EVERTAS

Package leaflet: Information for the user

Evertas, 4.6 mg/24 h, transdermal system, patch
Evertas, 9.5 mg/24 h, transdermal system, patch
Evertas, 13.3 mg/24 h, transdermal system, patch
Rivastigmine

Please read all of this leaflet carefully before starting to use the medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Evertas is and what it is used for

The active substance in Evertas is rivastigmine.
Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients
with Alzheimer-type dementia, there is a reduction in the number of nerve cells in the brain,
leading to decreased production of acetylcholine, a neurotransmitter (a substance enabling
nerve cells to communicate with each other). Rivastigmine works by inhibiting the enzymes
that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking
these enzymes, rivastigmine increases the concentration of acetylcholine in the brain, which
helps to alleviate the symptoms of Alzheimer's disease.
Evertas is used in the treatment of adult patients with mild to moderate Alzheimer's dementia,
a progressive brain disorder that gradually impairs memory, intellectual abilities, and behaviour.

2. Important information before using Evertas

When not to use Evertas

• if the patient is allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an allergic reaction to similar medicines (carbamate derivatives);
• if the patient develops a skin reaction extending beyond the area of skin covered by the patch, if the local reaction worsens (e.g. blisters, worsening skin inflammation, swelling), or if these changes do not resolve within 48 hours after removing the patch. If this applies to the patient, inform the doctor and do not apply the Evertas patch.

Warnings and precautions
Before starting treatment with Evertas, discuss this with the doctor or pharmacist if:

• the patient currently has or has ever had heart conditions, such as irregular or slow heart rhythm, QT prolongation, familial QT prolongation, torsade de pointes, or low blood potassium or magnesium levels;
• the patient currently has or has ever had an active peptic ulcer;
• the patient currently has or has ever had difficulty passing urine;
• the patient currently has or has ever had seizures;
• the patient currently has or has ever had asthma or severe respiratory disease;
• the patient has muscle tremors;
• the patient has low body weight;
• the patient experiences gastrointestinal symptoms such as nausea, vomiting, or diarrhoea. The patient may become dehydrated (lose too much fluid) if vomiting or diarrhoea persists for a prolonged period;
• the patient has liver function impairment. If any of these conditions apply, closer monitoring by the doctor during treatment with this medicine may be required.

If the patient has not applied a patch for more than three days, they should not apply a new patch
until they have discussed this with their doctor.
Children and adolescents
The use of Evertas in children and adolescents for the treatment of Alzheimer-type dementia is not recommended.
Evertas and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Evertas may affect the action of anticholinergic medicines, some of which are used to relieve stomach spasms (e.g. dicyclomine), in the treatment of Parkinson's disease (e.g. amantadine), or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).
The Evertas transdermal system patch must not be used simultaneously with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Concomitant use of these two medicines may cause adverse effects such as limb stiffness and hand tremors.
If the patient is due to undergo surgery while being treated with Evertas transdermal system patches, they should inform the doctor about using this medicine, as it may enhance the effect of certain muscle relaxants administered during anaesthesia.
Caution is advised when Evertas transdermal system patches are used concomitantly with beta-blockers (medicines such as atenolol used in the treatment of hypertension, angina pectoris, and other heart conditions). Concomitant use of these two medicines may lead to adverse effects such as slowed heart rate (bradycardia), resulting in fainting or loss of consciousness.
Caution is advised when Evertas is used concomitantly with other medicines that may affect heart rhythm or the cardiac conduction system (QT prolongation).
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
If the patient is pregnant, the benefits of treatment with Evertas should be weighed against the potential risks to the unborn child. Evertas should not be used during pregnancy unless absolutely necessary.
Breastfeeding is not recommended during treatment with Evertas transdermal system patches.
Driving and operating machinery
The doctor will advise the patient whether their condition allows safe driving and operating machinery. Evertas (patches) may cause fainting or severe confusion. If the patient feels unwell or disoriented, they should not drive, operate machinery, or perform any tasks requiring concentration.

3. How to use Evertas

This medicine should always be used exactly as described in the patient information leaflet or as directed by the doctor. If in doubt, consult a doctor or pharmacist.
WARNING:

• Remove the previous patch before applying a new one.
• Apply only ONE Evertas patch per day.
• Do not cut the patch into smaller pieces.
• Press the patch firmly with the palm of the hand and hold for at least 30 seconds.

Starting treatment
The doctor will inform the patient which Evertas patch strength is most suitable in their case.

• Treatment usually starts with Evertas 4.6 mg/24 h.
• The recommended, commonly used daily dose of Evertas is 9.5 mg/24 h. If the treatment is well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h.
• Only one Evertas patch should be applied at a time, and it should be replaced with a new one every 24 hours. During treatment, the doctor may adjust the dose according to the individual patient's needs.

