Prospect: information for the user

Rivastigmina Aurovitas Spain 4,6 mg/24 h transdermal patches EFG

Read this prospect carefully before starting to use this medication, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only to you, 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, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to use Rivastigmina Aurovitas Spain

3.How to use Rivastigmina Aurovitas Spain

4.Possible adverse effects

5.Storage of Rivastigmina Aurovitas Spain

6.Contents of the package and additional information

The active ingredient of Rivastigmina AurovitasSpainis rivastigmina.

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

Rivastigminais used for the treatment of adult patients with mild to moderately severe Alzheimer's disease, a progressive brain disorder that gradually affects memory, intellectual capacity, and behavior.

No useRivastigmina Aurovitas Spain

-If you are allergic to rivastigmina (the active ingredient in this medication) or to any of the other components of this medication (listed in section 6).

-If you have ever had an allergic reaction to a similar medication (carbamate derivatives).

-If you have a skin reaction that extends beyond the size of the patch, if there is a more intense local reaction (such as blisters, increased skin inflammation, swelling) and if there is no improvement within 48 hours after removing the transdermal patch.

If you find yourself in any of these situations, inform your doctor and do not use the transdermal patches ofrivastigmina.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

-If you have or have had any heart disease such as irregular or slow heart rhythm, prolonged QTc interval, family history of prolonged QTc interval, torsades de pointes, or low potassium or magnesium levels in the blood.

-If you have or have had any active stomach ulcer.

-If you have or have had any difficulty urinating.

-If you have or have had any seizures.

-If you have or have had any severe respiratory disease.

-If you suffer from tremors.

-If you have a low body weight.

-If you have gastrointestinal reactions such as nausea, vomiting, and diarrhea. You may become dehydrated (loss of a large amount of fluid) if the vomiting or diarrhea is prolonged.

-If you have liver problems (hepatic insufficiency).

If you find yourself in any of these situations, your doctor may consider the need for closer monitoring while you are on treatment.

If you have not used the patches for more than three days, do not put another one on without consulting your doctor.

Children and adolescents

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

Use ofRivastigmina Aurovitas Spainwith other medications

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

Rivastigmina may interfere with anticholinergic medications, some of which are used to relieve muscle cramps or stomach spasms (e.g., diciclomina), for the treatment of Parkinson's disease (e.g., amantadina), or to prevent motion sickness (e.g., difenhidramina, escopolamina, or meclizina).

The rivastigmina patches should not be administered at the same time as metoclopramida (a medication used to relieve or prevent nausea and vomiting). Taking the two medications together may cause problems such as stiffness in the limbs and hand tremors.

If you need to undergo surgery while using the rivastigmina transdermal patches, inform your doctor that you are using them, as they may excessively potentiate the effects of some anesthetic muscle relaxants.

Care should be taken when using rivastigmina patches with beta-blockers (medications such as atenolol used to treat hypertension, angina, and other cardiac conditions). Taking the two medications together may cause complications such as bradycardia (slow heart rate) that may lead to dizziness or loss of consciousness.

Care should be taken while using rivastigmina patches with other medications that may affect your heart rate or the electrical system of your heart (prolonged QT interval).

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, it is necessary to evaluate the benefits of using rivastigmina against the possible adverse effects on the fetus. This medication should not be used during pregnancy, unless it is clearly necessary.

You should not breastfeed during treatment with rivastigmina transdermal patches.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machinery safely. Rivastigmina transdermal patches may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive, use machinery, or perform other tasks that require your attention.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse again.

IMPORTANT:

•Remove the previous patch before putting on a new patch.

•Only one patch per day.

•Do not cut the patch into pieces.

•Press firmly the patch against the skin with the palm of your hand for at least 30 seconds.

How to start treatment

Your doctor will indicate the most suitable dose of rivastigmine for your case.

•Normally, treatment starts 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 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.

Your doctor may adjust the dose during treatment depending on your individual needs.

If you have not used the patches for more than three days, do not put on another patch before consulting your doctor. Treatment with a transdermal patch can be restarted at the same dose if treatment is not interrupted for more than three days. Otherwise, your doctor will have you restart treatment with rivastigmine 4.6 mg/24 h.

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

Where to place your rivastigmine transdermal patch

•Before putting on a patch, make sure the skin is clean, dry, and free of hair, powders, oils, moisturizers, or lotions that may prevent the patch from sticking well to the skin, without cuts, redness, or irritation.

•Remove any existing patch carefully before putting on a new one.This may expose you to an excessive amount of this medication, which could be potentially hazardous.

•Put onONEpatch per day inONESINGLEof the possible areas shown in the following diagrams:

-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 patch before putting on the new patch in a different area of the 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 to put a new patch in the same area of the skin again.

Howto place your rivastigmine transdermal patch

Rivastigmina Aurovitas Spain patches are thin, brown plastic patches that stick to the skin. Each patch is in a protective envelope that keeps it safe until you put it on. Do not open the envelope or remove the patch until you are ready to put it on.

You should wear the patch continuously until you change it for a new one. When you put on a new patch, you can try different areas to find the ones that are most comfortable and where your clothes do not rub against the patch.

How to remove your rivastigmine transdermal patch

Gently pull one of the edges of the patch to remove it slowly from the skin. If there are any remaining adhesive residues 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 solvents (nail polish remover or other solvents).

