RIVASTIGMINE VIATRIS 9.5 mg/24h TRANSDERMAL PATCHES

2. What you need to know before you use Rivastigmine Viatris

Do not use Rivastigmine Viatris

• If you are allergic to rivastigmine (the active substance in Rivastigmine Viatris) 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 was a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removing the transdermal patch.

If you are in any of these situations, inform your doctor and do not use Rivastigmine Viatris.

Warnings and precautions

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

• If you have, or have ever had, an irregular or slow heart rate (pulse).
• If you have heart failure.
• If you have had a heart attack.
• If you have, or have ever had, low potassium or magnesium levels 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 severe respiratory disease.
• If you suffer from tremors.
• If you have low body weight.
• If you have gastrointestinal reactions such as a feeling of nausea (nausea), general discomfort (vomiting), and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged.
• If you have 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.

Children and adolescents

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

Using Rivastigmine Viatris with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

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

In case you are given some of the following medicines, your doctor may have you undergo regular heart checks to make sure you do not have problems:

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

Rivastigmine 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), to treat an overactive bladder (e.g., oxybutynin, tolterodine), or to prevent motion sickness (e.g., diphenhydramine, scopolamine, or meclizine).

Rivastigmine Viatris 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.

In case you need to undergo surgery while using Rivastigmine Viatris, inform your doctor that you are using it, as it may be necessary to stop it because it may excessively potentiate the effects of some muscle relaxants used in anesthesia.

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 Viatris against the possible adverse effects for the fetus. Rivastigmine Viatris should not be used during pregnancy unless it is clearly necessary.

You should not breastfeed while being treated with Rivastigmine Viatris.

Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not carry out these activities unless your doctor tells you it is safe to do so. Rivastigmine Viatris may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

3. How to use Rivastigmine Viatris

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

IMPORTANT

• Remove the previous patch before applying a NEW patch.
• Apply ONLY ONE Rivastigmine Viatris 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.
• Avoid touching your eyes after handling the patch.

How to start treatment

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

• Treatment is usually started with Rivastigmine Viatris 4.6 mg/24 h.
• The recommended daily dose is Rivastigmine 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 medicine does not have a concentration of 13.3 mg/24 hours. For situations where this dose should be used, consult your pharmacist).
• 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 three days, do not apply another one before consulting your doctor, as you may be more likely to experience side effects. Treatment with the 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 Rivastigmine Viatris 4.6 mg/24 h.

Where to apply Rivastigmine Viatris patches

• 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 patch you are currently wearing 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 ONLY ONEof the following areas, as shown in the following diagrams:
• • Upper part of the right arm orleft arm.
  • Upper left part of the chest orupper right part of the chest (avoiding the breasts).
  • Upper left part of the back orupper right part of the back.
  • Lower left part of the back orlower right part of the back.

Every 24 hours, remove the previous patch before applying a NEW patch 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; 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 skin again.

How to apply Rivastigmine Viatris

The Rivastigmine Viatris patches are thin, cinnamon-colored plastic 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 from the pouch until you are ready to apply it.

Remove the existing patch carefully before applying a new one.

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

Each patch is in an individual protective pouch.

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

Cut the pouch along both scissor marks, without exceeding the indicated line. Tear the pouch to open it. Do not cut the entire length of the pouch to avoid damaging the patch.

Remove the patch from the pouch.

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

A protective film covers the adhesive side of the patch.

Remove the first sheet of the film without touching the adhesive side of the patch with your fingers.

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

Afterward, press the patch firmly against the skin with the palm of your hand for at least 30 seconds, and make sure the edges are well stuck.

If it helps, you can write on the patch, for example, the day of the week, with a fine-tipped, rounded 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 (choosing from those mentioned previously) to find the ones that are most comfortable for you and where clothing does not rub against the patch.

How to remove Rivastigmine Viatris

Gently pull one of the edges of the patch to slowly peel it off the skin. If there are any adhesive residues left 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).

Washing your hands

Wash your hands with water and soap after removing or applying the patch. In case of eye contact or if your eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if the symptoms do not resolve.

Can you wear Rivastigmine Viatris 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, sunbed) for extended periods.

What should you 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 apply Rivastigmine Viatris?

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

If you use more Rivastigmine 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 Toxicology Information Service, phone: 91 562 04 20 (indicating the medicine and the amount administered). You may need medical attention.

