RIVASTIGMINE SANDOZ 13.3 mg/24h TRANSDERMAL PATCHES

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

Do not use Rivastigmine Sandoz

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

Warnings and Precautions

Consult your doctor before starting to use Rivastigmine Sandoz:

• if you have or have ever had an irregular or slow heart rate (pulse),
• 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 a severe respiratory disease,
• if you suffer from tremors,
• if you are underweight,
• if you have gastrointestinal reactions such as a feeling of nausea (nausea), vomiting (vomiting) and diarrhea. You may become dehydrated (lose a large amount of fluids) 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 Sandoz should not be used in the pediatric population for the treatment of Alzheimer's disease.

Using Rivastigmine Sandoz with Other Medications

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

Rivastigmine Sandoz 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 Sandoz 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.

Caution should be exercised when using Rivastigmine 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 can lead to fainting or loss of consciousness.

If you need to undergo surgery while using Rivastigmine Sandoz transdermal patches, inform your doctor that you are using it, as it may 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 medication.

If you are pregnant, it is necessary to evaluate the benefits of using rivastigmine against the possible 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 Sandoz transdermal patches.

Driving and Using Machines

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

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

3. How to Use Rivastigmine Sandoz

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 putting on a NEW patch.
• Put on 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 Sandoz 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 Rivastigmine Sandoz patch at a time and replace the patch with a new one after 24 hours.

• When a dose not achievable with this medication is necessary, other doses are available.

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 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 rivastigmine 4.6 mg/24 h transdermal patches.

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

Where to Place Your Rivastigmine Sandoz Patch

• Before putting on a patch, make sure the skin is clean, dry, and hairless, without powders, oils, moisturizing creams, or lotions that may prevent the patch from sticking well to the skin, without cuts, redness, or irritations.
• Carefully remove any patch you are wearing before putting on a new one. Wearing multiple patches on your body may expose you to an excessive amount of this medication, and this can be potentially dangerous.
• Put on only ONEpatch per day in ONEof the possible areas as shown in the following diagrams:
• upper left orupper right arm,
• upper left orupper right chest (avoiding the breasts in women),
• upper left orupper right back,
• lower left orlower right back.

When changing patches, remove the previous day's patch before putting on a new patch 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 on a new patch in the same area of skin.

How to Apply Your Rivastigmine Sandoz Patch

The Rivastigmine Sandoz patches are thin, opaque plastic and stick to the skin. Each patch is in a protective pouch that protects it until it is applied. 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 put 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 Rivastigmine Sandoz Patch

Gently pull one of the edges of the patch to slowly detach it from the skin. If adhesive residues remain 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, rinse them immediately with plenty of water and seek medical advice if the symptoms do not resolve.

Can You Wear Your Rivastigmine 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 performing 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 that day and change it the next day at the usual time.

When and for How Long Should You Wear Your Rivastigmine Sandoz Patch

• To benefit from your treatment, you should put on a new patch every day, preferably at the same time.
• Wear only one Rivastigmine Sandoz patch at a time and replace the patch with a new one after 24 hours.

If You Use More Rivastigmine 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 Toxicology Information Service, phone: 91 562 04 20 (indicating the medication and the amount administered). You may need medical attention.

Some people who have accidentally taken too much rivastigmine have experienced nausea (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. A slowing of the heart rate and fainting may also occur.

If You Forget to Use Rivastigmine Sandoz

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 Interrupt Treatment with Rivastigmine Sandoz

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 disappear slowly 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.
• Feeling of agitation or numbness.
• Urinary incontinence (inability to retain 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 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.
• Tremors 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 symptoms, such as tremors, stiffness, and difficulty moving.
• Pisa syndrome (a condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side).
• Pancreatitis. The signs include pain in the upper part of the stomach, often accompanied by a feeling of dizziness (nausea) or feeling sick (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.

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

Other Adverse 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.
• Lack of appetite.
• Feeling of agitation.
• Feeling of general discomfort.
• Tremors 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)

• 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. The signs include severe pain in the upper part of the stomach, often with a feeling of dizziness (nausea) or feeling sick (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 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. Storage of Rivastigmine Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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.

Keep 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 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 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 collection point at 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.

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 container.

6. Package Contents and Additional Information

Composition of Rivastigmine Sandoz 13.3 mg/24 h Transdermal Patches

• The active ingredient is rivastigmine. Each patch releases 13.3 mg of rivastigmine in 24 hours, measures 15 cm2, and contains 27 mg of rivastigmine.
• The other components are:

• backing film: lacquered poly(ethylene terephthalate),
• medicinal reservoir: all-rac-alpha-tocopherol, poly(butyl methacrylate, methyl methacrylate) copolymer (3:1), acrylic copolymer,
• adhesive matrix: all-rac-alpha-tocopherol, silicone, dimethicone 12,500 cSt,
• release liner: fluorocoated polyester film,
• printing ink: resin, pigments, organic polymers/resins.

Appearance of the Product and Package Contents

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

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

Each sealed envelope contains one transdermal patch. The patches are available in packs of 7 or 30 envelopes and multi-packs of 60 (2 packs of 30) or 90 (3 packs of 30) envelopes.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 Member States of the European Economic Area under the following names:

Austria: Rivastigmin Sandoz 13,3 mg/24 Stunden - transdermales 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 transdermales Pflaster

Denmark: Rigmin

Spain: Rivastigmina Sandoz 13,3 mg/24 h parches transdérmicos 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: Rivastigmine Sandoz 13,3 mg/24 uur, pleisters voor transdermaal gebruik

Norway: Rigmin

Poland: Rivastigmine Sandoz

Portugal: Rivastigmine Sandoz

Romania: Rivastigmina Sandoz 13,3 mg/24 ore plaste transdermic

Sweden: Rigmin

Slovenia: Rivastigmin Sandoz 13,3 mg/24 h transdermalni obliž

Slovakia: Rivastigmin Sandoz 13,3 mg/24 h transdermálna náplast

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/