RIVASTIGMINE ARISTO 9.5 mg/24h TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the User

Rivastigmine Aristo 9.5 mg/24 h Transdermal Patches EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this 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 you use Rivastigmine Aristo
3. How to use Rivastigmine Aristo
4. Possible side effects
5. Storage of Rivastigmine Aristo
6. Contents of the pack and other information

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

The active substance of Rivastigmine Aristo is rivastigmine.

Rivastigmine belongs to a group of medicines called cholinesterase inhibitors. In patients with Alzheimer's dementia, certain nerve cells die in the brain, leading to low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, rivastigmine allows an increase in 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 you use Rivastigmine Aristo

Do not use Rivastigmine Aristo

• if you are allergic to rivastigmine (the active substance of Rivastigmine Aristo) or 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 have 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) 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, prolonged QTc, family history of prolonged QTc, torsades de pointes, or if you have low levels of potassium or magnesium in your blood.
• 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 severe respiratory disease, such as asthma.
• 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.

Rivastigmine Aristo with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Rivastigmine Aristo may interfere with anticholinergic medicines, some of which are medicines 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 Aristo transdermal patches should not be administered at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together may cause problems such as stiffness in the limbs and hand tremors.

If you need to undergo surgery while using Rivastigmine Aristo transdermal patches, 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 (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking the two medicines 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 Rivastigmine Aristo with other medicines that may affect heart rate or the heart's electrical system (prolonged QT).

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 medicine.

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

You should not breastfeed while using Rivastigmine Aristo transdermal patches.

Driving and using machines

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

3. How to use Rivastigmine Aristo

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

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.

How to start treatment

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

• Normally, treatment is started with Rivastigmine Aristo 4.6 mg/24 h.
• The recommended daily dose is Rivastigmine Aristo 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. (The 13.3 mg/24 h dose cannot be achieved with this product. For the conditions under which this dose should be used, consult other rivastigmine 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 after 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 your treatment with Rivastigmine Aristo 4.6 mg/24 h.

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

Where to apply your Rivastigmine Aristo 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 the existing patch carefully before applying a new one.Wearing multiple patches on your body could expose you to an excessive amount of this medicine, which could be potentially dangerous.
• Apply only onepatch per day to oneof the possible areas as shown in the following diagrams:

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

Every 24 hours, remove the previous patch before applying a new one to only one of the following possible areas.

Each time you change the patch, remove the previous day's patch before applying a new patch 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). Wait at least 14 days before applying a new patch to the same area of skin.

How to apply your Rivastigmine Aristo transdermal patch

Rivastigmine Aristo patches are thin, tan-colored plastic patches that stick to the skin. Each patch is in a protective 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.

If it helps, you can write on the patch, for example, the day of the week, with a fine-tipped 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 for you and where clothing does not rub against the patch.

How to remove your Rivastigmine 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 solvents (nail polish removers or other solvents).

After removing the patch, wash your hands with soap and water. If you 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 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 off partially while performing these activities.
• Do not expose the patch to an external heat source (e.g., excessive sunlight, sauna, solarium) for long periods.

What to do if a patch falls off

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

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

• To benefit from your treatment, apply a new patch every day, preferably at the same time.
• Wear only one Rivastigmine Aristo patch at a time and replace the patch with a new one after 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 medicine and the amount administered). You may need medical attention. Some people who have accidentally taken excessive amounts of rivastigmine orally have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. There may also be a slowing of the heart rate and fainting.

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 stop treatment with Rivastigmine Aristo

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

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

4. Possible Adverse Effects

Like all medicines, Rivastigmine Aristo 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
• Dizziness
• Feeling of agitation or numbness
• Urinary incontinence (inability to stop urine 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 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
• Feeling of agitation
• Feeling of general discomfort
• Tremor or feeling 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 with 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 intensely dizzy (vomiting) 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 is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, web: 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 envelope after CAD/EXP. The expiration date is the last day of the month indicated.
• This medicine does not require special storage conditions.
• Keep the transdermal patch in the envelope 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 facing inward and press. After inserting it into the original envelope, when disposing of the patch, make sure it is out of the reach of children. After removing the patch, do not touch your eyes, and wash your hands well with soap and water. If your household waste is eliminated by incineration, you can throw the patch in your household trash. If not, take the used patches to the pharmacy, preferably in the original packaging.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of 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.

Rivastigmine Aristo 9.5 mg/24 h transdermal patch:

Each transdermal patch releases 9.5 mg of rivastigmine in 24 hours, measures 9.2 cm2, and contains 13.8 mg of rivastigmine.

• The other components are:

Matrix:

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

Supporting layer:

• polyethylene/thermoplastic resin/polyester film coated with aluminum

Release layer:

• polyester film coated with fluoropolymer

Orange printing ink

Appearance of the Product and Package Contents

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

• "RIV-TDS 9.5 mg/24 h"

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

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:

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 Last Revision of this Prospectus: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/