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

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Rivastigmine Mylan is and what it is 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 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 alleviate symptoms of Alzheimer's disease.
Rivastigmine Mylan 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 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 develops a skin reaction extending beyond the area of skin covered by the patch, if the local reaction has worsened (e.g. blisters, worsening 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 currently has or has ever had heart conditions such as irregular or slow heartbeat, QT 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 currently has or has ever had low blood potassium or magnesium levels;
• the patient has ever had an active peptic ulcer;
• the patient currently has or has ever had difficulty passing urine;
• the patient currently has or has ever had epileptic seizures;
• the patient currently has or has ever had asthma or severe respiratory disease;
• the patient has muscle tremors;
• the patient has low body weight;
• the patient has gastrointestinal side effects 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;
• the patient has liver function disorders.

If any of these conditions apply, closer medical monitoring 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 your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.

Rivastigmine Mylan may enhance the effects 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 advised when Rivastigmine Mylan is used together with other medicines that may affect heart rhythm or the cardiac conduction system (QT 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);
• difenamid (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 Parkinson's disease (e.g. amantadine), for overactive bladder (e.g. oxybutynin, tolterodine), or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).

The Rivastigmine Mylan transdermal system should 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 side effects such as limb stiffness and hand tremors.

If the patient is scheduled for surgery while being treated with Rivastigmine Mylan, the patient should inform the doctor, as it may be necessary to discontinue the medicine, since it may enhance the effects 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 while using Rivastigmine Mylan.

Driving and operating machinery

The doctor will advise the patient whether their condition allows safe driving and operating of 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.

Starting treatment
The doctor will inform the patient which Rivastigmine Mylan patches are most suitable in their case.

• Treatment usually starts with Rivastigmine Mylan 4.6 mg/24 h.
• The recommended, usually effective 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 spoken with their doctor, as they may be at increased risk of 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 other liquids that might interfere with proper adhesion, 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
  • left or right side of the upper chest (avoid applying patches on the breasts)
  • left or right side of the upper back
  • left or right side of the lower 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 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 day on the left; one day on the chest or upper body, the next on the lower back). Do not apply the patch to the same site again within 14 days.
How the patient should apply Rivastigmine Mylan patches
Rivastigmine Mylan is a thin, light-brown transdermal patch made of plastic adhesive material. Each patch is individually sealed in a protective pouch. Do not open the pouch or remove the patch from it 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, as well as
patients restarting treatment with rivastigmine after a break,
should begin with the steps shown in the second illustration.

Each patch is sealed in a protective pouch. Open the pouch just before use.
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 entire length of the pouch to avoid damaging the patch.
Remove the patch from the pouch.
Peel off the beige-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.
Peel off one part of this protective layer, taking care not to touch the adhesive surface of the patch.

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 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 may now be labeled with a pen, for example with 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 (from those listed above) to find the most comfortable 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 similar products).
Handwashing
After removing or applying the patch, wash hands thoroughly with soap and water. If the medicine comes into contact with the eyes or causes eye redness, immediately rinse the eyes with plenty of water. If symptoms persist, consult a doctor.
Can the patient use Rivastigmine Mylan patches 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 external heat sources (e.g., excessive sunlight, sauna, sunbed).

What to do if the patch detaches
If the patch detaches on its own, apply a new one for the remainder of the day, then replace it at the usual time the next day.
When and for how long the patient should use Rivastigmine Mylan patches

• To achieve therapeutic benefit, a new patch must be applied every day, preferably at the same time each day.
• Only one Rivastigmine Mylan patch should be applied at a time, and it should be replaced 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 immediately and inform the doctor about the accidental application of more than one patch. Medical assistance may be required.
In some individuals who accidentally received too much rivastigmine, symptoms such as pupil constriction (miosis), skin redness and flushing (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 fatigue have been reported. 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 then be applied at the usual time the following day. Do not apply two patches at once to make up for a missed dose.
Stopping treatment with Rivastigmine Mylan
If treatment is stopped, inform the doctor or pharmacist.
If the patient has not used a patch for three days or more, they should not apply a new one without first consulting their doctor, as adverse effects are more likely.
If there are any further doubts about using this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects occur more frequently during the initial period of treatment or when the dose is being increased. Side effects usually gradually subside as the body adapts to the treatment.
If any of the following side effects occur, the patch should be removed
and the doctor should be informed immediately, as these effects may be serious:

• seizures
• changes in heart rhythm, which may be noticed as a very rapid heartbeat or a 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, 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 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 usual)
• urinary incontinence (inability to hold urine)

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

• 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 people):

• fainting

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

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

Frequency not known (frequency cannot be estimated from the 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 side 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 people):

• general malaise
• confusion
• increased sweating

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

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

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

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

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

• Severe vomiting, which may lead to oesophageal rupture

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Side effects can also be reported to the responsible entity. Reporting side 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 following
"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 prior opening.
After removing the patch, fold it in half with the adhesive side facing inwards and press firmly together.
Place the used patch into the sachet and then dispose of it in a place inaccessible to children.
After removing the patch, do not touch your eyes with your fingers before washing your hands thoroughly with soap and water.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package 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 cm² 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 cm² and contains 13.8 mg of rivastigmine.
• Other ingredients 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 backing 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 representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00