Rivastigmine Zentiva

Package leaflet: Information for the user

Rivastigmina Zentiva 4.6 mg/24 hours transdermal patch, 9.5 mg/24 hours transdermal patch

Generic medicine
Please read this leaflet carefully before 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Rivastigmina Zentiva contains the active substance rivastigmine.
Rivastigmine belongs to a class of substances known as cholinesterase inhibitors. In patients
with Alzheimer's dementia, certain brain cells die, resulting in low levels of 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, thereby improving the symptoms of
Alzheimer's disease.
Rivastigmina Zentiva is used to treat adult patients with mild to moderate Alzheimer's dementia, a progressive disorder of the central nervous system that gradually affects memory, learning ability, and behaviour.

2. What you need to know before using Rivastigmine Zentiva

Do not use Rivastigmine Zentiva:

• if you are allergic to rivastigmine or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction to medicines of a similar type (carbamate derivatives).
• if, when using the patch, you have experienced a skin reaction extending beyond the area where the patch was applied, or if you have had a more intense local reaction (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours after removing the patch. If this applies to you, inform your doctor and do not apply Rivastigmine Zentiva transdermal patches.

Warnings and precautions
Talk to your doctor or pharmacist before using Rivastigmine Zentiva:

• if you have or have previously had an irregular or slow heartbeat.
• if you have or have previously had an active stomach ulcer.
• if you have or have previously had difficulty urinating.
• if you have or have previously had seizures.
• if you have or have previously had asthma or severe respiratory disorders.
• if you suffer from tremors.
• if you have low body weight.
• if you experience gastrointestinal disorders such as nausea, vomiting, and diarrhea. If vomiting and diarrhea are persistent, you may become dehydrated (excessive loss of fluids).
• if you have impaired liver function. If any of these apply to you, your doctor may monitor you more frequently during treatment with this medicine.

If you have not applied a patch for more than three days, consult your doctor before applying the next one.
Children and adolescents
There is no indication for the specific use of Rivastigmine Zentiva in the pediatric population for the treatment of Alzheimer's disease.
Other medicines and Rivastigmine Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Rivastigmine Zentiva may interfere with anticholinergic medicines, including those 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 Zentiva must not be administered concurrently with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause side effects such as stiffness of the limbs and hand tremors.
If you are scheduled for surgery and are being treated with Rivastigmine Zentiva transdermal patches, inform your doctor, as they may enhance the effects of certain muscle relaxants during anesthesia.
Caution is recommended when Rivastigmine Zentiva patches are used concomitantly with beta-blockers (medicines such as atenolol, used to treat hypertension, angina, and other heart conditions). Taking both medicines together may cause adverse effects such as slowing of the heartbeat (bradycardia), which may lead to fainting or loss of consciousness.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, the benefits of using Rivastigmine Zentiva must be weighed against the potential risks to the unborn child. Rivastigmine Zentiva must not be used during pregnancy unless strictly necessary.
You must not breastfeed during treatment with Rivastigmine Zentiva transdermal patches.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive and use machinery safely. Rivastigmine Zentiva transdermal patches may cause fainting or severe confusion. If you feel faint or confused, do not drive, do not use machinery, and avoid any other activity requiring alertness.

3. How to use Rivastigmina Zentiva

Use this medicine exactly as described in this leaflet and according to your doctor's instructions. If you have any doubts, consult your doctor or pharmacist.
IMPORTANT:

• Remove the previous day’s patch before applying a NEW one.
• Wear only ONE Rivastigmina Zentiva patch 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.

Starting treatment
Your doctor will tell you which Rivastigmina Zentiva transdermal patch is most suitable for you.

• Treatment usually starts with Rivastigmina Zentiva 4.6 mg/24 hours.
• The usual recommended daily dose is Rivastigmina Zentiva 9.5 mg/24 hours. If well tolerated, your doctor may consider increasing the dose to 13.3 mg/24 hours (the 13.3 mg/24 hours dosage is not available for this product. For conditions requiring this dosage, please refer to other products containing rivastigmine for which transdermal patches of 13.3 mg/24 hours are available).
• Apply only one Rivastigmina Zentiva patch at a time and replace it with a new one every 24 hours. During treatment, your doctor may adjust the dose according to your individual needs.

