Rivastigmine Teva 13.3 mg/24 h transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivastigmine Teva 4.6 mg/24 h transdermal patches EFG

Rivastigmine Teva 9.5 mg/24 h transdermal patches EFG

Rivastigmine Teva 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. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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 could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Rivastigmina Teva and what is it used for

The active substance of Rivastigmina Teva is rivastigmine.

Rivastigmine belongs to a class 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 allows acetylcholine levels in the brain to increase, 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 ability, and behaviour.

2. What you need to know before using Rivastigmina Teva

Do not use Rivastigmina Teva

• if you are allergic to rivastigmine (the active substance in Rivastigmina Teva) 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 Teva transdermal patches.

Warnings and precautions

Talk to your doctor before starting Rivastigmina Teva

• if you have or have ever had heart disease, such as irregular or slow heart rate (pulse), QTc prolongation, family history of QTc prolongation, torsade de pointes, or low levels of potassium or magnesium in the blood,
• 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 severe respiratory disease,
• if you suffer from tremors,
• if you have low body weight,
• if you have gastrointestinal reactions such as feeling dizzy (nausea), dizziness (vomiting), and 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 any of these situations apply to you, 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.

Use in children and adolescents

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

Using Rivastigmina Teva with other medicines

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

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

Rivastigmina Teva 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 Teva transdermal patches, inform your doctor that you are using this medicine, as it may excessively enhance the effects of certain muscle relaxants used during anesthesia.

Caution is advised when using Rivastigmina Teva 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.

Caution is also advised when rivastigmine is taken together with other medicines that may affect your heart rhythm or the heart's electrical system (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, the benefits of using Rivastigmina Teva must be weighed against the potential risks to the fetus. Rivastigmina Teva must not be used during pregnancy unless clearly necessary.

You must not breastfeed during treatment with Rivastigmina Teva transdermal patches.

Driving and using machines

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

Follow exactly the instructions for use of this medicine as given 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 firmly on the patch 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 patches for you.

• 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 treating 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 more than three days, do not apply a new one without first consulting your doctor. Transdermal patch treatment may be restarted at the same dose if the treatment has not been interrupted for more than 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 rivastigmine transdermal patches

? Before applying a patch, make sure the skin is clean, dry, and free of hair, powders, oils, moisturizers, or lotions that could prevent the patch from adhering properly. The skin should not have cuts, redness, or irritation.

? Carefully remove any patch you are wearing 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 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)
• Upper left or upper right back
• Lower left or lower right back

Every 24 hours, remove the previous patch before applying a new one to ONLY ONE of the following possible areas.

Upper left or right arm Left or right side of chest

Upper left or right back Lower left or right back

Each time you change the patch, remove the patch from the previous day 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 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 site.

How to apply rivastigmine transdermal patches

Rivastigmine patches are thin, translucent plastic patches that adhere to the skin. Each patch is contained in a sealed pouch that protects it until the time of application. Do not open the pouch or remove the patch until you are ready to apply it.

Carefully remove the existing patch before applying a new one. Patients starting treatment for the first time, and patients restarting rivastigmine treatment after a treatment interruption, should begin with the second step.
Each patch is contained in an individual protective pouch. Open the pouch only when you are ready to apply the patch. Cut along the dotted line of the pouch with scissors and remove the patch from inside.
A protective liner divided into two parts covers the adhesive side of the patch. Remove the first part of the liner without touching the adhesive surface with your fingers.
Apply the adhesive side of the patch to the upper or lower back, upper arm, or chest. Then remove the second part of the protective liner.
Press the patch firmly onto the skin with the palm of your hand for at least 30 seconds, ensuring that 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 pen.

You must wear the patch continuously until it is time to replace it with a new one.

When applying a new patch, try different areas to find those that are most comfortable for you and where clothing does not rub against the patch.

How to remove Rivastigmina Teva 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 contact occurs with the eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.

