Leaflet: information for the user

Prometax 4,6mg/24h transdermal patch

Prometax 9,5mg/24h transdermal patch

Prometax 13,3mg/24h transdermal patch

rivastigmina

Read this 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, consult your doctor, pharmacist or nurse.
• 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, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

The active ingredient of Prometax 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 acetylcholine neurotransmitters (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, Prometax allows an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease.

Prometax 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 Prometax

• If you are allergic to rivastigmine (the active ingredient in Prometax) or to any of the other components of this medication (listed in section6).
• 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, increased skin inflammation, swelling) and if there is no improvement within 48hours after removing the transdermal patch.

If you find yourself in any of these situations, inform your doctor and do not use Prometax transdermal patches.

Warnings and precautions

Consult your doctor before starting to use Prometax:

• If you have or have had any heart problem such asirregular or slow heart rhythm,prolongation of QTc, 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 ulcer.
• 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 suffer from tremors.
• If you have a low body weight.
• If you have gastrointestinal reactions such as dizziness (nausea), dizziness (vomiting), and diarrhea. You may become dehydrated (loss of a large amount of fluid) if vomiting or diarrhea is 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 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

Prometax should not be used in the pediatric population for the treatment of Alzheimer's disease.

Other medications and Prometax

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

Prometax 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).

Prometax transdermal patches 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.

If you need to undergo surgery while using Prometax transdermal patches, inform your doctor that you are using them, as they may excessively potentiate the effects of some anesthetic muscle relaxants.

Care should be taken when using Prometax transdermal patches 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 decreased heart rate (bradycardia) that may lead to fainting or loss of consciousness.

Care should be taken when using Prometax with other medications 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 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 Prometax against the possible adverse effects on the fetus. Prometax should not be used during pregnancy unless it is clearly necessary.

You should not breastfeed during your treatment with Prometax transdermal patches.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machinery safely. Prometax transdermal patches 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 for Prometax transdermal patches indicated by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

IMPORTANT:

• Remove the previous patch before putting on a new one.
• Only one patch per day.
• Do not cut the patch into pieces.
• Press the patch firmly against the skin with the palm of your hand for at least 30 seconds.

How to start treatment

Your doctor will indicate the most suitable dose of Prometax transdermal patch for your case.

• Normally, treatment starts with Prometax 4.6 mg/24 h.
• The usual recommended daily dose is Prometax 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.
• Only wear one Prometax patch at the same time and replace the patch with a new one every 24 hours.

During treatment, your doctor may adjust the dose depending on your individual needs.

If you have not used the patches for more than three days, do not put on another one before consulting your doctor. The transdermal patch treatment 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 Prometax 4.6 mg/24 h.

Prometax can be used with food, drink, and alcohol.

Where to place your Prometax transdermal patch

• Before putting on a patch, make sure the skin is clean, dry, and hair-free, without powders, oils, moisturizers, or lotions that may prevent the patch from sticking well to the skin, without cuts, redness, or irritation.
• Remove any existing patch carefully before putting on a new one.The wearing of multiple patches on your body may expose you to an excessive amount of this medication, which could be potentially hazardous.
• Put on only ONE patch per day in ONE of the possible areas as shown in the following diagrams:

• upper left or upper right arm
• upper left or upper right 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 patch before putting on 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 to put a new patch in the same area of the skin again.

How to apply your Prometax transdermal patch

Prometax patches are thin, opaque plastic and stick to the skin. Each patch is in a protective envelope that protects it until you put it on. Do not open the envelope or remove the patch until you are ready to put it on.

You must wear the patch continuously until you replace it with a new one. When putting on 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 Prometax 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 Prometax 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 partially while doing these activities.

• Do not expose the patch to an external heat source (e.g. excessive sunlight, sauna, sunbed) for long periods of time.

What to do if a patch falls off

If a patch falls off, put on a new one for the rest of the day and change it the next day at the usual time.

When and for how long should you wear your Prometax transdermal patch

• To benefit from your treatment, you must put on a new patch every day, preferably at the same time.
• Only wear one Prometax patch at the same time and replace the patch with a new one every 24 hours.

