RIVASTIGMINE MYLAN PHARMA

Package leaflet: Information for the user

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

rivastigmine
Generic medicine
Read this entire leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform 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 using 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 Rivastigmina Mylan Pharma is and what it is used for

The active substance of Rivastigmina Mylan Pharma is rivastigmine.
Rivastigmine belongs to a class of substances known as cholinesterase inhibitors. In patients with
Alzheimer's dementia, certain brain cells die, resulting in low levels of 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 inhibiting these enzymes, rivastigmine increases acetylcholine levels in the brain, thereby improving the symptoms of Alzheimer's disease.
Rivastigmina Mylan Pharma is used for the treatment of adult patients with mild to moderate Alzheimer's dementia, a progressive disorder of the central nervous system that gradually affects memory, learning ability, and behaviour.

2. What you should know before using Rivastigmine Mylan Pharma

Do not use Rivastigmine Mylan Pharma

• if you are allergic to rivastigmine (the active substance in Rivastigmine Mylan Pharma) or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction to a similar type of medicine (carbamate derivatives).
• if you develop 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 does not improve within 48 hours after removing the patch.

If any of these apply to you, inform your doctor and do not apply Rivastigmine Mylan Pharma.
Warnings and precautions
Talk to your doctor or pharmacist before using Rivastigmine Mylan Pharma:

• if you have or have ever had a heart condition such as irregular or slow heartbeat, QTc interval prolongation, family history of QTc interval prolongation, torsades de pointes, or if you have low levels 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 disturbances such as nausea, vomiting, and diarrhea. If vomiting and diarrhea are persistent, you may become dehydrated (excessive fluid loss).
• if you have impaired liver function.

If you fall into any of these categories, your doctor may monitor you more frequently during treatment with this medicine.
Children and adolescents
There is no indication for the specific use of Rivastigmine Mylan Pharma in the pediatric population for the treatment of Alzheimer's disease.
Other medicines and Rivastigmine Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Rivastigmine Mylan Pharma may enhance the effects of certain medicines that lower blood pressure, for example 'beta-blockers' such as atenolol, 'calcium channel antagonists' such as amlodipine, nifedipine, 'antiarrhythmic agents' such as sotalol, amiodarone, digoxin, and pilocarpine (used to treat glaucoma). This may cause fainting.
Caution is recommended when Rivastigmine Mylan Pharma is taken together with other medicines that may affect heart rhythm or the heart's electrical system (QT interval prolongation).
Your doctor may perform regular heart checks to ensure it is functioning properly if you are also taking any of the following medicines:

• medicines used to treat mental health conditions, known as 'antipsychotics', for example chlorpromazine, levopromazine, sulpiride, amisulpride, tiapride, veralipride, pimozide, haloperidol, droperidol,
• a medicine known as cisapride (used to treat indigestion),
• citalopram (used to treat depression),
• difenoxin (used to treat peptic ulcer),
• halofantrine (used to treat malaria),
• mizolastine (used to treat allergies),
• methadone (an analgesic, also used in heroin dependence),
• intravenous erythromycin, pentamidine, moxifloxacin (antibiotics).

Rivastigmine Mylan Pharma may interfere with anticholinergic medicines, some of which are used to relieve stomach cramps or spasms (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 Pharma must not be administered concurrently with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking both medicines together may cause problems such as stiffness of the limbs and hand tremors.
If you are scheduled for surgery and are using Rivastigmine Mylan Pharma transdermal patches, inform your doctor, as they may increase the effects of certain muscle relaxants during anesthesia.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, the benefits of using Rivastigmine Mylan Pharma must be weighed against the potential risks to the unborn child. Rivastigmine Mylan Pharma should not be used during pregnancy unless strictly necessary.
You must not breastfeed while being treated with Rivastigmine Mylan Pharma.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive and use machines safely. Rivastigmine Mylan Pharma may cause fainting or severe confusion. If you feel faint or confused, do not drive, do not use machines, and do not perform any other activity requiring alertness.

