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.
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 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 find yourself in any of these situations, your doctor may consider the need for closer monitoring while you are being treated.
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. amantadina), or to prevent motion sickness (e.g. difenhidramina, escopolamina, or meclizina).
This medicationshould 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.
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 medicationwith 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 of QT).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, or if you 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 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.
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
Every 24 hours, remove the previous patch before applying a new one in only one of the possible areas. |
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 before reapplying a patch to the same area of skin.
How to apply your Alzerta transdermal patch
Alzerta patches are thin, brown, and adhere to the skin. Each patch is found in a protective envelope that protects it until it is applied. Do not open the envelope or remove the patch until you are ready to apply it.
Remove the existing patch carefully before applying a new one. Patients starting treatment for the first time and patients restarting treatment with rivastigmine after interrupting treatment should start with the second figure. | |
Each patch is found in an individual protective envelope. Only open the envelope when you are ready to apply the patch. Open the envelope by cutting along both scissors marks, but not beyond the indicated line. Do not cut the entire length of the envelope to avoid damaging the patch. Remove the patch from the envelope. | |
Remove the top cover from the patch, on the beige side, and discard it. A protective layer covers the adhesive side of the patch. Remove the first layer of the protective layer without touching the adhesive side of the patch with your fingers. | |
Place the adhesive side of the patch on the upper or lower back or on the arm or chest and then remove the second layer of the protective layer. | |
Press the patch firmly against the skin with the palm of your hand for at least 30seconds and ensure that the edges have adhered well. |
IMPORTANT:
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 change it for 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 of the edges 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?
What to do if a patch falls off
If a patch falls off, apply a new one for the rest of the day and change it the next day at the usual time.
How long and when should you wear your Alzerta transdermal patch?
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 amounts of rivastigmine have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations.They may also experience a slowing of heart rate and dizziness.
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)
Poorly frequent(may affect up to 1 in 100 people)
Rare(may affect up to 1 in 1,000 people)
Very rare(may affect up to 1 in 10,000 people)
Unknown(cannot be estimated from available data)
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)
Poorly frequent(may affect up to 1 in 100 people)
Rare(may affect up to 1 in 1,000 people)
Very rare(may affect up to 1 in 10,000 people)
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.
After removing a patch, fold it in half with the adhesive side inward and press. After placing it in the original overwrap, 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 may dispose of the patch in your household waste.
Medications should not be disposed of through drains 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. This way, you will help protect the environment.
The active ingredient 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 content of the container
Each transdermal patch is a thin, circular patch. The outer layer is a toasted color and carries the following orange printing:
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 containers containing 7, 30, or 42 sachets and in multiple containers containing 60 (2x30), 84 (2x42), or 90 (3x30) sachets.
Only some container 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
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/
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.