RIVASTIGMINA 4.6 MG/24 HOURS Трансдермальный пластырь

Содержание инструкции

1. Rivastigmina Mylan Pharma 4.6 mg/24 hour transdermal patch, 9.5 mg/24 hour transdermal patch
   1. What is Rivastigmina Mylan Pharma and what is it used for
   2. What you need to know before using Rivastigmina Mylan Pharma
   3. How to use Rivastigmina Mylan Pharma
   4. Possible side effects
   5. How to store Rivastigmina Mylan Pharma
   6. Package Contents and Other Information

Rivastigmina Mylan Pharma 4.6 mg/24 hour transdermal patch, 9.5 mg/24 hour transdermal patch

rivastigmina

Generic medicine

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

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

Contents of this leaflet:

• 1. What Rivastigmina Mylan Pharma is and what it is used for
• 2. What you need to know before you use Rivastigmina Mylan Pharma
• 3. How to use Rivastigmina Mylan Pharma
• 4. Possible side effects
• 5. How to store Rivastigmina Mylan Pharma
• 6. Contents of the pack and other information

1. What is Rivastigmina Mylan Pharma and what is it used for

The active ingredient of Rivastigmina Mylan Pharma is rivastigmine.
Rivastigmina belongs to a class of substances called cholinesterase inhibitors. In patients
with Alzheimer's dementia, some brain cells die, leading to low levels of
acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmina
works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
By blocking these enzymes, rivastigmina increases the levels of acetylcholine in the brain, improving the
symptoms of Alzheimer's disease.
Rivastigmina Mylan Pharma is used for the treatment of adult patients with Alzheimer's dementia of
mild to moderate severity, a progressive disorder of the central nervous system that
gradually affects memory, learning ability and behavior.

2. What you need to know before using Rivastigmina Mylan Pharma

Do not use Rivastigmina Mylan Pharma

• if you are allergic to rivastigmine (the active ingredient of Rivastigmina Mylan Pharma) or to any of the other ingredients of this medicine (listed in section 6).
• if you have already had an allergic reaction to a similar type of medicine (carbamate derivatives).
• if you have a skin reaction that spreads beyond the area where the patch was applied, if you have had a more intense local reaction (such as blisters, increased skin inflammation, swelling) and if it did not improve within 48 hours of removing the patch.

If this is the case, tell your doctor and do not apply Rivastigmina Mylan Pharma.

Warnings and precautions
Talk to your doctor or pharmacist before using Rivastigmina Mylan Pharma:

• if you have or have ever had a heart condition such as irregular or slow heartbeat, prolongation of the QT interval, a family history of prolongation of the QT interval, torsade de pointes, or have a low level of potassium or magnesium in your blood.
• if you have heart failure.
• if you have had a heart attack.
• if you have or have ever had low levels of potassium or magnesium in your blood.
• if you have or have ever had an active stomach ulcer.
• if you have or have ever had difficulty urinating.
• if you have or have ever had seizures.
• if you have or have ever had asthma or severe respiratory disorders.
• if you suffer from tremors.
• if you have a low body weight.
• if you experience gastrointestinal disorders such as nausea, vomiting and diarrhoea. If vomiting and diarrhoea are persistent, you may become dehydrated (excessive loss of fluids).
• if you have impaired liver function.

If you recognize yourself in any of these situations, your doctor may visit you more frequently during therapy with this medicine.

Children and adolescents
There is no indication for specific use of Rivastigmina Mylan Pharma in the pediatric population in the treatment of Alzheimer's disease.

Other medicines and Rivastigmina Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.
Rivastigmina Mylan Pharma can increase the effects of some medicines that lower blood pressure, e.g. ‘beta-blockers’, such as atenolol, ‘calcium channel antagonists’, e.g. amlodipine, nifedipine, ‘antiarrhythmic agents’, e.g. sotalol, amiodarone, digitalis and pilocarpine (used to treat glaucoma). This can cause fainting.
Caution is recommended when Rivastigmina Mylan Pharma is taken together with other medicines that can affect heart rhythm or the electrical system of the heart (prolongation of the QT interval).
The doctor may perform regular heart checks to ensure that it is functioning properly if you are also taking any of these medicines:

• medicines used to treat mental health problems, known as ‘antipsychotics’, e.g. chlorpromazine, levopromazine, sulpiride, amisulpride, tiapride, veralipride, pimozide, haloperidol, droperidol,
• a medicine known as 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 painkiller, also used in heroin dependence),
• erythromycin i.v., pentamidine, moxifloxacin (antibiotics).

