Alzerta 9.5 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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

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

Leaflet contents

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 adverse 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, resulting in low levels of the neurotransmitter acetylcholine (a substance that enables nerve cells to communicate with each other). Rivastigmine works by inhibiting 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 behavior.

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 severe 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 to use Alzerta:

• if you have or have ever had any heart problems such as irregular or slow heart rate (pulse), QTc prolongation, a family history of QTc prolongation, torsade de pointes, or if you have low blood levels of potassium or magnesium.

• if you have or have ever had an active stomach ulcer.

• if you have or have ever had difficulties in urination.

• 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, and diarrhea. You may become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea is prolonged.

• if you have liver problems (hepatic insufficiency).

If any of these situations apply to you, your doctor may consider it necessary to monitor you more closely 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

Inform 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 must not be administered 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 taking it, as it may excessively enhance the effects of certain muscle relaxants used during anesthesia.

Caution is required 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 decrease in heart rate (bradycardia), which may lead to fainting or loss of consciousness.

Caution is also required 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 adverse effects on 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 use machinery safely. This medicine may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive or use machinery or perform any other tasks requiring your attention.

3. How to use Alzerta

Follow exactly the administration instructions for 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 one.
• One patch per day only.
• 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 initiated with Alzerta 4.6 mg/24 h.
• The recommended usual daily dose is Alzerta 9.5 mg/24 h. If this dose is well tolerated, your treating physician 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 interruption does not exceed 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, ensure that 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 breasts in women)

• upper left or upper right back

• lower left or lower right back

Each time you change the patch, remove the previous day's patch before applying a new patch to a different skin site (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 skin area.

How to apply your Alzerta transdermal patch

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

If this helps, you may 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 that are 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 with the eyes occurs 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 to complete that day’s wearing time and replace 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 have accidentally applied more than one patch, remove all patches from the skin and inform your doctor or contact the Toxicology Information Service at telephone number: 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, diarrhoea, high blood pressure, and hallucinations. A slowing of 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 gradually disappear as your body becomes accustomed to the medicine.

If you notice any of the following adverse effects that could 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 urine)
• 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 of tiredness or weakness
• Weight loss
• Fever

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heartbeat
• 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 hands

Not known (cannot be estimated from available data)

• l
• Worsening of signs of Parkinson's disease – such as tremor, rigidity, and difficulty with movement
• Inflammation of the pancreas – symptoms include pain in the upper abdomen, frequently accompanied by nausea or vomiting
• Rapid 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, fatigue, and loss of appetite)
• Changes in blood tests indicating liver function abnormalities
• 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 experienced 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 – likely caused by spasm in the heart

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

• High blood pressure
• Inflammation of the pancreas – symptoms include severe upper abdominal pain, frequently with nausea or vomiting
• Gastrointestinal bleeding – manifested as blood in stools or in 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, consult 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: Website: 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 stated on the carton and on the sachet after EXP. The expiry date refers to the last day of the month indicated.

• Store the transdermal patch inside the sachet until 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 inwards and press firmly. Place it into the original sachet and dispose of the patch appropriately. Avoid touching your eyes with your fingers and wash your hands thoroughly with soap and water after removing the patch.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help 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 polyisobutene, anhydrous colloidal silica, light liquid paraffin, fluoropolymer-coated polyester film, orange printing ink.

Appearance of the product and contents of the container

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 liner. Alzerta 4.6 and 9.5 mg/24 h transdermal patches EFG are available in packages containing 7, 30 or 42 pouches, and in multiple packs containing 60 (2x30), 84 (2x42) or 90 (3x30) pouches.

Only certain 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 latest review of this leaflet: May 2025

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