Rivastigmine Milan

Package Leaflet: Information for the User

Rivastigmine Mylan, 4.6 mg/24 h, transdermal system, patch
Rivastigmine Mylan, 9.5 mg/24 h, transdermal system, patch
Rivastigmine

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet

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

1. What is Rivastigmine Mylan and what is it used for

The active substance of Rivastigmine Mylan is rivastigmine.
Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with Alzheimer's disease, there is a decrease in the number of nerve cells in the brain, which leads to a decrease in the concentration of acetylcholine, a neurotransmitter, produced by them. The action of rivastigmine is to block the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking the action of these enzymes, rivastigmine allows the concentration of acetylcholine in the brain to increase, which helps to alleviate the symptoms of Alzheimer's disease.
Rivastigmine Mylan is used to treat adult patients with mild to moderately severe Alzheimer's disease, a progressive brain disease that gradually disrupts memory, intellectual abilities, and behavior.

2. Important information before using Rivastigmine Mylan

When not to use Rivastigmine Mylan

• if the patient is hypersensitive to rivastigmine (the active substance of Rivastigmine Mylan) or to 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 has a skin reaction that extends beyond the area of skin covered by the patch, if the local reaction has worsened (e.g. blisters have appeared, inflammation of the skin has intensified, swelling), or if these changes have not resolved within 48 hours after removal of the patch.

If this situation applies to the patient, they should inform their doctor and not apply the Rivastigmine Mylan patch.

Warnings and precautions

Before starting treatment with Rivastigmine Mylan, the patient should discuss with their doctor or pharmacist if:

• the patient has or has had heart diseases such as irregular or slow heart rhythm, prolonged QT interval, family history of prolonged QT interval, torsades de pointes, or low potassium or magnesium levels in the blood;
• the patient has heart failure;
• the patient has had a heart attack in the past;
• the patient has or has had decreased potassium or magnesium levels in the blood;
• the patient has or has had an active stomach ulcer;
• the patient has or has had difficulty urinating;
• the patient has or has had seizures;
• the patient has or has had asthma or severe respiratory disease;
• the patient has muscle tremors;
• the patient has a low body mass;
• the patient has gastrointestinal reactions, such as nausea (vomiting), vomiting, and diarrhea. The patient may become dehydrated (lose too much fluid) if vomiting or diarrhea persists for a longer period;
• the patient has liver function disorders.

If any of these situations apply to the patient, closer monitoring by the doctor may be necessary during treatment with this medicine.

Children and adolescents

The use of Rivastigmine Mylan in children and adolescents is not appropriate for the treatment of Alzheimer's disease.

Rivastigmine Mylan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those obtained without a prescription.
Rivastigmine Mylan may enhance the effects of certain medicines that lower blood pressure, such as beta-blockers (e.g. atenolol), calcium channel blockers (e.g. amlodipine, nifedipine), anti-arrhythmic medicines (e.g. sotalol, amiodarone), digitalis glycosides, and pilocarpine (used to treat glaucoma). This may lead to fainting.
Caution should be exercised when Rivastigmine Mylan is used with other medicines that may affect heart rhythm or cardiac conduction (prolonged QT interval).
If the patient is taking any of the following medicines, the doctor may perform regular heart checks to ensure that the heart is working properly:

• medicines used to treat mental disorders, known as antipsychotics, e.g. chlorpromazine, levomepromazine, sulpiride, amisulpride, tiapride, veralipride, pimozide, haloperidol, droperidol,
• cisapride (used to treat indigestion),
• citalopram (used to treat depression),
• difemanil (used to treat stomach ulcers),
• halofantrine (used to treat malaria),
• mizolastine (used to treat allergies),
• methadone (a pain-relieving medicine, also used for heroin addiction),
• erythromycin i.v., pentamidine, moxifloxacin (antibiotics).