3. How to use Rivastigmina Mylan Pharma

Use this medicine exactly as instructed by 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 patch at a time.
• Do not cut the patch into pieces.
• Press firmly on the patch with the palm of your hand for at least 30 seconds.
• Avoid touching your eyes after handling the patch.

Starting 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 hours dosage is not available for this product. For conditions requiring this dosage, please consult your pharmacist).
• Apply only one Rivastigmina Mylan Pharma transdermal patch at a time and replace it with a new one every 24 hours.

During treatment, your doctor may adjust the dose according to your individual needs.
If you have not applied a patch for three days or more, do not apply the next one without first consulting your doctor, as you may be more likely to experience side effects. You may resume treatment with the same patch dose if therapy has been interrupted for no 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 Rivastigmina Mylan Pharma transdermal patches

• Before applying a patch, ensure the skin is clean, dry, and hair-free, and free of powders, oils, moisturizers, or lotions, which may prevent proper adhesion. The skin should be free of cuts, rashes, and/or irritation.
• Carefully remove any existing patch before applying a new one. Having more than one patch on the skin may expose you to an excessive amount of the medicine, which could be potentially dangerous.
• Apply ONE patch per day to ONE of the following sites shown in the figure below:
  • upper left arm or upper right arm
  • upper left chest or upper right chest (avoid the breast area)
  • upper left back or upper right back
  • lower left back or lower right back

Every 24 hours, remove the previous patch before applying a NEW one to ONE of the following possible sites.

When changing the patch, remove the previous day’s patch and apply the new one each time to a different site (for example, right side of the body one day and left side the next day, upper body one day and lower body the next). Do not reapply a new patch to the same skin site until at least 14 days have passed.
How to apply Rivastigmina Mylan Pharma transdermal patches
Rivastigmina Mylan Pharma patches are thin, light brown, plastic patches that adhere to the skin. Each patch is sealed in a protective pouch until ready for use. Do not open the pouch or remove the patch until just before application.

Carefully remove the existing patch before applying a new one.
For patients starting treatment for the first time or resuming treatment with rivastigmine after an interruption, please follow the instructions below next to the second image.

Each patch is sealed in its protective pouch.
Open the pouch only when you are ready to apply the patch.
Cut along the scissors mark, without going beyond the indicated line. Tear open the pouch. Do not cut the pouch along its entire length to avoid damaging the patch.
Remove the patch from the pouch. Remove the protective film from the top, skin-colored side of the patch, and discard it.

A protective liner covers the adhesive side of the patch.
Peel back one side of the protective liner and do not touch the adhesive surface of the patch with your fingers.

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

Press firmly on the patch with the palm of your hand for at least 30 seconds, ensuring the edges adhere well.
If helpful, you may write on the patch—for example, the day of the week—using a fine-tip ballpoint pen.
The patch should be worn continuously until it is time to replace it with a new one. If desired, when applying a new patch, you may try different sites to find those most comfortable for you and where clothing does not rub against the patch.
How to remove Rivastigmina Mylan Pharma transdermal patches
Gently lift one corner of the patch to slowly remove it from the skin. If adhesive residue remains on the skin, gently but thoroughly wet the area with warm water and mild soap, or use baby oil to remove it. Do not use alcohol or other solvents (such as nail polish remover or similar types).
Handwashing
After removing or applying a patch, wash your hands with water and soap. If you accidentally touch your eyes or if your eyes become red after handling the patch, rinse immediately with plenty of water and consult a doctor if symptoms do not improve.
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 come loose during these activities.
• Do not expose the patch to external sources of heat (e.g., excessive sunlight, sauna, sunbed) for prolonged periods.

