Evertas

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Evertas, 9.5 mg/24 h, transdermal system, patch
Rivastigminum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any side effects occur in the patient, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What is Evertas and what is it 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 is Evertas and what is it 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 enzymes that break down
acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking the action of these
enzymes, rivastigmine increases the concentration of acetylcholine in the brain, which helps
alleviate symptoms of Alzheimer's disease.
Evertas is used in the treatment of adult patients with mild to moderate Alzheimer-type dementia,
a progressive brain disorder that gradually impairs memory, intellectual abilities, and behavior.

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 spreading beyond the area of skin covered by the patch, if the local reaction worsens (e.g. blisters, worsening of skin inflammation, swelling), or if these changes do not resolve within 48 hours after removing the patch. If this situation applies to the patient, inform the doctor and do not apply the Evertas patch.

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

• the patient has or has ever had an irregular or slow heart rhythm;
• the patient has or has ever had an active peptic ulcer;
• the patient has or has ever had difficulty passing urine;
• the patient has or has ever had seizures;
• the patient 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 impaired liver function. If any of these conditions apply, closer medical monitoring may be required during treatment with this medicine.

If the patient has not applied a patch for more than three days, they should not apply a new patch until they have discussed it 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.
The Evertas transdermal system (patch) 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) should not be used at the same time as 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 using Evertas transdermal systems (patches), they must inform the doctor about their use, as they may enhance the effect of certain muscle relaxants administered during anaesthesia.
Caution is advised when the Evertas transdermal system (patch) is used together with beta-adrenergic blocking agents (beta-blockers such as atenolol, used in the treatment of hypertension, angina pectoris, and other heart conditions). Concomitant use of these two medicines may cause adverse effects such as slowing of the heart rate (bradycardia), leading to fainting or loss of consciousness.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
If the patient is pregnant, the benefits of using 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 while using Evertas transdermal systems (patches).
Driving and operating machinery
The doctor will advise the patient whether their condition allows safe driving and operating of 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 this patient leaflet or as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Evertas is available in doses of 4.6 mg/24 h and 9.5 mg/24 h.
WARNING:

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

Starting treatment
Your doctor will inform you which Evertas patches are best suited to your condition.

• Treatment usually starts with Evertas 4.6 mg/24 h.
• The recommended and commonly used daily dose of Evertas is 9.5 mg/24 h. If treatment is well tolerated, your doctor may consider increasing the dose to 13.3 mg/24 h (this dose cannot be achieved with this product. For conditions requiring such a dose, other rivastigmine products with transdermal systems delivering 13.3 mg/24 h should be used).
• Only one Evertas patch should be applied at a time and replaced 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 a new patch until you have spoken to your doctor. Treatment may be resumed with the same dose if the treatment interruption did not exceed three days. Otherwise, your doctor will recommend restarting treatment with the 4.6 mg/24 h Evertas dose.
Evertas may be used with food, drink, and alcohol.
Where to apply the Evertas patch

• Before applying the patch, ensure the skin at the intended site is clean, dry, and hairless, free from powder, oils, moisturizing creams, or lotions that may 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 you to excessive amounts of the 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 chest or upper right 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 (for example, one day on the right side of the body, the next on the left; one day on the upper body, the next on the lower body). Do not apply the patch to the same site within 14 days.
How to apply Evertas patches
Evertas is a thin, light brown, plastic 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.

Carefully remove the patch before applying a new one.
Patients starting treatment for the first time and patients restarting after a break in rivastigmine treatment 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 no further than the indicated line. Tear the pouch open. Do not cut the entire length of the pouch to avoid damaging the patch.
Remove the patch from the pouch.
Remove the protective liner from the upper, 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 surface.
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 your hand for at least 30 seconds,
ensuring its edges adhere well to the skin.

You 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. You may try different application sites to find the most convenient and least exposed to clothing friction.
How to 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 (such as nail polish remover or similar products).
After removing the patch, wash your hands with soap and water. If the medicine comes into contact with your eyes or if your eyes become red after contact with the patch, rinse your eyes immediately with plenty of water. If symptoms persist, consult your doctor.
Can Evertas patches be used during bathing, swimming, or in sunlight?

• Bathing, swimming, or showering should not affect the patch’s performance.
  Ensure the patch does not become dislodged 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 and replace it at the usual time the next day.
When and for how long to use Evertas patches

• For optimal effectiveness, apply a new patch daily, 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.

Overdose of Evertas
If you accidentally apply more than one patch, remove all patches immediately and inform your doctor about the incident. You may require medical assistance. 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.
Missed dose of Evertas
If you realize you have forgotten to apply a patch, do so as soon as possible. Apply the next patch at the usual time the following day. Do not apply two patches to make up for a missed dose.
Stopping Evertas treatment
If you stop using this medicine, inform your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
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 the treatment.
If any of the adverse reactions listed below occur, remove the patch and inform your doctor immediately,
as these reactions may be serious:
Common (occur in less than 1 in 10 patients):

• loss of appetite;
• dizziness;
• agitation or drowsiness;
• urinary incontinence (inability to properly control urination).

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

• heart rhythm disorders, such as slow heartbeat;
• seeing things that are not there (hallucinations);
• stomach ulcer;
• dehydration (loss of excessive amounts of fluid);
• excessive motor activity (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 unknown (cannot be estimated from available data):

• allergic reaction at the site of the patch, such as blisters or skin inflammation;
• worsening of Parkinson's disease symptoms – such as tremor, stiffness or leg pulling;
• pancreatitis – symptoms include severe pain in the upper abdomen, often with nausea (feeling sick) or vomiting;
• fast or irregular heartbeat;
• high blood pressure;
• seizures (fits);
• liver function disorders (yellowing of the skin, yellowing of the whites of the eyes, unexplained dark urine, or unexplained nausea, vomiting, fatigue and loss of appetite);
• abnormal liver function test results;
• anxiety;
• nightmares.

If any of the adverse reactions listed above occur, remove the patch and inform your doctor immediately.
Other adverse reactions reported with rivastigmine when administered as capsules or oral solution,
which may also occur with the use of patches:
Common (occur in less than 1 in 10 patients):

• excessive salivation;
• loss of appetite;
• anxiety;
• general malaise;
• tremor or confusion;
• increased sweating.

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

• heart rhythm disorders (e.g. fast 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 abdomen, often with nausea (feeling sick) 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 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Evertas

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine.
Keep the patch (transdermal system) in its sachet until ready to use.
Do not use a patch that is damaged or shows signs of prior opening.
After removing the patch, fold it in half with the adhesive side facing inward and press firmly together. Place the used patch back into the sachet and then dispose of it 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Evertas contains

• The active substance is 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.
• Other components are:
• Acrylate copolymer of 2-ethylhexyl acrylate and vinyl acetate
• Medium molecular weight polyisobutene
• High molecular weight polyisobutene
• Anhydrous colloidal silica
• Light liquid paraffin

Backing 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 patch. On the outer, light brown backing layer, the text “RIV-TDS 9.5 mg/24 h” is printed in orange ink.
Each patch is individually enclosed in a sealed pouch. Patches are available in packs containing 7, 30, 60 or 90 pouches.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Romania, country of export:
Zentiva, k.s., U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic
Manufacturer:
Luye Pharma AG, Am Windfeld 35, 83714 Miesbach, Germany
Zentiva S.A., B-dul Theodor Pallady nr. 50, Sector 3, Bucharest, Romania
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Romania, country of export: 11678/2019/01
11678/2019/02
11678/2019/03
11678/2019/04
Parallel Import Authorisation Number: 10/20