Rivastigmine mylan

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
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

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

Leaflet contents

1. What Rivastigmine Mylan is and what it is used for
2. What you need to know 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 Rivastigmine Mylan is and what it is used for

The active substance in Rivastigmine Mylan 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 blocking these enzymes, rivastigmine increases the concentration of acetylcholine in the brain, which helps to alleviate the symptoms of Alzheimer's disease.
Rivastigmine Mylan is used in the treatment of adult patients with mild to moderate Alzheimer's dementia, a progressive brain disorder that gradually impairs memory, intellectual abilities, and behaviour.

2. Important information before using Rivastigmine Mylan

When not to use Rivastigmine Mylan

• if the patient is allergic to rivastigmine (the active substance in 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 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 removing the patch.

If any of these situations apply to the patient, the doctor should be informed and the
Rivastigmine Mylan patch must not be applied.
Warnings and precautions
Before starting treatment with Rivastigmine Mylan, discuss with the doctor or
pharmacist if:

• the patient 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;
• the patient has heart failure;
• the patient has previously had a heart attack;
• the patient has or has ever had low blood potassium or magnesium levels;
• the patient has ever had an active peptic ulcer;
• the patient has or has ever had difficulties passing urine;
• the patient has or has ever had epileptic 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 side effects such as nausea (feeling sick), vomiting, and diarrhoea. The patient may become dehydrated (losing too much fluid) if vomiting or diarrhoea persists for a prolonged period;
• the patient has liver function disorders.

If any of these situations apply to the patient, closer monitoring by the doctor may be required
during treatment with this medicine.
Children and adolescents
Rivastigmine Mylan should not be used in children and adolescents for the treatment of
Alzheimer's disease.
Rivastigmine Mylan 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, including those available without a
prescription.
Rivastigmine Mylan may intensify the effect of certain blood pressure-lowering medicines, such as
“beta-blockers” (e.g. atenolol), “calcium channel blockers” (e.g. amlodipine, nifedipine), “antiarrhythmics” (e.g. sotalol, amiodarone), digitalis glycosides, and pilocarpine (used in glaucoma treatment). This may lead to fainting.
Caution is required when Rivastigmine Mylan is used together with other medicines that may affect heart rhythm or the cardiac conduction system (QT interval prolongation).
If the patient is taking any of the following medicines, the doctor may perform regular heart examinations to ensure the heart is functioning properly:

• medicines used to treat psychiatric 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 peptic ulcer),
• halofantrine (used to treat malaria),
• mizolastine (used to treat allergies),
• methadone (a pain-relieving medicine also used in heroin addiction),
• intravenous erythromycin, pentamidine, moxifloxacin (antibiotics).

Rivastigmine Mylan 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), in the treatment of overactive bladder (e.g. oxybutynin, tolterodine), or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).
The transdermal system of Rivastigmine Mylan must not be used simultaneously with
metoclopramide (a medicine used to relieve or prevent nausea and vomiting).
Concurrent use of these two medicines may cause side effects such as limb stiffness and hand tremors.
If the patient is to undergo surgery during treatment with Rivastigmine Mylan, the patient should
inform the doctor, as it may be necessary to discontinue the medicine, since it may intensify the effect of certain muscle relaxants used during anaesthesia.
Pregnancy and breastfeeding
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 Rivastigmine Mylan should be weighed against the possible risks to the unborn child. Rivastigmine Mylan should not be used during pregnancy unless absolutely necessary.
Breastfeeding must not be undertaken during treatment with Rivastigmine Mylan.
Driving and using machines
The doctor will inform the patient whether their condition allows safe driving and operating
machinery. Rivastigmine Mylan 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 Rivastigmine Mylan

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

• Before applying ONE new patch, the previous patch must be removed.
• Use only one Rivastigmine Mylan patch per day.
• Do not cut the patch into smaller pieces.
• Press the patch firmly with the palm of the hand and hold for at least 30 seconds.
• Avoid touching the eyes after applying the patch.