If the patient has not applied a patch for more than three days, they should not apply a new patch until they have spoken to their doctor. Treatment may be resumed with the same dose if the treatment interruption did not exceed three days. Otherwise, the doctor will advise restarting treatment with the 4.6 mg/24 h Evertas dose.
Evertas may be used with food, drink, and alcohol.
Where the patient should apply the Evertas patch

• Before applying the patch, ensure that the skin at the intended site is clean, dry, and hair-free, free from powder, oils, moisturizing creams, or lotions that could interfere with proper adhesion, and free from cuts, rashes, and/or irritation.
• Carefully remove any previously applied patches before applying a new one. Applying multiple patches may expose the patient to an excessive amount of medicine, which could be dangerous.
• Apply ONE patch per day to ONLY ONE of the following sites, as shown in the illustrations:
  • upper left arm or upper right arm
  • upper left side of the chest or upper right side of the chest (avoid applying patches on the breasts)
  • upper left back or upper right back
  • lower left back or lower right back

After 24 hours, remove the old patch before applying ONE new patch to ONLY ONE of the shown sites.

When changing the patch, remove the previous day’s patch before applying the new one to a different site (e.g., one day on the right side of the body, the next day on the left; one day on the upper part of the body, the next on the lower part). Do not apply the patch to the same site within 14 days.
How the patient should apply Evertas patches
Evertas is a thin, light brown, plastic transdermal patch applied to the skin. Each patch comes in a sealed protective pouch. Do not open the pouch or remove the patch until ready to apply it to the skin.

Carefully remove the previous patch before applying a new one.
Patients starting treatment for the first time, and patients restarting treatment after a break, should begin with the steps shown in the second illustration.

Each patch comes in a sealed protective pouch. Open the pouch just before use. Cut the pouch at both locations marked with scissors, but not beyond the indicated line. Tear open the pouch to remove the patch. Do not cut the entire length of the pouch to avoid damaging the patch.
Remove the patch from the pouch.

For Evertas 4.6 mg/24 h and 9.5 mg/24 h transdermal systems, the patch:
Remove the protective liner from the top, skin-facing side of the patch.
The adhesive side of the patch is protected by a protective layer. Remove one part of the protective layer without touching the adhesive side of the patch.

For Evertas 13.3 mg/24 h transdermal system, the patch:
The adhesive side of the patch is protected by a protective layer. Remove one part of the protective layer without touching the adhesive side of the patch.

Apply the adhesive side of the patch to the upper or lower back, upper arm, or chest area, then remove the second part of the protective layer.
Press the patch firmly with the palm of the hand for at least 30 seconds,

ensuring that the edges adhere well to the skin.
The patient may now label the patch with a pen, for example, with the day of the week.
The patch should be worn continuously until it is time to replace it with a new one. The patient may try different application sites to find the most convenient and least clothing-exposed location.
How the patient should remove the Evertas patch
Gently pull at one edge of the patch and slowly peel it off the skin. If adhesive residue remains on the skin, it can be removed by washing the area with warm water and mild soap or with baby oil. Do not use alcohol or other solvents (e.g., nail polish remover or similar products).
After removing the patch, wash hands with soap and water. If the medicine comes into contact with the eyes or if eye redness occurs after contact with the patch, immediately rinse the eyes thoroughly with plenty of water. If symptoms persist, consult a doctor.
Can the patient use Evertas patches during bathing, swimming, or in sunlight?

• Bathing, swimming, or showering should not affect the patch’s performance. Ensure the patch does not become loose during these activities.
• Do not expose the patch to prolonged external heat sources (e.g., excessive sunlight, sauna, sunbed).

What to do if the patch becomes detached
If the patch detaches on its own, apply a new one for the remainder of the day, then replace it at the usual time the next day.
When and for how long the patient should use Evertas patches

• To achieve the desired treatment effect, apply a new patch every day, preferably at the same time each day.
• Apply only one Evertas patch at a time and replace it with a new one every 24 hours.

Using more than the recommended dose of Evertas
If the patient accidentally applies more than one patch, remove all patches immediately and inform the doctor about the accidental application of more than one patch. Medical assistance may be required. In some individuals who accidentally received too much rivastigmine, symptoms such as nausea, vomiting, diarrhoea, high blood pressure, and hallucinations have occurred. Slowed heart rate and fainting may also occur.
Missing a dose of Evertas
If the patient realizes they forgot to apply a patch, they should do so as soon as possible. The next patch may be applied at the usual time the following day. Do not apply two patches to make up for a missed dose.
Stopping Evertas treatment
If treatment is discontinued, inform the doctor or pharmacist.
For any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Adverse reactions occur more frequently during the initial period of treatment or during dose escalation. Adverse reactions usually gradually subside as the body adapts to treatment.
If any of the adverse reactions listed below occur, remove the patch
and immediately inform your doctor, as these reactions may be severe:
Common (occur in less than 1 in 10 patients):

• loss of appetite;
• dizziness;
• restlessness;
• urinary incontinence (inability to properly retain urine);
• urinary tract infections;
• anxiety;
• depression;
• confusion;
• headache;
• fainting;
• stomach problems such as nausea or vomiting, diarrhoea;
• heartburn;
• abdominal pain;
• rash;
• allergic reaction at the site of application, such as blisters or skin inflammation;
• feeling of tiredness or weakness;
• weight loss;
• fever.