Some people who have used too much rivastigmine by mistake have experienced a decrease in pupil size (miosis), skin redness, and a feeling of heat (flushing), stomach pain, a feeling of discomfort (nausea), vomiting, diarrhea, slow heart rate, sudden difficulty breathing (bronchospasm), increased production of sputum, increased sweating, incontinence, or loss of bowel control, crying, low blood pressure, increased salivation, dizziness, tremors, headaches, drowsiness, confusion, high blood pressure, hallucinations, or lack of energy (general discomfort). In severe cases, muscle weakness, uncontrolled muscle twitches, seizures, and respiratory arrest or slower breathing have been documented.

If you forget to use Rivastigmine Viatris

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 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 another one before consulting your doctor, as you are more likely to experience side effects.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 can be serious, remove the patch and immediately inform your doctor:

• Epileptic seizures (convulsions).
• Changes in heart rhythm, which can be either a very rapid heart rate or a sensation of missed beats.
• Stomach ulcer (you may experience stomach pain and if you vomit, you may see blood or coffee grounds-like residue).
• Pancreatitis - signs include severe pain in the upper abdomen, often with a feeling of nausea (nausea) or vomiting.
• A feeling of being very confused, which can be associated with seeing, feeling, or hearing things that do not exist (hallucinations), a feeling of detachment from reality (delusional ideas), decreased or increased activity (delirium).
• Liver disorders (you may notice yellowing of the skin or the whites of the eyes, abnormal darkening of urine, unexplained nausea, vomiting, fatigue, and loss of appetite).

Other possible adverse effects could be:

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

• Headache.
• Lack or loss of appetite, weight loss.
• Feeling of anxiety, depression, dizziness.
• Fainting.
• Feeling of discomfort, malaise, diarrhea, indigestion/stomach burning, stomach pain.
• Feeling of agitation, fatigue, general weakness, low-grade fever.
• Skin rash and allergic skin reactions where the patch has been applied, such as eczema-like reactions, redness, itching, swelling, and irritation.
• Urinary tract infection (may present with pain when urinating or the need to go to the bathroom more frequently).
• Urinary incontinence (inability to properly hold urine).

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

• Heart problems, such as a slow heartbeat.
• Dehydration (loss of a large amount 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 legs or arms, restlessness, muscle spasms, tremors (e.g., in the hands).

Frequency Not Known(cannot be estimated from the available data):

• Worsening of Parkinson's disease symptoms; such as tremors, stiffness, feeling of sleepiness, and shuffling gait.
• Allergic skin reaction, such as blisters or inflamed skin, itching, hives, or redness.
• Rapid heartbeat.
• Seeing or hearing things that do not really exist (hallucinations).
• High blood pressure.
• Changes in laboratory tests that show liver function.
• Feeling of restlessness.
• Nightmares.
• Pisa syndrome (a condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side).

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):

• General feeling of discomfort.
• Feeling of confusion.
• Increased sweating.

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

• Chest pain - probably caused by heart spasms.
• Ulcer in the intestine.

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

• Gastrointestinal bleeding - manifested as blood in the stool or when being sick.

Frequency Not Known(cannot be estimated from the available data):

• Some people who have been severely nauseous 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 or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rivastigmine Viatris

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

This medicine does not require special storage conditions.

Store 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 placing it in the original envelope, make sure to dispose of the patch in a way that 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.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE 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 Viatris

The active ingredient is rivastigmine.

Each 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:

• Aluminum-coated polyethylene/thermoplastic resin/polyester film.

Release layer:

• Fluoropolymer-coated polyester film.
• Orange printing ink.

Product Appearance and Package Contents

Thin transdermal patch. The outer layer is cinnamon-colored and bears the following imprint in orange printing ink:

• "RIV-TDS 9.5 mg/24 h"

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Germany Rivastigmin Mylan 9.5 mg/24 Stunden transdermales Pflaster

Belgium Rivastigmine Mylan 9.5 mg/24 h Pleisters voor transdermaal gebruik

Spain Rivastigmina Viatris 9.5 mg/24 h parches transdérmicos EFG

France Rivastigmine Mylan Pharma 9.5 mg/24 h Dispositif transdermique

Italy Rivastigmina Mylan Pharma 9.5 mg/24 h

Netherlands Rivastigmin Pleister Mylan 9.5 mg/24 h Pleister voor transdermaal gebruik

Poland Rivastigmine Mylan

Portugal Rivastigmina Mylan

United Kingdom Eluden 9.5 mg/24 h transdermal patch

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/