Rivastigmine Aurovitas Spain 4.6 mg/24 h transdermal patches EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivastigmina Aurovitas Spain 4.6 mg/24 hours 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, 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects 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 adverse 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 blocking 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 there is 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 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 disease such as irregular or slow heartbeat, QTc interval prolongation, family history of QTc interval prolongation, torsades de pointes, or if you have low levels of potassium or magnesium in your blood.
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulties urinating.
• if you have or have ever had seizures.
• if you have or have ever had asthma or a severe respiratory disease.
• if you experience tremors.
• if you have low body weight.
• if you have gastrointestinal reactions such as nausea, vomiting, and diarrhea. You could become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea are prolonged.
• if you have liver problems (hepatic insufficiency).

If you are in any of these situations, 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

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

Use of Rivastigmina Aurovitas Spain with other medicines

Inform 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 this medicine, as it may excessively enhance the effects of certain muscle relaxants used during anesthesia.

Caution is advised 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 decreased heart rate (bradycardia), which could lead to fainting or loss of consciousness.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might 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. This medicine should not be used during pregnancy unless clearly necessary.

You must not breastfeed while being treated 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 attention.

3. How to use Rivastigmina Aurovitas Spain

Follow exactly the instructions for administering this medicine as 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 patch.
• Use 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 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 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 interruption does not exceed 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 could interfere with proper adhesion of the patch, 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 chest (avoiding breasts in women).
  • upper left or upper right back.
  • lower left or lower right back.

Each time you change the patch, remove the previous day's patch before applying a new patch to a different skin site (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 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 for use. 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, 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 derivatestinigmine 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 the patch comes into contact with your eyes, or if your eyes become red after handling the patch, immediately rinse them thoroughly with water and seek medical advice if symptoms do not resolve.

Can you wear your derivatestinigmine 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 next day.

When and for how long should you apply your derivatestinigmine transdermal patch?

• To benefit from treatment, 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 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 amount administered. You may require medical attention.

Some people who have accidentally taken excessive amounts of rivastigmine have experienced discomfort (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. Slowing of 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 you remember. 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 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 produce 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 becomes accustomed 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 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 tremor.

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, frequently 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 of restlessness.
• Nightmares.
• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal leaning 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 and contact your doctor immediately.

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 discomfort.
• 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 – likely 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 had severe vomiting have experienced 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, consult 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 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 ready to 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. When disposing of the used patch, place it back into its original sachet and ensure it is kept out of children's reach. After removing the patch, avoid touching your 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 any discarded packaging to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmina Aurovitas Spain

• The active substance is rivastigmine.

Rivastigmina Aurovitas Spain 4.6 mg/24 h transdermal patch EFG: Each patch releases 4.6 mg of rivastigmine over 24 hours, measures 4.6 cm² and contains 6.9 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 aluminum-coated backing layer, fluoropolymer-coated polyester film, orange printing ink.

Appearance of the product and contents of the pack

A thin, matrix-type transdermal patch composed of three layers. The outer layer is brownish in color and printed with “RIV-TDS 4.6 mg/24 h” in orange ink.

Each sachet contains one transdermal patch.

Rivastigmina Aurovitas Spain 4.6 mg/24 h transdermal patches EFG is available in packs containing 7 or 30 sachets, and in multipacks containing 60 sachets (2 packs of 30).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 authorized in the European Economic Area member states under the following names:

Spain: Rivastigmina Aurovitas Spain 4.6 mg/24 h transdermal patches EFG

Portugal: Rivastigmina Generis 4.6 mg/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 Medical Devices (AEMPS) (http://www.aemps.gob.es/).