Label: information for the user

RivastigmineViatris4,6 mg/24 h patchstransdermal EFG

rivastigmine

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

• Keep this label, 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 even if they 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 label.See section 4.

1. 6. Contents of the pack and additional information

The active ingredient of Rivastigmina Viatris is rivastigmina.

Rivastigmina belongs to the group of cholinesterase inhibitors. In patients with Alzheimer's disease, certain nerve cells die in the brain, resulting in 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 for an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease.

Rivastigmina Viatris 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 Viatris

• If you are allergic to rivastigmina (the active ingredient of Rivastigmina Viatris) or to any of the other components of this medication (listed in section6).
• 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 was a more intense local reaction (such as blisters, increased skin inflammation, swelling) and if it does not improve 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 Viatris.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Rivastigmina Viatris:

• If you have, or have ever had, an irregular or slow heart rhythm.
• If you have heart failure.
• If you have had a heart attack.
• If you have, or have ever had, 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, asthma or a severe respiratory disease.
• If you suffer from tremors.
• If you have a low body weight.
• If you have gastrointestinal reactions such as dizziness (nausea), general discomfort (vomiting), and diarrhea. You may become dehydrated (loss of a large amount of fluid) if vomiting or diarrhea are prolonged.
• If you have liver insufficiency.

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

Children and adolescents

There is no experience of the use of Rivastigmina Viatris in the pediatric population in the treatment of Alzheimer's disease.

Other medications and Rivastigmina Viatris

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication,including those purchased without a prescription.

Rivastigmina Viatris may increase the effects of some medications that lower blood pressure; for example, "beta blockers", such as atenolol; "calcium channel blockers", such as amlodipine, nifedipine; "antiarrhythmic medications", such as sotalol, amiodarone, digitals, and pilocarpine (used to treat glaucoma). This may cause you to faint.

If you are administered some of the following medications, your doctor may subject you to regular cardiac checks to ensure that you do not have any problems:

• Medications used to treat mental health problems known as "antipsychotics"; for example, chlorpromazine, levomepromazine, sulpiride, tiapride, veralipride, pimozide, haloperidol, droperidol.
• A medication known as cisapride (used to treat indigestion).
• Citalopram (used to treat depression).
• Difemanil (used to treat peptic ulcers).
• Halofantrine (used to treat malaria).
• Mizolastine (used to treat allergies).
• Methadone (a painkiller, also used in heroin addiction).
• Erythromycin IV, pentamidine, moxifloxacin (antibiotics).

Rivastigmina may interfere with anticholinergic medications some of which are medications used to relieve stomach cramps or spasms (for example, dicyclomine), to treat Parkinson's disease (for example, amantadine),to treat an overactive bladder (for example, oxybutynin, tolterodine) or to prevent motion sickness (for example, diphenhydramine, scopolamine, or meclizine).

Rivastigmina Viatris 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 Viatris, inform your doctor that you are using it, as you may need to stop it because it may excessively potentiate the effects of some anesthetic muscle relaxants.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or 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 Viatris against the possible adverse effects on the fetus. Rivastigmina Viatris should not be used during pregnancy unless it is clearly necessary.

You should not breastfeed during your treatment with Rivastigmina Viatris.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so. Rivastigmina Viatris may cause dizziness and drowsiness, mainly at the beginning of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist..

IMPORTANT

• Remove the previous patch before putting on a new patch.
• Only one patch ofRivastigmina Viatris should be applied 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.
• Avoid touching your eyes after handling the patch.

How to start treatment

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

• Normally, treatment starts with Rivastigmina Viatris 4.6 mg/24 h..
• The usual recommended daily dose is Rivastigmina Viatris 9.5 mg/24 h. If your condition does not improve after at least 6 months, your doctor may consider increasing the dose to 13.3 mg/24 h (This medication does not have a concentration of 13.3 mg/24 hours.For situations where you need to use this dose, consult your pharmacist).
• Only one transdermal patch should be worn at a time and the patch should be replaced 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 three days, do not apply a new one without consulting your doctor, as you may be more prone to experiencing adverse effects. Treatment with a transdermal patch can be restarted with the same dose if treatment is not interrupted for more than three days. Otherwise, your doctor will have you restart your treatment with Rivastigmina Viatris 4.6 mg/24 h.

