Alzerta 4.6 mg/24 h transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Alzerta 4.6 mg/24 h transdermal patches EFG

Alzerta 9.5 mg/24 h transdermal patches EFG

Rivastigmine

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

• Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Alzerta is and what it is used for
2. What you need to know before using Alzerta
3. How to use Alzerta
4. Possible side effects
5. How to store Alzerta
6. Contents of the pack and other information

1. What Alzerta is and what it is used for

The active substance in Alzerta is rivastigmine.

Rivastigmine belongs to the group of cholinesterase inhibitors. In patients with Alzheimer's dementia, certain nerve cells in the brain die, leading to low levels of the neurotransmitter acetylcholine (a substance that enables nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, rivastigmine increases acetylcholine levels in the brain, helping to reduce the symptoms of Alzheimer's disease.

Alzerta is used to treat adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual capacity, and behaviour.

2. What you need to know before starting Alzerta

Do not use Alzerta

• if you are allergic to rivastigmine (the active substance in Alzerta) or to 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 develop a skin reaction that spreads beyond the size of the patch, if you experience a more intense local reaction (such as blisters, skin inflammation, swelling), or if there is no improvement within 48 hours after removing the transdermal patch.

If any of these situations apply to you, inform your doctor and do not use Alzerta transdermal patches.

Warnings and precautions

Talk to your doctor before starting Alzerta:

• if you have or have ever had any heart problems such as irregular or slow heartbeat (pulse), QTc prolongation, a family history of QTc prolongation, torsade 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 a serious respiratory disease.
• if you suffer from tremors.
• if you have low body weight.
• if you experience gastrointestinal reactions such as nausea, vomiting, or diarrhea. You may become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea are prolonged.
• if you have liver problems (hepatic impairment).

If any of these situations apply to you, your doctor may consider closer monitoring during treatment.

If you have not used the patches for more than three days, do not apply a new one without first consulting your doctor.

Children and adolescents

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

Other medicines and Alzerta

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This medicine may interfere with anticholinergic medicines, some of which are 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 should not be used at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause problems such as stiffness in the limbs and hand tremors.

If you need to undergo surgery while using this medicine, inform your doctor that you are using it, as it may excessively enhance the effects of certain muscle relaxants used during anesthesia.

Caution is advised when using this medicine together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking both medicines together may cause complications such as a decreased heart rate (bradycardia), which may lead to fainting or loss of consciousness.

Caution is also advised when using Alzerta 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant, the benefits of using this medicine must be weighed against the potential risks to the fetus. This medicine should not be used during pregnancy unless clearly necessary.

You must not breastfeed while being treated with this medicine.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. This medicine may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive, operate machinery, or perform any other tasks requiring your attention.

3. How to use Alzerta

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

IMPORTANT:

• Remove the previous patch before applying a NEW patch.
• One patch only 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 determine the most appropriate dose of this medicine for your individual case.

• Treatment is usually started with Alzerta 4.6 mg/24 h.
• The usual recommended daily dose is Alzerta 9.5 mg/24 h. If this dose is well tolerated, your treating doctor may consider increasing the dose to 13.3 mg/24 h.
• Wear only one patch of this medicine at a time, and replace the patch with a new one every 24 hours.

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 apply a new one without first consulting your doctor. Transdermal patch treatment may be restarted at the same dose if the treatment has not been interrupted for more than three days. Otherwise, your doctor will instruct you to restart treatment with Alzerta 4.6 mg/24 h.

This medicine may be used with food, drink, and alcohol.

Where to apply your Alzerta transdermal patch

• Before applying a patch, make sure the skin is clean, dry, and hair-free, without powders, oils, moisturizers, or lotions that could prevent the patch from adhering properly, and without cuts, redness, or irritation.

• Carefully remove any existing patch before applying 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 ONE patch per day to ONE of the following areas, as shown in the diagrams below:

• upper left or upper right arm

• upper left or upper right side of the chest (avoiding the breasts in women)

• upper left or upper right side of the back

• lower left or lower right side of the back

Each time the patch is changed, the previous day's patch must be removed before applying the new patch to a different area of 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 before applying a new patch to exactly the same area of skin again.

How to apply your Alzerta transdermal patch

Alzerta patches are thin, tan-colored patches that adhere to the skin. Each patch is enclosed in a protective pouch until ready for use. Do not open the pouch or remove the patch until you are ready to apply it.

If this helps, you can write on the patch, for example the day of the week, using a fine-tipped rounded pen.

You must wear the patch continuously until it is time to replace it with a new one. When applying a new patch, you may try different areas to find those most comfortable for you and where clothing does not rub against the patch.

How to remove your Alzerta transdermal patch

Gently pull one edge of the patch to slowly peel it off the skin. If adhesive residue remains 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 solvent liquids (such as nail polish remover or other solvents).

After removing the patch, wash your hands with soap and water. If contact occurs with the eyes or if the eyes become red after handling the patch, immediately rinse thoroughly with plenty of water and seek medical advice if symptoms do not resolve.

