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 the entire leaflet carefully before use, 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, 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 of illness are the same.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 inhibiting 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 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 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 this with the doctor or pharmacist if:

• the patient has or has ever had heart conditions, such as irregular or slow heartbeat, QT interval prolongation, familial QT prolongation, torsade de pointes, or low blood potassium or magnesium levels;
• the patient has or has ever had an active gastric 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 liver function impairment. If any of these situations 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 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).
Evertas should not be used at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking these two medicines together 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 (patch), they should inform the doctor about its use, as it may enhance the effect of certain muscle relaxants administered during anaesthesia.
Caution is advised when Evertas is used together with beta-blockers (medicines such as atenolol used in the treatment of hypertension, angina, and other heart conditions). Concomitant use of these medicines may cause adverse effects such as slowing of the heart rate (bradycardia), leading to fainting or loss of consciousness.
Caution is advised when Evertas is used together with other medicines that may affect heart rhythm or the cardiac conduction system (QT interval prolongation).
Pregnancy, breastfeeding and fertility
If the patient is pregnant or 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 using Evertas should be weighed against the potential risks to the unborn child. Evertas should not be used during pregnancy unless clearly necessary.
Breastfeeding is not recommended while using Evertas transdermal system (patch).
Driving and operating machinery
The doctor will advise the patient whether their condition allows safe driving and operating of machinery. Evertas 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 directed by your doctor. If in doubt, consult your 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 your hand and hold it in place for at least 30 seconds.

Evertas is available in the following doses: 4.6 mg/24h, 9.5 mg/24h, and 13.3 mg/24h.
Starting treatment
Your doctor will inform you which Evertas patch strength is most suitable for your condition.

• Treatment usually starts with Evertas 4.6 mg/24h.
• The recommended and commonly used daily dose of Evertas is 9.5 mg/24h. If treatment is well tolerated, your doctor may consider increasing the dose to 13.3 mg/24h.
• Only one Evertas patch should be applied at a time, and it should be 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 without first discussing it with your doctor. Treatment may be resumed with the same dose if the treatment interruption did not exceed three days. Otherwise, your doctor will advise restarting treatment with the 4.6 mg/24h Evertas patch.
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 hair-free. Remove any powder, oils, moisturizing creams, or liquids that might interfere with proper adhesion. The skin should be free from cuts, rashes, and/or irritation.
• Carefully remove any previously applied patch 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 diagrams:
  • 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 (e.g., 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). Do not apply the patch to the same site within 14 days.
How to 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.

Carefully remove the previous patch before applying a new one.
Patients starting treatment for the first time, or resuming treatment after a break, should follow the steps shown in the second diagram.

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. 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 liner.
Peel off one part of the protective liner 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 liner.

Press the patch firmly with your palm for at least 30 seconds, ensuring the 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 other chemical agents).
After removing the patch, wash your hands with soap and water. If the medicine comes into contact with your eyes or causes eye redness, immediately rinse your eyes with plenty of water. If symptoms persist, consult your doctor.
Can Evertas patches be used during bathing, swimming, or in the sun?

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

• To achieve the desired 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.

Use of a higher than recommended dose 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, diarrhea, high blood pressure, and hallucinations have occurred. Slowed heart rate and fainting may also occur.
Missed dose of Evertas
If you realize you forgot 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 at once 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 everybody gets 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 immediately inform your doctor, as these reactions may be serious:

Common (affects less than 1 in 10 people):

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

Uncommon (affects less than 1 in 100 people):

• heart rhythm disorders, such as slow heartbeat;
• seeing things that are not there (hallucinations);
• stomach ulcer;
• dehydration (loss of excessive amounts of fluid);
• excessive movement (high level of activity, restlessness);
• aggression.

Rare (affects less than 1 in 1,000 people):
falls.

Very rare (affects less than 1 in 10,000 people):

• stiffness of arms or legs;
• hand tremor.

Frequency not known (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 shuffling gait;
• 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, abnormally dark urine, or unexplained nausea, vomiting, fatigue, and loss of appetite);
• changes in liver function test results;
• anxiety;
• nightmares;
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal tilting of the body and head to one side).

If any of the adverse reactions listed above occur, remove the patch and immediately inform your doctor.

Other adverse reactions reported with rivastigmine when used in capsule or oral solution form, which may also occur with the use of patches:

Common (affects less than 1 in 10 people):

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

Uncommon (affects less than 1 in 100 people):

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

Rare (affects less than 1 in 1,000 people):

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

Very rare (affects less than 1 in 10,000 people):

• 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine 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.
No special storage instructions apply.
Store the patch (transdermal system) in its sachet until the time of use.
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. Following this advice will help protect the environment.

6. Contents of the pack and other information

What Evertas contains

• The active substance is rivastigmine. Each patch delivers 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.
• The other components 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

Backing layer:

• Polyethylene/thermoplastic resin/Aluminum coated with polyester

Protective liner (removable):

• Fluoropolymer-coated polyester
  Orange ink

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

• “RIV-TDS 9.5 mg/24 h”

Each patch is individually packed 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 parallel importer.

Marketing Authorisation Holder in Romania, the country of export:
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Numbers in Romania, the country of export:
11678/2019/06
11678/2019/02
11678/2019/03
11678/2019/04
11678/2019/05
11678/2019/01
11678/2019/07
11678/2019/08

Parallel Import Authorisation Number: 284/20

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Poland: Evertas
Romania: Evertas 9.5 mg/24 h transdermal patch