Rivastigmine Aurovitas Spain 13.3 mg/24 h transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivastigmina Aurovitas Spain 13.3 mg/24 h transdermal patches EFG

Read the 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, pharmacist or nurse.
• 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, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Rivastigmina Aurovitas Spain is and what it is used for

The active substance in Rivastigmina Aurovitas Spain is rivastigmine.

Rivastigmine belongs to a group of substances known as 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 enables nerve cells to communicate with each other). Rivastigmine works by inhibiting the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, rivastigmine increases acetylcholine levels in the brain, helping to reduce the symptoms of Alzheimer's disease.

Rivastigmine 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 Aurovitas Spain

Do not use Rivastigmina Aurovitas Spain:

• if you are allergic to rivastigmine (the active substance in this medicine) 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 rivastigmine transdermal patches.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use this medicine:

• if you have or have ever had heart conditions such as irregular or slow heartbeat, QTc interval prolongation, family history of QTc prolongation, torsades de pointes, or if you have low blood levels of potassium or magnesium.
• 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 experience gastrointestinal reactions such as nausea, vomiting, and diarrhea. You may become dehydrated (loss of large amounts of fluid) 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 closer monitoring 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

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

Use of Rivastigmina Aurovitas Spain with other medicines

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

Rivastigmine 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).

Rivastigmine patches 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 rivastigmine transdermal patches, inform your doctor that you are using them, as they may excessively enhance the effects of certain muscle relaxants used during anesthesia.

Caution is required when using rivastigmine patches 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.

Caution is also required when using rivastigmine patches together with other medicines that may affect your heart rhythm or the electrical system of your heart (QT interval prolongation).

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 adverse effects on the fetus. This medicine must not be used during pregnancy unless clearly necessary.

Breastfeeding must not be performed during treatment with rivastigmine transdermal patches.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Rivastigmine transdermal patches may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive, operate machinery, or perform any other tasks requiring your full attention.

3. How to use Rivastigmina Aurovitas Spain

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

IMPORTANT:

• Remove the previous patch before applying a new one.
• 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 determine the most appropriate dose of rivastigmine for your individual case.

• Treatment is usually 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, your treating doctor may consider increasing the dose to 13.3 mg/24 h.
• Wear only one rivastigmine patch at a time and replace the patch with a new one every 24 hours.

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

Rivastigmine may be used with food, drink, and alcohol.

Where to apply your rivastigmine transdermal patch

• Before applying a patch, ensure the skin is clean, dry, and hair-free, without powders, oils, moisturizers, or lotions that may prevent the patch from adhering properly, and without cuts, redness, or irritation.
• Carefully remove any existing patch before applying a new one. Wearing multiple patches on your body could expose you to an excessive amount of this medicine, which could be potentially dangerous.
• Apply one patch per day to one of the following areas shown in the diagrams below:
  • upper left or upper right arm.
  • upper left or upper right side of the chest (avoiding breasts in women).
  • upper left or upper right side of the back.
  • lower left or lower right side of the back.

Each time the patch is changed, the previous day's patch must be removed before applying the new patch to 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 area of skin again.

How to apply your rivastigmine transdermal patch

Rivastigmina Aurovitas Spain patches are thin, brownish-colored plastic patches that adhere to the skin. Each patch is contained in a protective pouch until ready to be used. Do not open the pouch or remove the patch until the moment of application.

You must wear the patch continuously until it is time to replace it with a new one. When applying a new patch, you may try different areas to find those that are most comfortable for you and where clothing does not rub against the patch.

How to remove your rivastigmine transdermal 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 thoroughly with soap and water. If contact with the eyes occurs or if the eyes become red after handling the patch, immediately rinse with plenty of water and seek medical advice if symptoms do not resolve.

Can you wear your rivastigmine transdermal patch when bathing, swimming, or being exposed to sunlight?

• Bathing, swimming, or showering should not affect the patch. Make sure not to lose the patch 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 for the remainder of that day and change it at your usual time the following day.