Uncommon (occur in less than 1 in 100 patients):

• heart rhythm disorders, such as slow heartbeat;
• gastric ulcer;
• dehydration (loss of excessive amounts of fluid);
• excessive mobility (high level of activity, restlessness);
• aggression.

Rare (occur in less than 1 in 1,000 patients):

• falls.

Very rare (occur in less than 1 in 10,000 patients):

• stiffness of arms or legs;
• trembling of hands.

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

• worsening of Parkinson's disease symptoms – such as tremor, stiffness or leg pulling;
• pancreatitis – symptoms include severe pain in the upper part of the abdomen, often with nausea or vomiting;
• rapid or irregular heartbeat;
• high blood pressure;
• seizures (fits);
• liver function disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine, or unexplained nausea, vomiting, fatigue and loss of appetite);
• changes in liver function test results;
• restlessness;
• nightmares;
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal tilting 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 any of the adverse reactions listed above occur, remove the patch and immediately inform your doctor.
Other adverse reactions reported with rivastigmine capsules or
oral solution, which may also occur with the use of patches:
Common (occur in less than 1 in 10 patients):

• excessive salivation;
• restlessness;
• general malaise;
• tremor;
• increased sweating.

Uncommon (occur in less than 1 in 100 patients):

• heart rhythm disorders (e.g. rapid heartbeat);
• difficulty falling asleep;
• accidental falls.

Rare (occur in less than 1 in 1,000 patients):

• seizures (fits);
• peptic ulcer disease;
• chest pain – may be caused by heart spasm.

Very rare (occur in less than 1 in 10,000 patients):

• high blood pressure;
• pancreatitis – symptoms include severe pain in the upper part of the abdomen, often with nausea or vomiting;
• gastrointestinal bleeding – blood in stool or vomit;
• seeing things that are not there (hallucinations);
• violent vomiting, which may lead to rupture of the part of the gastrointestinal tract connecting the mouth to the stomach (oesophagus).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw.
Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or the representative of the marketing authorisation holder in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Evertas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
There are no special storage requirements for this medicine.
Before use, the patch should be stored in the sachet.
Do not use a patch that is damaged or shows signs of having been opened.
After removing the patch, fold it in half with the adhesive side inward and press firmly together. The used patch should be placed back into the sachet and then disposed of in a place inaccessible to children. After removing the patch, avoid touching the eyes with fingers before washing hands thoroughly with water and soap.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Evertas contains

• The active substance is rivastigmine.
  Evertas 4.6 mg/24 h transdermal system: each patch releases 4.6 mg of rivastigmine over 24 hours. The patch has a surface area of 4.6 cm² and contains 6.9 mg of rivastigmine.
  Evertas 9.5 mg/24 h transdermal system: each patch releases 9.5 mg of rivastigmine over 24 hours. The patch has a surface area of 9.2 cm² and contains 13.8 mg of rivastigmine.
  Evertas 13.3 mg/24 h transdermal system: each patch releases 13.3 mg of rivastigmine over 24 hours. The patch has a surface area of 12.8 cm² and contains 19.2 mg of rivastigmine.

• Other ingredients are:

Active layer:

• Acrylate copolymer of 2-ethylhexyl acrylate and vinyl acetate

Adhesive matrix layer:

• Medium molecular weight polyisobutene
• High molecular weight polyisobutene
• Anhydrous colloidal silica
• Light liquid paraffin

Outer layer:

• Polyethylene/thermoplastic resin/aluminum covered with polyester

Protective liner (removable):

• Polyester coated with fluoropolymer
• Orange ink

What Evertas looks like and contents of the pack
Each transdermal system is a thin, round patch. On the outer, light brown covering layer, there is an orange inscription:

• “RIV-TDS 4.6 mg/24 h”
• “RIV-TDS 9.5 mg/24 h”
• “RIV-TDS 13.3 mg/24 h”

Each patch is contained in an individual, tightly sealed pouch.
Evertas 4.6 mg/24 h transdermal system
Evertas 9.5 mg/24 h transdermal system
Patches are available in packs containing 7 or 30 transdermal systems, and in multipacks containing 60 (2x30) or 90 (3x30) transdermal systems.
Evertas 13.3 mg/24 h transdermal system
Patches are available in packs containing 30 transdermal systems, and in multipacks containing 60 (2x30) or 90 (3x30) transdermal systems.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer
Luye Pharma AG, Am Windfeld 35, 83714 Miesbach, Germany
S.C. Zentiva S.A., B-dul Theodor Pallady nr.50, sector 3, 032266 Bucharest, Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Evertas
Romania: Evertas 4.6 mg/24 h plasture transdermic
Romania: Evertas 9.5 mg/24 h plasture transdermic

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00