Rivastigmine Mylan may affect the action of anticholinergic medicines, some of which are used to relieve stomach cramps (e.g. dicyclomine), to treat Parkinson's disease (e.g. amantadine), to treat overactive bladder (e.g. oxybutynin, tolterodine), or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).
Rivastigmine Mylan transdermal system 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 disorders such as stiffness of the limbs and trembling of the hands.
If the patient is to undergo surgery during treatment with Rivastigmine Mylan, they should inform their doctor, as it may be necessary to stop using it, as it may enhance the effects of certain muscle relaxants used during anesthesia.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
If the patient is pregnant, the benefits of using Rivastigmine Mylan should be weighed against the potential effects of the medicine on the unborn child. Rivastigmine Mylan should not be used during pregnancy unless absolutely necessary.
While using Rivastigmine Mylan, the patient should not breastfeed.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive or use machines safely. Rivastigmine Mylan may cause fainting or severe dizziness. If the patient feels weak or disoriented, they should not drive, operate machinery, or perform other tasks that require concentration.

3. How to use Rivastigmine Mylan

This medicine should always be used exactly as the doctor or pharmacist has instructed. If the patient is unsure, they should ask their doctor or pharmacist.

IMPORTANT:

• Before applying ONE new patch, the previous patch should be removed.
• Only ONE Rivastigmine Mylan patch should be used per day.
• The patch should not be cut into smaller pieces.
• The patch should be pressed firmly with the inner side of the hand and held for at least

30 seconds.

• The patient should avoid touching their eyes after applying the patch.

How to start treatment

The doctor will inform the patient which Rivastigmine Mylan patches are best for their case.

• Treatment usually starts with Rivastigmine Mylan 4.6 mg/24 h.
• The recommended, usually used daily dose of Rivastigmine Mylan is 9.5 mg/24 h. If the patient's condition does not improve after at least 6 months, the doctor may consider increasing the dose to 13.3 mg/24 h (this dose cannot be achieved with this product). In cases where such a dose is required, the patient should ask their pharmacist for advice.
• Only one patch should be applied at a time and changed for a new one every 24 hours.

During treatment, the doctor may adjust the dose of the medicine to the individual patient's needs.
If the patient has not applied a patch for three days or more, they should not apply a new patch until they have spoken to their doctor, as they may be more likely to experience side effects. Treatment can be resumed using the same dose if the break in treatment does not exceed three days. Otherwise, the doctor may recommend continuing treatment with a dose of 4.6 mg/24 h Rivastigmine Mylan.

Where to apply the Rivastigmine Mylan patch

• Before applying the patch, the patient should make sure that the skin in the planned application area is clean, dry, and hairless, free from powder, oils, creams, or liquids that could prevent the patch from sticking properly, free from cuts, rashes, and/or irritations,
• The patient should carefully remove any previously applied patches before applying a new one.Applying multiple patches to the skin may expose the patient to an excessive amount of medicine, which can be dangerous.
• The patient should apply ONEpatch per day to ONLY ONEof the following areas, as shown in the diagrams:
• upper part of the left arm orupper part of the right arm
• upper part of the chest on the left side oron the right side (the patient should avoid applying patches to the breast)
• upper part of the back on the left side oron the right side
• lower part of the back on the left side oron the right side

After 24 hours, the old patch should be removed before applying ONE new patch to ONLY ONE of the shown areas.

When changing the patch, the patient should remove the previous day's patch before applying a new patch to a different area (e.g. one day on the right side of the body, the next day on the left, one day on the chest or upper part of the body, the next day on the lower part of the back). The patient should not apply a patch to the same area within 14 days.

How the patient should apply the Rivastigmine Mylan patches

Rivastigmine Mylan comes in the form of thin, light-brown patches made of plastic, which are stuck to the skin. Each patch is in a tightly closed protective sachet. The patient should not open the sachet or remove the patch from the sachet until they are ready to apply it to the skin. The patient should carefully remove the old patch before applying a new one.
Patient starting treatment (for the first time) and patients restarting treatment with rivastigmine after a break should start with the actions shown in the second diagram.