Can you wear Rivastigmina Teva 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 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 Rivastigmina Teva transdermal patches

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

If you use more Rivastigmina Teva than you should

If you accidentally apply more than one patch, remove all patches from the skin and inform your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20 (indicating the medication and amount administered). Medical attention may be required. 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 Teva

If you realize you have forgotten to apply a patch, do so as soon as possible. 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 rivastigmine

Inform your doctor or pharmacist if you discontinue use of the patches.

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 Teva transdermal patches can produce adverse effects,
although not everyone will experience them.

You may experience adverse effects more frequently when starting 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.

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Dizziness
• Feeling agitated
• Urinary incontinence (inability to properly control urination)
• Urinary tract infection
• Anxiety
• Depression
• Confusion
• Headache
• Fainting
• Stomach problems such as feeling unwell (nausea) or feeling sick (vomiting), diarrhoea
• Heartburn
• Stomach pain
• Rash
• Allergic reaction at the site where the patch was applied, such as blisters or skin swelling
• Feeling tired or weak
• Weight loss
• Fever

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm problems such as slow heart rate
• Stomach ulcer
• Dehydration (excessive loss of fluids)
• 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 in arms or legs and hand tremors

Not known (frequency cannot be estimated from available data)

• Worsening of signs of Parkinson’s disease, such as tremor, stiffness and difficulty moving
• Inflammation of the pancreas; signs include pain in the upper part of the stomach, frequently accompanied by feeling unwell (nausea) or feeling sick (vomiting)
• Fast or irregular heartbeat
• High blood pressure
• Seizures (fits)
• 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 liver function tests
• Restlessness
• Nightmares
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side)
• Seeing things that are not there (hallucinations)
• Tremor
• Drowsiness
• Rash, itching
• Redness of the skin
• Blisters

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 and which may also occur with the patches:

Common (may affect up to 1 in 10 people)

• Excessive saliva
• Restlessness
• Feeling generally unwell
• Tremor
• 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)

• Seizures (fits)
• Intestinal ulcer
• Chest pain, which may be caused by heart spasm

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

• High blood pressure
• Inflammation of the pancreas: signs include severe pain in the upper stomach, often accompanied by feeling unwell (nausea) or feeling sick (vomiting)
• Gastrointestinal bleeding; manifested as blood in the stools or in vomit
• Seeing things that are not there (hallucinations)
• Some people who have had severe vomiting have experienced a tear in part of the digestive tube connecting the mouth to the stomach (oesophagus)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivastigmine Teva

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 sachet after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special temperature conditions.

Keep the transdermal patch inside the sachet until ready to use.

Do not use any patch if it appears damaged or shows signs of tampering.

Store in the original packaging to protect it from light.

After removing a patch, fold it in half with the adhesive side facing inwards and press together. 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 the eyes and wash hands thoroughly with water and soap.

If household waste is disposed of by incineration, the used patch may be discarded in household waste. Otherwise, return used patches to the pharmacy, preferably in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Empty containers and unused medicines should be taken to the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivastigmine Teva

The active substance is rivastigmine.

Rivastigmine Teva 4.6 mg/24 h transdermal patches EFG

Each patch releases 4.6 mg of rivastigmine over 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 over 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 over 24 hours, measures 15 cm², and contains 27 mg of rivastigmine.

The other components are:

Backing layer: Polyester film
Fluorinated polyester film

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

Adhesive matrix: Adhesive silicone

Printing ink: Black printing ink

Nature of the product and contents of the pack

Each transdermal patch is a thin patch composed of three layers. The outer layer is translucent and white, printed 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 individually packed in child-resistant sealed pouches.

Rivastigmine Teva 4.6 mg/24 h transdermal patches EFG

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

Rivastigmine Teva 9.5 mg/24 h transdermal patches EFG

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

Rivastigmine Teva 13.3 mg/24 h transdermal patches EFG

Patches are available in packs containing 7, 30, 60 and 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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma S.L.U.
C/ Anabel Segura, nº 11 Edificio Albatros B, 1st floor
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 medicinal product is authorised in the Member States of the European Economic Area (EEA)

under 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 most recent review of this leaflet:

Detailed 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/