RIVASTIGMINE TEVAGEN 9.5 mg/24h TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the User

Rivastigmine Tevagen 4.6 mg/24 h Transdermal Patches EFG

Rivastigmine Tevagen 9.5 mg/24 h Transdermal Patches EFG

Rivastigmine Tevagen 13.3 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 Pack

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

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

The active substance of Rivastigmine Tevagen is rivastigmine.

Rivastigmine belongs to a class of medicines called cholinesterase inhibitors. In patients with Alzheimer's dementia, certain nerve cells die in the brain, causing low levels of the neurotransmitter acetylcholine (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 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 Tevagen

Do not use Rivastigmine Tevagen

• if you are allergic to rivastigmine (the active substance of Rivastigmine Tevagen) 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 have a skin reaction that extends 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 during the 48 hours after removing the transdermal patch.

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

Warnings and precautions

Consult your doctor before starting to use Rivastigmine

• if you have or have ever had any heart disease such as irregular or slow heart rate, prolonged QTc, family history of prolonged QTc, torsades de pointes, or low potassium or magnesium levels in the 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, vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged,

(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.

Use in children and adolescents

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

Other medicines and Rivastigmine Tevagen

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

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), or to prevent travel sickness (e.g., diphenhydramine, scopolamine, or meclizine).

Rivastigmine 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.

In case you need to undergo surgery while using Rivastigmine transdermal patches, inform your doctor that you are using it, as it may potentiate the effects of some muscle relaxants during anesthesia.

Caution should be exercised when using Rivastigmine 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 rivastigmine is taken with other medicines that may affect your heart rate or the electrical system of your heart (prolonged QT).

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, it is necessary to evaluate the benefits of using Rivastigmine Tevagen against the possible adverse effects for the fetus. This medicine should not be used during pregnancy unless it is clearly necessary.

You should not breastfeed while being treated with Rivastigmine patches.

Driving and using machines

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

Follow exactly the instructions for administration of Rivastigmine Tevagen transdermal patches given by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse.

IMPORTANT:

• Remove the previous patch before putting on a NEW patch.
• 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 patches for your case.

• Normally, treatment is started with Rivastigmine Tevagen 4.6 mg/24 h.
• The recommended daily dose is usually Rivastigmine Tevagen 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 Rivastigmine 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 your treatment with Rivastigmine Tevagen 4.6 mg/24 h.

Rivastigmine can be used with food, drink, and alcohol

Where to apply Rivastigmine Tevagen transdermal patches

? Before putting on 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 irritations.

? Remove any existing patch carefully before putting on a new one.Wearing multiple patches on your body could expose you to an excessive amount of this medicine, which could be potentially dangerous.

? Put ONEpatch per day on 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)
• upper left or upper right back
• lower left or lower right back

Every 24 hours, remove the previous patch before putting on a NEW patch in ONLY ONE of the following possible areas.

Each time you change the patch, you must remove the previous day's patch before putting on a new one in a different area of the skin each time (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). Wait at least 14 days before putting a new patch in the same area of skin again.

How to apply Rivastigmine Tevagen transdermal patches

Rivastigmine Tevagen patches are thin and brown in color and stick to the skin. Each patch is in a sealed pouch that protects it until you are ready to use 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-tip pen.

You should wear the patch continuously until it is time to change it for a new one. When you put on a new patch, you can try different areas to find the ones that are most comfortable for you and where your clothes do not rub against the patch.

How to remove Rivastigmine Tevagen transdermal patches

Gently pull on 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. In case of contact with the eyes or if the 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 Tevagen transdermal patches 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, sunbed) for long periods.

What to do if a patch falls off

If a patch falls off, put on 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 Rivastigmine Tevagen transdermal patches

• To benefit from your treatment, you should put on 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 Tevagen than you should

If you accidentally put on more than one patch, remove all patches from the skin and inform your doctor, 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 accidentally taken too high doses of rivastigmine orally have had 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 Tevagen

If you realize you have forgotten to put on a patch, put one on immediately. The next day, put on the next patch at the usual time. Do not put on two patches to make up for the one you forgot.

