Rivastigmine Kern Pharma 13.3 mg/24 h transdermal patches EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivastigmine Kern Pharma 4.6 mg/24 h transdermal patches EFG

Rivastigmine Kern Pharma 9.5 mg/24 h transdermal patches EFG

Rivastigmine Kern Pharma 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, ask your doctor or pharmacist.
• 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 or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rivastigmine Kern Pharma is and what it is used for
2. What you need to know before using Rivastigmine Kern Pharma
3. How to use Rivastigmine Kern Pharma
4. Possible side effects
5. How to store Rivastigmine 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 in 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 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 capacity, and behaviour.

2. What you need to know before using Rivastigmine Kern Pharma

Do not use Rivastigmine Kern Pharma

• if you are allergic to rivastigmine (the active substance in this medicine) 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.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use this medicine.

• 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 experience gastrointestinal reactions such as nausea, vomiting, and diarrhea. You could 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 it necessary to carry out closer monitoring while you are on 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

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

Use of Rivastigmine Kern Pharms with other medicines

Inform 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).

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 rivastigmine transdermal patches, inform your doctor that you are using them, as they 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 decreased heart rate (bradycardia), which may lead to fainting or loss of consciousness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might 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 should not be used during pregnancy unless clearly necessary.

You must not breastfeed during treatment with this medicine.

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 or use machinery or perform any other tasks requiring your attention.

3. How to use Rivastigmina Kern Pharma

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

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.

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 doctor may consider increasing the dose to 13.3 mg/24 h.
• Wear only one rivastigmine 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 can 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 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, 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 patch to only one of the possible areas listed above.

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; or one day on the upper body and the next day on the lower body). Wait at least 14 days before reapplying a patch to the exact same skin area.

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 the time of application.

Carefully remove the existing patch before applying a new one.

• Each patch is individually packaged in a 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.

• 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 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 and ensure the edges are properly adhered.

If helpful, you may write on the patch (e.g., the day of the week) using a fine-tipped rounded ballpoint pen.

The patch should be worn continuously until it is time to replace it with a new one. When applying a new patch, try different sites to find the most comfortable location 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 you have contact with your eyes or if your eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms persist.

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 the patch falls off

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

When and for how long to apply 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 it with a new one every 24 hours.

If you use more Rivastigmina Kern Pharma than you should

If you accidentally apply more than one patch, remove all patches from the skin and inform your doctor or pharmacist, or contact the Toxicology Information Service at telephone: 91 562 04 20 (indicating the medicine and amount administered). 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 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 your 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 stop using the patches.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

You may experience side effects more frequently when you first start treatment or when your dose is increased. Generally, side effects will gradually disappear as your body gets used to the medicine.

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

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Dizziness
• Feeling 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 heart rate
• 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 (frequency 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 the patch, 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 pain in the upper part of the stomach, often 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
• Feeling of restlessness
• Nightmares

If you notice any of the side effects listed above, remove the patch immediately and inform your doctor without delay.

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

Common (may affect up to 1 in 10 people)

• Excessive saliva
• Loss of appetite
• Feeling of restlessness
• General feeling of being unwell
• 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 – symptoms include severe pain in the upper part of the stomach, often with nausea or vomiting
• Gastrointestinal bleeding – seen as blood in the stools or when vomiting
• Seeing things that are not real (hallucinations)
• Some people who have had severe vomiting have experienced a tear in the part of the digestive tract connecting the mouth to the stomach (oesophagus)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting side 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.

Keep the transdermal patch inside the sachet until ready for 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 together. After placing it back into the original sachet, ensure it is disposed of in a place inaccessible to children. After removing the patch, avoid touching your eyes and wash your hands thoroughly with water and soap. If your household waste is incinerated, you may dispose of the patch in your home waste. Otherwise, return used patches to a pharmacy, preferably in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at pharmacies. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmina Kern Pharma

• The active substance in Rivastigmina Kern Pharma is rivastigmine:

• Rivastigmina Kern Pharma 4.6 mg/24 h transdermal patches EFG: Each patch delivers 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 delivers 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 delivers 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, methyl methacrylate copolymer) and ethyl acetate], and adhesive matrix [adhesive silicone].

Nature of the product and contents of the pack

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”.

Patches are available in packs containing 30 or 60 sachets.

Only certain pack sizes may be marketed.

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

Eurofins PHAST GmbH

Kardinal-Wendel-Strasse 16

66424 Homburg, Germany

Date of the most recent revision of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es