Rivastigmina Mylan Pharma can interfere with anticholinergic medicines, some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), for the treatment of 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).
Rivastigmina Mylan Pharma should not be administered at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together can cause problems such as stiffness of the limbs and tremors in the hands.
If you are to undergo surgery and are being treated with Rivastigmina Mylan Pharma patches, tell your doctor, as they may increase the effects of some muscle relaxants during anesthesia.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, the benefits of using Rivastigmina Mylan Pharma must be weighed against the possible effects on the unborn child. Rivastigmina Mylan Pharma should not be used during pregnancy unless strictly necessary.
You should not breastfeed during treatment with Rivastigmina Mylan Pharma.

Driving and using machines
Your doctor will tell you if your condition allows you to drive and use machines safely. Rivastigmina Mylan Pharma can cause fainting or severe confusion. If you feel faint or confused, do not drive, use machines and do not perform any other activity that requires vigilance.

3. How to use Rivastigmina Mylan Pharma

Use this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

IMPORTANT:

• Remove the patch from the previous day before applying a NEW one.
• Wear only one Rivastigmina Mylan Pharma patchper day.
• Do not cut the patch into pieces.
• Press the patch firmly with the palm of your hand for at least 30 seconds.
• Avoid touching your eyes after handling the patch.

How to start treatment
Your doctor will tell you which Rivastigmina Mylan Pharma transdermal patch is most suitable for you.

• Treatment usually starts with Rivastigmina Mylan Pharma 4.6 mg/24 hours.
• The usual recommended daily dose is Rivastigmina Mylan Pharma 9.5 mg/24 hours. If your condition does not improve after at least 6 months, your doctor may consider increasing the dose to 13.3 mg/24 hours (The 13.3 mg/24 hour dosage is not available for this product. For conditions where this dosage must be used, ask your pharmacist for advice).
• Apply only one Rivastigmina Mylan Pharma transdermal patch at a time and replace the patch with a new one every 24 hours.

During treatment, your doctor may vary the dose to adjust it to your individual needs.
If you have not applied a patch for three days or more, do not apply the next one before consulting
your doctor, as you are more likely to experience unwanted effects. You can resume treatment with
the patch at the same dose if you have not applied the patches for more than 3 days. Alternatively, your
doctor may advise you to continue treatment with Rivastigmina Mylan Pharma 4.6 mg/24 hours.

Where to apply the Rivastigmina Mylan Pharma transdermal patches

• Before applying a patch, make sure the skin is clean, dry and hairless, free of dust, oils, moisturizers or lotions that may prevent the patch from adhering correctly, and that it is without cuts, rashes and/or irritations.
• Carefully remove any patch before applying a new one.Having more patches on the skin could expose you to an excessive amount of medicine, which could be potentially dangerous.
• Apply ONLY ONEpatch per day to ONLY ONEof the possible locations highlighted in the figure below:
• upper left arm orupper right arm
• upper left chest orupper right chest (avoid the breast)
• upper left back orupper right back
• lower left back orlower right back

Every 24 hours remove the previous patch before placing a NEW ONE on ONE of the
following possible locations.

When changing the patch, you must remove the patch from the previous day before applying a new one each time in a different place (for example, on the right side of the body one day and on the
left side the next day, on the upper part of the body one day and on the lower part the
next day). Do not apply a new patch to the same skin area again before 14 days have passed.

How to apply the Rivastigmina Mylan Pharma transdermal patches
The Rivastigmina Mylan Pharma patches are thin, light brown in color, made of plastic material that
sticks to the skin. Each patch is sealed in a sachet that protects it until it is time to
use it. Do not open the sachet or remove the patch until just before application.

Carefully remove any patch already present before
applying a new one.
For patients starting treatment for the first time and for
patients resuming treatment with rivastigmine after
an interruption, please follow the instructions below next to the second image.
Each patch is sealed in its protective sachet.
You should only open the sachet when you are ready to apply the patch.
Cut the sachet along the scissor mark, without exceeding the
indicated line. Open the sachet by tearing it. Do not cut the
sachet along its entire length to avoid damaging the
patch.
Remove the patch from the sachet. Remove the protective film from the
flesh-colored top part of the patch and discard it.

