Prospecto: information for the patient

Rivastigmina Sandoz 13.3 mg/24 h transdermal patches EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people 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 prospect. See section 4.

1.Rivastigmina Sandoz and its use

2.What you need to knowbeforestarting touse Rivastigmina Sandoz

3.How to use Rivastigmina Sandoz

4.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 known as cholinesterase inhibitors. In patients with Alzheimer's disease, certain nerve cells die in the brain, causing 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 liquids) 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 pediatric patients 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.

Care should be taken when using Rivastigmina Sandoz together with beta blockers (medications such as atenolol used to treat hypertension, angina, and other cardiovascular 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.

If you need to undergo surgery while using Rivastigmina Sandoz transdermal patches, inform your doctor that you are using them, as they may potentiate the effects of some anesthetic muscle relaxants.

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, 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 machinery safely.

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

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

IMPORTANT:

• Remove the previous patch before putting a new one.
• Put 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 Rivastigmina Sandoz patch at a 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 more than three days, do not put a new one 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 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 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 must be removed before putting a new patch in a different area of the skin 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 area of the skin 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 protects it until it is put on. Do not open the envelope or remove the patch until it is time to put it on.

If this helps, you can write on the patch, for example, the day of the week, with a fine-pointed red pen.

You must wear the patch continuously until it is time to change it for 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 of the edges 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 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 taking a shower 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 a new one on for the rest of the day and change it the next day at the usual time.

When and for how long to wear your Rivastigmina Sandoz patch

• To benefit from your treatment, you must put a new patch every day, preferably at the same time.
• Wear only one Rivastigmina Sandoz patch at a 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 the 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 dizziness 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 often when you first 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 saliva.
• 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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging and on the containerafter 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.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of your 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.

If your household waste is incinerated, you can dispose of the patch in your home trash. If not, take the used patches to the pharmacy, preferably in the original packaging.

Rivastigmina Sandoz 13.3 mg/24 h Transdermal Patches Composition

• The active ingredient is rivastigmina.Each patch releases 13.3 mg of rivastigmina in 24 hours, measures 15 cm2and contains 27 mg of rivastigmina.
• The other components are:

• Back film: poly(ethylene terephthalate) coated,
• Medicine reservoir:all rac-alpha-tocopherol, poly-(butylmethacrylate, methylmethacrylate)(3:1) copolymer, acrylic copolymer,
• Adhesive matrix:all rac-alpha-tocopherol, silicone, dimethicone12,500 cSt,
• Release support: fluorinated polyester film coated,
• Printing ink: resin, pigments, organic polymers/resins.

Product Appearance and Packaging Contents

Thin, matrix-type transdermal patch, composed of three layers.

Medicine release system with a circular shape of 15 cm2, superficial layer (beige color), bi-layer adhesive matrix and a rectangular covering layer with pores superimposed. The outer layer is marked with «RIV 13.3 mg/24 h».

Each sealed box contains a transdermal patch. The patches are available in boxes of 7 or 30 and multi-boxes of 60 (2 boxes of 30) or 90 (3 boxes of 30) patches.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer

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 Via de les Corts

Catalanes, 764

08013 Barcelona

Spain

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

Austria: Rivastigmin Sandoz 13.3 mg/24 Stunden - transdermal Pflaster

Belgium: Rivastigmin Sandoz 13.3 mg/24u Pleister voor transdermaal gebruik

Czech Republic: Rivastigmine Sandoz 13.3 mg/24 h

Germany: Rivastigmin - 1 A Pharma 13.3 mg/24Stunden transdermal Pflaster

Denmark: Rigmin

Spain: Rivastigmina Sandoz 13.3 mg/24 h transdermal patches EFG

Finland: Rivastigmine Sandoz

Italy: RIVASTIGMINA SANDOZ GmbH

Luxembourg: Rivastigmin Sandoz 13.3 mg/24u système transdermique

Malta: Rivastigmine Sandoz 13.3 mg/24 hours Transdermal System

Netherlands: RivastigmineSandoz 13.3 mg/24 uur, patches for transdermal use

Norway: Rigmin

Poland: Rivastigmine Sandoz

Portugal: Rivastigmine Sandoz

Romania: Rivastigmina Sandoz 13.3 mg/24 ore plaster transdermic

Sweden: Rigmin

Slovenia: Rivastigmin Sandoz 13.3 mg/24 h transdermalni obliž

Slovakia: Rivastigmin Sandoz 13.3 mg/24 h transdermalná náplast

Last review date of this leaflet:March 2025

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