RIVASTIGMINE TECNIGEN 9.5 mg/24h TRANSDERMAL PATCHES EFG

2. What you need to know before starting to use Rivastigmine TecniGen

Do not use Rivastigmine TecniGen

• if you are allergic to rivastigmine 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 patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling), and if there is no improvement within 48 hours after removing the transdermal patch.

If you are in any of these situations, inform your doctor and do not use Rivastigmine TecniGen transdermal patches.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Rivastigmine 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 severe respiratory disease.
• if you suffer from tremors.
• if you have low body weight.
• if you have gastrointestinal reactions such as a feeling of nausea (nausea), vomiting (vomiting), and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged.
• if you have liver problems (liver failure).

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

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

Children and adolescents

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

Using Rivastigmine TecniGen with other medications

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

Rivastigmine TecniGen may interfere with anticholinergic medications, some of which are medications 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 TecniGen transdermal patches should not be administered at the same time as metoclopramide (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.

In case you need to undergo surgery while using Rivastigmine TecniGen transdermal patches, inform your doctor that you are using it, as it may potentiate the effects of some muscle relaxants used in anesthesia.

Caution should be exercised when using Rivastigmine TecniGen transdermal patches with beta blockers (medications such as atenolol used to treat hypertension, angina, and other heart conditions). Taking the two medications together may cause complications such as a decrease in heart rate (bradycardia) that can lead to fainting or loss of consciousness.

Using Rivastigmine TecniGen with food and drinks

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

Pregnancy and breastfeeding

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

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

You should not breastfeed during treatment with Rivastigmine TecniGen.

Driving and using machines

Your doctor will inform you if your condition allows you to drive or use machinery safely. Rivastigmine TecniGen transdermal patches may cause dizziness and severe confusion. If you feel dizzy or confused, do not drive or use machinery, nor perform other tasks that require your attention.

3. How to use Rivastigmine TecniGen

Follow the instructions for administration of Rivastigmine TecniGen transdermal patches indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse again.

IMPORTANT:

• Remove the previous patch before putting on a 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 indicate the most suitable dose of Rivastigmine TecniGen transdermal patches for your case.

• Normally, treatment is started with Rivastigmine TecniGen 4.6 mg/24 h.
• The recommended daily dose is Rivastigmine 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 put on another one without consulting your doctor first. Treatment with the transdermal patch 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 Rivastigmine TecniGen 4.6 mg/24 h.

Where to place your Rivastigmine TecniGen transdermal patches

• Before putting on a patch, make sure the skin is:
• clean, dry, and hairless,
• free of powders, oils, moisturizers, or lotions that may prevent the patch from sticking well to the skin,
• free of cuts, redness, or irritations.

• Remove any patch you are currently wearing before putting on a new one. Wearing multiple patches on your body could expose you to an excessive amount of this medication, which could be potentially dangerous.

• 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 the breasts in women)
• upper left or upper right back
• lower left or lower right back

Every 24 hours, remove the previous patch before putting on a NEW patch in ONLY ONE of the following possible areas

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

How to apply your Rivastigmine TecniGen transdermal patches

The Rivastigmine TecniGen patches are thin, transparent plastic and stick to the skin. Each patch is in a protective envelope that protects it until you are ready to put it 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 who are starting treatment for the first time and patients who are restarting treatment with Rivastigmine 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 divided protective film covering the adhesive side of the patch. Remove the first sheet of the film 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 the breasts in women) and then remove the second sheet of the protective film.

• Press the patch firmly with your hand and make sure the edges are well stuck.

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

You should wear the patch continuously until it is time to change it for a new one. When you put 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 Rivastigmine TecniGen transdermal patches

Gently pull one of the edges of the patch to slowly peel it off the skin. If there are any 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 get the patch in your eyes or if your eyes become red after handling the patch, rinse them immediately with plenty of water and seek medical advice if the symptoms do not resolve.

Can you wear your Rivastigmine TecniGen transdermal patches when bathing, swimming, or exposing yourself to the sun?

• Bathing, swimming, or showering should not affect the patch. Make sure it does not peel off partially while you perform these activities.
• Do not expose the patch to an external heat source (e.g., excessive sunlight, sauna, solarium) for long periods.

