Package leaflet: Information for the user

Atmina, 4.6 mg/24 h, transdermal system, patch
Atmina, 9.5 mg/24 h, transdermal system, patch
Rivastigminum
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Atmina is and what it is used for
What you need to know before using Atmina
How to use Atmina
Possible side effects
How to store Atmina
Contents of the pack and other information

1. What Atmina is and what it is used for

The active substance in Atmina is rivastigmine.
Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients
with Alzheimer-type dementia, certain nerve cells in the brain degenerate, leading to a decrease
in the neurotransmitter 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 blocking these enzymes, rivastigmine increases the concentration of acetylcholine in the brain, which helps alleviate the symptoms of Alzheimer's disease.
Atmina is used in the treatment of adult patients with mild to moderately severe Alzheimer-type dementia, a progressive brain disorder causing gradual impairments in memory, intellectual abilities, and behavior.

2. Information before using Atmina

When not to use Atmina

if the patient is allergic to rivastigmine (the active substance in Atmina) or to any of the other ingredients of this medicine (listed in section 6);
if the patient has ever had an allergic reaction to similar medicines (carbamate derivatives);
if the patient has a skin reaction extending beyond the area of skin covered by the patch, if the local reaction has worsened (e.g. blisters, increased skin inflammation, swelling), or if these changes have not resolved within 48 hours after removing the patch. If this applies to the patient, inform the doctor and do not apply the Atmina patch.

Warnings and precautions
Before starting treatment with Atmina, discuss the following with the doctor or pharmacist:

if the patient has or has ever had heart conditions such as irregular or
slow heart rhythm, prolonged QT interval, familial QT prolongation,
torsade de pointes, or low blood potassium or magnesium levels;
if the patient has or has ever had an active peptic ulcer;
if the patient has or has ever had difficulty passing urine;
if the patient has or has ever had seizures;
if the patient has or has ever had asthma or severe respiratory disease;
if the patient has muscle tremors;
if the patient has low body weight;
if the patient has gastrointestinal side effects such as nausea, vomiting, or diarrhoea. The patient may become dehydrated (losing too much fluid) if vomiting or diarrhoea persists for a prolonged period;
if the patient has liver function disorders.

If any of these conditions apply, the doctor may carry out closer monitoring of the patient during treatment with this medicine.
If the patient has not applied a patch for more than three days, the patient should not apply a new patch without first discussing it with the doctor.
All applied patches must be carefully removed before applying a new one. Do not apply more than one patch at the same time. Applying several (or more than one) patches to the skin may expose the patient to an excessive dose of the medicine.

Children and adolescents
The use of Atmina in children and adolescents for the treatment of Alzheimer's disease is not recommended.

Atmina and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Atmina, transdermal system in the form of a 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).
Atmina, transdermal system in the form of a patch, must not be used at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting).
Concurrent 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 Atmina transdermal system in the form of a patch, the patient must inform the doctor about its use, as it may enhance the effect of certain muscle relaxants used during anaesthesia.
Caution is advised when Atmina transdermal system in the form of a patch is used together with beta-blockers (medicines such as atenolol, used in the treatment of hypertension, angina pectoris, and other heart conditions). Concurrent use of these two medicines may cause adverse effects such as slowing of the heart rate (bradycardia), leading to fainting or loss of consciousness.
Caution is advised when Atmina is used together with other medicines that may affect heart rhythm or the cardiac conduction system (prolongation of QT interval).

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 the doctor or pharmacist before using this medicine.
If the patient is pregnant, the benefits of using Atmina should be weighed against the possible risks to the unborn child. Atmina should not be used during pregnancy unless absolutely necessary.
Breastfeeding is not recommended while using Atmina.

Driving and operating machinery
The doctor will advise the patient whether their condition allows safe driving and operating machinery. Atmina, transdermal system in the form of a patch, may cause fainting or severe confusion. If the patient feels unwell or disoriented, they must not drive, operate machinery, or perform any other tasks requiring concentration.

3. How to use Atmina

This medicine should always be used exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Starting treatment

Your doctor will inform you which Atmina patch is most suitable for your individual case.

Treatment usually starts with Atmina 4.6 mg/24 h.
The recommended, commonly used daily dose of Atmina is 9.5 mg/24 h. If this dose is well tolerated, your doctor may consider increasing the dose to 13.3 mg/24 h. However, the 13.3 mg/24 h dose cannot be achieved with Atmina. For conditions requiring such a dose, other transdermal systems containing rivastigmine with a strength of 13.3 mg/24 h are available.
Only one rectangular patch and one oval, self-adhesive protective cover should be applied at a time (as described in detail below). The patches must be changed twice weekly, no later than every 4 days. Patches should be changed on two fixed days of the week:

Every
Monday and Friday OR
Tuesday and Saturday OR
Wednesday and Sunday OR
Thursday and Monday OR
Friday and Tuesday OR
Saturday and Wednesday OR
Sunday and Thursday.

Always apply the new patch at the same time of day. To help you remember, write down the days and time when you change the patch.

