Rivastigmine Tecnigen 9.5 mg/24 h transdermal patches EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Rivastigmine TecniGen 9.5 mg/24 h Transdermal Patches EFG

Read the entire leaflet carefully before you start using this medicine, as 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 and should not be given to other people, even if they have the same symptoms as you, as 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.

Leaflet Contents:

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

1. What is Rivastigmina TecniGen and what is it used for?

The active substance in Rivastigmina TecniGen 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 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.

Rivastigmina TecniGen 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 behavior.

2. What you need to know before using Rivastigmina TecniGen

Do not use Rivastigmina TecniGen

• if you are allergic to rivastigmine 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 Rivastigmina TecniGen transdermal patches.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Rivastigmina TecniGen:

• 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 difficulty 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 dizzy (nausea), dizziness (vomiting), or diarrhea. You may become dehydrated (loss of large amounts of fluid) if vomiting or diarrhea is prolonged.
• if you have liver problems (hepatic insufficiency).

If you are in any of these situations, your doctor may consider it necessary to monitor you more closely 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

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

Using Rivastigmina TecniGen with other medicines

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

Rivastigmina TecniGen 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).

Rivastigmina TecniGen 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 Rivastigmina TecniGen 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 Rivastigmina TecniGen 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 slow heart rate (bradycardia), which may lead to fainting or loss of consciousness.

Use of Rivastigmina TecniGen with food and drink

Food and drink do not affect the use of Rivastigmina TecniGen transdermal patches, as rivastigmine enters the bloodstream through the skin.

Pregnancy and breastfeeding

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 Rivastigmina TecniGen must be weighed against the potential risks to the fetus. Rivastigmina TecniGen must not be used during pregnancy unless clearly necessary.

You must not breastfeed during treatment with Rivastigmina TecniGen.

Driving and using machines

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

Follow exactly the administration instructions for Rivastigmina TecniGen transdermal patches as given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

IMPORTANT:

• Remove the previous patch before applying ONE new patch.
• 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.

How to start treatment

Your doctor will determine the most appropriate dose of Rivastigmina TecniGen transdermal patches for your individual case.

• Treatment is usually started with Rivastigmina TecniGen 4.6 mg/24 h.
• The usual recommended daily dose is Rivastigmina TecniGen 9.5 mg/24 h.
• Wear only one 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 several days, do not apply a new one without first consulting your doctor. Transdermal patch treatment may be restarted at the same dose if treatment has not been interrupted for more than three days. Otherwise, your doctor will instruct you to restart treatment with Rivastigmina TecniGen 4.6 mg/24 h.

Where to apply your Rivastigmina TecniGen transdermal patches

• Before applying a patch, ensure the skin is:

• clean, dry, and hair-free,

• free of powders, oils, moisturizers, or lotions that may prevent the patch from adhering properly,

• free of 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 medication, 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 ONE new patch to ONLY ONE of the following possible sites.

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

How to apply your Rivastigmina TecniGen transdermal patches

Rivastigmina TecniGen patches are thin, translucent plastic patches that adhere to the skin. Each patch is enclosed 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.

Patients starting treatment for the first time and patients restarting treatment with
Rivastigmina TecniGen after interruption should begin with the second figure.

• Each patch is contained in an individual protective pouch.

Open the pouch only when you are ready to apply the patch.

Cut the pouch along the dotted line 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 onto the upper or lower back, upper arm, or chest (avoiding breasts in women), then remove the second half of the protective liner.

• Press the patch firmly with your hand and ensure the edges are properly adhered.

If helpful, you may write on the patch—for example, 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 areas where clothing does not rub against the patch.

How to remove your Rivastigmina TecniGen transdermal patches

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 get the medication on 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 Rivastigmina TecniGen transdermal patches 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 a patch falls off

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

When and for how long you should wear your Rivastigmina TecniGen transdermal patches

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

If you use more Rivastigmina TecniGen than you should

If you accidentally apply 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 amounts of Rivastigmina TecniGen orally 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 TecniGen

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 TecniGen

Inform your doctor or pharmacist if you discontinue using the patches.

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

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

4. Possible adverse effects

Like all medicines, Rivastigmine TecniGen transdermal patches may produce adverse effects, although not everyone experiences them.

You may experience adverse effects more frequently when starting your 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 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)
• Aggression

Rare (may affect up to 1 in 1,000 people)

• Falls

Very rare (may affect up to 1 in 10,000 people)

• Stiffness in arms and legs
• Tremor in hands

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, rigidity, and difficulty with movement
• Inflammation of the pancreas – symptoms 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
• Feeling restless
  • 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, which may also occur with transdermal patches:

Frequent (may affect up to 1 in 10 people)

• Excessive saliva
• Loss of appetite
• Feeling agitated
• General feeling of being unwell
  • Tremor or feeling confused
  • Increased sweating

Uncommon (may affect up to 1 in 100 people)

• Irregular heart rate (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, frequently with nausea or vomiting
• Gastrointestinal bleeding – manifested as blood in stool or vomit
• Seeing things that are not real (hallucinations)
• Some people who have experienced severe vomiting have had 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, consult your doctor or nurse, 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 Medicinal Products: https://www.notificaran.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmine TecniGen

Keep this medicine out of the sight and reach of children.

Do not use Rivastigmine TecniGen after the expiry date which is 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 its sachet until use. Keep it in the original packaging to protect it from light.

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. When disposing of the patch, place it back into the original sachet and ensure it is kept out of children's reach. After removing the patch, avoid touching your eyes and wash your hands thoroughly with soap and water. If your household waste is incinerated, you may dispose of 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, please consult your pharmacist on how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Rivastigmina TecniGen

The active substance in Rivastigmina TecniGen is rivastigmine:

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

The other components are: Fluoropolymer-coated polyester film, acrylic copolymer adhesive (butyl methacrylate-co-methyl methacrylate), and silicone adhesive.

Appearance of the product and contents of the pack

Each transdermal patch is round-shaped and consists of a three-layer transdermal matrix: an outer release liner, a drug reservoir, and an adhesive layer.

The patch is labeled as: “Rivastigmina 9.5mg/24h”

Each transdermal patch is individually packaged in a pouch.

Each pouch contains one transdermal patch. The pouches are packed in a cardboard carton.

Available in packs containing 7, 10, 30, 60 or 90 pouches, and in multipacks containing 60 (2 x 30) or 90 (3 x 30) pouches.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid) SPAIN

Manufacturer

Eurofins PHAST GmbH

Kardinal-Wendel-Strasse 16, 66424 Homburg,

Germany

ACC GmbH Analytical Clinical Concepts Schöntalweg 9, 63849 Leidersbach

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Rivastigmina TecniGen 9.5 mg/24 h transdermal patches EFG

Date of the most recent review of this leaflet: September 2017

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/