Each patch is in a tightly closed protective sachet. The sachet should be opened just before using the patch.
The patient should cut the sachet at the two marked places with scissors, but no further than the indicated line. The patient should tear the sachet to open it. The patient should not cut the sachet along its entire length to avoid damaging the patch.
The patient should remove the patch from the sachet.
The patient should remove the protective backing (colored) from the top of the patch and discard it.

The adhesive side of the patch is protected by a protective layer.
The patient should remove one part of the protective layer without touching the adhesive side of the patch.

The patient should apply the adhesive side of the patch to the upper or lower part of the back, upper part of the arm, or chest, and then remove the second part of the protective layer.

The patient should press the patch firmly with their hand for at least 30 seconds, making sure that its edges stick well to the skin.
The patient can now sign the patch with a pen, e.g. with the name of the day of the week.

The patient should wear the patch continuously until it is time to change it for a new one. The patient can try different application areas (choosing from the ones indicated above) to find the most convenient and least exposed to abrasion by clothing.

How the patient should remove the Rivastigmine Mylan patch

The patient should gently pull one edge of the patch and slowly peel it off the skin. If any adhesive residue remains on the skin, it can be removed by washing the area with warm water and mild soap or baby oil. The patient should not use alcohol or other solvents (nail polish remover or other products).

Washing hands

After removing or applying the patch, the patient should wash their hands with soap and water. If the medicine comes into contact with the eyes or if the eyes become red after contact with the patch, the patient should immediately rinse their eyes with plenty of water, and if the symptoms do not disappear, they should consult a doctor.

Can the patient use Rivastigmine Mylan patches while bathing, swimming, or in the sun?

• Bathing, swimming, or showering should not affect the action of the patch. The patient should make sure that the patch is not loosened during these activities.
• The patient should not expose the patch to prolonged external heat sources (e.g. excessive sun exposure, sauna, solarium).

What to do if the patch comes off

If the patch comes off, the patient should apply a new one for the rest of the day and then change it at the usual time the next day.

When and for how long should the patient use Rivastigmine Mylan patches

• To get the effect of the treatment, the patient should apply a new patch every day, preferably at the same time every day.
• The patient should apply only one Rivastigmine Mylan patch at a time and change it for a new one every 24 hours.

Using more than the recommended dose of Rivastigmine Mylan

If the patient accidentally applies more than one patch, they should remove all patches and inform their doctor about the accidental application of more than one patch. The patient may need medical attention.
In some people who have accidentally taken too much rivastigmine, the following have occurred: decreased pupil size (miosis), redness of the skin, and a feeling of heat (hot flashes), abdominal pain, nausea, vomiting, diarrhea, slow heart rate, sudden breathing difficulties (bronchospasm), increased production of mucus, increased sweating, loss of bladder control, crying, low blood pressure, increased salivation, dizziness, trembling, headache, drowsiness, confusion, high blood pressure, hallucinations, and lack of energy. In severe cases, muscle weakness, muscle spasms, seizures, and slowing or stopping of breathing have been observed.

Missing a dose of Rivastigmine Mylan

If the patient realizes they have forgotten to apply a patch, they should immediatelydo so. The next patch can be applied at the usual time the next day. The patient should not apply two patches to make up for a missed dose.

Stopping treatment with Rivastigmine Mylan

If the patient stops using the medicine, they should inform their doctor or pharmacist.
If the patient does not apply a patch for three days or more, they should not start using a new patch before consulting their doctor, as they are more likely to experience side effects.
If the patient has any further questions about using this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivastigmine Mylan can cause side effects, although not everybody gets them.
Side effects are more common during the initial treatment period or when the dose is increased. Side effects usually disappear slowly as the body gets used to the treatment.

