ALZERTA Two Per Week 4.6 mg/24h Transdermal Patches

Introduction

Package Leaflet: Information for the Patient

Alzerta twice a week 4.6 mg/24 h transdermal patches

Alzerta twice a week 9.5 mg/24 h transdermal patches

Rivastigmine

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Alzerta twice a week and what is it used for
2. What you need to know before starting to use Alzerta twice a week
3. How to use Alzerta twice a week
4. Possible side effects
5. Storage of Alzerta twice a week
6. Contents of the pack and further information

1. What is Alzerta twice a week and what is it used for

The active substance of Alzerta twice a week is rivastigmine.

Rivastigmine belongs to the group of cholinesterase inhibitors. In patients with Alzheimer's dementia, certain nerve cells die in the brain, causing 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 the increase of acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease.

Alzerta twice a week is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability, and behavior.

2. What you need to know before starting to use Alzerta twice a week

Do not use Alzerta twice a week

• if you are allergic to rivastigmine (the active substance of Alzerta twice a week) 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 during the 48 hours after removing the transdermal patch.

If you are in any of these situations, inform your doctor and do not use Alzerta twice a week transdermal patches.

Warnings and precautions

Consult your doctor before starting to use Alzerta twice a week:

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

• 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 nausea, 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 more than three days, do not put on another one without consulting your doctor first.

Remove any patch carefully before putting on a new one. Do not apply more than one patch at a time. Wearing multiple (or more than one) transdermal patches on your body could expose you to a higher amount of this medication than you should.

Children and adolescents

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

Other medications and Alzerta twice a week

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

This medication may interfere with anticholinergic medications, some of which are medications 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 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 tremors.

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

Caution should be exercised 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 can lead to fainting or loss of consciousness.

Caution should be exercised when using Alzerta twice a week with other medications that may affect heart rate or the heart's electrical system (QT prolongation).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 for the fetus. This medication should not be used during pregnancy unless it is clearly necessary.

You should not breastfeed during treatment with this medication.

Driving and using machines

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

3. How to use Alzerta twice a week

Follow your doctor's instructions for using this medication exactly. If you are in 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.

• Treatment with Alzerta twice a week usually starts with 4.6 mg/24 h.
• The recommended daily dose is 9.5 mg/24 h. If this dose is well tolerated, the treating doctor may consider increasing the dose to 13.3 mg/24 h. The dose of 13.3 mg/24 h cannot be achieved with Alzerta twice a week. For conditions where this dosage is required, other rivastigmine patches containing the 13.3 mg/24 h dose are available.
• Wear only one rectangular transdermal patch and one oval adhesive cover at a time, and replace them twice a week, at most after 4 days.

You must change the patches on two fixed days:

Each one on

Monday and Friday OR

Tuesday and Saturday OR

Wednesday and Sunday OR

Thursday and Monday OR

Friday and Tuesday OR

Saturday and Wednesday OR

Sunday and Thursday.

Always change the patches at the same time of day. As a reminder, you should write down these days and the time of day.

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 put on another one without consulting your doctor first. 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 treatment with Alzerta twice a week 4.6 mg/24 h.

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

Where to place your Alzerta twice a week 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.
• Remove any patch you are wearing carefully before applying a new one.Wearing multiple patches on your body could expose you to an excessive amount of this medication, which could be potentially dangerous.
• Apply ONErectangular transdermal patch along with one oval adhesive cover to ONLY ONEof the possible areas as shown in the following diagrams:

• upper part of the left orright arm
• upper left orupper right part of the chest (avoiding the breasts)
• upper left orupper right part of the back
• lower left orlower right part of the back

Each time you change the patch, you must remove the previous patch before applying a new patch to a different area of the skin (for example, on the right side of the body for four days, and then on the left side for three days, or on the upper part of the body for four days and then on the lower part for three days). Wait at least 14 days before applying a new patch to exactly the same area of skin.

How to apply your Alzerta twice a week transdermal patch

Alzerta twice a week is for transdermal use.

The Alzerta twice a week patches consist of two parts:

• a rectangular, translucent patch that contains the active substance (transdermal patch) sealed in a pouch, and
• an oval, beige patch without active substance (adhesive cover) also sealed in a pouch. This pouch is larger than the pouch containing the transdermal patch.