Where to place Rivastigmina Viatris transdermal patches

• Make sure the skin is clean, dry, and free of hair, powders, oils, moisturizers, or lotions that may prevent the patch from sticking well to the skin, without cuts, redness, or irritation..
• Remove the previous patch carefully before applying a new one..Wearing multiple patches on your body may expose you to an excessive amount of this medication, which could be potentially hazardous.
• Applyonly onepatch per day inoneof the following areas, as shown in the following diagrams:.
• • Upper right or left arm.
  • Upper left or right chest (avoiding the breasts).
  • Upper left or right back.
  • Lower left or right back.

Every 24 hours, remove the previous patch before applying a new one inonly oneof the possible areas.

Each time you change the patch, the previous patch should be removed 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; and one day on the chest or upper back and the next day on the lower back). Wait at least 14 days before applying a new patch to the same area of the skin..

How to apply Rivastigmina Viatris

Rivastigmina Viatris patches are thin, orange-colored plastic patches that stick to the skin. Each patch is in a protective envelope that keeps it safe until it is applied. Do not open the envelope or remove the patch from the envelope until you are ready to apply it..

Remove the previous patch carefully before applying a new one..

Patients starting treatment for the first time and patients restarting treatment with rivastigmina after interrupting treatment should start with the second figure..

Each patch is in an individual protective envelope.

Only open the envelope when you are ready to apply the patch.

Open the envelope by cutting along both perforations, without exceeding the indicated line. Tear the envelope to open it. Do not cut the entire length of the envelope to avoid damaging the patch.

Remove the patch from the envelope.

Remove the skin-colored backing from the top of the patch and discard it.

A protective liner covers the adhesive side of the patch.

Remove the first liner without touching the adhesive side of the patch..

Place the adhesive side of the patch on the upper or lower back, or on the arm or chest, and then remove the second liner.

Press the patch firmly against the skin with the palm of your hand for at least 30 seconds and make sure the edges have stuck well.

If this 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 replaced with a new one. When applying a new patch, you can try different areas (choosing from the previously mentioned ones) to find the ones that are most comfortable and where clothing does not rub against the patch..

How to remove Rivastigmina Viatris

Gently pull one edge 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 help remove them. Do not use alcohol or other solvents (nail polish removers or other solvents).

Wash your hands

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

Can Rivastigmina Viatris be worn when bathing, swimming, or exposed to the sun??

• Bathing, swimming, or showering should not affect the patch. Make sure it does not come loose while performing these activities..
• Do not expose the patch to an external heat source (for example, 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 replace it the next day at the usual time..

How long and when to wear Rivastigmina Viatris

• To benefit from your treatment, apply a new patch every day, preferably at the same time.
• Only wear one Rivastigmina Viatris patch at a time and replace it with a new one every 24 hours.

If you use more Rivastigmina Viatris than you should

If you accidentally apply more than one patch, remove all patches from the skin and inform your doctor or pharmacist, or call the Toxicological 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 too much rivastigmina have experienced a decrease in pupil size (miosis), skin redness, and a sensation of heat (hot flashes), stomach pain, nausea, vomiting, diarrhea, slow heart rate, sudden difficulty breathing (bronchospasm), increased sputum production, increased sweating, incontinence or loss of bowel control, crying, low blood pressure, increased salivation, dizziness, tremors, headaches, drowsiness, confusion, high blood pressure, hallucinations, or general malaise. In severe cases, muscle weakness, uncontrollable muscle tics, seizures, or respiratory arrest or slower breathing have been documented.

What to do if you forget to use Rivastigmina Viatris

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

What to do if you interrupt treatment with Rivastigmina Viatris

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

If you have not used the patches for three days or more, do not apply a new one without consulting your doctor, as you may be more prone to experiencing adverse effects.

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

Like all medicines, this medicine 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 medicine.

