Rivastigmine Stadafarma 4.6 mg/24 h transdermal patches EFG

Package leaflet: Information for the user

Introduction

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

Contents of the leaflet

1. What Rivastigmina Stadafarma is and what it is used for
2. What you need to know before using Rivastigmina Stadafarma
3. How to use Rivastigmina Stadafarma
4. Possible adverse effects
5. How to store Rivastigmina 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 increases the levels of acetylcholine 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 ability, and behaviour.

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 develop a skin reaction that spreads beyond the size of the patch, if you experience 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 heartbeat (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 difficulty urinating
• if you have or have ever had seizures
• if you have or have ever had asthma or a severe respiratory disease
• if you experience tremors
• if you have low body weight
• if you have 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 it, 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 a decrease in 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 risks to 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 using this medicine given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse 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 doctor 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. Treatment with the transdermal patch may be restarted at the same dose if the treatment interruption was no longer 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, 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 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 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 applying a new patch to the exact same skin area.

How to apply your rivastigmine transdermal patch

Rivastigmine patches are thin, beige-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 the time of application.

If this helps, you can write on the patch, for example the day of the week, using a pen with a fine rounded tip.

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 rivastigmine transdermal patch

Gently pull one edge of the patch to slowly peel it away from 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, hands should be washed 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 persist.

Can you wear your rivastigmine 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 for the remainder of that day and replace it at your usual time the next day.

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. You may require medical attention. Some people who have accidentally taken excessive oral doses of rivastigmine have experienced discomfort (nausea), vomiting, diarrhea, 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 telephone number: 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
• Feeling agitated or drowsy
• 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 tremors

Frequency not known (cannot be estimated from available data)

• Allergic reaction at the site of application, such as blisters or skin inflammation
• Worsening of signs of Parkinson's disease – such as tremor, rigidity, and difficulty moving
• Inflammation of the pancreas – symptoms 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, unusually dark urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Changes in liver function tests
• 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 reported with rivastigmine capsules or oral solution, which may also occur with the patches:

Frequent (may affect up to 1 in 10 people)

• Excessive salivation
• Loss of appetite
• Feeling agitated
• General feeling of discomfort
• Tremor or feeling confused
• Increased sweating

Uncommon (may affect up to 1 in 100 people)

• Irregular heart rhythm (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 – possibly due to 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, often with nausea or vomiting
• Gastrointestinal bleeding – seen as blood in the stool or in vomit
• Seeing things that are not there (hallucinations)
• Some people who have experienced severe vomiting have developed a tear in the tube 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.

Keep the transdermal patch inside the sachet until it is used.

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, dispose of the patch safely, ensuring it remains out of the reach of children. After removing the patch, avoid touching your eyes and wash your hands thoroughly with water and soap. 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 their original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging 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.

Rivastigmina Stadafarma 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.

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

Nature of the product and contents of the pack

Thin, round transdermal patch. The outer layer is brownish in color and printed in orange ink with:

• “RIV-TDS 4.6 mg/24 h”
• “RIV-TDS 9.5 mg/24 h”

Each sachet 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 packs containing 7, 30 or 42 sachets, and in multipacks containing 60 (2x30), 84 (2x42) or 90 (3x30) sachets.

Some pack sizes may not 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 revision of this leaflet: April 2025

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