Prospecto: iInformation for the patient

Rivastigmina Sandoz9.5 mg/24 h transdermal patches EFG

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who 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 prospectus. See section 4.

1.What is Rivastigmina Sandoz and how is it used

2.What you need to knowbeforestarting touse Rivastigmina Sandoz

3.How to use Rivastigmina Sandoz

4.Possible adverse effects

5.Storage of Rivastigmina Sandoz

6.Contents of the package and additional information

The active ingredient of Rivastigmina Sandoz is rivastigmina.

Rivastigmina belongs to the group of substances known as 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 an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease.

Rivastigmina Sandoz 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 Sandoz

• if you are allergic to rivastigmina (the active ingredient of Rivastigmina Sandoz) or to any of the other ingredients 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 size of the patch, if there is a more intense local reaction (such as blisters, increased skin inflammation, swelling) and if there is no improvement 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 Sandoz transdermal patches.

Warnings and precautions

Consult your doctor before starting to use Rivastigmina Sandoz:

• if you have or have had any irregular or slow heart rhythm,
• if you have or have had any active stomach ulcer,
• if you have or have had any difficulty urinating,
• if you have or have had any seizures,
• if you have or have had any asthma or severe respiratory disease,
• if you suffer from tremors,
• if you have low body weight,
• if you have gastrointestinal reactions such as dizziness (nausea), dizziness (vomiting), and diarrhea. You may become dehydrated (loss of a large amount of fluids) if vomiting or diarrhea is prolonged,
• if you have liver problems (hepatic insufficiency).

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

If you have not used the patches for more than three days, do not apply another one without consulting your doctor first.

Children and adolescents

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

Use of Rivastigmina Sandoz with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication,

Rivastigmina Sandoz may interfere with anticholinergic medications some of which are medications used to relieve stomach cramps or spasms (e.g., diciclomina), for the treatment of Parkinson's disease (e.g., amantadina) or to prevent motion sickness (e.g., difenhidramina, escopolamina or meclizina).

Rivastigmina Sandoz should not be administered at the same time as metoclopramida (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 Sandoz transdermal patches, inform your doctor that you are using them, as they may excessively potentiate the effects of some anesthetic muscle relaxants.

Caution should be exercised when using Rivastigmina Sandoz 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) that may lead to fainting or loss of consciousness.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant and it is necessary to evaluate the benefits of using rivastigmina against the possible adverse effects on the fetus. Rivastigmina should not be used during pregnancy unless it is clearly necessary.

You should not breastfeed during your treatment with Rivastigmina Sandoz transdermal patches.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machines safely.

Rivastigmina may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive, use machines, or perform other tasks that require attention.

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

IMPORTANT:

• Remove the old patch before putting a new one.
• Wear 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 Rivastigmina Sandoz for your case.

• Normally, treatment starts with rivastigmina 4.6 mg/24 h*.
• The usual recommended daily dose is rivastigmina 9.5 mg/24 h*. If this dose is well tolerated, your doctor may consider increasing the dose to 13.3 mg/24 h.
• Wear only one patch of Rivastigmina Sandoz at the same time and replace the patch with a new one every 24 hours.

* If a dose is not achievable with this medication, other doses are available.

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 put a new one on without consulting your doctor. Treatment with transdermal patches 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 Rivastigmina 4.6 mg/24 h transdermal patches.

Rivastigmina Sandoz can be used with food, drinks, and alcohol.

Where to place your Rivastigmina Sandoz patch

• Before putting on a patch, make sure the skin is clean, dry, and free of hair, powders, oils, creams, or lotions that may prevent the patch from sticking well to the skin, without cuts, redness, or irritation.
• Remove any existing patch carefully before putting on a new one.Wearing multiple patches on your body may expose you to an excessive amount of this medication, which can be potentially hazardous.
• Put on onlyONEpatch per day inONEof the possible areas as shown in the following diagrams:
• upper left or upper right arm,
• upper left or upper right chest (avoiding breasts in women),
• upper left or upper right back,
• lower left or lower right back.

When changing patches, the previous patch should be removed before putting on a new patch in a different skin area each time (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 to put a new patch in the same skin area again.

How to apply your Rivastigmina Sandoz patch

Rivastigmina Sandoz patches are thin, opaque plastic and stick to the skin. Each patch is in a protective envelope that keeps it safe until it is put on. Do not open the envelope or remove the patch until you are ready to put it on.

Writing on the patch with a fine-tip pen may help you remember the day of the week.

You should wear the patch continuously until you replace it with a new one. When putting on 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 Rivastigmina Sandoz patch

Gently pull one edge of the patch to remove it slowly 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 remove it. Do not use alcohol or other solvents (nail polish removers or other solvents).

After removing the patch, wash your hands with water and soap. 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 you wear your Rivastigmina Sandoz 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 doing 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, put on a new one for the rest of the day and replace it the next day at the usual time.

When and for how long to wear your Rivastigmina Sandoz patch

• To benefit from your treatment, wear a new patch every day, preferably at the same time.
• Wear only one patch of Rivastigmina Sandoz at the same time and replace the patch with a new one every 24 hours.

If you use more Rivastigmina Sandoz than you should

If you accidentally put on 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 taken). You may need medical attention.

Some people who have taken accidentally high doses of rivastigmina have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. Slowed heart rate and fainting may also occur.

