Label: information for the user

Rivastigmina TecniGen 9.5 mg/24 h transdermal patchesEFG

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed for you and should not be given to others, 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 not listed in this label. See section 4.

The active ingredient of Rivastigmina TecniGen is rivastigmina.

Rivastigmina belongs to the group of cholinesterase inhibitors. In patients with Alzheimer's disease, certain nerve cells die in the brain, causing low levels of acetylcholine neurotransmitters (a substance that allows nerve cells to communicate with each other). Rivastigmina acts by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, rivastigmina allows an increase in acetylcholine 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 disease, a progressive brain disorder that gradually affects memory, intellectual capacity, and behavior.

Do not use Rivastigmina TecniGen

-if you are allergic to rivastigmina or any of the other components of this medication (listed in section 6).

-if you have ever had an allergic reaction to a similar medication (carbamate derivatives)

-if you have a skin reaction that extends beyond the size of the patch, if there is a more intense local reaction (such as blisters, increased skin inflammation, swelling) and if there is no improvement within 48 hours after removing the transdermal patch.

If you find yourself in any of these situations, inform your doctor and do not use Rivastigmina TecniGen transdermal patches.

Warnings and precautions

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

-if you have or have had any irregular or slow heart rhythm.

-if you have or have had any active stomach ulcer.

-if you have or have had any difficulty urinating.

-if you have or have had any seizures.

-if you have or have had any asthma or severe respiratory disease.

-if you suffer from tremors.

-if you have a low body weight.

-if you have gastrointestinal reactions such as dizziness (nausea), dizziness (vomiting), and diarrhea. You may become dehydrated (loss of a large amount of fluid) if vomiting or diarrhea is prolonged.

-if you have liver problems (hepatic insufficiency).

If you find yourself in any of these situations, your doctor may consider the need for closer monitoring while you are being treated.

If you have not used the patches for more than three days, do not apply another one without consulting your doctor first.

Children and adolescents

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

Use of Rivastigmina TecniGen with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Rivastigmina TecniGen may interfere with anticholinergic medications, some of which are medications used to relieve stomach cramps or spasms (e.g. diciclomina), for the treatment of Parkinson's disease (e.g. amantadina) or to prevent motion sickness (e.g. difenhidramina, escopolamina, or meclizina).

Rivastigmina TecniGen transdermal patches should not be administered at the same time as metoclopramida (a medication used to relieve or prevent nausea and vomiting). Taking the two medications 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 potentiate the effects of some anesthetic muscle relaxants.

Care should be taken when using Rivastigmina TecniGen transdermal patches with beta blockers (medications such as atenolol used to treat hypertension, angina, and other cardiovascular diseases). Taking the two medications together may cause complications such as bradycardia (slow heart rate) that may lead to fainting or loss of consciousness.

Use of Rivastigmina TecniGen with food and drinks

Food and drinks do not affect the use of Rivastigmina TecniGen transdermal patches, as rivastigmina passes into the bloodstream through the skin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, it is necessary to evaluate the benefits of using Rivastigmina TecniGen against the possible adverse effects on the fetus. Rivastigmina TecniGen should not be used during pregnancy unless it is clearly necessary.

You should not breastfeed during your treatment with Rivastigmina TecniGen.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive or use machinery safely. Rivastigmina TecniGen transdermal patches may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive, use machinery, or perform other tasks that require your attention.

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

IMPORTANT:

• Remove the previous patch before putting on 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.

How to start treatment

Your doctor will indicate the most suitable dose of Rivastigmina TecniGen transdermal patches for your case.

-Normally, treatment starts 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 the same time and replace the patch with a new one every 24 hours.

Your doctor may adjust the dose during treatment depending on your individual needs.

If you have not used the patches for several days, do not put on another one without consulting your doctor first. Treatment with transdermal patches can be restarted at the same dose if treatment is not interrupted for more than three days. Otherwise, your doctor will have you restart your treatment with Rivastigmina TecniGen 4.6 mg/24 h.