A protective film covers the adhesive side of the patch
Peel off one side of the protective film and do not touch the
adhesive part of the patch with your fingers.

Place the adhesive side of the patch on the upper or
lower back, or on the upper arm or chest, then remove the second side of the protective film.

Press the patch firmly with the palm of your hand for at least
30 seconds, making sure the edges adhere well.
If it helps, you can write on the patch with a fine-tip ballpoint pen, for example, the day of the week.
The patch should be worn continuously until it is time to replace it with a new one. If you wish, when applying a new patch, you can try different points to find those that are most
comfortable for you and where clothing does not rub against the patch.

How to remove the Rivastigmina Mylan Pharma transdermal patches
Gently lift a corner of the patch to remove it slowly from the skin. If adhesive residue remains on the skin, wet the area thoroughly but gently with
lukewarm water and mild soap, or use baby oil to remove it. Alcohol
or other solvents (for removing nail polish or other types) should not be used.

Washing your hands
After removing or applying a patch, wash your hands with water and soap. If your eyes come into contact with the patch or if your eyes become red after handling the patch, rinse immediately with
plenty of water and consult a doctor if symptoms do not subside.

Can you apply the Rivastigmina Mylan Pharma transdermal patch while bathing,
swimming, or sunbathing?

• Bathing, swimming or showering should not interfere with the patch. Make sure the patch does not detach during these activities.
• Do not expose the patch to external heat sources (e.g. excessive sunlight, sauna, solarium) for long periods of time.

What to do if a patch comes off
If a patch comes off, apply a new one for the remainder of the day, then replace the patch the
next day at the usual time.

When and for how long to apply the Rivastigmina Mylan Pharma transdermal patches

• To benefit from the treatment, you must apply a new patch every day, preferably at the same time.
• Apply only one Rivastigmina Mylan Pharma patch at a time and replace it with a new one after 24 hours.

If you use more Rivastigmina Mylan Pharma than you should
If you accidentally apply more than one patch, remove all patches from the skin and tell your doctor that you
have accidentally applied more than one patch. You may need medical attention.
Some people who have accidentally taken an excessive amount of rivastigmine have experienced
pupil constriction (miosis), skin flushing and heat waves, stomach pain, nausea, vomiting, diarrhea, slowed heartbeat, sudden difficulty
breathing (bronchospasm), increased mucus production, increased sweating, incontinence
or loss of bowel control, crying, low blood pressure, increased salivation, dizziness,
tremors, headache, drowsiness, confusion, high blood pressure, hallucinations and lack of energy
(malaise). In severe cases, muscle weakness, muscle contractions, convulsions
and slowed or stopped breathing have been reported.

If you forget to use Rivastigmina Mylan Pharma
If you realize you have forgotten to apply a patch, apply immediatelyone. You can
apply the next patch the following day at the scheduled time. Do not apply two patches to
make up for the missed one.

If you stop using Rivastigmina Mylan Pharma
If you stop treatment with the patch, tell your doctor or pharmacist.
If you have not applied a patch for three days or more, do not apply the next one before consulting
your doctor, as you are more likely to experience unwanted effects.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects may be more frequent when you start taking the medicine or
when you increase the dose. Generally, side effects will gradually disappear as
the body gets used to the medicine.

Remove the patch and immediately inform your doctor if you notice any of the following
side effects become severe:

• Convulsions
• Changes in heart rate that you may notice as a very high frequency or a sensation of missed heartbeats
• Stomach ulcer (may cause stomach pain and, if you vomit, it may contain fresh blood or appear as if it contains coffee grounds)
• Pancreatitis - manifests as severe pain in the upper abdomen, often accompanied by nausea or vomiting
• A feeling of severe confusion, which may be associated with seeing, hearing, or perceiving things that do not exist (hallucinations), a feeling of being out of reality (illusion), and increased or decreased activity (delirium)
• Liver disorders (you may notice yellowing of the skin or the white of the eye, abnormally dark urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)

Other possible side effects include:
Common(may affect up to 1 in 10 people):

• Headache
• Decreased or loss of appetite, weight loss
• Feeling of anxiety, depression, dizziness
• Fainting
• Nausea, vomiting, diarrhea, indigestion/heartburn, stomach pain
• Feeling of agitation, fatigue, general weakness, feverish
• Skin rash and allergic reactions at the patch application site, such as eczematous reactions, redness, itching, swelling, and irritation
• Urinary infection (you may feel pain when urinating or need to urinate more often)
• Urinary incontinence (inability to adequately control urination)

