Prospecto: Information for the User

Alzerta 4,6 mg/24 h Transdermal Patches EFG

Alzerta 9,5 mg/24 h Transdermal Patches EFG

Rivastigmina

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to 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 prospectus.See section 4.

1.What Alzerta is and for what it is used

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

3.How to use Alzerta

4.Possible adverse effects

5.Storage of Alzerta

6.Contents of the package and additional information

The active ingredient of Alzerta is rivastigmine.

Rivastigmine belongs to the group of cholinesterase inhibitors. In patients with Alzheimer'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, rivastigmine allows an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease.

Alzerta 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 Alzerta

• If you are allergic to rivastigmine (the active ingredient in Alzerta) 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, 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 Alzerta transdermal patches.

Warnings and precautions

Consult your doctor before starting to use Alzerta:

• If you have or have had any heart problems such as irregular or slow heart rhythm, prolonged QTc, family history of prolonged QTc, torsades de pointes, or if you have low blood levels of potassium or magnesium.

• If you have or have had any active stomach ulcers.
• 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 nausea, 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 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 more than three days, do not apply another one without consulting your doctor first.

Children and adolescents

There is no experience of the use of this medication in the pediatric population in the treatment of Alzheimer's disease.

Other medications and Alzerta

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This medication may interact with anticholinergic medications, some of which are 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. difenhidramina, escopolamina, or meclizina).

This medication should not be administered at the same time as metoclopramide (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 tremor.

If you need to undergo surgery while using this medication, 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 this medication with beta blockers (medications such as atenolol used to treat hypertension, angina, and other heart 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.

Care should be taken when using Alzerta with other medications that may affect heart rhythm or the heart's electrical system (prolongation QT).

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 this medication against the possible adverse effects on the fetus. This medication 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. This medication 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 indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How to start treatment

Your doctor will indicate the most suitable dose of this medication for your case.

• Normally, treatment begins with Alzerta 4.6 mg/24 h.
• The recommended daily dose is Alzerta 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 patch of this medication 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 apply 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 with Alzerta 4.6 mg/24 h.

This medication can be used with food, drink, and alcohol.

Where to place your Alzerta transdermal patch

• Before applying a patch, make sure the skin is clean, dry, and free of hair, powders, oils, moisturizers, or lotions that may prevent the patch from adhering well to the skin, without cuts, redness, or irritation.
• Remove any existing patch carefully before applying a new one.This may expose you to an excessive amount of this medication, which could be potentially hazardous.
• Apply only one patch per day in one of the possible areas as shown in the following diagrams:

• upper left or right armorupper left or right chest (avoiding breasts in women)
• upper left or right back
• lower left or right back

During treatment, your doctor may adjust the dose depending on your individual needs.

Each time you change the patch, remove the previous patch before applying a new one 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 apply a new patch in the same area of the skin.

Howto apply your Alzerta transdermal patch

Alzerta patches are thin, brown, and stick to the skin. Each patch is found in a protective envelope that protects it until you apply it. Do not open the envelope or remove the patch until you are ready to apply it.

IMPORTANT:

• Remove the previous patch before applying 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.

You can write on the patch, for example, the day of the week, with a fine-tip red pen.

You must wear the patch continuously until you replace it with a new one. When applying a new patch, you can try different areas to find the ones that are most comfortable and where clothing does not rub against the patch.

How to remove your Alzerta transdermal patch

Gently pull one edge 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 Alzerta transdermal patch when bathing, swimming, or exposing yourself to the sun?

• The bath, swimming, or shower should not affect the patch. Make sure it does not come loose during these activities.

• Do not expose the patch to an external heat source (e.g., excessive sunlight, sauna, solarium) for long periods.

What to do if a patch falls off

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

How long and when should you wear your Alzerta transdermal patch?

• To benefit from your treatment, you must apply a new patch every day, preferably at the same time.
• Wear only one patch of this medication at a time and replace the patch with a new one every 24 hours.

If you use more Alzerta than you should

If you accidentally applied more than one patch, remove all patches from the skin and inform your doctor or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount administered). You may need medical attention. Some people who have taken accidentally high doses of rivastigmine 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 Alzerta

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 compensate for the one you forgot.

If you interrupt treatment with Alzerta

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 medications, Alzerta transdermal patches 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. Generally, side effects will slowly disappear as your body gets used to the medication.

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).

Poorly frequent(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 arms and legs
• Tremor in the hands

Unknown(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
• Syndrome of Pisa (condition involving involuntary muscle contraction and abnormal tilting of the body and head to one side)
• Inflammation of the pancreas – symptoms include upper stomach pain, often accompanied by nausea or vomiting
• Irregular heart rhythm or rapid heart rate
• 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 anxiety
• 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 salivation
• Loss of appetite
• Sensation of agitation
• Sensation of general discomfort
• Tremor or sensation of confusion
• Increased sweating

Poorly frequent(may affect up to 1 in 100 people)

• Irregular heart rhythm (e.g. rapid heart rate)
• Difficulty sleeping
• 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
• Inflammation of the pancreas– 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 experienced intense vomiting have had a tear in the esophagus (the tube that connects the mouth to the stomach)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even ifit 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, Website: www.notificaRAM.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the sight and reach of children.

• No use this medication after the expiration date that appears on the box and on the package after CAD. The expiration date is the last day of the month indicated.

• Store the transdermal patch inside the package 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 package, dispose of the patch.Do not touch your eyes with your fingers and wash your hands with water and soap after removing the patch. If your household waste is disposed of by incineration, you can throw the patch in your household waste.

Medications should not be thrown down the drain or in the trash. Deposit the containers and medications you do not need at the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of Alzerta

The active principle is rivastigmina.

Alzerta 4.6 mg/24 h transdermal patches EFG:

Each transdermal patch releases 4.6 mg of rivastigmina in 24 hours. Each transdermal patch of 4.6 cm2contains 6.9 mg of rivastigmina.

Alzerta 9.5 mg/24 h transdermal patches EFG:

Each transdermal patch releases 9.5 mg of rivastigmina in 24 hours. Each transdermal patch of 9.2 cm2contains 13.8 mg of rivastigmina.

The other components are coated polyester/aluminum/poly(2-ethylhexyl acrylate, vinyl acetate), polyisobutene of medium and high molecular weight, anhydrous colloidal silica, light liquid paraffin, coated polyester film with fluoropolymer, orange printing ink.

Appearance of the product and contents of the packaging

Each transdermal patch is a thin, circular patch. The outer layer is a toasted color and carries the following orange printing:

• “RIV-TDS 4.6 mg/24h”.
• “RIV-TDS 9.5 mg/24h”.

Each transdermal patch is sealed in a sachet. Each transdermal patch is protected by a sheet. Alzerta 4.6 and 9.5 mg/24 h transdermal patches EFG, are available in packaging containing 7, 30 or 42 sachets and in multiple packaging containing 60 (2x30), 84 (2x42) or 90 (3x30) sachets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible manufacturer

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

Last review date of this leaflet: December 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/