Rivastigmine Sandoz 9.5 mg/24 h transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rivastigmine Sandoz 9.5 mg/24 h transdermal patches EFG

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Rivastigmina Sandoz is and what it is used for

The active substance in Rivastigmina Sandoz is rivastigmine.

Rivastigmine belongs to a group of medicines called cholinesterase inhibitors. In patients with Alzheimer's dementia, certain nerve cells in the brain die, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, rivastigmine helps increase the levels of acetylcholine in the brain, thereby helping to reduce the symptoms of Alzheimer's disease.

Rivastigmina Sandoz is used to treat adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual capacity, and behavior.

2. What you need to know before using Rivastigmina Sandoz

Do not use Rivastigmina Sandoz

• if you are allergic to rivastigmine (the active substance in Rivastigmina Sandoz) 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 develop a skin reaction that spreads beyond the size of the patch, if you experience a more intense local reaction (such as blisters, increasing skin inflammation, swelling), or 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 Rivastigmina Sandoz transdermal patches.

Warnings and precautions

Talk to your doctor before starting to use Rivastigmina 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 serious respiratory disease,
• if you have tremors,
• if you have low body weight,
• if you have gastrointestinal reactions such as nausea, vomiting, and diarrhea. You may become dehydrated (loss of large amounts of fluids) if vomiting or diarrhea is prolonged,
• if you have liver problems (hepatic insufficiency).

If you are in any of these situations, your doctor may consider closer monitoring while you are on treatment.

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

Children and adolescents

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

Use of Rivastigmina Sandoz with other medicines

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

Rivastigmina Sandoz may interfere with anticholinergic medicines, some of which are 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).

Rivastigmina Sandoz must not be administered at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines 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 this medicine, as it may excessively enhance the effects of certain muscle relaxants used during anesthesia.

Caution is advised when using Rivastigmina Sandoz together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking both medicines together may cause complications such as a decreased heart rate (bradycardia), which may lead to fainting or loss of consciousness.

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, the benefits of using rivastigmine must be weighed against the potential risks to the fetus. Rivastigmine must not be used during pregnancy unless clearly necessary.

You must not breastfeed during treatment with Rivastigmina Sandoz transdermal patches.

Driving and using machines

Your doctor will advise you whether 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 any other tasks requiring attention.

3. How to use Rivastigmina Sandoz

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

IMPORTANT:

• Remove the previous patch before applying a NEW patch.
• Apply only ONE patch per day.
• Do not cut the patch into pieces.
• Press the patch firmly onto the skin with the palm of your hand for at least 30 seconds.

How to start treatment

Your doctor will determine the most appropriate dose of Rivastigmine Sandoz for your individual case.

• Treatment is usually started with rivastigmine 4.6 mg/24 h*.

• The usual recommended daily dose is rivastigmine 9.5 mg/24 h*. If this dose is well tolerated, your treating doctor 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 every 24 hours.

• When a dose not achievable with this medicine is required, other dosage strengths are available.

During treatment, your doctor may adjust the dose according to your individual needs.

If you have not used the patches for three days, do not apply a new one without first consulting your doctor. Treatment with transdermal patches may be restarted at the same dose if the treatment interruption does not exceed three days. Otherwise, your doctor will instruct you to restart treatment with the Rivastigmine 4.6 mg/24 h transdermal patch.

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

Where to apply your Rivastigmine Sandoz patch

• Before applying a patch, ensure the skin is clean, dry, and free of hair, as well as free of powders, oils, moisturizers, or lotions that may prevent the patch from adhering properly to the skin, and without cuts, redness, or irritation.
• Carefully remove any existing patch before applying a new one. Wearing multiple patches on your body may expose you to an excessive amount of this medicine, which could be potentially dangerous.
• Apply only ONE patch per day to ONE of the following areas, as shown in the diagrams below:
• 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.

When changing the patch, remove the previous day's patch before applying a new patch, each time placing it on a different area of skin (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 before applying a new patch to exactly the same skin area again.

How to apply your Rivastigmina Sandoz patch

Rivastigmina Sandoz patches are thin, opaque plastic patches that adhere to the skin. Each patch is contained in a protective pouch until ready for use. Do not open the pouch or remove the patch until it is time to apply it.

If this helps you, you may write on the patch, for example the day of the week, using a fine-tipped rounded pen.

You must wear the patch continuously until it is time to replace it with a new one. When applying a new patch, try different areas to find those most comfortable for you 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 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 solvent liquids (such as nail polish remover or other solvents).

After removing the patch, wash your hands with water and soap. If contact with the eyes occurs or if the eyes become red after handling the patch, immediately rinse thoroughly with plenty of water and seek medical advice if symptoms persist.

Can you wear your Rivastigmina Sandoz patch while bathing, swimming, or in sunlight?

• Bathing, swimming, or showering should not affect the patch. Make sure it does not partially detach during these activities.
• Do not expose the patch to external heat sources (e.g., excessive sunlight, sauna, sunbed) for prolonged periods.

What to do if your patch falls off

If your patch falls off, apply a new one to cover the remainder of that day and change it at your usual time the next day.

