Rivastigmine Kern Pharma 9.5 mg/24 h transdermal patches EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivastigmina Kern Pharma 4.6 mg/24 h transdermal patches EFG

Rivastigmina Kern Pharma 9.5 mg/24 h transdermal patches EFG

Rivastigmina Kern Pharma 13.3 mg/24 h transdermal patches EFG

Read this 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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Rivastigmina Kern Pharma is and what it is used for

The active substance of Rivastigmina Kern Pharma is rivastigmine.

Rivastigmine belongs to a group of medicines called 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 allows 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 capacity, and behaviour.

2. What you need to know before starting Rivastigmina Kern Pharma

Do not use Rivastigmina Kern Pharma

• If you are allergic to rivastigmine (the active substance in Rivastigmina Kern Pharma) 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 there is 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 Rivastigmina Kern Pharma.

Warnings and precautions

Talk to your doctor or pharmacist before starting Rivastigmina Kern Pharma.

• If you have or have ever had an irregular or slow heart rate (pulse).
• 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 experience tremors.
• If you have low body weight.
• If you have gastrointestinal reactions such as feeling sick (nausea), sickness (vomiting), or diarrhoea. You may become dehydrated (loss of large amounts of fluid) if vomiting or diarrhoea is prolonged.
• If you have liver problems (hepatic insufficiency).

If any of these situations apply to you, your doctor may consider it necessary to monitor you more closely during treatment.

If you have not used the patches for several days, do not apply a new one without first consulting your doctor.

Use in children and adolescents

Rivastigmina Kern Pharma must not be used in the paediatric population for the treatment of Alzheimer's disease.

Taking Rivastigmina Kern Pharmawith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Rivastigmina Kern Pharma may interfere with anticholinergic medicines, some of which are used to relieve stomach cramps or spasms (e.g. dicycloverine), for the treatment of Parkinson's disease (e.g. amantadine), or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).

This medicine 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 Rivastigmina Kern Pharma transdermal patches, inform your doctor that you are using this medicine, as it may excessively enhance the effects of certain muscle relaxants used during anaesthesia.

Caution is advised when using Rivastigmina 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.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, 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 foetus. Rivastigmina Kern Pharma must not be used during pregnancy unless clearly necessary.

You must not breast-feed during treatment with Rivastigmina Kern Pharma transdermal patches.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Rivastigmina 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 Kern Pharma

Follow exactly the administration instructions for this medicine as described in this leaflet and as directed by your doctor. If in doubt, consult your doctor, pharmacist, or nurse.

IMPORTANT:

• Remove the previous patch before applying 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.

Starting treatment

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

• 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 Rivastigmina Kern Pharma 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 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 with rivastigmine 4.6 mg/24 h.

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

Where to apply your Rivastigmina Kern Pharma transdermal patch

• Before applying a patch, ensure that 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

Every 24 hours, remove the previous patch before applying a new one to only one of the following possible areas.

Each time you change the patch, remove the patch from the previous day before applying the new patch to a different area of 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 before applying a new patch to exactly the same area of skin.

How to apply your Rivastigmina Kern Pharma transdermal patch

Rivastigmine patches are thin, translucent plastic 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 any existing patch before applying a new one.

• Each patch is contained in an individual protective pouch. Open the pouch only when you are ready to apply the patch.

Cut the pouch at one end with scissors and remove the patch from the pouch.

• A split protective liner covers the adhesive side of the patch. Remove the first half of the liner without touching the adhesive surface with your fingers.

• Place the adhesive side of the patch on the lower back, upper back, upper arm, or chest (avoiding breasts in women), then remove the second half of the protective liner.

• Press the patch firmly with the palm of your hand for at least 30 seconds, ensuring that the edges are properly adhered.

If helpful, you may write something on the patch, such as the day of the week, using a pen with a fine rounded tip.

The patch should be worn continuously until it is time to replace it with a new one. When applying a new patch, you may try different sites to find the most comfortable areas where clothing does not rub against the patch.