Can you wear your Alzerta transdermal patch while bathing, swimming, or in sunlight?

• Bathing, swimming, or showering should not affect the patch. Make sure it does not partially detach during these activities.

• Do not expose the patch to external heat sources (e.g., excessive sunlight, sauna, sunbed) for prolonged periods.

What to do if your patch falls off

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

When and for how long should you apply your Alzerta transdermal patch?

• To benefit from your treatment, you must apply a new patch every day, preferably at the same time each day.
• 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 contact the Toxicology Information Service at telephone: 91 562 04 20 (indicating the medication and the amount administered). You may require medical attention. Some people who have accidentally taken excessive amounts of rivastigmine have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. Slowing of the heart rate and fainting may also occur.

If you forget to use Alzerta

If you realize you have forgotten to apply a patch, do so immediately. The next day, apply the following patch at your usual time. Do not apply two patches to make up for the missed one.

If you stop using Alzerta

Inform your doctor or pharmacist if you discontinue using the patches.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Alzerta transdermal patches may produce adverse effects, although not everyone experiences them.

You may experience adverse effects more frequently when starting treatment or when your dose is increased. Generally, adverse effects will gradually disappear as your body becomes accustomed to the medicine.

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

Frequent (may affect up to 1 in 10 people)

• Loss of appetite
• Dizziness
• Feeling of restlessness
• Urinary incontinence (inability to properly control urination)
• Urinary tract infection
• Anxiety
• Depression
• Confusion
• Headache
• Fainting
• Stomach problems such as nausea, vomiting, diarrhea
• Heartburn
• Stomach pain
• Rash
• Allergic reaction at the application site, such as blisters or skin swelling
• Feeling tired or weak
• Weight loss
• Fever

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heart rate
• Stomach ulcer
• Dehydration (loss of large amounts 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 arms or legs and
• Tremor in the hands

Not known (cannot be estimated from available data)

• Worsening of signs of Parkinson's disease – such as tremor, stiffness, and difficulty moving
• Inflammation of the pancreas – signs include pain in the upper abdomen, frequently accompanied by nausea or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Epileptic seizures (convulsions)
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, tiredness, and loss of appetite)
• Changes in liver function tests
• Feeling of restlessness
• Nightmares
• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)
• Seeing things that are not there (hallucinations)
• Tremor
• Drowsiness
• Skin rash, itching
• Redness of the skin
• Blisters

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

Other adverse effects reported with rivastigmine capsules or oral solution and which may also occur with patches:

Frequent (may affect up to 1 in 10 people)

• Excessive saliva
• Feeling of restlessness
• General feeling of discomfort
• Tremor
• Increased sweating

Uncommon (may affect up to 1 in 100 people)

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

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

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

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

• High blood pressure
• Inflammation of the pancreas – signs include severe upper abdominal pain, frequently with nausea or vomiting
• Gastrointestinal bleeding – manifested as blood in stools or vomit
• Seeing things that are not there (hallucinations)
• Some people who have experienced severe vomiting have developed a tear in part of the digestive tract connecting the mouth to the stomach (esophagus)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alzerta

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

• Do not use this medicine after the expiry date which is stated on the carton and on the pouch after EXP. The expiry date refers to the last day of the month indicated.

• Store the transdermal patch inside the pouch until ready to use.

• Do not use any patch if it appears damaged or shows signs of tampering.

After removing a patch, fold it in half with the adhesive side facing inwards and press together. Place it into the original pouch and dispose of the patch properly. Do not touch your eyes with your fingers and wash your hands thoroughly with water and soap after removing the patch.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This helps protect the environment.

6. Package contents and other information

Composition of Alzerta

The active substance is rivastigmine.

Alzerta 4.6 mg/24 h transdermal patches EFG:

Each transdermal patch releases 4.6 mg of rivastigmine over 24 hours. Each 4.6 cm² transdermal patch contains 6.9 mg of rivastigmine.

Alzerta 9.5 mg/24 h transdermal patches EFG:

Each transdermal patch releases 9.5 mg of rivastigmine over 24 hours. Each 9.2 cm² transdermal patch contains 13.8 mg of rivastigmine.

The other components are polyethylene-coated laminate/thermoplastic resin/aluminum, poly[(2-ethylhexyl) acrylate, vinyl acetate], medium and high molecular weight polyisobutylene, anhydrous colloidal silica, light liquid paraffin, fluoropolymer-coated polyester film, orange printing ink.

Appearance of the product and contents of the pack

Each transdermal patch is a thin, circular patch. The outer surface is brownish in color and printed in orange ink with:

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

Each transdermal patch is sealed in a pouch. Each transdermal patch is protected by a protective liner. Alzerta 4.6 and 9.5 mg/24 h transdermal patches EFG are available in packs containing 7, 30 or 42 pouches, and in multipacks containing 60 (2x30), 84 (2x42) or 90 (3x30) pouches.

Only certain pack 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 most recent revision of this package leaflet: May 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/