Leaflet: information for the user

rivastigmina cinfa 9.5 mg/24 h transdermal patches EFG

Read this 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, consult 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, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

The active ingredient ofrivastigmina cinfais rivastigmina.

Rivastigmina belongs to the group of cholinesterase inhibitors. In patients with Alzheimer's disease, certain nerve cells die in the brain, causing low levels of acetylcholine neurotransmitters (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 cinfaallows an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease.

Rivastigmina cinfais 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.

Do not use rivastigmina cinfa

• if you are allergic to rivastigmina or 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 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 are in any of these situations, inform your doctor and do not userivastigmina cinfatransdermal patches.

Warnings and precautions

Consult your doctor or pharmacist before starting to userivastigmina cinfa:

• if you have or have had any irregular or slow heart rhythm.
• 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 dizziness (nausea), dizziness (vomiting) and diarrhea. You may become dehydrated (loss of a large amount 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 the need for closer monitoring while you are being treated.

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

Children and adolescents

This medicinemust not be used in the pediatric population for the treatment of Alzheimer's disease.

Use of rivastigmina cinfa with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

Rivastigminamay interfere with anticholinergic medicines some of which are used to relieve stomach cramps or 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).

This medicinemust not be administered at the same time as metoclopramida (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together may cause problems such as stiffness in the limbs and hand tremor.

If you need to undergo surgery while usingrivastigminatransdermal 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 usingthis medicinewith beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions). Taking the two medicines together may cause complications such as a decrease in heart rate (bradycardia) that may lead to fainting or loss of consciousness.

Pregnancy, breastfeeding and fertility

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

If you are pregnant, it is necessary to evaluate the benefits of usingrivastigminaagainst the possible adverse effects on the fetus. Rivastigminamust not be used during pregnancy unless it is clearly necessary.

You must not breastfeed during your treatment withthis medicine.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you must not do so unless your doctor tells you it is safe to do so. Rivastigminamay cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, you must not drive or operate machinery.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

IMPORTANT:

• Remove the previous patch before putting on 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 indicate the most suitable dose ofrivastigmina cinfatransdermal patches for your case.

• Normally, treatment starts withrivastigmina cinfa4,6 mg/24 h.
• The recommended daily dose isrivastigmina cinfa9,5 mg/24 h. If this dose is well tolerated, your doctor may consider increasing the dose to 13,3 mg/24 h.
• Wear only onerivastigmina cinfapatch 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 a new one without 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 your treatment withrivastigmina cinfa4,6 mg/24 h.

Rivastigminacan be used with food, drinks, and alcohol.

Where to place your rivastigmina cinfa 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.The wearing of multiple patches on your body may expose you to an excessive amount of this medication, which could be potentially hazardous.
• Put ononly ONEpatch per day inONEof the possible areas as 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

Every 24 hours, remove the previous patch before putting on a new one in ONLY ONE of the possible areas.

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.

How to apply your rivastigmina cinfa transdermal patches

Therivastigmina cinfapatches are thin, opaque plastic and stick to the skin. Each patch is in a protective envelope that protects it until you put it on. Do not open the envelope or remove the patch until you are ready to put it on.

Remove the existing patch carefully before putting on a new one.

Patients starting treatment for the first time and patients restarting treatment with rivastigmina after interrupting treatment should start with the second figure.

You must 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 rivastigmina cinfa transdermal patch

Gently pull one of the edges of the patch to slowly remove it 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 removers 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 rivastigmina cinfa transdermal patch when bathing, swimming, or exposing yourself to the sun?

• Bathing, swimming, or showering should not affect the patch. Make sure it does not come off partially while doing these activities.
• Do not expose the patch to an external heat source (e.g. excessive sunlight, sauna, solarium) 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 rivastigmina cinfa transdermal patches

• To benefit from your treatment, you must put on a new patch every day, preferably at the same time.
• Wear only onerivastigmina cinfapatch at a time and replace the patch with a new one every 24 hours.

If you use more rivastigmina cinfa than you should

If you accidentally put on more than one patch, remove all the patches from the skin and inform your doctor. You may need medical attention. Some people who have taken accidentally high doses ofrivastigminaorally have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. A slowing of heart rate and fainting may also occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use rivastigmina cinfa

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 with rivastigmina cinfa

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 may cause side effects, although not everyone will experience them.

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

If you notice any of the following serious side effects, 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 stop urinating properly).

Infrequent(may affect up to 1 in 100 people)

• Heart rhythm problems 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 arms and legs
• Tremor 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 or rapid heart rate
• High blood pressure
• Seizures (convulsions)
• Liver disorders (yellowing of the skin, yellowing of the whites 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 side effects listed above, remove the patch and immediately inform your doctor.

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

Frequent(may affect up to 1 in 10 people)

• Excessive saliva
• Loss of appetite
• Sensation of agitation
• Sensation of general discomfort
• Tremor or sensation of confusion
• Increased sweating

Infrequent(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 – likely caused by a heart spasm

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

• High blood pressure
• Pancreatitis – symptoms include severe upper stomach pain often accompanied by 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 been severely nauseated (vomiting) have had a tear in the esophagus (the tube that connects the mouth to the stomach)

Frequency not known(cannot be estimated from available data)

• Pisa syndrome (condition involving involuntary muscle contraction and abnormal inclination of the body and head to one side)

Patients with dementia or Parkinson's disease

These patients experience some side effects more frequently and also have some additional side effects:

Frequency not known(cannot be estimated from available data)

• Pisa syndrome (condition involving involuntary muscle contraction and abnormal inclination of the body and head to one side)

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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es.Reporting side effects can help provide more information about 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 pouch after CAD. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

Store the transdermal patch inside the pouch until use.

After removing a patch, fold it in half with the adhesive side inwards and press. After placing it in the original pouch, ensure that it is out of sight and reach of children. After removing the patch, do not touch your eyes, and wash your hands thoroughly with water and soap.

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. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Rivastigmina cinfa composition

Appearance of the product and contents of the packaging

Rivastigmina cinfa 9.5 mg/24 h transdermal patches are presented in the form of a transdermal patch composed of three layers. The outer layer has a rounded shape. Each package contains a transdermal patch.

Rivastigmina cinfa 9.5 mg/24 h transdermal patches are available in packages containing 60 packages.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

or

Eurofins PHAST GmbH

Kardinal-Wendel-Strasse 16,

66424 Homburg, Germany

or

ACC GmbH Analytical Clinical Concepts

Schöntalweg 9,

63849 Leidersbach, Germany

Last review date of this leaflet:January 2025

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/80659/P_80659.html

QR code to:https://cima.aemps.es/cima/dochtml/p/80659/P_80659.html