When and for how long you should apply your rivastigmine transdermal patch

• To benefit from treatment, you must apply a new patch every day, preferably at the same time each day.
• Wear only one rivastigmine patch at a time and replace the patch with a new one every 24 hours.

If you use more Rivastigmina Aurovitas Spain than you should

If you have accidentally applied 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 feeling unwell (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. A slowed heart rate and fainting may also occur.

If you forget to use Rivastigmina Aurovitas Spain

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 Aurovitas Spain

Inform your doctor or pharmacist if you discontinue 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 you first start treatment or when your dose is increased. Generally, adverse effects will gradually disappear as your body becomes accustomed to the medicine.

If you notice any of the following adverse effects, which may be serious, remove the patch immediately and inform your doctor without delay.

Frequent (may affect up to 1 in 10 people)

• Loss of appetite
• Dizziness
• Feeling of restlessness
• Urinary incontinence (inability to properly retain urine)
• Urinary tract infection
• Anxiety
• Depression
• Confusion
• Headache
• Fainting
• Stomach problems such as nausea, vomiting, diarrhea
• Heartburn
• Stomach pain
• Rash
• Allergic reaction at the site of patch application, such as blisters or skin swelling
• Feeling of tiredness or weakness
• Weight loss
• Fever

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm problems, such as slow heart rate
• Stomach ulcer
• Dehydration (loss of large amounts of fluid)
• 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 or legs and hand tremors

Frequency not known (cannot be estimated from available data)

• Worsening of signs of Parkinson's disease – such as tremor, rigidity, and difficulty moving
• Inflammation of the pancreas – signs 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 liver function tests
• Feeling of restlessness
• Nightmares
• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)
• Seeing things that are not there (hallucinations)
• Tremor
• Drowsiness
• Skin rash, itching
• Redness of the skin
• Blisters

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

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

Frequent (may affect up to 1 in 10 people)

• Excessive saliva
• Feeling of restlessness
• General feeling of being unwell
• Tremor
• 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 – signs include severe pain in the upper abdomen, often with nausea or vomiting
• Gastrointestinal bleeding – manifested as blood in stools or in vomit
• Seeing things that are not there (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 adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmina Aurovitas Spain

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

Do not use this medicine after the expiry date which is stated on the carton and on the sachet after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Keep the transdermal patch inside its sachet 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 together. When disposing of the used patch, place it back into its original sachet and ensure it is kept out of the reach of children. After removing the patch, avoid touching the eyes and wash your hands thoroughly with water and soap.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmina Aurovitas Spain

• The active substance is rivastigmine.

Rivastigmina Aurovitas Spain 13.3 mg/24 h transdermal patch EFG: Each patch releases 13.3 mg of rivastigmine over 24 hours, measures 12.8 cm² and contains 19.2 mg of rivastigmine.

• The other components are: poly[(2-ethylhexyl) acrylate, vinyl acetate], medium and high molecular weight polyisobutene, anhydrous colloidal silica, light liquid paraffin, polyethylene/thermoplastic resin/polyester laminate with aluminium backing, fluoropolymer-coated polyester film, orange printing ink.

Presentation of the product and contents of the pack

Thin transdermal patch of matrix type, composed of three layers. The outer layer is brownish in colour and marked with “RIV-TDS 13.3 mg/24 h” in orange ink.

Each sachet contains one transdermal patch.

Rivastigmina Aurovitas Spain 13.3 mg/24 h transdermal patches EFG is available in packs of 5 or 30 sachets and in multipacks containing 60 sachets (2 packs of 30).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

Luye Pharma AG

Am Windfeld 35

83714 Miesbach, Bavaria

Germany

This medicinal product is authorised in the European Economic Area member states under the following names:

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

Portugal: Rivastigmina Generis Phar 13.3mg/24h Transdermal patch

Date of the most recent review of this leaflet: December 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/).