Rivastigmine Aurovitas Spain 9.5 mg/24 h transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivastigmine Aurovitas Spain 9.5 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 must not give it to others, 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 Rivastigmine Aurovitas Spain is and what it is used for
2. What you need to know before using Rivastigmine Aurovitas Spain
3. How to use Rivastigmine Aurovitas Spain
4. Possible adverse effects
5. How to store Rivastigmine 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 behaviour.

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 interval prolongation, torsades de pointes, or low levels of potassium or magnesium in your blood.
• if you have or have ever had active stomach ulcers.
• 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 serious respiratory disease.
• if you experience 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 are 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 patch 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 decrease in heart rate (bradycardia), which may 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 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 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 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 ONE new patch.
• 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, make sure the skin is clean, dry, and hair-free, without 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 could expose you to an excessive amount of this medicine, which could be potentially dangerous.
• Apply ONE patch per day to ONE SINGLE area shown in the following diagrams:
  • 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.

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 skin area again.

How to apply your rivastigmine transdermal patch

Rivastigmine 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 it is time to apply it.

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 derivate 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 (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 derivate rivastigmine transdermal patch while 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 derivate 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 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 telephone number 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 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 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 may cause adverse effects, although not everyone experiences them.

You may experience adverse effects more frequently when starting treatment or when your dose is increased. Generally, adverse effects 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
• Restlessness
• Urinary incontinence (inability to properly retain urine)
• Urinary tract infection
• Anxiety
• Depression
• Confusion
• Headache
• Fainting
• Stomach problems such as nausea, vomiting, diarrhoea
• Heartburn
• Stomach pain
• Rash
• Allergic skin reaction at the application site, such as blisters or skin swelling
• Feeling tired or weak
• 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)
• Aggression

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 Parkinson's disease symptoms – such as tremor, stiffness, and difficulty moving
• Inflammation of the pancreas – symptoms include pain in the upper abdomen, often accompanied by nausea or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Seizures (epileptic fits)
• 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
• 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 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
• 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)

• Seizures (epileptic fits)
• 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 – symptoms include severe pain in the upper abdomen, often with nausea or vomiting
• Gastrointestinal bleeding – seen as blood in the stool 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 (oesophagus)

Reporting of adverse effects

If you experience any 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmine 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 the 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 firmly. When disposing of the used patch, place it back into the 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 soap and water.

Medicines must not be disposed of via wastewater or household waste. Take empty containers and unused medicines to 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 9.5 mg/24 h transdermal patch EFG: Each patch releases 9.5 mg of rivastigmine over 24 hours, has a surface area of 9.2 cm² and contains 13.8 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 laminate, fluoropolymer-coated polyester film, orange printing ink.

Appearance of the medicinal 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 9.5 mg/24 h” in orange ink.

Each sachet contains one transdermal patch.

Rivastigmina Aurovitas Spain 9.5 mg/24 h transdermal patches EFG is available in packs containing 30 sachets and in multi-packs 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 9.5 mg/24 h transdermal patches EFG

Portugal: Rivastigmina Generis 9.5 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 for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).