How to remove your Rivastigmina Kern Pharma 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, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.

Can you wear your Rivastigmina Kern Pharma transdermal patch when bathing, swimming, or being exposed to 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 the patch falls off

If the patch falls off, apply a new one for the remainder of that day and change it the next day at the usual time.

When and for how long to wear your Rivastigmina Kern Pharma transdermal patch

• To benefit from your treatment, apply a new patch every day, preferably at the same time.
• Wear only one rivastigmine transdermal patch at a time and replace the patch with a new one every 24 hours.

If you use more Rivastigmina Kern Pharma than you should

If you have accidentally applied more than one patch, remove all patches from the skin and inform your doctor or pharmacist, or call the Toxicology Information Service at telephone: 91 562 04 20 (indicating the medicine and amount administered). Medical attention may be required. Some people who have accidentally taken excessively high amounts of rivastigmine orally have experienced discomfort (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. A slowing of heart rate and fainting may also occur.

If you forget to use Rivastigmina Kern Pharma

If you realize you have forgotten to apply a patch, do so immediately. The next day, apply the following patch at the usual time. Do not apply two patches to make up for the missed one.

If you stop using Rivastigmina Kern Pharma

Inform your doctor or pharmacist if you discontinue use of 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, Rivastigmine Kern Pharma transdermal patches 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 gets used 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)
• Aggression

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)

• Pisa syndrome (a condition involving involuntary muscle contractions and abnormal tilting of the body and head to one side)
• 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 – symptoms include upper abdominal pain, often accompanied by nausea or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Epileptic seizures (fits)
• 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 liver function tests
• Restlessness
• Nightmares

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

Other adverse effects observed with Rivastigmine capsules or oral solution, which may also occur with the patches:

Frequent (may affect up to 1 in 10 people)

• Excessive saliva
• Loss of appetite
• Feeling agitated
• 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 (fits)
• 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 – 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 part of the digestive tube connecting the mouth to the stomach (oesophagus)

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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmine Kern Pharma

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. 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 facing inwards and press firmly. After placing it back into the original sachet, ensure it is disposed of safely and kept out of the reach of children. After removing the patch, avoid touching your eyes and wash your hands thoroughly with soap and water. If 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 drains or household waste bins. Instead, dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Package contents and other information

Composition of Rivastigmina Kern Pharma

The active substance is rivastigmine:

• Rivastigmina Kern Pharma 4.6 mg/24 h transdermal patches EFG: Each patch releases 4.6 mg of rivastigmine over 24 hours, measures 5 cm² and contains 9 mg of rivastigmine.

• Rivastigmina Kern Pharma 9.5 mg/24 h transdermal patches EFG: Each patch releases 9.5 mg of rivastigmine over 24 hours, measures 10 cm² and contains 18 mg of rivastigmine.

• Rivastigmina Kern Pharma 13.3 mg/24 h transdermal patches EFG: Each patch releases 13.3 mg of rivastigmine over 24 hours, measures 15 cm² and contains 27 mg of rivastigmine.

• Other components are: film [polyester sheet, silicone-coated polyester film, and fluoropolymer-coated polyester film], drug matrix [acrylic adhesive (2-ethylhexyl acrylate, methyl acrylate and acrylic acid), acrylic copolymer (butyl methacrylate, co-methyl methacrylate) and ethyl acetate] and adhesive matrix [adhesive silicone].

Nature of the product and pack contents

Each sachet contains one transdermal patch. The outer surface is white and marked with “Rivastigmina 4.6 mg/24 h”, “Rivastigmina 9.5 mg/24 h” or “Rivastigmina 13.3 mg/24 h”.

The patches are available in packaging containing 60 sachets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

PHAST Gesellschaft für Pharmazeutische Qualitätsstandards GmbH

Kardinal-Wendel-Strasse 16

D-66424 Homburg, Germany

Date of the most recent revision of this package leaflet: January 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