Rivastigmine Stadafarma 9.5 mg/24 h transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rivastigmine Stadafarma 4.6 mg/24 h transdermal patches EFG

Rivastigmine 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 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 of Rivastigmina Stadafarma is rivastigmine.

Rivastigmine belongs to the class 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 inhibiting the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By inhibiting these enzymes, rivastigmine increases acetylcholine levels in the brain, helping to reduce the symptoms of Alzheimer's disease.

Rivastigmine is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual capacity, 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 difficulties urinating
• if you have or have ever had seizures
• if you have or have ever had asthma or a serious 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 during 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 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 administering this medicine as given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

IMPORTANT:

???Remove the previous patch before applying a new one.

???One patch only 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.

Starting treatment

Your doctor will determine the most appropriate dose of rivastigmine transdermal patch for your condition.

• 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 depending on 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 interruption does not exceed three days. Otherwise, your doctor will instruct you to restart treatment at 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, ensure 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 existing patch 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, tan-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 it is time to apply it.

	Carefully remove the existing patch before applying a new one. Patients starting treatment for the first time and patients restarting rivastigmine treatment after interruption should begin with the second step.
	Each patch is contained in an individual protective pouch. Open the pouch only when you are ready to apply the patch. Cut along both scissors marks on the pouch, but not beyond the lines. Tear open the pouch. Do not cut the entire length of the pouch to avoid damaging the patch. Remove the patch from the pouch.
	Remove and discard the upper skin-colored cover of the patch. A protective liner covers the adhesive side of the patch. Peel back one side of the protective liner and avoid touching the adhesive surface of the patch with your fingers.
	Apply the adhesive side of the patch to the upper or lower back, upper arm, or chest, then remove the second part of the protective liner.
	Press the patch firmly onto the skin with the palm of your hand for at least 30 seconds and ensure the edges are properly adhered.

If this helps, you can 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, 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 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 the product comes into contact with the eyes 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 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 to complete the remainder of that day and change 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 as soon as possible. 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 using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience 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 gets used to the medicine.

If you notice any of the following adverse effects, which may be serious, remove the patch immediately and inform your doctor without delay.

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)

• Problems with your heart rhythm 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 the arms and legs
• Tremor in the hands

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, stiffness, and difficulty moving
• Inflammation of the pancreas – signs include pain in the upper part of the stomach, 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 indicating liver function abnormalities
• 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 immediately and inform your doctor without delay.

Other adverse effects experienced with oral 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
• Restlessness
• General feeling of 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 – 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 – signs include severe pain in the upper stomach, often with nausea or vomiting
• Gastrointestinal bleeding – seen as blood in stools or in vomit
• Seeing things that are not there (hallucinations)
• Some people who have experienced severe vomiting have developed a tear in 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.

Keep 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, dispose of the patch safely, ensuring it remains out of the reach of children. After removing the patch, avoid touching the 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 the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection 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 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 surface is brownish in colour 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 multiple packs containing 60 (2x30), 84 (2x42) or 90 (3x30) sachets.

Only certain pack sizes may be marketed.

Marketing Authorisation 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 of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).