Rivastigmine CINFA 9.5 mg/24 h transdermal patches EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivastigmine cinfa 9.5 mg/24 h 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. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Rivastigmine cinfa is and what it is used for.

2. What you need to know before using Rivastigmine cinfa.

3. How to use Rivastigmine cinfa.

4. Possible adverse effects.

5. How to store Rivastigmine cinfa.

6. Contents of the pack and other information

1. What rivastigmine cinfa is and what it is used for

The active substance in Rivastigmine cinfa is rivastigmine.

Rivastigmine belongs to the group of 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 cinfa increases acetylcholine levels in the brain, helping to reduce the symptoms of Alzheimer's disease.

Rivastigmine cinfa 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 cinfa

Do not use Rivastigmina cinfa

• if you are allergic to rivastigmine 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 extends 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 rivastigmine:

• If you have or have ever had heart problems such as irregular or slow heartbeat (pulse), QTc prolongation, family history of QTc prolongation, torsade 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 difficulties with urination.
• 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 have gastrointestinal reactions such as feeling dizzy (nausea), dizziness (vomiting), or 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 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

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

Other medicines and Rivastigmina cinfa

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).

This medicine should 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 this medicine 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 together with other medicines that may affect heart rhythm or the heart's electrical system (QT 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. Rivastigmine should not be used during pregnancy unless clearly necessary.

You must not breastfeed while receiving treatment with this medicine.

Driving and using machines

Your condition may affect your ability to drive or operate machinery, and you should not carry out these activities unless your doctor tells you it is safe to do so. Rivastigmine may cause dizziness and drowsiness, particularly at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

3. How to use rivastigmine cinfa

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

IMPORTANT:

• Remove the previous patch before applying a NEW patch.
• One patch only 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.

Starting treatment

Your doctor will determine the most appropriate dose of rivastigmine transdermal patches 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 can 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, drinks, and alcohol.

Where to apply your Rivastigmine cinfa transdermal patch

• Before applying a patch, ensure the skin is clean, dry, and hair-free, without powders, oils, moisturizers, or lotions that could prevent 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 ONLY ONE patch per day to ONLY ONE of the following areas, as 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

Every 24 hours, remove the previous patch before applying a NEW patch to ONLY ONE of the following possible areas

Each time you change the patch, remove the patch from the previous day before applying the new one to a different skin area (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 reapplying a patch to the exact same skin area.

How to apply your Rivastigmine cinfa transdermal patches

Rivastigmine patches are thin, opaque plastic patches that adhere to the skin. Each patch comes in a protective pouch that keeps it safe until you are ready to use it. Do not open the pouch or remove the patch until it is time to apply it.

Carefully remove any existing patch before applying a new one.

Patients starting treatment for the first time, and patients restarting treatment after an interruption, should begin with the second figure.

• Each patch is contained in an individual protective pouch. Open the pouch only when you are ready to apply the patch. Cut along the dotted line with scissors and remove the patch from the pouch.

• A split protective liner covers the adhesive side of the patch. Remove the first half of the liner without touching the adhesive surface with your fingers.

• Place the adhesive side of the patch on the upper or lower back, or on the upper arm or chest (avoiding breasts in women), then remove the second half of the protective liner.

• Press the patch firmly onto the skin with the palm of your hand for at least 30 seconds, ensuring the edges are well adhered.

• If helpful, you may write on the patch, for example the day of the week, using a pen with a fine rounded tip.

The patch should be worn continuously until it is time to replace it with a new one. When applying a new patch, try different areas to find the most comfortable ones where clothing does not rub against the patch.

How to remove your Rivastigmine cinfa 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 with soap and water. If you have contact with your eyes or if your eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms persist.

Can you wear your Rivastigmine cinfa transdermal patch while bathing, swimming, or in the sun?

• Bathing, swimming, or showering should not affect the patch. Make sure it does not partially detach during these activities.
• Do not expose the patch to external heat sources (e.g., excessive sunlight, sauna, tanning bed) for prolonged periods.

What to do if the patch falls off

If the patch falls off, apply a new one for the remainder of that day and change it at the usual time the next day.

When and for how long to use your Rivastigmine cinfa transdermal patches

• To benefit from your treatment, apply a new patch every day, preferably at the same time.
• Wear only one Rivastigmine cinfa patch at a time and replace it with a new one every 24 hours.

If you use more Rivastigmine cinfa than you should

If you accidentally apply more than one patch, remove all patches from the skin and inform your doctor. You may require medical attention. Some people who have accidentally taken excessive oral doses of rivastigmine have experienced discomfort (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. Slowing of heart rate and fainting may also occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Rivastigmine cinfa

If you realize you have forgotten to apply a patch, do so immediately. The next day, apply the following patch at the usual time. Do not apply two patches to make up for the missed one.

If you stop using Rivastigmine cinfa

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 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 will gradually disappear as your body gets used 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 agitated or drowsy
• Urinary incontinence (inability to properly control urination)

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heart rate
• Seeing things that are not really there (hallucinations)
• 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 the arms and legs
• Hand tremors

Frequency not known (cannot be estimated from available data)

• Allergic reaction at the site of patch application, such as blisters or skin swelling
• Worsening of signs of Parkinson's disease – such as tremor, stiffness, and difficulty moving
• Inflammation of the pancreas – symptoms include upper abdominal pain, 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 liver function tests
• Feeling restless
• Nightmares

If you notice any of the adverse effects listed above, remove the patch and contact your doctor immediately.

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

Frequent (may affect up to 1 in 10 people)

• Excessive saliva
• Loss of appetite
• Feeling agitated
• General feeling of discomfort
• Tremor or confusion
• 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 – symptoms include severe upper abdominal pain, frequently with nausea or vomiting
• Gastrointestinal bleeding – seen as blood in stools or vomiting blood
• Seeing things that are not there (hallucinations)
• Some people who have had severe vomiting have developed a tear in part of the digestive tract connecting the mouth to the stomach (esophagus)

Frequency not known (cannot be estimated from available data)

• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)

Patients with dementia or Parkinson's disease

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

Frequency not known (cannot be estimated from available data)

• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)

Reporting of adverse effects

If you experience any type of 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 System for Pharmacovigilance of Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmine cinfa

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 pouch after EXP. The expiry date refers to the last day of the month indicated.

Do not use any patch if it appears damaged or shows signs of tampering.

Store in the original packaging to protect from light.

Keep the transdermal patch inside the pouch until ready for use.

After removing a patch, fold it in half with the adhesive side inwards and press together. When disposing of the patch, place it back into the original pouch and ensure it is out of sight and 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 collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmina cinfa

• The active substance is rivastigmine. Each patch contains 18 mg of rivastigmine in 10 cm² and releases 9.5 mg of rivastigmine over 24 hours.

• The other components are: polyester film, silica-coated polyester film, fluoropolymer-coated polyester film, acrylic adhesive (Duro-Tak 87-235A), acrylate copolymer (Plastoid B), ethyl acetate, silicone adhesive (Bio-PSA 7-4302), and ink.

Appearance of the product and contents of the pack

Rivastigmina cinfa 9.5 mg/24 h transdermal patches are presented as transdermal patches consisting of a round-shaped adhesive patch with a rectangular backing film. Each sachet contains one transdermal patch.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

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

Date of the most recent revision of this leaflet: December 2024

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/.

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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