How to start treatment
The doctor will inform the patient which Rivastigmine Mylan patches are best suited for their case.

• Treatment usually begins with Rivastigmine Mylan 4.6 mg/24 h.
• The recommended, commonly 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 treating physician may consider increasing the dose to 13.3 mg/24 h (this dose cannot be achieved with this product). In cases requiring such a dose, consult the pharmacist for advice.
• Only one patch should be applied at a time, and it should be replaced with a new one every 24 hours.

During treatment, the doctor may adjust the dose according to the individual needs of the patient.
If the patient has not applied a patch for three days or more, they should not apply a new patch
until they have consulted their doctor, as they may be at increased risk of experiencing
adverse effects. Treatment may be resumed using the same dose if the treatment interruption
was less than three days. Otherwise, the doctor may recommend continuing treatment with the
4.6 mg/24 h dose of Rivastigmine Mylan.
Where to apply the Rivastigmine Mylan patch

• Before applying the patch, ensure that the skin at the intended site is clean, dry, and hair-free, free of powder, oils, moisturizing creams, or lotions that could interfere with proper adhesion of the patch, and free from cuts, rashes, and/or irritation.
• 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 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 to 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 indicated sites.

When changing the patch, remove the patch from the previous day before applying a new patch at a different site (for example, one day on the right side of the body and the next day on the left, one day on the chest or upper body and the next on the lower back). Do not apply the patch to the same site within 14 days.
How the patient should apply Rivastigmine Mylan patches
Rivastigmine Mylan is available as thin, light-brown adhesive patches made of synthetic material applied to the skin. Each patch is contained in a sealed protective pouch. Do not open the pouch or remove the patch from the pouch until it is time to apply it to the skin.

Carefully remove the old patch before applying a new one.
Patients starting treatment for the first time or
patients resuming treatment with rivastigmine after a break
should begin with the steps shown in the second
illustration.

Each patch is contained in a sealed protective pouch. Open the pouch just 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 open it. Do not cut the pouch along its entire length to avoid damaging the patch.
Remove the patch from the pouch.
Remove the (skin-colored) protective liner from the top side of the patch and discard it.

The adhesive side of the patch is protected by a protective layer. Remove one part of the protective layer, taking care not to touch the adhesive side of the patch.

Apply the adhesive side of the patch to the upper or lower back, upper arm, or chest, then remove the second part of the protective layer.
Press the patch firmly with the palm of the hand for at least 30 seconds, ensuring that the edges adhere well to the skin.
The patch can now be labeled with a pen, for example with the name of 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 (choosing from those listed above) to find the most convenient and least clothing-irritated location.
How the patient should remove the Rivastigmine Mylan 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 agents).
Washing hands
After removing or applying the patch, wash hands with water and soap. If the medicine comes into contact with the eyes or causes eye redness after contact with the patch, immediately rinse the eyes with plenty of water, and if symptoms persist, consult a doctor.
Can the patient use Rivastigmine Mylan patches during bathing, swimming, or in the sun?

• Bathing, swimming, or showering should not affect the performance of the patch. Ensure that 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 patch for the remainder of the day, then change it at the usual time the next day.
When and for how long the patient should use Rivastigmine Mylan patches

• To achieve the desired treatment effect, apply a new patch every day, preferably at the same time each day.
• Apply only one Rivastigmine Mylan patch at a time and replace it with a new one every 24 hours.

