Product Information for the Patient

Rivastigmina Stadafarma 4.6 mg/24 h Transdermal Patches EFG

Rivastigmina Stadafarma 9.5 mg/24 h Transdermal Patches EFG

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

-Keep this product information, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

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

1.What is Rivastigmina Stadafarma and what is it used for

2.What you need to know before starting to use Rivastigmina Stadafarma

3.How to use Rivastigmina Stadafarma

4.Possible adverse effects

5.Storage of Rivastigmina Stadafarma

6.Contents of the package and additional information

The active ingredient of Rivastigmina Stadafarma is rivastigmina.

Rivastigmina belongs to the group of cholinesterase inhibitors. In patients with Alzheimer's disease, certain nerve cells die in the brain, causing low levels of acetylcholine neurotransmitters (a substance that allows nerve cells to communicate with each other). Rivastigmina acts by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, rivastigmina allows an increase in acetylcholine in the brain, helping to reduce the symptoms of Alzheimer's disease.

Rivastigmina 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 Rivastigmina Stadafarma

-if you are allergic to rivastigmina (the active ingredient) or to any of the other components of this medication (listed in section 6).

-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 48 hours after removing the transdermal patch.

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

Warnings and precautions

Consult your doctor before starting to use Rivastigmina Stadafarma:

-if you have or have had any irregular or slow heart rhythm.

-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 asthma or 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

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

Other medications and Rivastigmina Stadafarma

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

Rivastigmina may interfere with anticholinergic medications, some of which are medications 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).

Rivastigmina 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 rivastigmina 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 rivastigmina transdermal patches with beta blockers (medications such as atenolol used to treat hypertension, angina, and other cardiovascular conditions). Taking the two medications together may cause complications such as a decrease in heart rate (bradycardia) that may lead to dizziness or loss of consciousness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machinery safely. Rivastigmina transdermal patches may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive, operate machinery, or engage in 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, 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 rivastigmine transdermal patch for your case.

-Normally, treatment starts with rivastigmine 4.6 mg/24 h.

-The usual recommended daily dose is rivastigmine 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.

-Wear only one transdermal patch at a time and replace the patch with a new one every 24 hours.

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 put on 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 rivastigmine 4.6 mg/24 h.

Rivastigmine can be used with food, drink and alcohol.

Where to place your rivastigmine 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 inONEof the possible areas 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 day's 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 rivastigmine transdermal patch

The rivastigmine patches are thin, brown-colored and stick to the skin. Each patch is found 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.

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

You must wear the patch continuously until you change it for 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 rivastigmine transdermal patch

Gently pull one edge of the patch to slowly peel it off 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 rivastigmine 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, solarium)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 rivastigmine transdermal patch?

?To benefit from your treatment, you must put on a new patch every day, preferably at the same time.

?Wear only one rivastigmine patch at a time and replace the patch with a new one every 24 hours.

If you use more Rivastigmina Stadafarma 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 accidentally taken too much rivastigmine orally have experienced nausea, vomiting, diarrhea, high blood pressure and hallucinations. They may also experience a slowing of heart rate and dizziness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Rivastigmina Stadafarma

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 Rivastigmina Stadafarma

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

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can 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. Side effects usually disappear gradually as your body gets used to the medicine.

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

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)

?Hypervigilance (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 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 severe upper stomach 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 whites of the eyes, darkening of the urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)

?Changes in liver function tests

?Sensation of anxiety

?Nightmares

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

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 - probably caused by a spasm in the heart

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

?High blood pressure

?Pancreatitis - symptoms include severe upper stomach pain, often accompanied by nausea or vomiting

?Gastrointestinal bleeding - manifested as blood in the stool or vomiting blood

?Seeing things that do not exist (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 or pharmacist, 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: https://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. The expiration date is the last day of the month indicated.

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, ensure that it is out of the reach of children. After removing the patch, do not touch your eyes, and wash your hands thoroughly with water and soap. If your household waste is disposed of by incineration, you can throw the patch in your household waste. If not, take the used patches to the pharmacy, preferably in the original packaging.

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

Rivastigmina Stadafarma Composition

The active ingredient is rivastigmina.

Rivastigmina Stadafarma 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.

Rivastigmina Stadafarma 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: polyethylene / thermoplastic resin / aluminum-coated polyester film, poly [(2-ethylhexyl) acrylate, vinyl acetate], medium and high molecular weight polyisobutene, anhydrous colloidal silica, light liquid paraffin, polyester film coated with fluoropolymer, orange printing ink.

Product appearance and packaging contents

Thin, circular transdermal patch. The outer layer is brown and marked in orange ink with:

- “RIV-TDS 4.6 mg/24 h”

- “RIV-TDS 9.5 mg/24 h”

Each package contains one transdermal patch. Each transdermal patch is protected by a protective liner.

Rivastigmina Stadafarma 4.6 mg/24 h and Rivastigmina Stadafarma 9.5 mg/24 h are available in packages containing 7, 30, or 42 packages and multiple packages containing 60 (2x30), 84 (2x42), or 90 (3x30) packages.

Only some package sizes may be commercially available.

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible person for manufacturing

Luye Pharma AG

Am Windfeld 35, 83714 Miesbach

Germany

or

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2, A-1190 Wien

Austria

Last review date of this leaflet:June 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).