If you have not applied a patch for more than three days, do not apply the next one without first consulting your doctor. You may resume treatment with the same dose if therapy has been interrupted for no more than 3 days; otherwise, your doctor will restart treatment with Rivastigmina Zentiva 4.6 mg/24 hours.
Rivastigmina Zentiva may be used while eating food, drinking beverages, or consuming alcohol.
Where to apply Rivastigmina Zentiva transdermal patches
Before applying a patch, make sure the skin is clean, dry, and free of hair, powders, oils, moisturizers, or lotions, which may prevent the patch from adhering properly. The skin should be free of cuts, rashes, or irritation.
Carefully remove any existing patch before applying a new one. Having more than one patch on the skin could expose you to an excessive amount of medicine, which could be potentially dangerous.
Apply ONE patch per day to ONE of the application sites shown in the figure below:

• upper left arm or upper right arm
• upper left chest or upper right chest (avoid breasts)
• upper left back or upper right back
• lower left back or lower right back

Every 24 hours, remove the previous patch before applying a NEW ONE to ONE of the following possible sites.

When changing the patch, remove the previous day’s patch and apply the new one each time to a different site (for example, right side of the body one day and left side the next, upper body one day and lower body the next). Do not reapply a new patch to the same skin site until at least 14 days have passed.
How to apply Rivastigmina Zentiva transdermal patches
Rivastigmina Zentiva patches are thin, light brown, plastic patches that adhere to the skin. Each patch is sealed in a protective pouch until ready for use. Do not open the pouch or remove the patch until immediately before application.

Carefully remove the existing patch before applying a new one.
For patients starting treatment for the first time and for patients resuming treatment with rivastigmine after an interruption, please follow the instructions below next to the second image.

Each patch is sealed in its protective pouch. Open the pouch only when you are ready to apply the patch.
Cut along the scissors mark, without going beyond the indicated line. Open the pouch by tearing it open. Do not cut the pouch along its entire length to avoid damaging the patch.
Remove the patch from the pouch.
Peel off the protective film from the top, skin-colored side of the patch and discard it.

A protective liner covers the adhesive side of the patch.
Peel back one side of the protective liner and avoid touching the adhesive surface of the patch with your fingers.

Place the adhesive side of the patch on the upper or lower back, upper arm, or chest, then remove the second side of the protective liner.

Press firmly on the patch with the palm of your hand for at least 30 seconds, ensuring the edges adhere well.
If helpful, you may write on the patch (e.g., the day of the week) using a fine-tip ballpoint pen.
The patch should be worn continuously until it is time to replace it with a new one. If desired, when applying a new patch, you may try different sites to find those most comfortable for you and where clothing does not rub against the patch.
How to remove your Rivastigmina Zentiva transdermal patch
Gently lift one corner of the patch to slowly remove it from the skin. If adhesive residue remains on the skin, gently but thoroughly wet the area with warm water and mild soap, or use baby oil to remove it. Do not use alcohol or other solvents (such as nail polish remover or similar products).
After removing the patch, wash your hands with water and soap. If you get the medicine on your hands and it comes into contact with your eyes, or if your eyes become red after handling the patch, rinse immediately with plenty of water and consult a doctor if symptoms do not improve.
Can you apply your Rivastigmina Zentiva transdermal patch while bathing, swimming, or sunbathing?
Bathing, swimming, or showering should not interfere with the patch. Make sure the patch does not come loose during these activities.
Do not expose the patch to external sources of heat (e.g., excessive sunlight, sauna, sunbed) for prolonged periods.
What to do if the patch comes off
If the patch comes off, apply a new one for the remainder of the day, then replace the patch the next day at the usual time.
When and for how long to apply your Rivastigmina Zentiva transdermal patch
To benefit from treatment, apply a new patch every day, preferably at the same time each day.
Apply only one Rivastigmina Zentiva patch at a time and replace it with a new one after 24 hours.
If you use more Rivastigmina Zentiva than you should
If you accidentally apply more than one patch, remove all patches from the skin and inform your doctor that you accidentally applied more than one patch. You may need medical treatment. Some people who accidentally took an excessive amount of rivastigmine experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. Slowing of the heart rate and fainting may also occur.
If you forget to use Rivastigmina Zentiva
If you realize you have forgotten to apply a patch, apply a new one immediately. You may apply the next patch the following day at the usual time. Do not apply two patches to make up for the missed one.
If you stop using Rivastigmina Zentiva
If you stop treatment with the patch, inform your doctor or pharmacist.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be more common when you first start using the medicine or when your dose is increased.
Generally, side effects will gradually disappear as your body gets used to the medicine.
Remove the patch and contact your doctor immediately if you notice any of the following
side effects becomes severe:
Common (may affect up to 1 in 10 people):

• Loss of appetite
• Dizziness
• Feeling agitated or drowsy
• Urinary incontinence (inability to properly control urine).