When and for how long to apply your Rivastigmina Sandoz patch

• To benefit from your treatment, you must apply a new patch every day, preferably at the same time each day.
• 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 apply more than one patch, remove all patches from the skin and inform your doctor or pharmacist, or call the Toxicology Information Service at 91 562 04 20 (indicating the medication and the amount administered). You may require medical attention.

Some people who have accidentally taken excessive amounts of rivastigmine have experienced discomfort (nausea), vomiting, diarrhoea, high blood pressure, and hallucinations. A slowing of heart rate and fainting may also occur.

If you forget to use Rivastigmina Sandoz

If you realize you have forgotten to apply a patch, do so immediately. The next day, apply the following patch at your usual time. Do not apply two patches to make up for the missed one.

If you stop using Rivastigmina Sandoz

Inform your doctor or pharmacist if you discontinue use of the patches.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You may experience adverse effects more frequently when starting treatment or when your dose is increased. Generally, adverse effects will gradually disappear as your body gets used to the medicine.

If you notice any of the following adverse effects, which may be serious, remove the patch and contact your doctor immediately:

Frequent (may affect up to 1 in 10 people)

• Loss of appetite.
• Dizziness.
• Feeling restless or drowsy.
• Urinary incontinence (inability to properly retain urine).

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heart rate.
• Seeing things that are not really there (hallucinations).
• Stomach ulcer.
• Dehydration (loss of large amounts 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 arms and legs.
• Hand tremors.

Not known (cannot be estimated from available data)

• Allergic reaction at the site of patch application, such as blisters or skin inflammation.
• Worsening of signs of Parkinson's disease, such as tremor, stiffness, and difficulty moving.
• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side).
• Inflammation of the pancreas. Symptoms include pain in the upper abdomen, often accompanied by nausea or vomiting.
• Fast or irregular heartbeat.
• High blood pressure.
• Epileptic seizures (convulsions).
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, tiredness, and loss of appetite).
• Changes in blood tests indicating liver function abnormalities.
• Feeling restless.
• Nightmares.

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

Other adverse effects experienced with rivastigmine capsules or oral solution, which may also occur with the patches:

Frequent (may affect up to 1 in 10 people)

• Excessive saliva.
• Loss of appetite.
• Feeling restless.
• General feeling of being unwell.
• Tremor or confusion.
• Increased sweating.

Uncommon (may affect up to 1 in 100 people)

• Irregular heartbeat (e.g. fast heartbeat).
• Difficulty sleeping.
• Accidental falls.

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

• Epileptic seizures (convulsions).
• Intestinal ulcer.
• Chest pain, probably caused by spasm in the heart.

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

• High blood pressure.
• Inflammation of the pancreas. Symptoms include severe upper abdominal pain, often with nausea or vomiting.
• Gastrointestinal bleeding, manifested as blood in the stool or vomit.
• Seeing things that are not real (hallucinations).
• Some people who have experienced severe vomiting have developed a tear in part of the digestive tract connecting the mouth to the stomach (esophagus).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmina Sandoz

Keep the transdermal patch in the original package to protect from light and moisture. Store at temperatures not exceeding 30°C. Do not refrigerate or freeze. Keep out of reach and sight of children. Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of that month. After removal from the original packaging, the transdermal patch should be used immediately. Discard any unused patches properly according to local regulations.

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

Do not use this medicine after the expiry date stated on the pouch and on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep the transdermal patch inside the pouch until the moment of use.

Do not use any patch if it appears damaged or shows signs of tampering.

After removing a patch, fold it in half with the adhesive side inwards and press firmly.

After placing it in the original pouch, ensure the used patch is kept out of children's reach. After removing the patch, avoid touching the eyes and wash your hands thoroughly with water and soap. If household waste is disposed of by incineration, the patch may be discarded in household waste. Otherwise, return used patches to a pharmacy, preferably in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmine Sandoz 9.5 mg/24 h Transdermal Patches

• The active substance is rivastigmine. Each patch releases 9.5 mg of rivastigmine over 24 hours, measures 10 cm², and contains 18 mg of rivastigmine.
• The other components are lacquered poly(ethylene terephthalate) film, all rac-alpha-tocopherol, poly(butyl methacrylate, methyl methacrylate), acrylic copolymer, silicone, dimethicone, fluoropolymer-coated polyester film, resin, pigments, organic polymers/resins.

Appearance of the product and contents of the pack

The patches are thin, matrix-type transdermal patches composed of three layers. The outer layer is beige in colour and marked with «RIV» and «9.5 mg/24 h».

Each sealed pouch contains one transdermal patch. The patches are available in packs of 7, 30, 60 (2 packs of 30), 90 (3 packs of 30) pouches.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Hexal AG
Industriestrasse 25
83607 Holzkirchen
Germany

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
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 medicinal product is authorized in the European Economic Area (EEA) member states under 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 parches transdérmicos 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 plăsturi transdermice
Slovakia: Rivastigmin Sandoz 9,5 mg/24 h transdermálna náplasť
Slovenia: Rivastigmin Sandoz 9,5 mg/24 h transdermalni obliž
Sweden: Rivastigmine Sandoz
United Kingdom: Rivastigmine Sandoz 9.5 mg/24 hours Transdermal System

Date of the most recent review of this leaflet: March 2025

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