What to do if the patch comes off
If the patch comes off, apply a new one for the remainder of the day, then replace the patch at the usual time the next day.
When and for how long to apply Rivastigmina Mylan Pharma transdermal patches

• To benefit from treatment, 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 inform your doctor that you have accidentally applied more than one patch. You may need medical treatment.
Some people who accidentally took an excessive amount of rivastigmine have experienced reduced pupil size (miosis), skin redness and flushing, stomach pain, nausea, vomiting, diarrhea, slowed heart rate, sudden breathing difficulty (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, seizures, 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 one immediately. You may apply the next patch the following day at the usual 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, inform your doctor or pharmacist.
If you have not applied a patch for three days or more, do not apply the next one without first consulting your doctor, as you may be more likely to experience side effects.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects may be more common when you first start using the medicine or when the dose is increased. Generally, side effects will gradually disappear as your body gets used to the medicine.
Remove the patch and contact your doctor immediately if you notice any of the following
side effects becoming severe:

• Seizures
• Changes in heart rhythm that you may notice as a very fast heartbeat or a sensation of missing heartbeats
• Stomach ulcer (you may experience stomach pain and, if you vomit, the vomit may contain fresh blood or look like coffee grounds)
• Inflammation of the pancreas – characterized by severe pain in the upper part of the stomach, often accompanied by nausea or vomiting
• Severe confusion, which may be associated with seeing, hearing, or sensing things that are not there (hallucinations), feeling detached from reality (delusion), and increased or decreased activity (delirium)
• Liver problems (you may notice yellowing of the skin or the white part of the eye, abnormally dark-coloured urine, or unexplained nausea, vomiting, tiredness, 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
• Feelings of anxiety, depression, dizziness
• Fainting
• Nausea, vomiting, diarrhoea, indigestion/heartburn, stomach pain
• Feeling restless, tiredness, general weakness, feeling feverish
• Skin rash and allergic skin reactions at the application site, such as eczema-like reactions, redness, itching, swelling, and irritation
• Urinary tract infection (you may feel pain when urinating or need to urinate more frequently)
• Urinary incontinence (inability to properly control urination)

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

• Heart problems such as slow heartbeat
• Dehydration (excessive loss of body fluids)
• Hyperactivity (high level of activity, restlessness)
• Aggressiveness

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

• Falls

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

• Stiffness in arms or legs, restlessness, muscle spasms, tremor such as trembling hands

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

• Worsening of Parkinson's disease symptoms such as tremor, stiffness, drowsiness, and shuffling gait
• Allergic reaction, with blisters or inflamed skin, itching, hives, or redness
• Fast heartbeat
• Seeing or hearing things that are not there (hallucinations)
• High blood pressure
• Changes in liver function test results
• Feeling of restlessness
• Nightmares

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

• General feeling of being unwell
• Feeling confused
• Increased sweating

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

• Chest pain – this may be caused by heart spasm
• Intestinal ulcer

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

• Intestinal bleeding – evident by the presence of blood in the stool or vomit

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

• In some people who experienced severe vomiting, a tear occurred in the tube connecting the mouth to the stomach (oesophagus)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the sachet after
Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Keep the transdermal patch in its sachet until the time of use.
Do not use the patch if it is damaged or shows signs of tampering.
After removing a patch, fold it in half with the adhesive sides together and press them firmly. Place
the used patch back into its original sachet and dispose of it in such a way that children cannot
access it. Avoid touching your eyes with your fingers and wash your hands thoroughly with soap and water after removing the patch.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Rivastigmina Mylan Pharma contains

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

Description of the appearance of Rivastigmina Mylan Pharma and pack contents
Each transdermal patch is thin. The outer surface is light brown and printed in orange ink with the following text:

• “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 Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Batch Release Responsible Manufacturer
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 names:
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 system
France Rivastigmine Viatris 9.5 mg/24 h Transdermal system
Italy Rivastigmina Mylan Pharma
Italy Rivastigmina Mylan Pharma
Netherlands Rivastigmin Pleister Viatris 4.6 mg/24 hours Transdermal patch
Netherlands Rivastigmin Pleister Viatris 9.5 mg/24 hours 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