Use of more than the recommended dose of Rivastigmine Mylan
If the patient accidentally applies more than one patch, remove all patches and immediately inform the doctor about the accidental application of more than one patch. The patient may require medical assistance.
In some individuals who accidentally used too much rivastigmine, symptoms such as reduced pupil size (miosis), skin redness and sensation of warmth (hot flushes), abdominal pain, nausea, vomiting, diarrhea, slow heart rate, sudden breathing difficulties (bronchospasm), increased mucus production, increased sweating, loss of bladder control, tearing, low blood pressure, increased salivation, dizziness, tremor, headache, drowsiness, confusion, high blood pressure, hallucinations, and lack of energy have occurred. In severe cases, muscle weakness, muscle cramps, seizures, and respiratory depression or arrest have been observed.
Missed dose of Rivastigmine Mylan
If the patient realizes they have forgotten to apply a patch, they should do so immediately. The next patch can be applied at the usual time the following day. Do not apply two patches to make up for a missed dose.
Stopping use of Rivastigmine Mylan
If treatment is discontinued, inform the doctor or pharmacist.
If the patient has not used a patch for three days or more, they should not use a new one without first consulting their doctor, as adverse effects are more likely to occur.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects occur more frequently during the initial period of treatment or when increasing the dose.
Adverse effects usually gradually subside as the body adapts to the treatment.
If any of the following adverse effects occur, the patch should be removed immediately
and the doctor should be informed without delay, as these effects may be severe:

• seizures
• changes in heart rhythm, which may be observed as very rapid heartbeat or the sensation of missed heartbeats
• stomach ulcers (the patient may experience abdominal pain and vomiting may contain fresh blood or appear as if containing coffee grounds)
• pancreatitis – symptoms include severe pain in the upper abdomen, often accompanied by nausea or vomiting
• severe confusion, which may be associated with 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 develop yellowing of the skin or whites of the eyes, abnormally dark urine, unexplained nausea, vomiting, fatigue, and loss of appetite)

Other adverse effects:
Common (may affect up to 1 in 10 patients):

• headache
• loss of appetite or reduced appetite, weight loss
• restlessness, depression, dizziness
• fainting
• nausea, vomiting, diarrhoea, 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 include pain during urination or more frequent urination than normal)
• urinary incontinence (inability to control urination)

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

• heart problems, such as slow heartbeat
• dehydration (loss of excessive amounts of fluids)
• hyperactivity (high level of activity, restlessness)
• aggression

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

• fainting

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

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

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

• allergic reaction, such as blisters or inflammatory skin condition, itching, urticaria, or redness
• worsening of Parkinson's disease symptoms – such as tremor, stiffness, drowsiness, and shuffling gait
• rapid heartbeat
• high blood pressure
• changes in liver function test results
• feeling of restlessness
• seeing or hearing things that do not exist (hallucinations)
• nightmares

Other adverse effects observed during treatment with rivastigmine capsules
or oral solution, which may also occur with the use of patches:
Common (may affect up to 1 in 10 patients):

• general malaise
• confusion
• increased sweating

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

• peptic ulcer disease
• chest pain – may be caused by constriction of heart blood vessels

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

• gastrointestinal bleeding – presenting as blood in stool or in vomit

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

• Severe vomiting, which may lead to oesophageal rupture

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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
Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Rivastigmine Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet under "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
There are no special requirements for storage of this medicinal product.
Before use, the patch should be stored in its sachet.
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 turned inwards 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 soap and water.
Medicines should not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Rivastigmine Mylan contains

• The active substance is rivastigmine.
• Rivastigmine Mylan 4.6 mg/24 h transdermal systems: each patch delivers 4.6 mg of rivastigmine over 24 hours. The patch has a surface area of 4.6 cm² and contains 6.9 mg of rivastigmine.
• Rivastigmine Mylan 9.5 mg/24 h transdermal systems: 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.
• Other components are: Acrylate copolymer of 2-ethylhexyl acrylate and vinyl acetate, Polyisobutene of medium molecular weight, Polyisobutene of high molecular weight, Anhydrous colloidal silica, Light liquid paraffin

Backing layer:
Polyethylene/thermoplastic resin/Aluminium coated with polyester
Protective liner (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, the following text is printed in orange ink:

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

Each patch is contained in an individual sealed pouch. The patches are available in packs containing 7 or 30 pouches, and in multipack containers containing 60 or 90 pouches. Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product and its trade names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00