Atmina

Package leaflet: Information for the patient

Atmina, 4.6 mg/24 h, transdermal system, patch
Atmina, 9.5 mg/24 h, transdermal system, patch
Rivastigminum
Please read all of this leaflet carefully before using the medicine, as 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 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 others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Atmina is and what it is used for
2. Important information before using Atmina
3. How to use Atmina
4. Possible side effects
5. How to store Atmina
6. 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 known as 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 to 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. Important 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, worsening of skin inflammation, swelling), or if these skin changes have not resolved within 48 hours after patch removal. If this applies to the patient, they should inform their doctor and must not apply the Atmina patch.

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

• if the patient currently has or has ever had heart conditions such as irregular or
  slow heart rhythm, QT interval prolongation, familial QT prolongation,
  torsade de pointes, or low blood potassium or magnesium levels;

• if the patient currently has or has ever had an active peptic ulcer;

• if the patient currently has or has ever had difficulty urinating;

• if the patient currently has or has ever had seizures;

• if the patient currently 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 disorders such as nausea (feeling sick), vomiting, or diarrhoea. The patient may become dehydrated (lose too much fluid) if vomiting or diarrhoea persists for a prolonged period;

• if the patient has impaired liver function.

If any of these conditions apply to the patient, the doctor may carry out closer monitoring
during treatment with this medicine.
If the patient has not applied a patch for more than three days, they must not apply a new patch until
they have discussed this with their doctor.
All previously 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 your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Atmina, transdermal patch, must not be used concomitantly
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 to undergo surgery while using Atmina transdermal patches,
they should inform their doctor about using this medicine, as it may enhance the effect of
certain muscle relaxants administered during anaesthesia.
Caution is advised when Atmina transdermal 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 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 concomitantly 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 become pregnant, she should consult her doctor or pharmacist before using this medicine.
If the patient is pregnant, the benefits of using Atmina should be weighed against the potential risks to the unborn child. Atmina should not be used during pregnancy unless clearly necessary.
Breastfeeding must not be undertaken during treatment with Atmina.

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

3. How to use Atmina

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.

Starting treatment

The doctor will inform the patient which Atmina patch is most suitable in a given 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, the doctor may consider increasing the dose to 13.3 mg/24 h. A dose of 13.3 mg/24 h 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), and they should be changed twice weekly, no later than after 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.

A new patch should always be applied at the same time of day. To help remember, note down the days and time of patch change.

During treatment, the doctor may adjust the dose according to the individual patient's needs.

If a patient has missed applying a patch for more than three days, they should not apply a new patch without first discussing it with the doctor. Treatment with patches may be resumed with the same dose if the treatment interruption did not exceed three days. Otherwise, the doctor will recommend resuming treatment with a dose of 4.6 mg/24 h of Atmina.

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

Where to apply Atmina transdermal 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 might interfere with proper adhesion of the patch, and free from cuts, rashes, and (or) irritations.

• Carefully remove all previously applied patches before applying a new one. Applying multiple patches to the skin may expose the patient to excessive amounts of the 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 figures below:
  • 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.

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

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

How the patient should apply Atmina transdermal 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	Patch made of fabric without active substance (for securing)

Do not open the sachet or remove the patch from the sachet until the time of application 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) and patients resuming rivastigmine treatment after a break should start with the steps shown in the second illustration.
	Each patch is individually contained 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 the pouch open to remove the patch. Do not cut the pouch along its entire length to avoid damaging the patch. Remove the rectangular, semi-transparent transdermal delivery system (patch) from the pouch.
	The adhesive layer of the patch is protected by a protective liner. Peel off one part of the protective liner, taking care not to touch 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, then remove the second part of the protective liner.
	Press the patch firmly with the palm of your hand for about 15 seconds, ensuring that its edges adhere well to the skin.

Then apply the oval , self-adhesive protective cover.

	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 drug-free adhesive protective liner. Remove the oval, beige, self-adhesive protective liner from the pouch.
	The adhesive layer of the protective liner is protected by a protective backing. Remove the smaller part of the protective backing without touching the patch's adhesive surface with fingers.
	Apply the adhesive surface of the protective liner onto the previously applied transdermal patch system so that it is completely covered, then remove the second part of the protective backing.
	Firmly press the patch with the palm of your hand for at least 30 seconds, ensuring that its edges adhere properly to the skin.

For some patients, it may be helpful to write with a fine pen on the protective liner
e.g. 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 for the new patch to select the most convenient location that is not prone to being rubbed off by clothing.
How should the patient remove the Atmina transdermal patch?
Gently pull one edge of the self-adhesive protective liner 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 (e.g. nail polish remover or similar products).
After removing the patch, wash hands thoroughly with water and soap. If the medication 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, and if symptoms persist, seek medical advice.
Can the patient use the Atmina transdermal patch while bathing, swimming, or in the sun?

• 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, solarium).
  What to do if the patch detaches
  If the patch detaches on its own, apply a new one and then change it at the usual time.
  When and for how long should the patient use the Atmina transdermal patch?

• To ensure effective treatment, apply a new patch twice a week, no later than every four days, preferably at the same time of day.

• Only one rectangular transdermal patch and one oval self-adhesive protective liner should be applied at a time, and they should be replaced with new ones on two fixed days of the week.
  Use of more than the recommended dose of Atmina
  If the patient accidentally applies more than one rectangular transdermal 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 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 Atmina
If the patient realizes they forgot to apply the patch, they should do so immediately, provided that 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 another patch until they have spoken with their doctor.
Discontinuation of Atmina treatment
If treatment with the patches is discontinued, inform the doctor or pharmacist.
If there are 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 not everyone will experience them.
Adverse reactions may occur more frequently during the initial period of treatment or when the dose is being increased. Adverse reactions usually gradually subside as the body adapts to the treatment.
If any of the adverse reactions listed below occur, the patch should be removed and you should immediately inform your doctor, as these reactions may be severe:

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 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 (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
• Trembling of hands

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

• Allergic reaction at the site of the 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 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)

If any of the adverse reactions listed above occur, the patch should be removed and your doctor should be informed immediately.

Other adverse reactions reported with rivastigmine when administered in capsule or oral solution form, 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 disorders (e.g. fast heartbeat)
• Difficulty falling asleep
• 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 angina

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 of Adverse Drug Reactions at 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.
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 the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box and sachet after: "EXP". The expiry date refers to the last day of the stated month.
• There are no special storage instructions for this medicine.
• Do not use a patch if it 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. Place the used patch into the sachet and then dispose of it 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Atmina contains
The active substance in Atmina 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 (covering) layer: poly(ethylene terephthalate) film.
Active layer: tocopherol, poly(acrylate of 2-ethylhexyl, 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 pack
Each transdermal system is a thin, rectangular patch with rounded corners. The patch is semi-transparent 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 individually enclosed in a 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 cardboard carton containing the transdermal system, patch, includes a protective cover designed to secure the transdermal system, patch.
Each protective cover is a thin, beige, oval-shaped patch.
Protective covers are individually enclosed in sealed pouches. The pouches are labelled as follows:
Adhesive protective cover without active substance.
All 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 packs containing 2, 8, 16, or 24 transdermal systems (patches), each pack including 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 European Economic Area member states 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