Where to place your Rivastigmina TecniGen transdermal patches

-Before putting on a patch, make sure the skin is:

-clean, dry, and hair-free,

-without powders, oils, moisturizers, or lotions that prevent the patch from sticking well to the skin,

-without cuts, redness, or irritation.

-Remove any existing patch carefully before putting on a new one.new.The wearing of multiple patches on your body may expose you to an excessive amount of this medication, which could be potentially hazardous.

-Put on only one patch per day in one of the following areas, as shown in the following diagrams:

-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

Change the patch every 24 hours by removing the previous patch before putting on a new one in only one of the possible areas.

Each time you change the patch, remove the previous day's patch before putting on a new patch in a different area of the 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 to put a new patch in the same skin area again.

How to apply your Rivastigmina TecniGen transdermal patches

Rivastigmina TecniGen patches are thin, translucent plastic and stick to the skin. Each patch is in a protective envelope that protects it until it is put on. Do not open the envelope or remove the patch until you are ready to put it on.

Remove the existing patch carefully before putting on a new one.

Patients starting treatment for the first time and patients restarting treatment with Rivastigmina TecniGen after interrupting treatment should start with the second figure

-Each patch is in an individual protective envelope.

Only open the envelope when you are ready to put on the patch.

Cut the envelope along the dotted line with scissors and remove the patch from the envelope.

-A protective laminate divided into two sheets covers the adhesive side of the patch. Remove the first sheet of the laminate without touching the adhesive side of the patch with your fingers.

• Place the adhesive side of the patch on the upper or lower back or on the upper arm or chest (avoiding breasts in women) and then remove the second sheet of the laminate.

-Press the patch firmly with your hand and make sure the edges have stuck well.

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

You must wear the patch continuously until you change it for a new one. When putting on a new patch, you can try different areas to find the ones that are most comfortable and where clothing does not rub against the patch.

How to remove your Rivastigmina TecniGen transdermal patches

Gently pull one of the edges of the patch to remove it slowly from the skin. If there are any remaining adhesive residues 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 solvents (nail polish removers or other solvents).

After removing the patch, wash your hands with soap and water. If you come into contact with your eyes or if your eyes become red after handling the patch, wash immediately with plenty of water and seek medical advice if the symptoms do not resolve.

Can you wear your Rivastigmina TecniGen transdermal patches when bathing, swimming, or exposed to the sun?

-Bathing, swimming, or showering should not affect the patch. Make sure it does not come off partially while doing these activities.

-Do not expose the patch to an external heat source (e.g. excessive sunlight, sauna, solarium) for long periods of time.

What to do if a patch falls off

If a patch falls off, put on a new one for the rest of the day and change it the next day at the usual time.

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

-To benefit from your treatment, you must put on a new patch every day, preferably at the same time.

-Wear only one Rivastigmina TecniGen patch at the same time and replace the patch with a new one every 24 hours.

If you use more Rivastigmina TecniGen than you should

If you accidentally put on more than one patch, remove all the patches from the skin and inform your doctor. You may need medical attention. Some people who have taken accidentally high doses of Rivastigmina TecniGen orally have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. A slowing of heart rate and fainting may also occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 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 put on a patch, put it on immediately. The next day, put on the next patch at the usual time. Do not put on two patches to compensate for the one you forgot.

If you interrupt treatment with Rivastigmina TecniGen

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

If you have not used the patches for several days, do not put on another one without consulting your doctor first.

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

Like all medicines, Rivastigmina TecniGen transdermal patches may cause side effects, although not everyone will experience them.

You may experience side effects more frequently when you start treatment or when your dose is increased. Side effects usually fade away as your body gets used to the medicine.

If you notice any of the following serious side effects, remove the patch and immediately inform your doctor.

Frequent (may affect up to 1 in 10 people)

• Loss of appetite
• Sensation of dizziness
• Sensation of agitation or numbness
• Urinary incontinence (inability to stop urinating properly).