During treatment, your doctor may adjust the dose according to your individual needs.

If you have missed applying a patch for more than three days, do not apply a new one without first discussing it with your doctor. Treatment with patches may be resumed at the same dose if the treatment interruption was less than three days. Otherwise, your doctor will advise restarting treatment with the 4.6 mg/24 h dose of Atmina.

Atmina may be used with food, drink, and alcohol.

Where to apply Atmina transdermal system (patch)

Before applying the patch, ensure that the skin at the intended site is clean, dry, and hairless, free from powder, oils, moisturizing creams, or lotions that might interfere with proper adhesion of the patch, and free from cuts, rashes, and/or irritation.

Carefully remove any previously applied patch before applying a new one. Applying multiple patches to the skin may expose the patient to an excessive amount of medicine, which could be dangerous.
Apply ONE rectangular patch together with one self-adhesive protective cover to ONLY ONE of the following sites, as shown in the illustrations below:
- 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 back on the left side or on the right side
- lower back on the left side or on the right side.

Remove the previous patch no later than 4 days before applying ONE new patch and one self-adhesive protective cover to ONLY ONE of the following possible sites.

Silhouette diagram of male bodies showing injection sites on the front and back of the torso, including arms, chest, and buttocks

When changing the patch, remove the previous patch before applying the new one to a different site (e.g., 4 days on the right side of the body, then 3 days on the left side, then 4 days on the upper area, followed by 3 days on the lower area). Do not apply the patch to the same site within 14 days.

How to apply Atmina transdermal system (patch)

Atmina is intended for transdermal use.

Atmina consists of two parts:

one rectangular, semi-transparent patch containing the active substance (transdermal system), which is contained in a sealed pouch, and
one oval, beige-colored fabric patch without active substance (self-adhesive protective cover), which is also contained in a sealed pouch. This pouch is larger than the pouch containing the transdermal patch system.


Transdermal system in the form of a patch containing the active substance	Non-active substance-containing fabric patch (for fixation)

Do not open the sachet or remove the patch from the sachet until the time of applying it to the skin.
The rectangular transdermal system, patch, should always be applied first.

	Carefully remove the previous patch before applying a new one. Patients starting treatment (for the first time) as well as patients resuming rivastigmine treatment after a break should start with the steps shown in the second picture.
	Each patch is individually packed in a sealed pouch. Open the pouch immediately before using the patch. Cut the pouch at both locations marked with scissors, but no further than the indicated line. Tear open the pouch to remove the patch. Do not cut the pouch along its entire length to avoid damaging the patch. Remove the rectangular, semitransparent transdermal delivery system (patch) from the pouch.
	The adhesive layer of the patch is protected by a protective liner. Remove one part of the protective liner without touching the adhesive surface of the patch with fingers.
	Apply the adhesive side of the patch to the upper or lower back, upper arm, or chest area, and then remove the second part of the protective liner.
	Press the patch firmly with the palm of the hand for approximately 15 seconds, ensuring that its edges adhere well to the skin.

Then apply the oval , self-adhesive protective cover.

	Cut the sachet at both locations marked with scissors, but no further than the indicated line. Tear the sachet open. Do not cut the entire length of the sachet to avoid damaging the drug-free adhesive protective liner. Remove the oval, beige, self-adhesive protective cover from the sachet.
	The adhesive layer of the protective cover is protected by a protective liner. Remove the smaller part of the protective liner, taking care not to touch the patch's adhesive surface with fingers.
	Apply the adhesive surface of the protective cover onto the previously applied transdermal patch system, completely covering it, then remove the second part of the protective liner.
	Firmly press the patch with the palm of your hand for at least 30 seconds, ensuring its edges adhere properly to the skin.

For some patients, it may be helpful to write the day of the week in fine handwriting on the protective patch cover.
The patch should be worn continuously until it is time to replace it with a new one. The patient may try different application sites for the new patch to select the most convenient location that is least likely to be rubbed off by clothing.

How the patient should remove Atmina transdermal system patch

Gently pull one edge of the self-adhesive protective cover and slowly peel it off the skin together with the transdermal system.
If the transdermal system remains on the skin, gently pull one edge and 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 olive oil. Do not use alcohol or other solvents (such as nail polish remover or similar products).
After removing the patch, wash hands thoroughly with water and soap. In case of contact with eyes or eye redness after contact with the patch, immediately rinse eyes with plenty of water, and if symptoms persist, seek medical advice.

Can the patient use Atmina transdermal system patch during bathing, swimming, or in sunlight?

Bathing, swimming, or showering should not affect the performance of the patch. However, ensure that the patch does not become dislodged during these activities.
Do not expose the patch to prolonged heat from external 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 and then change it again at the usual time.

When and for how long should the patient use Atmina transdermal system patch?

To achieve therapeutic effect, apply a new patch twice weekly, no later than every four days, preferably at the same time of day.
Only one rectangular transdermal system patch and one oval self-adhesive protective cover should be applied at a time, and they should be replaced with new ones on two fixed days of the week.