If you forget to use Rivastigmina Sandoz

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

If you interrupt treatment with Rivastigmina Sandoz

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

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

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. Side effects usually disappear gradually 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:

Frequent(may affect up to 1 in 10 people)

• Loss of appetite.
• Sensation of dizziness.
• Sensation of agitation or numbness.
• Urinary incontinence (inability to retain urine properly).

Infrequent(may affect up to 1 in 100 people)

• Problems with your heart rhythm, such as slow heart rate.
• Seeing things that do not exist (hallucinations).
• Stomach ulcer.
• Dehydration (loss of a large amount of fluids).
• 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)

• Rigidity of the arms and legs.
• Tremor in the hands.

Unknown(cannot be estimated from available data)

• Allergic reaction where the patch was applied, such as blisters or skin inflammation.
• Worsening of Parkinson's disease symptoms, such as tremor, rigidity, and difficulty moving.
• Pisa syndrome (condition involving involuntary muscle contraction and abnormal tilting of the body and head to one side).
• Pancreatitis. Symptoms include upper stomach pain, often accompanied by dizziness (nausea) or vomiting.
• Fast or irregular heart rhythm.
• High blood pressure.
• Seizures (convulsions).
• Liver disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine, or unexplained nausea, vomiting, fatigue, and loss of appetite).
• Changes in liver function tests.
• Sensation of restlessness.
• Nightmares.

If you notice any of the side effects listed above, remove the patch and immediately inform your doctor.

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

Frequent(may affect up to 1 in 10 people)

• Excessive salivation.
• Loss of appetite.
• Sensation of agitation.
• Sensation of general discomfort.
• Tremor or sensation of confusion.
• Increased sweating.

Infrequent(may affect up to 1 in 100 people)

• Irregular heart rhythm (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, likely caused by heart spasms.

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

• High blood pressure.
• Pancreatitis. Symptoms include severe upper stomach pain, often accompanied by dizziness (nausea) or vomiting.
• Gastrointestinal bleeding, manifested as blood in the stool or vomiting blood.
• Seeing things that do not exist (hallucinations).
• Some people who have been severely dizzy (vomiting) 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, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for 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 packaging and on the container after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store the transdermal patch inside the packaging 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 along the adhesive side towards the inside and press.

After introducing it into the original packaging, when disposing of the patch, ensure it remains out of the reach of children. After removing the patch, do not touch your eyes, and wash your hands thoroughly with water and soap. If your household waste is disposed of by incineration, you may dispose of the patch in your household waste. If not, take used patches to the pharmacy, preferably in the original packaging.

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 containers and medications you no longer need. By doing so, you will help protect the environment.

Rivastigmina Sandoz 9.5 mg/24 h Transdermal Patches Composition

• The active ingredient is rivastigmina. Each patch releases 9.5 mg of rivastigmina in 24 hours, measures 10 cm2 and contains 18 mg of rivastigmina.
• The other components are laminated poly(ethylene terephthalate), all rac-alpha-tocopherol, poly-(butylmethacrylate, methylmethacrylate), acrylic copolymer, silicone, dimethicone, polyester film coated with fluoropolymer, resin, pigments, organic polymers/resins.

Appearance of the product and contents of the package

They are fine, matrix-type transdermal patches, composed of three layers. The outer layer is beige-colored and marked with "RIV" and "9.5 mg/24 h".

Each sealed sachet contains a transdermal patch. The patches are available in packs of 7, 30, 60 (2 packs of 30), 90 (3 packs of 30) sachets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

Hexal AG

Industriestrasse 25

83607 Holzkirchen

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria: Rivastigmin Sandoz 9.5 mg/24 Stunden - transdermales Pflaster

Belgium: Rivastigmin Sandoz 9.5 mg/24u Pleister voor transdermaal gebruik

Czech Republic: Rivastigmine Sandoz 9.5 mg/24 h

Germany: Rivastigmin - 1 A Pharma 9.5 mg/24 Stunden transdermales Pflaster

Denmark: Rivastigmine Sandoz

Spain: Rivastigmina Sandoz 9.5 mg/24 h transdermal patches EFG

Finland: Rivastigmine Sandoz

France: RIVASTIGMINE Sandoz 9.5 mg/24 h, dispositif transdermique

Ireland: Rivastigmine Sandoz 9.5 mg/24 hours Transdermal System

Italy: RIVASTIGMINA SANDOZ GmbH

Luxembourg: Rivastigmin Sandoz 9.5 mg/24u système transdermique

Malta: Rivastigmine Sandoz 9.5 mg/24 hours Transdermal System

Netherlands: Rivastigmine Sandoz 9.5 mg/24 uur, pleisters voor transdermaal gebruik

Norway: Rivastigmine Sandoz

Poland: Rivastigmine Sandoz

Portugal: Rivastigmine Sandoz

Romania: Rivastigmina Sandoz 9.5 mg/24 ore plastru transdermic

Sweden: Rivastigmine Sandoz

Slovakia: Rivastigmin Sandoz 9.5 mg/24 h transdermalná náplast

Slovenia: Rivastigmin Sandoz 9.5 mg/24 h transdermalni obliž

United Kingdom: Rivastigmine Sandoz 9.5 mg/24 hours Transdermal System

Last review date of this leaflet:March 2025

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/