RIVASTIGMINE KERN PHARMA 13.3 mg/24h TRANSDERMAL PATCHES

2. What you need to know before you use Rivastigmine Kern Pharma

Do not useRivastigmine Kern Pharma

• if you are allergic to rivastigmine (the active substance of this medicine) 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, increasing skin inflammation, swelling) and if there is no improvement during the 48 hours after removing the transdermal patch.

If you are 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 medicine.

• if you have or have ever had an irregular or slow heart rate (pulse).
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures.
• if you have or have ever had asthma or severe respiratory disease.
• if you suffer from tremors.
• if you have low body weight.
• if you have gastrointestinal reactions such as a feeling of nausea (nausea), vomiting (vomiting) and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged.
• if you have liver problems (liver failure).

If you are in any of these situations, your doctor may consider it necessary to monitor you more closely while you are being treated.

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

Use in children and adolescents

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

Use ofRivastigmine Kern Pharmawith other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Rivastigmine may interfere with anticholinergic medicines, some of which are medicines 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 must not be administered at the same time as metoclopramide (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 tremors.

In case you need to undergo surgery while using rivastigmine transdermal patches, inform your doctor that you are using it, as it may potentiate the effects of some muscle relaxants in anesthesia.

Caution should be exercised when using rivastigmine transdermal patches together with 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 can lead to fainting or loss of consciousness.

Pregnancy, breastfeedingand fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

You should not breastfeed while using this medicine.

Driving and using machines

Your doctor will inform you if your illness 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 or use machinery, or perform other tasks that require your attention.

3. How to use Rivastigmine Kern Pharma

Follow exactly the instructions for administration of this medicine contained in this leaflet and as 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 onto 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.

• 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, the doctor treating you 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 after 24 hours.

During treatment, your doctor may adjust the dose 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 apply your Rivastigmine Kern Pharma transdermal patch

• Before applying a patch, make sure the skin is clean, dry, and hairless, without powders, oils, moisturizers, or lotions that may prevent the patch from sticking well to the skin, without cuts, redness, or irritation.
• Carefully remove any patch you are wearing before putting on 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 ONEpatch per day to ONLY ONEof the possible areas as shown in the following diagrams:

• upper left orupper right arm
• upper left orupper right chest (avoiding the breasts in women)
• upper left orupper right back
• lower left orlower right back

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

Each time you change the patch, you must remove the previous day's patch before applying a new patch to a different area of the skin (e.g., 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 area of skin.

How to apply your Rivastigmine Kern Pharma transdermal patch

Rivastigmine patches are thin, transparent plastic and stick to the skin. Each patch is in a pouch that protects it until you are ready to apply it. Do not open the pouch or remove the patch until you are ready to apply it.

Carefully remove any existing patch before applying a new one.

• Each patch is in an individual protective pouch. The pouch should only be opened when you are ready to apply the patch.

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

• A divided protective film, consisting of two sheets, covers the adhesive side of the patch. Remove the first sheet of the film without touching the adhesive side of the patch with your fingers.

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

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

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

You should wear the patch continuously until it is time to change it for a new one. When you apply a new patch, you can try different areas to find the ones that are most comfortable for you and where clothing does not rub against the patch.

How to remove your Rivastigmine Kern Pharma transdermal patch

Gently pull one of the edges of the patch to slowly peel it off the skin. If there are any 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. In case of contact with the eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if the symptoms do not resolve.

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

• Bathing, swimming, or showering should not affect the patch. Make sure it does not peel off partially while performing these activities.
• Do not expose the patch to an external heat source (e.g., excessive sunlight, sauna, sunbed) for long periods.

What to do if a patch falls off

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

When and for how long should you wear your Rivastigmine Kern Pharma transdermal patch

• To benefit from your treatment, you should apply a new patch every day, preferably at the same time.
• Wear only one rivastigmine transdermal patch at a time and replace the patch with a new one after 24 hours.