Use of a higher than recommended dose of Atmina

If the patient accidentally applies more than one rectangular transdermal system patch, remove all patches immediately and inform the doctor about the accidental application of more than one patch. The patient may require medical assistance. In some individuals who accidentally received excessive rivastigmine, symptoms such as nausea, vomiting, diarrhea, high blood pressure, and hallucinations have occurred. Slowing of heart rate and fainting may also occur.

Missed dose of Atmina

If the patient realizes they have forgotten to apply the patch, they should do so immediately, provided the treatment interruption has not exceeded three days.
The next patch may be applied at the usual time on the scheduled day to return to the regular dosing schedule. Do not apply two patches to make up for a missed dose. If the patient has not worn a patch for more than three days, they should not apply a new patch until they have consulted their doctor.

Stopping treatment with Atmina

If treatment with the patches is discontinued, inform the doctor or pharmacist.
For any further questions regarding the use of this medicine, consult the 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 may 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 (may affect up to 1 in 10 people)

Loss of appetite
Dizziness
Agitation or drowsiness
Urinary incontinence (inability to properly control urination)

Uncommon (may affect up to 1 in 100 people)

Heart rhythm disturbances, 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 (may affect up to 1 in 1,000 people)

Falls

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

Stiffness of arms or legs
Tremor of hands

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

Allergic reaction at the site of patch application, 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 (epileptic fits)
Liver function abnormalities (yellowing of the skin, yellowing of the whites of the eyes, unexplained dark-colored 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 causing abnormal tilting of the body and head to one side)

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 (may affect up to 1 in 10 people)

Excessive salivation
Loss of appetite
Restlessness
General malaise
Tremor or confusion
Increased sweating

Uncommon (may affect up to 1 in 100 people)

Heart rhythm disturbances (e.g. fast heartbeat)
Difficulty sleeping
Accidental falls

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

Seizures (epileptic fits)
Peptic ulcer disease
Chest pain – may be caused by heart spasm

Very rare (may affect up to 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 esophagus (the part of the digestive tract connecting the mouth to the stomach)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Atmina

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and sachet following: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
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 facing inward and press firmly. The used patch should be placed back into the sachet and then disposed of in a place inaccessible to children. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Atmina contains
The active substance is rivastigmine.
Atmina 4.6 mg/24 h, transdermal system, patch:
Each transdermal system, patch, releases 4.6 mg of rivastigmine over 24 hours. Each transdermal system, patch, with a surface area of 10.8 cm², contains 25.92 mg of rivastigmine.
Atmina 9.5 mg/24 h, transdermal system, patch:
Each transdermal system, patch, releases 9.5 mg of rivastigmine over 24 hours. Each transdermal system, patch, with a surface area of 21.6 cm², contains 51.84 mg of rivastigmine.

Other components are:
Outer (protective) layer: poly(ethylene terephthalate) film.
Active layer: tocopherol, poly(2-ethylhexyl acrylate, vinyl acetate) (1:1) copolymer of butyl acrylate and butyl methacrylate.
Active substance-permeable membrane: polyethylene film.
Adhesive layer: medium molecular weight polyisobutylene, high molecular weight polyisobutylene, high molecular weight polybutylene.
Protective (removable) layer: silicone-coated polyester film.
Printing: Blue ink.

What Atmina looks like and contents of the packaging
Each transdermal system is a thin, rectangular patch with rounded corners. The patch is semitransparent and bears the following marking:
Atmina, 4.6 mg/24 h, transdermal system, patch: RID-TDS 4.6 mg/24 h
Atmina, 9.5 mg/24 h, transdermal system, patch: RID-TDS 9.5 mg/24 h

Each transdermal system, patch, is contained in an individual, tightly sealed pouch. The pouches are labelled as follows:
Atmina, 4.6 mg/24 h, transdermal system, patch
Atmina, 9.5 mg/24 h, transdermal system, patch

Additionally, each carton containing the transdermal system, patch, includes a protective cover designed to secure the transdermal system, patch.
Each protective cover is a thin, oval-shaped, beige patch.
The protective covers are individually packed in tightly sealed pouches. The pouches are labelled as follows:
Adhesive protective cover without active substance.
All components are packed in a cardboard carton.

Atmina, 4.6 mg/24 h, transdermal system, patch and Atmina, 9.5 mg/24 h, transdermal system, patch are available in packaging containing 2, 8, 16, or 24 transdermal systems (patches), each accompanied by 2, 8, 16, or 24 adhesive protective covers, respectively.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
e-mail: [email protected]

Manufacturer
Luye Pharma AG
Am Windfeld 35
83714 Miesbach
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Spain: Alzerta dos por semana 4.6 mg/24 h parches transdérmicos
Alzerta dos por semana 9.5 mg/24 h parches transdérmicos
Germany: Rivez zweimal wöchentlich 4.6 mg/24 Stunden Transdermales Pflaster
Rivez zweimal wöchentlich 9.5 mg/24 Stunden Transdermales Pflaster
Poland: Atmina