What to do if a patch falls off

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

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

• To benefit from your treatment, you should put on a new patch every day, preferably at the same time.
• Wear only one Rivastigmine TecniGen patch at a time and replace the patch with a new one every 24 hours.

If you use more Rivastigmine TecniGen than you should

If you have accidentally put on more than one patch, remove all patches from the skin and inform your doctor. You may need medical attention. Some people who have taken accidentally high doses of Rivastigmine TecniGen orally have experienced nausea (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. A slowing of the 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 Rivastigmine 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 make up for the one you forgot.

If you interrupt treatment with Rivastigmine 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.

4. Possible Adverse Effects

Like all medicines, Rivastigmine TecniGen transdermal patches may produce adverse effects, although not all people will suffer from them.

You may have adverse effects more frequently when starting your treatment or when your dose is increased. Generally, the adverse effects will slowly disappear as your body gets used to the medicine.

If you notice any of the following adverse effects that may be serious, remove the patch and immediately inform your doctor.

Frequent(may affect up to 1 in 10 people)

• Lack of appetite
• Dizzy sensation
• Sensation of agitation or numbness
• Urinary incontinence (inability to stop urine properly).

Uncommon(may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heart rate
• Seeing things that do not really exist (hallucinations)
• Stomach ulcer
• Dehydration (loss of a large amount 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 the available data)

• Allergic reaction where the patch was applied, such as blisters or skin inflammation
• Worsening of Parkinson's disease signs – such as tremor, stiffness, and difficulty moving
• Pancreatitis – signs include severe pain in the upper part of the stomach, often accompanied by a feeling of dizziness (nausea) or dizziness (vomiting)
• Fast or irregular heart rate
• High blood pressure
• Seizures (convulsions) -
• Liver disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormal darkening of urine or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Changes in tests that show liver function
• Feeling of restlessness
  • Nightmares
  • Pisa syndrome (a condition that involves involuntary muscle contraction 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 immediately inform your doctor.

Other adverse effects experienced with Rivastigmine capsules or oral solution and that may occur with transdermal patches:

Frequent(may affect up to 1 in 10 people)

• Excessive saliva
• Lack of appetite

• Sensation of agitation
• Sensation of general discomfort
  • Tremor or feeling of confusion
  • Increased sweating.

Uncommon(may affect up to 1 in 100 people)

• Irregular heart rate (e.g., fast heart rate)
• Difficulty sleeping
• Accidental falls

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

• Seizures (convulsions)
• Ulcer in the intestine
• Chest pain – probably caused by spasm in the heart

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

• High blood pressure
• Pancreatitis – signs include severe pain in the upper part of the stomach, often with a feeling of dizziness (nausea) or dizziness (vomiting)
• Gastrointestinal bleeding – manifested as blood in the stool or when vomiting
• Seeing things that do not exist (hallucinations)
• Some people who have been intensely dizzy (vomiting) have had a tear in part of the digestive tube that connects their mouth to their stomach (esophagus)

Reporting of Adverse Effects

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

5. Conservation of Rivastigmine TecniGen

Keep this medicine out of sight and reach of children.

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

Keep the transdermal patch inside the envelope until use. Keep 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 tampering.

After removing a patch, fold it in half with the adhesive side facing in and press. After introducing it into the original envelope, when disposing of the patch, make sure it is out of the reach of children. After removing the patch, do not touch your eyes, and wash your hands well with water and soap. If your household waste is eliminated by incineration, you can throw the patch in your household trash. If not, take the used patches to the pharmacy, preferably in the original packaging.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rivastigmine TecniGen

The active principle of Rivastigmine TecniGen is rivastigmine:

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

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

Appearance of the Product and Package Contents

Each transdermal patch is round in shape and consists of a three-layer transdermal matrix: an external release layer, a reservoir with the medicine, and an adhesive layer.

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

Each transdermal patch is individually packaged in an envelope.

Each envelope contains a transdermal patch. The envelopes are packaged in a cardboard box.

They are available in packages containing 7, 10, 30, 60, or 90 envelopes and in multi-packages containing 60 (2 x 30) or 90 (3 x 30) envelopes.

Only some package sizes may be marketed.

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

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

Date of the last revision of this prospectus:September 2017

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