If you stop treatment with Rivastigmine Tevagen

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

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

4. Possible Adverse Effects

Like all medicines, Rivastigmine transdermal patches may cause adverse effects, although not all people may 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 agitation or numbness
• Urinary incontinence (inability to stop urine properly).

Uncommon(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 (excessive loss of fluids)
• 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(frequency cannot be estimated from the available data)

• Allergic reaction on the skin where the patch was used, such as blisters or skin inflammation.
• Worsening of Parkinson's disease symptoms, such as tremor, stiffness, and difficulty moving,

• Pancreatitis, signs include severe pain in the upper abdomen, often accompanied by a feeling of 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
• Pisa syndrome (a disease that involves involuntary muscle contraction with abnormal flexion of the body and head to one side

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 fatigue
• Feeling of general discomfort
• Tremor or feeling of confusion
• Increased sweating

Uncommon(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 heart spasm

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

• High blood pressure
• Pancreatitis: signs include severe pain in the upper abdomen, often with a feeling of nausea or vomiting.
• Gastrointestinal bleeding; manifested as blood in the stool or when vomiting
• Seeing things that do not really exist (hallucinations)
• Some people who have been intensely dizzy (vomiting) have had a tear in

part of the digestive tube that connects the mouth to the stomach (esophagus)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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. Conservation of Rivastigmine Tevagen

• 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 the envelope after CAD.

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 notice that it is damaged or shows signs of tampering.
• After removing a patch, fold it in half with the adhesive side facing in and press. After placing it in the original envelope, make sure to dispose of the patch 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 down the drain or into the trash. Deposit the containers 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 containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rivastigmine Tevagen

The active ingredient is rivastigmine.

Rivastigmine Tevagen 4.6 mg/24 h transdermal patches EFG:

Each transdermal patch releases 4.6 mg of rivastigmine in 24 hours. Each 4.3 cm2 transdermal patch contains 6.4 mg of rivastigmine.

Rivastigmine Tevagen 9.5 mg/24 h transdermal patches EFG

Each transdermal patch releases 9.5 mg of rivastigmine in 24 hours. Each 8.5 cm2 transdermal patch contains 12.8 mg of rivastigmine.

Rivastigmine Tevagen 13.3 mg/24 h transdermal patches EFG

Each transdermal patch releases 13.3 mg of rivastigmine in 24 hours. Each 12.8 cm2 transdermal patch contains 19.2 mg of rivastigmine.

The other components are:

External layer:

polyethylene/thermoplastic resin/polyester film coated with aluminum

Medicinal reservoir layer:

poly[(2-ethylhexyl)acrylate, vinyl acetate]

Adhesive matrix layer:

polyisobutene of medium molecular weight

polyisobutene of high molecular weight

anhydrous colloidal silica

light liquid paraffin

Release layer:

polyester film (polyethylene terephthalate) coated with fluoropolymer

orange printing ink

Appearance of the Product and Package Contents

Each transdermal patch is a thin, circular patch. The external layer is brown in color and marked in orange with the following:

Rivastigmine Tevagen 4.6 mg/24 h transdermal patches EFG

“RIV-TDS 4.6 mg/24 h”

Rivastigmine Tevagen 9.5 mg/24 h transdermal patches EFG

“RIV-TDS 9.5 mg/24 h”

Rivastigmine Tevagen 13.3 mg/24 h transdermal patches EFG

“RIV-TDS 13.3 mg/24 h”

Each transdermal patch is packaged in a sealed envelope.

Rivastigmine Tevagen 4.6 mg/24 h transdermal patches EFGand Rivastigmine Tevagen 9.5 mg/24 h transdermal patches EFGare available in packages containing 7, 30, or 42 envelopes and in multi-packages containing 60 (2 x 30) or 84 (2x42) or 90 (3 x 30) envelopes.

Rivastigmine Tevagen 13.3 mg/24 h transdermal patches EFGis available in packages containing 7 or 30 envelopes and in multi-packages containing 60 (2 x 30) and 90 (3 x 30) envelopes.

Not all package sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

Luye Pharma AG

Am Windfeld 35

83714 Miesbach,

Germany

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

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

This medicine is authorized in the Member States of the European Economic Areawith the following names

Date of the last revision of this prospectus:March 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86431/P_86431.html