Package Insert: Information for the Patient

Rivanex 4.6 mg/24h Transdermal Patches EFG

Rivastigmine

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

-Conserve this package insert, as you may need to refer to it again.

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

-This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms 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 package insert. See section 4.

1.What is Rivanex and how is it used

2.What you need to know before starting to use Rivanex

3.How to use Rivanex

4.Possible adverse effects

5.Storage of Rivanex

6.Contents of the package and additional information

The active ingredient of Rivanex patches is rivastigmine.

Rivastigmine belongs to the group of cholinesterase inhibitors. In patients withAlzheimer'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). Rivastigmine acts by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Rivanex allows for an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease.

Rivanex 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.

Do not use Rivanex:

- if you are allergic to rivastigmine or 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 before starting to use thismedication:

- 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 liquids) if vomiting or diarrhea are 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.

Children and adolescents:

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

Other medications and Rivanex:

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

Rivastigminemay 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, escopolamine, or meclicina).

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

Caution should be exercised when using this medication 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.

Use of Rivanex with food, drinks, and alcohol:

Thismedicationcan be used with food, drinks, and alcohol.

Pregnancy, breastfeeding, 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 rivastigmineagainst the possible adverse effects on the fetus. Thismedicationshould not be used during pregnancy unless it is clearly necessary.

You should not breastfeed during your treatment with rivastigmine.

Driving and operating machinery:

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so.

Rivanex patches may cause dizziness and drowsiness, mainly at the beginning of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

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

• Normally, treatment begins withrivastigmina4.6 mg/24 h.
• The usual recommended daily dose isrivastigmina9.5 mg/24 h. If this dose is well tolerated, your treating doctor may consider increasing it to 13.3 mg/24 h.
• Only wear one patch ofrivastigminaat the same 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 it has not been interrupted for more than three days. Otherwise, your doctor will have you restart your treatment withrivastigmina4.6 mg/24 h.

Where to place your Rivanex 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. Wearing multiple patches on your body may expose you to an excessive amount of this medication, which could be potentially hazardous.
• Put ononlyonepatch 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 inwomen)

- 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 onlyone of the possible areas.

Each time you change the patch, you must remove the previous day's 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 Rivanex transdermal patches

Rivanex patches 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 Rivanex after interrupting treatment should start with the second figure.

Each patch is in an individual protective envelope. Only open the envelope when you are ready to put on the patch. Cut the envelope along the dotted line with scissors and remove the patch from the envelope.

A protective sheet covers the adhesive side of the patch. Remove the first sheet without touching the adhesive side of the patch with your fingers.

Place the adhesive side of the patch on the upper or lower back or on the arm or chest and then remove the second sheet of the protective sheet.

Press the patch firmly against the skin 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 on the patch, for example, the day of the week, with a fine-tipped red 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 the clothing does not rub against the patch.

How to remove Rivanex transdermal patches

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, washimmediatelywith plenty of water and seek medical advice if the symptoms do not resolve.

Can you wear Rivanex transdermal patches 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 Rivanex transdermal patches

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

If you use more Rivanex than you should

If you accidentally put on more than one patch, remove all the patches from the skin, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication.
Some people who have taken accidentally high doses of rivastigmina have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. A slowing of heart rate and fainting may also occur.

If you forget to use Rivanex

If you realize you have forgotten to put on a patch, put it onimmediately. 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 Rivanex

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 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:

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)

• 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 fluids).
• 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 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
• Torticollis (condition involving involuntary muscle contraction and abnormal tilting of the body and head to one side).

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 salivation.
• Loss of appetite
• Sensation of agitation
• Sensation of general discomfort.
• Trembling or sensation of confusion.
• Increased sweating.

Infrequent(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)

• Ulcer in the intestine.
• Seizures (convulsions)
• Chest pain – likely caused by heart spasms.

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

• Gastrointestinal bleeding – manifested as blood in the stool or vomiting blood.
• High blood pressure
• Pancreatitis – symptoms include severe upper stomach pain, often accompanied by nausea or vomiting (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 tube that connects their mouth to their stomach (esophagus).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Pharmacovigilance of Medicines for Human Use, https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require any special storage temperature. Store in the original packaging to protect it from light. Store the transdermal patch inside the sachet until use.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the sachet. 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.

After removing a patch, fold it in half with the adhesive side inwards and press. After placing it in the original sachet, ensure that it is out of 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 packaging and unused medications at the SIGRE Pointofthe pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

Composition of Rivanex

The active ingredient is rivastigmina. Each patch releases 4.6 mg of rivastigmina in 24 hours, measures 5 cm² and contains 9 mg of rivastigmina.

The other components are: outer layer [polyester film, silicone-coated polyester film, fluorine-coated polyester film], adhesive matrix [acrylic adhesive (DURO-TAK87-235A), acrylate copolymer (PLASTOID B) and ethyl acetate], adhesive layer [silicone adhesive (BIO-PSA 7-4302)] and ink.

Appearance of the product and content of the container

Rivanex 4.6 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.

Rivanex 4.6 mg/24 h transdermal patches are available in containers that contain 30 or 60 packages. Some package sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

NEURAXPHARM SPAIN, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí - (Barcelona)

Spain

Responsible for manufacturing

Eurofins PHAST GmbH

Kardinal-Wendel-Strasse 16,

66424 Homburg,

Germany

Last review date of this leaflet: January 2025

Other sources of information

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