed with orange ink: "RIV-TDS 13.3 mg/24 h".

Each pouch contains one transdermal patch.

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

c/ Solana, 26

28850 – Torrejon de Ardoz

Spain

Manufacturer

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 under the following names:

Germany Demelora 13.3 mg/24 Stunden Transdermales Pflaster

Spain Rivastigmina Aristo 13.3 mg/24 h patches transdérmicos EFG

Italy Demelora Demelora 13.3 mg/24 h

Netherlands Rivastigmine Aurobindo 13.3 mg/24 hr, Pleister voor transdermaal gebruik

Portugal Rivastigmina Bluepharma

Date of the Last Revision of this Leaflet:February 2025

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