RIVASTIGMINE STADAFARMA 9.5 mg/24h TRANSDERMAL PATCHES

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

Do not use Rivastigmine Stadafarma

• if you are allergic to rivastigmine (the active substance) 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 transdermal patches.

Warnings and Precautions

Consult your doctor before starting to use rivastigmine:

• if you have or have had any heart problems, such as irregular or slow heart rhythm, QTc prolongation, family history of QTc prolongation, torsades de pointes, or if you have low blood potassium or magnesium levels
• if you have or have had any active stomach ulcers
• if you have or have had any difficulty urinating
• if you have or have had any seizures
• if you have or have had any severe respiratory diseases, 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 should not be used in the pediatric population for the treatment of Alzheimer's disease.

Other Medications and Rivastigmine Stadafarma

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medications.

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.

If 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 used in anesthesia.

Caution should be exercised when using rivastigmine 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), which may lead to fainting or loss of consciousness.

Caution should be exercised when using rivastigmine with other medications that may affect heart rhythm 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 against the potential adverse effects for the fetus. Rivastigmine 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 machines safely. Rivastigmine transdermal patches may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive or use machines, and do not perform other tasks that require your attention.

3. How to Use Rivastigmine Stadafarma

Follow the administration instructions of this medication exactly as indicated by your doctor. If you are in doubt, consult your doctor, pharmacist, or nurse again.

IMPORTANT:

???Remove the previous patch before applying 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 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 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 treatment with rivastigmine 4.6 mg/24 h.

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

Where to Apply 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 irritations.

? Remove any previous 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, 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

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

How to Apply Your Rivastigmine Transdermal Patch

Rivastigmine patches are thin, brown, and 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 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 them. 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 While 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 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 Transdermal Patch?

? To benefit from your treatment, 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 after 24 hours.

If You Use More Rivastigmine Stadafarma Than You Should

If you accidentally apply more than one patch, remove all patches from the skin and inform your doctor. You may need medical attention. Some people who have accidentally taken high doses of rivastigmine orally have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. They may also experience a slowing of the heart rate and fainting.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Use Rivastigmine Stadafarma

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 Stadafarma

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

If you have any other questions about the use of this medication, 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 may be serious, remove the patch and inform your doctor immediately.

Frequent(may affect up to 1 in 10 people)

? Loss of appetite

? Feeling of 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 signs – such as tremor, stiffness, and difficulty moving

? Pancreatitis – signs include severe pain in the upper part of the stomach, often accompanied by a feeling of dizziness (nausea) or dizziness (vomiting)

? Fast or irregular heart rate

? High blood pressure

? Epileptic 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 analyzes 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)

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

? Loss 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)

? Epileptic 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 dizziness (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 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. Conservation of Rivastigmine Stadafarma

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.

Keep the transdermal patch inside 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 inward and press. After introducing 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 water and soap. 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 containers and medicines you no longer need in the SIGRE Point of the pharmacy. 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 Stadafarma

The active principle is rivastigmine.

Rivastigmine Stadafarma 4.6 mg/24 h transdermal patches EFG:

Each transdermal patch releases 4.6 mg of rivastigmine in 24 hours. Each 4.6 cm2 transdermal patch contains 6.9 mg of rivastigmine.

Rivastigmine Stadafarma 9.5 mg/24 h transdermal patches EFG:

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

The other components are: polyethylene/thermoplastic resin/polyester film coated with aluminum, poly [(2-ethylhexyl) acrylate, vinyl acetate], polyisobutene of medium and high molecular weight, anhydrous colloidal silica, light liquid paraffin, polyester film coated with fluoropolymer, orange printing ink.

Product Appearance and Package Contents

Thin circular transdermal patch. The outer layer is brown in color and is marked in orange ink with:

• “RIV-TDS 4.6 mg/24 h”
• “RIV-TDS 9.5 mg/24 h”

Each envelope contains a transdermal patch. Each transdermal patch is protected by a protective film.

Rivastigmine Stadafarma 4.6 mg/24 h and Rivastigmine Stadafarma 9.5 mg/24 h are available in packages containing 7, 30, or 42 envelopes and multiple packages containing 60 (2x30), 84 (2x42), or 90 (3x30) envelopes.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Luye Pharma AG

Am Windfeld 35, 83714 Miesbach

Germany

or

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2, A-1190 Wien

Austria

Date of the Last Revision of this Prospectus:April 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/).