After removing the patch, wash your hands with soap and water. If you come into contact with your eyes or if your eyes become red after handling the patch, wash immediately with plenty of water and seek medical advice if the symptoms do not resolve.

Can you wear your rivastigmine transdermal patch when bathing, swimming, or exposing yourself to the sun?

•Bathing, swimming, or showering should not affect the patch. Make sure you do not lose the patch during these activities.

•Do not expose the patch to an external heat source (e.g. excessive sunlight, sauna, tanning bed) for long periods of time.

What to do if a patch falls off

If a patch falls off, put on a new one for the rest of the day and change it the next day at the usual time.

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

•To benefit from treatment, you should put on a new patch every day, preferably at the same time.

•Wear only one rivastigmine patch at a time and replace the patch with a new one every 24 hours.

If you use moreRivastigmina Aurovitas Spainthan you should

If you accidentally put on more than one patch, remove all the patches from the skin and inform your doctor or pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. You may need medical attention.

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

If you forgot to useRivastigmina Aurovitas Spain

If you realize you have forgotten to put on a patch, put it on immediately. The next day, put on the next patch at the usual time. Do not put on two patches to compensate for the one you forgot.

If you interrupt treatment withRivastigmina Aurovitas Spain

Inform your doctor or pharmacist if you stop using the patches.

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

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

You may experience side effects more frequently when you first start treatment or when your dose is increased. Side effects usually disappear gradually as your body gets used to the medicine.

If you notice any of the following side effects, which can be serious, remove the patch and immediately inform your doctor.

Frequent(may affect up to 1 in 10 people)

•Loss of appetite.

•Sensation of dizziness.

•Sensation of agitation or numbness.

•Urinary incontinence (inability to retain urine properly).

Poorly frequent(may affect up to 1 in 100 people)

•Problems with your heart rhythm, such as slow heart rate.

•Seeing things that do not exist (hallucinations).

•Stomach ulcer.

•Dehydration (loss of a large amount 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)

•Rigidity of the arms and legs.

•Trembling in the hands.

Frequency not known(cannot be estimated from available data)

•Allergic reaction where the patch was applied, such as blisters or skin inflammation.

•Worsening of Parkinson's disease symptoms – such as tremor, rigidity, and difficulty moving.

•Pancreatitis – symptoms include upper stomach pain, often accompanied by nausea or vomiting.

•Irregular heart rhythm or rapid heart rate.

•High blood pressure.

•Seizures (convulsions).

•Liver disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine, or unexplained nausea, vomiting, fatigue, and loss of appetite).

•Changes in liver function tests.

•Sensation of restlessness.

•Nightmares.

If you notice any of the above side effects, remove the patch and immediately inform your doctor.

Other side effects observed with capsules or oral solution of rivastigmine and that may occur with patches:

Frequent(may affect up to 1 in 10 people)

•Excessive salivation.

•Loss of appetite.

•Sensation of agitation.

•Sensation of general discomfort.

•Trembling or sensation of confusion.

•Increased sweating.

Poorly frequent(may affect up to 1 in 100 people)

•Irregular heart rhythm (e.g. rapid heart rate).

•Difficulty sleeping.

•Accidental falls.

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

•Seizures (convulsions).

•Ulcer in the intestine.

•Chest pain – probably caused by heart spasms.

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

•High blood pressure.

•Pancreatitis – symptoms include severe upper stomach pain, often with nausea or vomiting.

•Gastrointestinal bleeding – manifested as blood in the stool or vomiting blood.

•Seeing things that do not exist (hallucinations).

•Some people who have had intense vomiting have had a tear in the tube that connects the mouth to the stomach (esophagus).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the overwrap after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Keep the transdermal patch inside the overwrap until use.

Do not use any patch if you observe that it is damaged or shows signs of manipulation.

After removing a patch, fold it in half with the adhesive side inward and press. After placing it in the original overwrap, when disposing of the patch, ensure it remains out of the reach of children. After removing the patch, do not touch your eyes, and wash your hands thoroughly with water and soap. If your household waste is disposed of by incineration, you may dispose of the patch in your household waste. If not, take used patches to the pharmacy, preferably in the original packaging.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. In this way, you will help protect the environment.

Composition ofRivastigmina Aurovitas Spain

-The active ingredient is rivastigmina.

Rivastigmina Aurovitas Spain 4,6 mg/24 h transdermal patch EFG: Each patch releases 4.6 mg of rivastigmina in 24hours, measures 4.6 cm2and contains 6.9 mg of rivastigmina.

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

Appearance of the product and content of the container

Thin, matrix-type transdermal patch composed of three layers. The outer layer is a toasted color and marked with “RIV-TDS 4.6 mg/24 h” in orange ink.

Each carton contains one transdermal patch.

Rivastigmina Aurovitas Spain 4,6 mg/24 h transdermal patches EFG is available in containers with 7 or 30 cartons and in multi-containers containing 60 cartons (2 containers of 30).

Only some container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

Luye Pharma AG

Am Windfeld 35

83714 Miesbach, Bavaria

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Spain:Rivastigmina Aurovitas Spain 4,6 mg/24 h transdermal patches EFG

Portugal:Rivastigmina Generis

Last review date of this leaflet:November 2023

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