Do not open the pouch or remove the patch until you are ready to apply it.

Application alwaysstarts with the rectangular transdermal patch.

If it helps, you can write on the adhesive cover, for example, the day of the week, with a fine-tip pen.

You should wear the patch continuously until it is time to 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 for you and where clothing does not rub against the patch.

How to remove your Alzerta twice a week transdermal patch

Gently pull one of the edges of the adhesive cover of the patch to slowly detach it from the skin along with the patch.

If the transdermal patch remains on the skin, gently pull one edge until it is completely detached from 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, wash them immediately with plenty of water and seek medical advice if the symptoms do not resolve.

Can you wear your Alzerta twice a week 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 while you perform 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, and change it on the usual day/hour.

When and for how long should you wear your Alzerta twice a week transdermal patch?

• To benefit from your treatment, you should apply a new patch twice a week, at most after four days, preferably at the same time of day.

• Wear only one rectangular transdermal patch and one oval adhesive cover at a time, and replace the patch with a new one twice a week on two fixed days.

If you use more Alzerta twice a week than you should

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

If you realize you have forgotten to apply a patch, apply it immediately, if treatment has not been interrupted for more than three days.

Replace this patch at the usual time of day on the usual day, to return to your dosing schedule.

Do not apply two transdermal patches to make up for the one you forgot. If you have not applied a patch for more than three days, do not apply the next one without talking to your doctor first.

If you interrupt treatment with Alzerta twice a week

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.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people will 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)

• Loss 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)

• Allergic reaction where the patch was applied, such as blisters or skin inflammation
• Worsening of Parkinson's disease symptoms – such as tremor, stiffness, and difficulty moving.
• Pisa syndrome (a condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side)
• Pancreatitis – signs include pain in the upper part of the stomach, often accompanied by a feeling of nausea or 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
• Loss 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 nausea or vomiting
• Gastrointestinal bleeding – manifested as blood in the stool or when vomiting
• Seeing things that do not exist (hallucinations)
• Some people who have suffered from intense 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 a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Alzerta two per week

• 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 after CAD. The expiration date is the last day of the month indicated.
• This medicine does not require special storage conditions.

• 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 its envelope, dispose of the patch in such a way that children cannot manipulate it.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of 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 Alzerta two per week

The active principle is rivastigmine.

Alzerta two per week 4.6 mg/24 h transdermal patches:

Each transdermal patch releases 4.6 mg of rivastigmine in 24 hours. Each 10.8 cm2 transdermal patch contains 25.92 mg of rivastigmine.

Alzerta two per week 9.5 mg/24 h transdermal patches:

Each transdermal patch releases 9.5 mg of rivastigmine in 24 hours. Each 21.6 cm2 transdermal patch contains 51.84 mg of rivastigmine.

The other components of the transdermal patch are:

External layer: polyethylene terephthalate film.

Active layer: tocopherol, poly[(2-ethylhexyl)acrylate, vinyl acetate (1:1)], copolymer of butyl acrylate and butyl methacrylate.

Permeable membrane to the drug: polyethylene film

Adhesive layer: medium molecular weight polyisobutylene, high molecular weight polyisobutylene, polybutene.

Release layer: siliconized polyester film.

Blue printing ink.

Product Appearance and Package Contents

Each transdermal patch is a thin, rectangular patch with rounded edges. The patch is translucent and labeled with:

• Alzerta two per week 4.6 mg/24 h transdermal patches:RID-TDS 4.6 mg/24h
• Alzerta two per week 9.5 mg/24 h transdermal patches:RID-TDS 9.5 mg/24h

The transdermal patches come sealed and separated in envelopes. The envelopes are labeled with:

• Alzerta two per week 4.6 mg/24 h transdermal patches
• Alzerta two per week 9.5 mg/24 h transdermal patches

In addition to each transdermal patch, the package includes adhesive covers for fixation.

Each adhesive cover is thin, beige, and oval.

The adhesive covers come sealed and separated in envelopes. The envelopes are labeled with: Adhesive cover without active substance.

Alzerta two per week 4.6 mg/24 h transdermal patchesand Alzerta two per week 9.5 mg/24 h transdermal patchesare available in packages containing 2, 8, 16, or 24 transdermal patches and 2, 8, 16, or 24 adhesive covers.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

Date of the last revision of this prospectus:November2024

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/