Infrequent (may affect up to 1 in 100 people)

• Problems with your heart rhythm, such as slow heart rate
• Seeing things that are not really there (hallucinations)
• Stomach ulcer
• Dehydration (loss of a large amount 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 the arms and legs

-Trembling in the hands

Unknown (cannot be estimated from available data)

-Allergic reaction where the patch was applied, such as blisters or skin inflammation

-Worsening of Parkinson's disease symptoms – such as tremor, stiffness, and difficulty moving

-Pancreatitis – symptoms include severe upper stomach pain, often accompanied by nausea or vomiting

-Irregular heart rhythm or rapid heart rate

-High blood pressure

-Seizures (convulsions)

-Liver disorders (yellowing of the skin, yellowing of the white of the eyes, abnormal darkening of the urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)

-Changes in liver function tests

-Sensation of restlessness

• Nightmares
• Syndrome of Pisa (condition involving involuntary muscle contraction and abnormal tilting of the body and head to one side).

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

Other side effects experienced with Rivastigmina capsules or oral solution and that may occur with transdermal patches:

Frequent (may affect up to 1 in 10 people)

• Excessive salivation
• Loss of appetite

-Sensation of agitation

-Sensation of general discomfort

• Trembling or sensation of confusion
• Increased sweating.

Infrequent (may affect up to 1 in 100 people)

-Irregular heart rhythm (e.g. rapid heart rate)

-Difficulty sleeping

-Accidental falls

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

-Seizures (convulsions)

-Ulcer in the intestine

-Chest pain – likely caused by a heart spasm

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

-High blood pressure

-Pancreatitis – symptoms include severe upper stomach pain, often accompanied by nausea or vomiting

-Gastrointestinal bleeding – manifested as blood in the stool or vomiting blood

-Seeing things that are not really there (hallucinations)

-Some people who have been severely nauseated (vomiting) have had a tear in part of the digestive tube that connects their mouth to their stomach (esophagus)

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaran.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Rivastigmina TecniGen after the expiration date that appears on the box and on the overwrap after CAD:. The expiration date is the last day of the month indicated.

Store the transdermal patch inside the overwrap until use. Store in the original packaging to protect it from light.

Do not use any patch if you observe that it is damaged or shows signs of manipulation.

After removing a patch, fold it in half with the adhesive side inwards and press. After placing it in the original overwrap, ensure that it is out of the reach of children. After removing the patch, do not touch your eyes, and wash your hands thoroughly with water and soap. If your household waste is disposed of by incineration, you can dispose of the patch in your household waste. If not, take the used patches to the pharmacy, preferably in the original packaging.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Rivastigmina TecniGen

The active ingredient of Rivastigmina TecniGen is rivastigmine:

• Rivastigmina TecniGen 9.5 mg/24 h transdermal patches: Each patch releases 9.5 mg of rivastigmine in24 hours, measures 10 cm2and contains 18 mg of rivastigmine.

The other components are: Polyester film coated with fluoropolymer, adhesive copolymer (butyl methacrylate-co-methyl methacrylate) and silicone adhesive.

Appearance of the product and content of the container

Each transdermal patch has a round shape and is formed by a transdermal matrix of three layers: an external release layer, a reservoir with the medication, and an adhesive layer.

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

Each transdermal patch is individually packaged in a sachet.

Each sachet contains one transdermal patch. The sachets are packaged in a cardboard box.

They are available in containers that contain 7, 10, 30, 60 or 90 sachets and in multi-containers that contain 60 (2 x 30) or 90 (3 x 30) sachets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. deBruselas, 13, 3rd floor.

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing

Eurofins PHAST GmbH

Kardinal-Wendel-Strasse 16, 66424 Homburg,

Germany

ACC GmbH Analytical Clinical Concepts Schöntalweg 9, 63849 Leidersbach

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

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

Date of the last review of this leaflet:September 2017

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