If you use more Prometax than you should

If you accidentally put on more than one patch, remove all the patches from the skin and inform your doctor. You may need medical attention. Some people who have taken accidentally high doses of Prometax orally have had a feeling of discomfort (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. They may also experience a slowing of heart rate and fainting.

If you forget to use Prometax

If you realize you have forgotten to put on a patch, put it on immediately. The next day, put on the next patch at the usual time. Do not put on two patches to compensate for the one you forgot.

If you interrupt treatment with Prometax

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 medicines, Prometax 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 medicine.

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).

Infrequent(may affect up to 1 in 100 people)

• Problems with your heart rhythm such as slow heart rate
• Seeing things that are not really there (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)

• Rigidity of the 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
• Pancreatitis – symptoms include upper abdominal pain, often accompanied by nausea or vomiting
• Irregular heart rhythm or rapid heart rate
• High blood pressure
• Seizures (convulsions)
• 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 anxiety
• Nightmares
• Torticollis (a condition that involves involuntary muscle contraction and abnormal tilting of the body and head to one side).

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

Other side effects experienced with Prometax 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

Infrequent(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 heart spasms

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

• High blood pressure
• Pancreatitis – symptoms include severe upper abdominal pain, often accompanied by nausea or vomiting
• Gastrointestinal bleeding – manifested as blood in the stool or vomiting blood
• Seeing things that are not really there (hallucinations)
• Some people who have been severely nauseated (vomiting) have had a tear in the esophagus, the tube that connects their mouth to their stomach.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it 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: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

• Do not use this medication after the expiration date that appears on the box and on the package after CAD/EXP. The expiration date is the last day of the month indicated.

• Do not store at a temperature above 25°C.
• Store the transdermal patch inside the package until use.
• 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 inwards and press. After placing it in the original package, when disposing of the patch, ensure it remains out of the reach of children. After removing the patch, do not touch your eyes, and wash your hands thoroughly with water and soap.Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Prometax

-The active ingredient is rivastigmina.

-Prometax 4,6mg/24h transdermal patch: Each patch releasing 4,6mg of rivastigmina in 24hours, measures 5cm2and contains 9mg of rivastigmina.

-Prometax 9,5mg/24h transdermal patch: Each patch releasing 9,5mg of rivastigmina in 24hours, measures 10cm2and contains 18mg of rivastigmina.

-Prometax 13,3mg/24h transdermal patch: Each patch releasing 13,3mg of rivastigmina in 24hours, measures 15cm2and contains 27mg of rivastigmina.

-The other components are laminated polyethylene terephthalate, alpha tocopherol, poly-(butylmethacrylate, methylmethacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film coated with fluoropolymer.

Appearance of the product and contents of the package

Transdermal patch composed of three layers. The outer layer is beige and marked with:

-«Prometax», «4.6mg/24h» and «AMCX».

-«Prometax», «9.5mg/24h» and «BHDI».

-«Prometax», «13.3mg/24h» and «CNFU».

Each blister pack contains a transdermal patch. The patches are available in packages containing 7 or 30blister packs and in multi-packages containing 60 or 90blister packs. Only some package sizes may be marketed.

Marketing Authorization Holder

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

Manufacturer

LTS Lohmann Therapie – Systeme AG

Lohmannstrasse 2

56626 Andernach

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

België/Belgique/Belgien,????????,Ceská republika,Danmark,Deutschland,Eesti,Ελλ?δα,España, France,Hrvatska,Ireland,Ísland,Italia,Κ?προς,Latvija,Lietuva,Luxembourg/Luxemburg,Magyarország,Malta,Nederland,Norge,Österreich,Polska, Portugal,România,Slovenija,Slovenská republika,Suomi/Finland,Sverige

Almirall, S.A.

Tél/Tel/Te?./Tlf./Τηλ/Sími/Tel./Tlf/Puh: +34 93 306 42 00

Last update of this leaflet: 12/2024

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu