Rivastigmine Sandoz 13.3 mg/24 h transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rivastigmine Sandoz 13.3 mg/24 h transdermal patches EFG

Read the entire leaflet carefully before you start using this medicine, as 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 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 ability, and behaviour.

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 any of these situations apply to you, 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 suffer from 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 any of these situations apply to you, your doctor may consider it necessary to monitor you more closely during 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.

Using Rivastigmina Sandoz with other medicines

Tell 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.

Caution is required 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 decrease in heart rate (bradycardia), which 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 this medicine, as it may excessively enhance the effects of certain muscle relaxants used during anesthesia.

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 should be weighed against the potential adverse effects on 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.

Rivastigmine may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive, use machines, or perform any tasks requiring alertness.

3. How to use Rivastigmina Sandoz

Follow exactly the instructions for use of 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 firmly on the patch against 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 Rivastigmina 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 Rivastigmina 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 forms are available.

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

If you have not used the patches for more than three days, do not apply a new one without first consulting your doctor. Transdermal patch treatment may be restarted at the same dose if the treatment has not been interrupted for more than three days. Otherwise, your doctor will instruct you to restart treatment with the rivastigmine 4.6 mg/24 h transdermal patch.

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

Where to apply your Rivastigmina Sandoz patch

• Before applying a patch, ensure that the skin is clean, dry, and hair-free, without powders, oils, moisturizers, or lotions that could 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 possible sites, as shown in the diagrams below:
• 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 the patch, remove the previous day's patch before applying a new one, 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 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 that are most comfortable for you and where clothing will not rub against the patch.

How to remove your Rivastigmina Sandoz patch

Gently pull one edge 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 you get the medicine 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 symptoms do not resolve.

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 sources of heat (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 complete that day’s treatment and replace 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 it 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 too much rivastigmine have experienced discomfort (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. A slowed 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 as soon as possible. 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 stop using 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 immediately and contact your doctor without delay:

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Dizziness
• Feeling agitated or drowsy
• Urinary incontinence (inability to properly control urination)

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heartbeat
• Seeing things that are not really there (hallucinations)
• Stomach ulcer
• Dehydration (loss of large amounts of body 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 in movement
• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)
• Pancreatitis (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, unexplained nausea, vomiting, fatigue, and loss of appetite)
• Changes in liver function tests
• Restlessness
• Nightmares

If you notice any of the adverse effects listed above, remove the patch immediately and inform your doctor without delay.

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

Common (may affect up to 1 in 10 people)

• Excessive salivation
• Loss of appetite
• Feeling agitated
• 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 of the heart

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

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

Reporting of adverse effects

If you experience any adverse effect, consult 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 Rivastigmine Sandoz

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 its pouch until the time 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 back into the original pouch, dispose of the patch safely, ensuring it remains out of the reach of children. After removing the patch, avoid touching the eyes and wash your hands thoroughly with water and soap.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

If your household waste is incinerated, you may dispose of the used patch in your household waste. Otherwise, take the used patches to the pharmacy, preferably in their original packaging.

6. Contents of the pack and other information

Composition of Rivastigmina Sandoz 13.3 mg/24 h transdermal patches

• The active substance is rivastigmine. Each patch releases 13.3 mg of rivastigmine over 24 hours, measures 15 cm², and contains 27 mg of rivastigmine.

• The other components are:

• Backing film: coated poly(ethylene terephthalate),

• Drug 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: coated fluoropolyester film,

• Printing ink: resins, pigments, organic polymers/resins.

Appearance of the product and contents of the pack

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

Drug delivery system circular in shape, 15 cm², with a beige surface film, a two-layer adhesive matrix, and a superimposed rectangular porous covering layer. The outer layer is printed with «RIV 13.3 mg/24 h».

Each sealed pouch contains one transdermal patch. The patches are available in packs of 7 or 30 pouches and multipacks of 60 (2 packs of 30) or 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 Via de les Corts Catalanes, 764
08013 Barcelona
Spain

This medicinal product 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/24 Stunden transdermales 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: 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 plâsturi transdermice
Sweden: Rigmin
Slovenia: Rivastigmin Sandoz 13.3 mg/24 h transdermalni obliž
Slovakia: Rivastigmin Sandoz 13.3 mg/24 h transdermálna náplasť

Date of most recent revision of this leaflet: March 2025

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