Prospect: Information for the User

Rivastigmina Kern Pharma 4.6 mg/24 h Transdermal Patches EFG

Rivastigmina Kern Pharma 9.5 mg/24 h Transdermal Patches EFG

Rivastigmina Kern Pharma 13.3 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 or pharmacist.

-This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms of the disease as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

The active ingredient of Rivastigmina Kern Pharma is rivastigmina.

Rivastigmina belongs to a group of medicines called 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 allows an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease.

Rivastigmina is 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 Kern Pharma

• If you are allergic to rivastigmine (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 rivastigmine.

Warnings and precautions

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

• 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 asthma or 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 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 several days, do not put another one on without consulting your doctor first.

Use in children and adolescents

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

Use ofRivastigmina Kern Pharmawith other medications

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

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

This medication 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 rivastigmine transdermal patches, inform your doctor that you are using it, as it may excessively potentiate the effects of some anesthetic muscle relaxants.

Care should be taken when using rivastigmine transdermal patches together with beta blockers (medications such as atenolol used to treat hypertension, angina, and other cardiovascular conditions). Taking the two medications together may cause complications such as a decrease in heart rate (bradycardia) that may lead to fainting or loss of consciousness.

Pregnancy, lactationand 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 rivastigmine against the possible adverse effects on the fetus. Rivastigmine should not be used during pregnancy unless it is clearly necessary.

You should not breastfeed during your treatment with this medication.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machinery safely. Rivastigmine 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 contained in this leaflet and those indicated by your doctor. In case of doubt, consult your doctor, pharmacist or nurse.

IMPORTANT:

• Remove the previous patch before putting on a new patch
• 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 of rivastigmine transdermal patch for your case.

• Normally, treatment starts with rivastigmine 4.6 mg/24 h.
• The usual 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.
• Only wear 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 three days, do not put on another one before consulting your doctor. Treatment with the 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 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 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 patch in ONLY ONE of the possible areas.

Each time you change the patch, remove the previous patch from the day before 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 before putting a new patch in the same area of the skin again.

How to apply your Rivastigmina Kern Pharma transdermal patch

The rivastigmine patches are thin, transparent 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.

• Each patch is in an individual protective envelope. Only open the envelope when you are ready to put on the patch.

Cut the envelope at one end with scissors and remove the patch from the envelope.

• A protective laminate with two sheets covers the adhesive side of the patch. Remove the first sheet without touching the adhesive side of the patch.

• Place the adhesive side of the patch on the upper part of the lower back or on the upper arm or chest (avoiding breasts in women) and then remove the second sheet of the protective laminate.

• Press the patch firmly with the palm of your hand for at least 30 seconds and make sure the edges have stuck well.

If this helps, you can write something on the patch, for example, the day of the week, with a fine-tip ballpoint pen.

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 Kern Pharma 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 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 rivastigmine 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 Kern Pharma transdermal patch

• To benefit from your treatment, you must put on a new patch every day, preferably at the same time.
• Only wear one transdermal rivastigmine patch at a time and replace the patch with a new one every 24 hours.

If you use more Rivastigmina Kern Pharma than 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 doses of rivastigmine orally have experienced nausea, vomiting, diarrhea, high blood pressure and hallucinations. They may also experience a slowing of heart rate and fainting.

If you forget to use Rivastigmina Kern Pharma

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 Kern Pharma

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 often when you first 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.

Common(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)

Uncommon(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
• Tremorin the hands

Unknown(cannot be estimated from available data)

• Pisa syndrome (condition involving involuntary muscle contraction and abnormal tilting of the body and head to one side)
• 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 severe upper stomach pain, often accompanied by nausea or vomiting
• Fast or irregular heart rhythm
• 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 side effects listed above, remove the patch and immediately inform your doctor.

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

Common(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

Uncommon(may affect up to 1 in 100 people)

• Irregular heart rhythm (e.g. fast 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 heart spasms

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 – manifests 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 their mouth to their stomach

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance 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 pouch. The expiration date is the last day of the month indicated.

Store the transdermal patch inside the pouch 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 inwards and press. After placing it in the original pouch, ensure that 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 the used patches to the pharmacy, preferably in the original packaging.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Rivastigmina Kern Pharma

• The active ingredient of Rivastigmina Kern Pharma is rivastigmina:
• Rivastigmina Kern Pharma 4.6 mg/24 h transdermal patches EFG: Each patch releases 4.6 mg of rivastigmina in 24 hours, measures 5 cm2and contains 9 mg of rivastigmina.
• Rivastigmina Kern Pharma 9.5 mg/24 h transdermal patches EFG: Each patch releases 9.5 mg of rivastigmina in 24 hours, measures 10 cm2and contains 18 mg of rivastigmina.
• Rivastigmina Kern Pharma 13.3 mg/24 h transdermal patches EFG: Each patch releases 13.3 mg of rivastigmina in 24 hours, measures 15 cm2and contains 27 mg of rivastigmina.

• The other components are: film [polyester film, silicone-coated polyester film, and fluoropolymer-coated polyester film], medication matrix [acrylic adhesive (2-ethylhexyl acrylate, methyl acrylate, and acrylic acid), acrylic copolymer (butyl methacrylate, co-methyl methacrylate) and ethyl acetate] and adhesive matrix [silicone adhesive].

Appearance of the product and contents of the packaging

Each pack contains a transdermal patch. The outer part is white and marked with “Rivastigmina 4.6 mg/24 h”, “Rivastigmina 9.5 mg/24 h” or “Rivastigmina 13.3 mg/24 h”.

The patches are available in packs containing 30 or 60 packs.

Only some sizes of packs may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for Manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

or

Eurofins PHAST GmbH

Kardinal-Wendel-Strasse 16

66424 Homburg, 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