Rivastigmine Stadafarma 13.3 mg/24 h transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rivastigmine Stadafarma 13.3 mg/24 h transdermal patches EFG

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

Contents of the leaflet

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

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

The active substance in Rivastigmina Stadafarma 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 blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, rivastigmine allows an increase in acetylcholine levels in the brain, helping to reduce the symptoms of Alzheimer's disease.

Rivastigmine 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 using Rivastigmina Stadafarma

Do not use Rivastigmina Stadafarma

• if you are allergic to rivastigmine (the active substance) 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 experience a skin reaction that spreads beyond the size of the patch, if you have a more intense local reaction (such as blisters, increasing 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 rivastigmine transdermal patches.

Warnings and precautions

Talk to your doctor before starting to use rivastigmine:

• if you have or have ever had heart problems such as irregular or slow heart rate (pulse), QTc prolongation, 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 severe 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 are prolonged.
• if you have liver problems (hepatic insufficiency)

If any of these situations apply to you, your doctor may consider closer monitoring while you are on 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

Rivastigmine must not be used in the pediatric population for the treatment of Alzheimer's disease.

Other medicines and Rivastigmina Stadafarma

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

Rivastigmine 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).

Rivastigmine transdermal patches 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 rivastigmine transdermal patches, inform your doctor that you are using this medicine, as it may excessively enhance the effects of certain muscle relaxants used during anesthesia.

Caution is advised when using rivastigmine transdermal patches 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 decreased heart rate (bradycardia), which may lead to fainting or loss of consciousness.

Caution is also advised when using rivastigmine 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 rivastigmine must be weighed against the potential adverse effects on the fetus. Rivastigmine must not be used during pregnancy unless clearly necessary.

You must not breastfeed during treatment with rivastigmine transdermal patches.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Rivastigmine transdermal patches 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 Rivastigmina Stadafarma

Follow exactly the instructions for the administration of rivastigmine transdermal patches 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 rivastigmine transdermal patch for your individual case.

• Treatment is usually started 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, your treating physician 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.

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 rivastigmine 4.6 mg/24 h.

Rivastigmine may be used with food, drink, and alcohol.

Where to apply your rivastigmine 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 to the skin, and without cuts, redness, or irritation.

? Carefully remove any patch you are currently wearing before applying a new one. Wearing multiple patches on your body could expose you to an excessive amount of this medication, which could be potentially dangerous.

? Apply ONLY ONE patch per day to ONE of the following possible sites, as shown in the diagrams below:

• 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 applying the new one 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 reapplying a new patch to the exact same skin area.

How to apply your rivastigmine transdermal patch

Rivastigmine patches are thin, brownish in color, and 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 the time of application.

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 most comfortable for you 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 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 rivastigmine transdermal patch while bathing, swimming, or in the sun?

? 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, and then change it the next day at your usual time.

When and for how long should you apply your rivastigmine 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 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 have accidentally applied more than one patch, remove all patches from the skin and inform your doctor. Medical attention may be needed. Some people who have accidentally taken excessive oral doses of rivastigmine have experienced discomfort (nausea), vomiting, diarrhoea, high blood pressure, and hallucinations. Slowing of the heart rate and fainting may also occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 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 Rivastigmina Stadafarma

Inform your doctor or pharmacist if you stop 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, this medicine can cause 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
• Sensation of restlessness or numbness
• Urinary incontinence (inability to properly control urination)

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heartbeat
• Seeing things that are not really there (hallucinations)
• 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 and legs
• Hand tremor

Not known (cannot be estimated from available data)

• Allergic reaction at the site of patch application, such as blisters or skin swelling
• 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 blood tests showing 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)

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
• Loss of appetite
• Restlessness
• Feeling of general discomfort
• Tremor or confusion
• 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 pain in the upper abdomen, often with nausea or vomiting
• Gastrointestinal bleeding – manifested as blood in stools or in vomit
• Seeing things that are not real (hallucinations)
• Some people who have experienced severe vomiting have developed a tear in the 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmine Stadafarma

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 the time of 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. After placing it back into the original sachet, ensure that it is kept out of the reach of children. After removing the patch, avoid touching the eyes and wash your hands thoroughly with soap and water. If your household waste is disposed of by incineration, you may discard the patch in your household waste. Otherwise, return used patches to the pharmacy, preferably in the original packaging.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmina Stadafarma

The active substance is rivastigmine.

Each transdermal patch releases 13.3 mg of rivastigmine over 24 hours. Each 12.8 cm² transdermal patch contains 19.2 mg of rivastigmine.

The other components are: polyethylene / thermoplastic resin / polyester film coated with 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 pack

Thin, circular transdermal patch. The outer layer is brownish in color and printed in orange ink with: “RIV-TDS 13.3 mg/24 h”.

Each pouch contains one transdermal patch.

Rivastigmina Stadafarma 13.3 mg/24 h is available in packs containing 7 or 30 pouches, and in multiple packs containing 60 (2x30) or 90 (3x30) pouches.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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

Date of the most recent review of this leaflet: April 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).