If the patient experiences any of the following side effects, they should remove the patch and immediately tell their doctor, as these effects can be severe:

• seizures
• changes in heart rhythm, which may be observed as very fast heart rate or feeling of missing heartbeats
• stomach ulcers - the patient may experience abdominal pain and vomiting may contain fresh blood or look like coffee grounds
• pancreatitis - symptoms include severe pain in the upper part of the abdomen, often with nausea or vomiting
• severe dizziness, which may be accompanied by seeing, hearing, or feeling things that do not exist (hallucinations), loss of contact with reality (delusions), and increased or decreased activity (delirium)
• liver function disorders - the patient may experience yellowing of the skin, eyes, abnormal darkening of urine, or unexplained nausea, vomiting, fatigue, and loss of appetite

Other side effects:

Common(may affect up to 1 in 10 people):

• headache
• loss of appetite, weight loss
• feeling of anxiety, depression, dizziness
• fainting
• nausea, vomiting, diarrhea, indigestion/heartburn, abdominal pain
• agitation, fatigue, general weakness, fever
• skin rash and allergic skin reactions such as eczema-like reactions, redness, itching, swelling, and irritation
• urinary tract infection - may be accompanied by pain when urinating or more frequent urination than normal
• urinary incontinence (inability to hold urine)

Uncommon(may affect up to 1 in 100 people):

• heart problems, such as slow heart rate
• dehydration (loss of too much fluid)
• hyperactivity (high level of activity, restlessness)
• aggression

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

• fainting

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

• stiffness of the arms or legs, restlessness, muscle spasms, trembling, such as hand trembling

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

• allergic reaction, such as blisters or skin inflammation, itching, hives, or redness
• worsening of Parkinson's disease symptoms - such as trembling, stiffness, drowsiness, and shuffling gait
• fast heart rate
• high blood pressure
• changes in liver function test results
• feeling of anxiety
• seeing or hearing things that do not exist (hallucinations)
• nightmares

Other side effects observed with the use of rivastigmine in capsule or oral solution form, which may also occur with patch use:

Common(may affect up to 1 in 10 people):

• general malaise
• feeling of confusion
• increased sweating

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

• intestinal ulcer disease
• chest pain - may be caused by coronary artery spasm

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

• gastrointestinal bleeding - manifested as blood in the stool or vomit

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

• severe vomiting, which may lead to rupture of the esophagus

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal 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
Side effects can also be reported to the marketing authorization holder.

5. How to store Rivastigmine Mylan

The medicine should be kept out of the sight and reach of children.
The patient should 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 month stated.
There are no special storage instructions for the medicinal product.
Before use, the patch should be stored in the sachet.
The patient should not use a patch that is damaged or shows signs of opening.
After removing the patch, the patient should fold it in half with the adhesive side inwards and press firmly. The used patch should be placed in the sachet and then discarded in a place inaccessible to children. After removing the patch, the patient should not touch their eyes with their fingers before washing their hands with soap and water.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Rivastigmine Mylan contains

• The active substance is rivastigmine.
• Rivastigmine Mylan 4.6 mg/24 h transdermal systems: each patch releases 4.6 mg of rivastigmine over 24 hours. The patch has a surface area of 4.6 cm and contains 6.9 mg of rivastigmine.
• Rivastigmine Mylan 9.5 mg/24 h transdermal systems: each patch releases 9.5 mg of rivastigmine over 24 hours. The patch has a surface area of 9.2 cm and contains 13.8 mg of rivastigmine.
• Other ingredients are: 2-ethylhexyl acrylate copolymer and vinyl acetate, medium molecular weight polyisobutene, high molecular weight polyisobutene, anhydrous colloidal silica, light liquid paraffin

Outer layer:
Polyethylene/thermoplastic resin/aluminum coated with polyester
Protective layer (removable):
Polyester coated with fluoropolymer
Orange ink

What Rivastigmine Mylan looks like and contents of the pack

Each transdermal system is a thin patch. On the outer, light-brown covering layer, there is an inscription printed with orange ink:

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

Each patch is in an individual, tightly closed sachet. The patches are available in packs of 7 or 30 sachets and in multipacks of 60 or 90 sachets. Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer

McDermott Laboratories Ltd. T/A Gerard Laboratories T/A Mylan Dublin
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland
Mylan Hungary Kft
H-2900 Komárom
Mylan utca 1
Hungary
Luye Pharma AG
Am Windfeld 35, 83714 Miesbach,
Germany
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Phone: +48 22 546 64 00

Date of last revision of the leaflet: May 2024