RIVASTIGMINE TEVA 13.3 mg/24h TRANSDERMAL PATCHES

2. What you need to know before you use Rivastigmine Teva

Do not use Rivastigmine Teva

• if you are allergic to rivastigmine (the active substance of Rivastigmine Teva) or 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 have a skin reaction that extends beyond the size of the patch, 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 Teva transdermal patches.

Warnings and precautions

Consult your doctor before starting to use Rivastigmine Teva

• if you have or have ever had any heart disease such as irregular or slow heart rate, prolonged QTc, family history of prolonged QTc, torsades de pointes, or low potassium or magnesium levels in the blood,
• 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 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, vomiting, and diarrhea. You may become dehydrated (lose a large amount of fluid) if vomiting or diarrhea is prolonged,

(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.

Use in children and adolescents

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

Use of Rivastigmine Teva with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Rivastigmine Teva may interfere with anticholinergic medicines, some of which are medicines used to relieve stomach cramps or spasms (e.g., dicyclomine), for the treatment of Parkinson's disease (e.g., amantadine), or to prevent travel sickness (e.g., diphenhydramine, scopolamine, or meclizine).

Rivastigmine Teva should not be administered at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together may cause problems such as stiffness in the limbs and hand tremors.

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

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

Caution should be exercised when rivastigmine is taken with other medicines that may affect your heart rate or the electrical system of your heart (QT prolongation).

Pregnancy, breastfeeding, and fertility

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

You should not breastfeed while using Rivastigmine Teva transdermal patches.

Driving and using machines

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

3. How to use Rivastigmine Teva

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse.

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 patches for your case.

• Treatment is usually started with rivastigmine 4.6 mg/24 h.
• The recommended daily dose is rivastigmine 9.5 mg/24 h. If this dose is well tolerated, the doctor treating you 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 depending on your individual needs.

If you have not used the patches for more than three 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 - 4.6 mg/24 h.

Rivastigmine can be used with food, drink, and alcohol

Where to apply Rivastigmine Teva transdermal patches

? Before putting on a patch, make sure the skin is clean, dry, and hairless, without powders, oil, moisturizer, or lotion that may prevent the patch from sticking well to the skin, without cuts, redness, or irritation.

? 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 medicine, which could be potentially dangerous.

? Put ONEpatch per day on ONEof the possible areas, as shown in the following diagrams:

• upper left or upper right arm
• upper left or upper right chest (avoiding the breasts)
• 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.

Front

Ó Ó Ó Ó

Back

Ó Ó Ó

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

How to apply Rivastigmine Teva transdermal patches

Rivastigmine patches are thin, transparent plastic and stick to the skin. Each patch is in a sealed pouch that protects it until you are ready to put it on. Do not open the pouch or remove the patch until you are ready to put it on.

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 for you and where your clothes do not rub against the patch.

How to remove Rivastigmine Teva transdermal patches

Gently pull on 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 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 immediately with plenty of water and seek medical advice if the symptoms do not resolve.

Can you wear Rivastigmine Teva 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 performing these activities.
• Do not expose the patch to an external heat source (e.g., excessive sunlight, sauna, sunbed) 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 Rivastigmine Teva 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 patch at a time and replace the patch with a new one every 24 hours.

If you use more Rivastigmine Teva than you should

If you accidentally put on more than one patch, remove all patches from the skin and inform your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20 (indicating the medicine and the amount administered). You may need medical attention. Some people who have accidentally taken too high doses of rivastigmine orally have had nausea, vomiting, diarrhea, high blood pressure, and hallucinations. There may also be a slowing of the heart rate and fainting.

If you forget to use Rivastigmine Teva

If you realize you have forgotten to put on a patch, put one on as soon as you remember. 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 stop treatment with rivastigmine

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

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 Teva transdermal patches may produce adverse effects, although not all people 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 inform your doctor immediately.

Common(may affect up to 1 in 10 people)

• Lack of appetite
• Decreased appetite
• Dizzy sensation
• Numbness sensation
• Restlessness sensation
• Urinary tract infection (infection in the parts of the body that store or through which urine passes)
• Urinary incontinence (inability to stop urine properly)
• Stomach problems such as discomfort (nausea) or feeling sick (vomiting), diarrhea, indigestion, and stomach pain
• Anxiety
• Depression
• Headache
• Fainting
• Feeling of tiredness or weakness
• Fever
• Weight loss
• Confusion
• Delirium
• Rash
• Skin reaction at the patch application site, such as redness, rash, swelling, inflammation, or skin irritation.