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

• Seizures (convulsions).
• Changes in heart rhythm, which can be either a very fast heart rate or a sensation of missing beats.
• Stomach ulcer (you may experience stomach pain and if you vomit, blood or coffee ground-like material may appear).
• Pancreatitis – symptoms include severe upper stomach pain often with a sensation of dizziness (nausea) or dizziness (vomiting).
• Sensation of feeling very confused, which can be associated with seeing, feeling, or hearing things that do not exist (hallucinations), sensation of being detached from reality (delusions), decreased or increased activity (delirium).
• Liver damage (you may notice a yellowish color of the skin or in the white of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, fatigue, and loss of appetite).

Other possible side effects may include:

Frequent(may affect up to 1 in 10 people):

• Headache.
• Loss or lack of appetite, weight loss.
• Sensation of anxiety, depression, dizziness.
• Fainting.
• Sensation of discomfort, unease, diarrhea, indigestion/heartburn, stomach pain.
• Sensation of restlessness, fatigue, general weakness, low-grade fever.
• Skin eruptions and allergic skin reactions where the patch has been applied, such as reactions similar to eczema, redness, itching, swelling, and irritation.
• Urinary tract infection (you may experience pain while urinating or need to urinate more frequently).
• Urinary incontinence (inability to stop urinating properly).

Rare(may affect up to 1 in 100 people):

• Cardiac problems, such as a slow heart rate.
• Dehydration (loss of a large amount of fluid).
• Hypervigilance (high level of activity, restlessness).
• Aggression.

Uncommon(may affect up to 1 in 1,000 people):

• Falls.

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

• Rigidity of legs or arms, restlessness, muscle spasms, tremors (e.g., in the hands).

Frequency not known(cannot be estimated from available data):

• Worsening of Parkinson's disease symptoms; such as tremors, stiffness, feeling sleepy, and dragging the feet.
• Allergic skin reaction, such as blisters or inflamed skin, itching, urticaria, or redness.
• Fast heart rate.
• Seeing or hearing things that do not exist (hallucinations).
• High blood pressure.
• Changes in liver function tests.
• Sensation of restlessness.
• Nightmares.
• Pisa syndrome (a condition that involves involuntary muscle contractions and abnormal tilting of the body and head to one side).

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

Frequent(may affect up to 1 in 10 people):

• Sensation of general discomfort.
• Sensation of confusion.
• Increased sweating.

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

• Chest pain – likely caused by heart spasms.
• Ulcer in the intestine.

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

• Gastrointestinal bleeding – manifests as blood in the stool or vomiting.

Frequency not known(cannot be estimated from available data):

• Some people who have been severely dizzy have had a tear in the esophagus, the tube that connects their mouth to their stomach.

Reporting side effects

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

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. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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 inwards and press. After placing it in the original overwrap, when disposing of the patch ensure 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.

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. This will help protect the environment.

Composition of Rivastigmina Viatris

The active ingredient is rivastigmina.

Each patch releases 4.6 mg of rivastigmina in 24 hours, measures 4.6 cm2and contains 6.9 mg of rivastigmina.

The other components are:

Matrix:

Backing layer:

Release layer:

Appearance of the product and contents of the package

Thin transdermal patch. The outer layer is orange and carries the following printed in orange printing ink:

• «RIV‑TDS 4.6 mg/24 h»

Each package contains a transdermal patch. Patches are available in packages containing 7 or 30 patches and in multi-packages containing 60 or 90 patches. Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer responsible:

McDermott Laboratories Ltd trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13,

Ireland

or

Mylan Hungary Kft

Mylan utca 1

Komárom, 2900

Hungary

or

Luye Pharma AG

Am Windfeld 27 and 35

83714 Miesbach

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyRivastigmin Mylan 4.6 mg/24Hours transdermal patch

BelgiumRivastigmine Mylan 4.6 mg/24 h Plasters for transdermal use

SpainRivastigmina Viatris 4.6 mg/24 h patchestransdermal EFG

FranceRivastigmine Mylan Pharma 4.6 mg/24 h transdermal device

ItalyRivastigmina Mylan Pharma 4.6 mg/24 h

NetherlandsRivastigmin Plaster Mylan 4.6 mg/24 h Plaster for transdermaluse

PolandRivastigmine Mylan

PortugalRivastigmina Mylan

United KingdomEluden 4.6 mg/24 h transdermal patch

Last review date of this leaflet:February 2025

Further 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/