Patient Information Leaflet: Package Insert

Alzerta two times a week 4.6 mg/24 h transdermal patches

Alzerta two times a week 9.5 mg/24 h transdermal patches

Rivastigmina

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to use Alzerta two times a week

4. Possible side effects

5. Storage of Alzerta two times a week

6. Contents of the pack and additional information

The active ingredient of Alzerta two times a week is rivastigmine.

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

Alzerta two times a week 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 dos por week

• if you are allergic to rivastigmine (the active ingredient in Alzerta dos por week) or to any of the other components (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, 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 dos por week transdermal patches.

Warnings and precautions

Consult your doctor before starting to use Alzerta dos por week:

• if you have or have had any heart problems such as irregular or slow heart rhythm, QTc prolongation, family history of QTc prolongation, 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 severe respiratory disease.
• if you have 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 put another one on without consulting your doctor.

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

Children and adolescents

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

Other medicines and Alzerta dos por week

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

This medicine may interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. diciclomina), for the treatment of Parkinson's disease (e.g. amantadina) or to prevent motion sickness (e.g. difenhidramina, escopolamina, or meclizina).

This medicine should not be administered at the same time as metoclopramida (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 tremor.

If you need to undergo surgery while using this medicine, 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 medicine 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 may lead to fainting or loss of consciousness.

Caution should be exercised when using Alzerta dos por week together with other medicines that may affect heart rhythm or the heart's electrical system (QT prolongation).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

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

You should not breastfeed during your treatment with this medicine.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machinery safely. This medicine may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive, use machinery, or engage in other tasks that require your attention.

Follow exactly the administration instructions of this medication as 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 with Alzerta two times a week starts with a dose of 4.6 mg/24 h.
• The usual recommended daily dose is 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. The dose of 13.3 mg/24 h cannot be achieved with Alzerta two times a week. For states where this dosage is required, other patches of rivastigmine containing the dose of 13.3 mg/24 h are available.
• Wear only one transdermal patchrectangularand one oval adhesive cover at the same time (as detailed below) andreplace them two times a week, at most after 4 days.

You must change the patches ontwo 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.

Change the patches always at the same time of the day. As a reminder, you should note these days and the time of the day.

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 another one before 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 two times a week 4.6 mg/24 h.

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

Where to place your Alzerta two times a week transdermal patch

• Beforeapplying 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 carefully any existing patch before applying a new one.The wearing of multiple patches on your body may expose you to an excessive amount of this medication andthis could be potentially hazardous.
• ApplyONEtransdermal patch rectangular along with one oval adhesive cover inONEof the possible areas as shown in the following diagrams:

• upper part of the left or right armorupper part of the left or right chest(avoiding the breasts)
• upper part of the left or right back
• lower part of the left or right back

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

Howto apply your Alzerta two times a week transdermal patch

Alzerta two times a week is for transdermal use.

The Alzerta two times a week patches are formed of two parts:

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

Do not open the package or remove the patch until the time to apply it.

The applicationalwaysstarts with the transdermal patchrectangular.

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

You must wear the patch continuously until you change it for a new one. When applying a new patch, you can try different areas to find the ones that are most comfortable for you and where your clothes do not rub against the patch.

How to remove your Alzerta two times a week transdermal patch

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

If the transdermal patch remains on the skin, gently pull one edge until it comes off completely from the skin.

If there are 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 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 two times 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 performing 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, apply a new one and change it at the usual time.

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

• To benefit from your treatment, you must apply a new patch two times a week, at most after 4 days, preferably at the same time of the day.

• Wear only one transdermal patch rectangular and one oval adhesive cover at the same time and replace the patch with a new one two times a week ontwo fixed days.

If you use more Alzerta two times a week than you should

If you accidentally applied more than one transdermal patchrectangular, 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 amounts of rivastigmine have had nausea, vomiting, diarrhea, high blood pressure, and hallucinations.Slowing of heart rate and fainting may also occur.

If you forgot to use Alzerta two times a week

If you realize you forgot 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 the day to return to your dosing schedule.

Do not apply two patches to compensate for the one you forgot. If you have not applied a patch for more than three days, do not apply the next one before speaking with your doctor.

If you interrupt treatment with Alzerta two times 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.

Like all medications, this medication 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
• Trembling 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)

• Organic 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 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

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

• Irregular heart rhythm (e.g. rapid 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 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 part of 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 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 on 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 blister pack after CAD. The expiration date is the last day of the month indicated.
• This medication does not require special conditions for conservation.

• 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 inward and press. After placing it in its container, dispose of the patch in a way that children cannot manipulate it.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Alzerta two times a week

The active ingredient is rivastigmine.

Alzerta two times a week 4.6 mg/24 h transdermal patches:

Each transdermal patch releases 4.6 mg of rivastigmine in 24 hours. Each transdermal patch of 10.8 cm2contains 25.92 mg of rivastigmine.

Alzerta two times a week 9.5 mg/24 h transdermal patches:

Each transdermal patch releases 9.5 mg of rivastigmine in 24 hours. Each transdermal patch of 21.6 cm2contains 51.84 mg of rivastigmine.

The other components of the transdermal patch are:

Outer film:polyethylene terephthalate film.

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

Permeable drug membrane:polyethylene film.

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

Release film:siliconized polyester film.

Blue printing ink.

Appearance of the product and contents of the package

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

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

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

• Alzerta two times a week 4.6 mg/24 h transdermal patches
• Alzerta two times a 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 are sealed and separated in blisters. The blisters are labeled with: Adhesive cover without active substance.

Alzerta two times a week 4.6 mg/24 h transdermal patchesandAlzerta two times a 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 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:November2024

The 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/