Uncommon (may affect up to 1 in 100 people):

• Heart rhythm disorders, such as slow heartbeat
• Seeing things that are not really there (hallucinations)
• Stomach ulcer
• Dehydration (excessive loss of body 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 the arms or legs
• Hand tremors.

Frequency not known (frequency cannot be estimated from the available data):

• Allergic reactions at the application site of the patch, such as blisters or inflamed skin
• Worsening of symptoms of Parkinson’s disease – for example tremor, stiffness, and shuffling walk
• Inflammation of the pancreas – manifested by severe pain in the upper abdomen, often accompanied by nausea or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Seizures
• Liver disorders (yellowing of the skin and whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Changes in liver function test results
• Feeling restless
• Nightmares. Remove the patch and contact your doctor immediately if you notice any of the side effects listed above.

Other side effects observed with rivastigmine capsules or oral solution and which may occur with the
patch:
Common (may affect up to 1 in 10 people):

• Excessive salivation
• Loss of appetite
• Feeling restless
• General feeling of being unwell
• Tremors or confusion
• Increased sweating.

Uncommon (may affect up to 1 in 100 people):

• Irregular heartbeat (e.g. fast heartbeat)
• Sleep disorders
• Accidental falls.

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

• Seizures
• Intestinal ulcer
• Chest pain – this may be caused by heart spasm.

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

• High blood pressure
• Inflammation of the pancreas – manifested by severe pain in the upper abdomen, often accompanied by nausea or vomiting
• Intestinal bleeding – manifested by blood in the stool or vomit
• Seeing things that are not there (hallucinations)
• In some people who had severe vomiting, rupture of the tube connecting the mouth to the stomach (esophagus) occurred.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivastigmina Zentiva

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 on the sachet after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Keep the transdermal patch in its sachet until the time of use.
Do not use the patch if it is damaged or shows signs of tampering.
After removing a patch, fold it in half with the adhesive sides together and press them firmly. Place the used patch back into its original sachet and dispose of it in such a way that children cannot access it.
Avoid touching your eyes with your fingers and wash your hands thoroughly with water and soap after removing the patch.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rivastigmina Zentiva contains

• The active substance is rivastigmine.
• Rivastigmina Zentiva 4.6 mg/24 hours transdermal patches: Each patch releases 4.6 mg of rivastigmine over 24 hours, measures 4.6 cm and contains 6.9 mg of rivastigmine.
• Rivastigmina Zentiva 9.5 mg/24 hours transdermal patches: Each patch releases 9.5 mg of rivastigmine over 24 hours, measures 9.2 cm and contains 13.8 mg of rivastigmine.
• The other components are: Matrix:
  • poly[(2-ethylhexyl)acrylate, vinyl acetate]
  • medium and high molecular weight polyisobutene
  • anhydrous colloidal silica
  • light liquid paraffin
    Backing layer:
  • polyester film coated with polyethylene/thermoplastic resin/aluminum
    Release liner:
  • polyester film coated with fluoropolymer
    Orange printing ink

Description of the appearance of Rivastigmina Zentiva and pack contents
Each transdermal patch is thin. The outer layer is light brown and bears the following text printed in orange ink:

• “RIV-TDS 4.6 mg/24 h”
• “RIV-TDS 9.5 mg/24 h”

Each transdermal patch is sealed in a pouch. The patches are available in packs containing 7, 30 or 42 pouches, and in multiple packs containing 60, 84 or 90 pouches. Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l. - Viale Luigi Bodio 37/B, 20158 Milan, Italy

Manufacturer
Luye Pharma AG - Am Windfeld 35, 83714 Miesbach, Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:

Germany
Rivastigmin Zentiva 4.6 mg/24 Stunden transdermales Pflaster
Rivastigmin Zentiva 9.5 mg/24 Stunden transdermales Pflaster

Greece
Rivastigmine/Zentiva

Spain
Rivastigmina Zentiva 4.6 mg/24 h parches transdérmicos EFG
Rivastigmina Zentiva 9.5 mg/24 h parches transdérmicos EFG

France
RIVASTIGMINE Zentiva 4.6 mg/24 h Dispositif transdermique
RIVASTIGMINE Zentiva 9.5 mg/24 h Dispositif transdermique

Italy
Rivastigmina Zentiva

United Kingdom
Somniton 4.6 mg/24 h transdermal patch
Somniton 9.5 mg/24 h transdermal patch