Uncommon(may affect up to 1 in 100 people)

• Heart rhythm problems, such as slow heart rate
• Stomach ulcer
• Dehydration (excessive fluid loss)
• 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)

• Tremors, muscle spasms, or movement disorders resulting from effects on a part of the brain that regulates movement

Unknown(frequency cannot be estimated from available data)

• Itching, redness, blisters, allergic skin inflammation.
• Worsening of Parkinson's disease symptoms, such as tremors, rigidity, and difficulty moving

• Pancreatitis, signs include upper stomach pain, often accompanied by nausea (dizzy sensation) or vomiting (feeling sick)
• Fast or irregular heart rate
• Hallucinations (seeing, hearing, or feeling things that do not exist)
• High blood pressure
• Seizures (attacks)
• Tremors
• Somnolence
• Liver inflammation (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 liver function tests
• Feeling of restlessness
• Nightmares
• Pisa syndrome (a disease that involves involuntary muscle contraction with abnormal flexion of the body and head to one side)

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

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

Common(may affect up to 1 in 10 people)

• General discomfort sensation
• Confusion sensation
• Increased sweating

Uncommon(may affect up to 1 in 100 people)

• Difficulty sleeping

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

• Intestinal ulcer
• Chest pain, jaw and back pain, caused by physical exertion and problems with blood flow to the heart

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

• Gastrointestinal bleeding; manifested as blood in the stool or when vomiting
• Some people who have been intensely nauseous (vomiting) have had a tear in part of the digestive tube that connects their mouth to their stomach (esophagus)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, 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.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rivastigmine Teva

Keep this medicine out of sight and reach of children.

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

This medicine does not require special temperature conditions.

Store the transdermal patch in the envelope until use.

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

Keep it in the original packaging to protect it from light.

After removing a patch, fold it in half with the adhesive side inward and press. After introducing it into the original envelope, make sure to dispose of the patch out of the reach of children. After removing the patch, do not touch your eyes, and wash your hands well with soap and water. 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 at the SIGRE collection point in 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

Rivastigmine Teva Composition

The active ingredient is rivastigmine.

Rivastigmine Teva 4.6 mg/24 h transdermal patches EFG

Each patch releases 4.6 mg of rivastigmine in 24 hours, measures 5 cm2, and contains 9 mg of rivastigmine.

Rivastigmine Teva 9.5 mg/24 h transdermal patches EFG

Each patch releases 9.5 mg of rivastigmine in 24 hours, measures 10 cm2, and contains 18 mg of rivastigmine.

Rivastigmine Teva 13.3 mg/24 h transdermal patches EFG

Each patch releases 13.3 mg of rivastigmine in 24 hours, measures 15 cm2, and contains 27 mg of rivastigmine.

The other components are:

Backing layer: Polyester film

Polyester film coated with fluorine

Medicament reservoir: Acrylic adhesive, polyacrylate copolymer (butyl methacrylate-2-methyl methacrylate)

Adhesive matrix: Silicone adhesive

Printing ink: Black printing ink

Product Appearance and Package Contents

Each transdermal patch is a thin patch composed of three layers. The outer layer is translucent, white, and marked in black with the following:

Rivastigmine Teva 4.6 mg/24 h transdermal patches EFG

"Rivastigmine 4.6 mg/24 h"

Rivastigmine Teva 9.5 mg/24 h transdermal patches EFG

"Rivastigmine 9.5 mg/24 h"

Rivastigmine Teva 13.3 mg/24 h transdermal patches EFG

"Rivastigmine 13.3 mg/24 h"

Each patch is packaged in individual child-resistant envelopes, sealed.

Rivastigmine Teva 4.6 mg/24 h transdermal patches EFG

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

Rivastigmine Teva 9.5 mg/24 h transdermal patches EFG

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

Rivastigmine Teva 13.3 mg/24 h transdermal patches EFG

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura, nº 11 Edificio Albatros B, 1ª planta

28108 Alcobendas – Madrid

Spain

Manufacturer

Eurofins Phast GmbH

Kardinal-Wendel-Strasse 16

66424 Homburg

Germany

Delph-i GmbH

Schöntalweg 7+9

63849 Leidersbach,

Germany

Merckle GmbH

Ludwig-Merckle-Strasse, 3 Blaubeuren D-89143

Germany

Teva Operations Poland SP.Z.O.O.

Ul. Mogilska 80

31-546 Krakow, Poland

This medicine is authorized in the Member States of the European Economic Area

with the following names

Austria Rivastigmin ratiopharm 4.6 mg/24 Stunden transdermales Pflaster

Rivastigmin ratiopharm 9.5 mg/24 Stunden transdermales Pflaster

Rivastigmin ratiopharm 13.3 mg/24 Stunden transdermales Pflaster

Germany Rivastigmin-ratiopharm 4.6 mg/24 Stunden transdermales Pflaster

Rivastigmin-ratiopharm 9.5 mg/24 Stunden transdermales Pflaster

Rivastigmin-ratiopharm 13.3 mg/24 Stunden transdermales Pflaster

Spain Rivastigmina Teva 4.6 mg/24 h Parche transdérmico EFG

Rivastigmina Teva 9.5 mg/24 h Parche transdérmico EFG

Rivastigmina Teva 13.3 mg/24 h Parche transdérmico EFG

Netherlands Rivastigmine Teva 4.6 mg/24 u, pleister voor transdermaal gebruik

Rivastigmine Teva 9.5 mg/24 u, pleister voor transdermaal gebruik

Rivastigmine Teva 13.3 mg/24 u, pleister voor transdermaal gebruik

Portugal Rivastigmina Teva

Rivastigmina Teva

Rivastigmina Teva

Slovenia Rivastigmin Teva 4.6 mg/24 h transdermalni obliž

Rivastigmin Teva 9.5 mg/24 h transdermalni obliž

Rivastigmin Teva 13.3 mg/24 h transdermalni obliž

United Kingdom Erastig 13.3 mg/24 h transdermal patch

Date of the last revision of this prospectus: March 2025

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