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

• Problems with your heart such as slow heartbeat
• Dehydration (excessive fluid loss)
• Hyperactivity (elevated activity level, 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 in the arms or legs, restlessness, muscle spasms, tremor such as shaking hands

Not known(frequency cannot be estimated based on available data)

• Symptoms of Parkinson's disease worsen, such as tremor, rigidity, drowsiness, and shuffling gait
• Allergic reaction, with blisters or inflamed skin, itching, hives, or redness
• Fast heartbeat
• Seeing or hearing things that do not exist (hallucinations)
• High blood pressure
• Changes in test values indicating how the liver is working
• Feeling of restlessness
• Nightmares.

Other side effects observed with rivastigmine capsules or oral solution and that may
occur with the patch:
Common(may affect up to 1 in 10 people):

• General feeling of discomfort
• Feeling of confusion
• Increased sweating

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

• Chest pain - this may be caused by a cardiac spasm
• Ulcer in the intestine

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

• Bleeding from the intestine - manifests with the presence of blood in the stool or vomit

Not known(frequency cannot be estimated based on available data)

• In some people who have had severe vomiting, rupture of the tract connecting the mouth to the stomach (esophagus) has occurred

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Rivastigmina Mylan Pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the sachet after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Store the transdermal patch in the sachet until the time of use.
Do not use the patch if it is damaged or if it shows signs of tampering.
After removing a patch, fold it in half with the adhesive sides inwards and press them together. Put
the used patch back into its original sachet and dispose of it in such a way that children cannot
reach it. Do not touch your eyes with your fingers and wash your hands with water and soap after removing the
patch.
Do not dispose of any medicine in the drains or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Rivastigmina Mylan Pharma contains

• The active ingredient is rivastigmine.
• Rivastigmina Mylan Pharma 4.6 mg/24 hour transdermal patches: Each patch releases 4.6 mg of rivastigmine in 24 hours, measures 4.6 cm and contains 6.9 mg of rivastigmine.
• Rivastigmina Mylan Pharma 9.5 mg/24 hour transdermal patches: Each patch releases 9.5 mg of rivastigmine in 24 hours, measures 9.2 cm and contains 13.8 mg of rivastigmine.
• The other ingredients are: Matrix:
• poly [(2-ethylhexyl)acrylate, vinyl acetate]
• polyisobutene with intermediate and high molecular weight
• anhydrous colloidal silica
• light liquid paraffin Covering laminate:
• polyester film coated with polyethylene/thermoplastic resin/aluminum Release laminate:
• polyester film coated with fluoropolymer. Orange printing ink

Description of the appearance of Rivastigmina Mylan Pharma and package contents
Each transdermal patch is thin. The outer layer is light brown and bears the writing,
printed with orange ink:

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

Each transdermal patch is sealed in a sachet. The patches are available in packs containing
7 or 30 sachets and in multiple packs containing 60 or 90 sachets. Not all pack sizes may be
marketed.

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer Responsible for Batch Release
Mylan Hungary Kft./ Mylan Hungary Ltd
Mylan Utca 1.
Komarom 2900
Hungary
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 denominations:
Belgium Rivastigmine Viatris 4.6 mg/24 h Transdermal patches
Belgium Rivastigmine Viatris 9.5 mg/24 h Transdermal patches
Spain Rivastigmin Viatris 4.6 mg/24 h Transdermal patch
Spain Rivastigmin Viatris 9.5 mg/24 h Transdermal patch
France Rivastigmine Viatris 4.6 mg/24 h Transdermal device
France Rivastigmine Viatris 9.5 mg/24 h Transdermal device
Italy Rivastigmina Mylan Pharma
Italy Rivastigmina Mylan Pharma
Netherlands Rivastigmin Pleister Viatris 4.6 mg/24 uur Transdermal patch
Netherlands Rivastigmin Pleister Viatris 9.5 mg/24 uur Transdermal patch
Poland Rivastigmine Mylan
Poland Rivastigmine Mylan
Portugal Rivastigmina Mylan
Portugal Rivastigmina Mylan
United Kingdom Eluden 4.6 mg/24 h transdermal patch
United Kingdom Eluden 9.5 mg/24 h transdermal patch