If you use more Rivastigmine Kern Pharma than you should

If you have accidentally applied more than one patch, remove all patches from the skin and inform your doctor or pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medicine and the amount administered). You may need medical attention. Some people who have accidentally taken excessive amounts of rivastigmine orally have had nausea, vomiting, diarrhea, high blood pressure, and hallucinations. There may also be a slowing of the heart rate and fainting.

If you forget to use Rivastigmine Kern Pharma

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

If you stop using Rivastigmine Kern Pharma

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

If you have any further questions on 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 all people suffer from them.

You may have adverse effects more frequently when starting your treatment or when your dose is increased. Generally, adverse effects will slowly disappear as your body gets used to the medicine.

If you notice any of the following adverse effects that may be serious, remove the patch and inform your doctor immediately.

Frequent(may affect up to 1 in 10 people)

• Lack of appetite
• Dizzy sensation
• Feeling of agitation or numbness
• Urinary incontinence (inability to stop urine properly)

Infrequent(may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heart rate
• Seeing things that do not really exist (hallucinations)
• Stomach ulcer
• Dehydration (loss of a large amount 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
• Tremor in the hands

Unknown(cannot be estimated from the available data)

• Pisa syndrome (a condition that involves 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 signs – such as tremor, stiffness, and difficulty moving
• Pancreatitis – signs include severe pain in the upper part of the stomach, often accompanied by a feeling of dizziness (nausea) or dizziness (vomiting)
• Fast or irregular heart rate
• High blood pressure
• Epileptic seizures (convulsions)
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormal darkening of urine or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Changes in analyzes that show liver function
• Feeling of restlessness
• Nightmares

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

Other adverse 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
• Lack of appetite
• Feeling of agitation
• Feeling of general discomfort
• Tremor or feeling of confusion
• Increased sweating

Infrequent(may affect up to 1 in 100 people)

• Irregular heart rate (e.g., fast heart rate)
• Difficulty sleeping
• Accidental falls

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

• Epileptic seizures (convulsions)
• Ulcer in the intestine
• Chest pain – probably caused by spasm in the heart

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

• High blood pressure
• Pancreatitis – signs include severe pain in the upper part of the stomach, often with a feeling of dizziness (nausea) or dizziness (vomiting)
• Gastrointestinal bleeding – manifested as blood in the stool or when vomiting
• Seeing things that do not exist (hallucinations)
• Some people who have been intensely dizzy (vomiting) have had a tear in part of the digestive tube that connects their mouth to their stomach (esophagus)

Reporting of Adverse Effects

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

5. Conservation of Rivastigmine Kern Pharma

Keep this medicine out of sight and reach of children.

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

Keep the transdermal patch inside the envelope until use.

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

After removing a patch, fold it in half with the adhesive side facing in and press. After introducing it into the original envelope, when disposing of the patch, make sure it is out of the reach of children. After removing the patch, do not touch your eyes, and wash your hands well with water and soap. If your household waste is eliminated by incineration, you can throw the patch in your household trash. If not, take the used patches to the pharmacy, preferably in the original packaging.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rivastigmine Kern Pharma

• The active principle of Rivastigmine Kern Pharma is rivastigmine:
• Rivastigmine Kern Pharma 4.6 mg/24 h transdermal patches EFG: Each patch releases 4.6 mg of rivastigmine in 24 hours, measures 5 cm2, and contains 9 mg of rivastigmine.
• Rivastigmine Kern Pharma 9.5 mg/24 h transdermal patches EFG: Each patch releases 9.5 mg of rivastigmine in 24 hours, measures 10 cm2, and contains 18 mg of rivastigmine.
• Rivastigmine Kern Pharma 13.3 mg/24 h transdermal patches EFG: Each patch releases 13.3 mg of rivastigmine in 24 hours, measures 15 cm2, and contains 27 mg of rivastigmine.

• The other components are: film [polyester sheet, silicone-coated polyester film, and fluoropolymer-coated polyester film], drug 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 Package Contents

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

The patches are available in packages containing 30 or 60 envelopes.

Only some package sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

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

Date of the Last Revision of this Prospectus: January 2025

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