Rivastigmina Aurovitas

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

The active substance of Rivastigmine Aurovitas is rivastigmine.
Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with Alzheimer's disease, certain nerve cells in the brain die, causing a decrease in the concentration of acetylcholine, a neurotransmitter (a substance that allows nerve cells to communicate with each other). The action of rivastigmine involves blocking 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 Aurovitas is used to treat adult patients with mild to moderate Alzheimer's disease, a progressive brain disease that causes gradual memory, intellectual, and behavioral disorders.

2. Important information before using Rivastigmine Aurovitas

When not to use Rivastigmine Aurovitas

Warnings and precautions

Before starting to use Rivastigmine Aurovitas, the patient should discuss it with their doctor:

If any of these situations apply to the patient, during the use of this medicine, it may be necessary for the doctor to closely monitor the patient's condition.
If the patient has not applied a patch for more than three days, they should not apply a new patch until they have talked to their doctor.

Children and adolescents

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

Rivastigmine Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Rivastigmine Aurovitas may affect the action of anticholinergic medicines, such as those used to relieve stomach cramps (e.g., dicyclomine), to treat Parkinson's disease (e.g., amantadine), or to prevent motion sickness (e.g., diphenhydramine, scopolamine, or meclizine).
Rivastigmine Aurovitas, transdermal system, patch 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 hand tremors.
If the patient is to undergo surgery while using Rivastigmine Aurovitas, transdermal system, patch, they should tell their doctor about its use, as this medicine may enhance the action of certain muscle relaxants used during anesthesia.
Care should be taken when Rivastigmine Aurovitas, transdermal system, patch is used with beta-adrenergic blockers (medicines such as atenolol, used to treat high blood pressure, angina, and other heart diseases). Taking these two medicines together may cause disorders such as slow heart rate (bradycardia) leading to fainting or loss of consciousness.

Rivastigmine Aurovitas with food, drink, and alcohol

Rivastigmine Aurovitas can be used with food, drink, and alcohol.

Pregnancy, breastfeeding, and fertility

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 Aurovitas should be weighed against the potential effects of the medicine on the unborn child. Rivastigmine Aurovitas should not be used during pregnancy unless it is absolutely necessary.
While using Rivastigmine Aurovitas, transdermal system, patch, the patient should not breastfeed.

Driving and using machines

The doctor will inform the patient whether their health condition allows them to drive vehicles and operate machines safely. Rivastigmine Aurovitas, transdermal system, patch may cause fainting or severe confusion. If the patient feels weak or is disoriented, they should not drive vehicles, operate machines, or perform any tasks that require concentration.

3. How to use Rivastigmine Aurovitas

Rivastigmine Aurovitas, transdermal system, patch should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

WARNING:

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

30 seconds.

How to start treatment

The doctor will inform the patient which Rivastigmine Aurovitas, transdermal system, patch is best for their case.

• Treatment usually starts with Rivastigmine Aurovitas, 4.6 mg/24 h.
• The recommended daily dose is usually one patch of Rivastigmine Aurovitas, 9.5 mg/24 h per day.
• Only one Rivastigmine Aurovitas patch should be applied at a time, and it should be changed for a new one after 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 more than three days, they should not apply a new patch until they have talked to their doctor. Patch treatment can be resumed using the same dose if the treatment interruption does not exceed three days. Otherwise, the doctor will recommend resuming treatment with a dose of 4.6 mg/24 h of Rivastigmine Aurovitas.

Where the patient should apply the Rivastigmine Aurovitas patch, transdermal system, patch

• Before applying the patch, the patient should make sure that the skin in the application area is:
• clean, dry, and hairless,
• cleansed of powders, oils, moisturizing creams, or liquids that could prevent the patch from sticking properly,
• free of cuts, rashes, and/or irritations.
• The patient should carefully remove any previously applied patches before applying a new one.Having more patches on the body may expose the patient to an excessive amount of medicine, which can be potentially hazardous.
• The patient should apply onepatch per day to only oneof the possible application sites shown in the following figures:
• 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 breasts)
• 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 patient should remove the old patch before applying ONE new patch to ONLY ONE of the possible application sites shown below.

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 and the next day on the left, one day on the upper part of the body and the next on the lower part). The patient should not apply a new patch to the same skin area within 14 days.

How the patient should apply Rivastigmine Aurovitas, transdermal system, patch

Rivastigmine Aurovitas is in the form of thin, non-transparent plastic patches that are stuck to the skin. Each patch is in a sealed protective sachet. The patient should not open the sachet or remove the patch until they are ready to apply it to the skin.
The patient should carefully remove the old patch before applying a new one.
Patient's starting treatment for the first time and patients restarting treatment with Rivastigmine Aurovitas after an interruption should start with the actions shown in the second figure.

• Each patch is in a sealed protective sachet. The sachet should be opened just before applying the patch to the skin. The patient should cut the sachet along the edge at the dashed line and then remove the patch from the sachet.

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

• The patient should apply the adhesive surface 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 palm for at least 30 seconds, making sure that the edges adhere well to the skin.

If necessary, the patient can write the day of the week on the patch with a pen when it is applied. The patch should be worn continuously until it is replaced with a new one. The patient can check different application sites for the new patch to find the most convenient one that is not exposed to abrasion by clothing.

How the patient should remove Rivastigmine Aurovitas

The patient should gently pull one edge of the patch and then 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 and other products).
After removing 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 resolve, they should consult their doctor.

Can the patient wear Rivastigmine Aurovitas, transdermal system, patch while bathing, swimming, or in the sun?

• Bathing, swimming, or showering should not affect the patch's action. The patient should make sure that the patch does not come loose during these activities.
• The patient should not expose the patch to external heat sources (e.g., excessive sun exposure, sauna, solarium) for an extended period.

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 the patient should wear Rivastigmine Aurovitas, transdermal system, patch

• To achieve a beneficial effect, the patient should apply a new patch every day, preferably at the same time each day.
• The patient should apply only one Rivastigmine Aurovitas patch at a time and change it for a new one every 24 hours.

Using more than the recommended dose of Rivastigmine Aurovitas

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 patients who have accidentally taken too much Rivastigmine Aurovitas, nausea (vomiting), vomiting, diarrhea, high blood pressure, and hallucinations have occurred. There may also be slow heart rate and fainting.

Missing a dose of Rivastigmine Aurovitas

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 next day. The patient should not apply two patches to make up for a missed dose of the medicine.

Stopping the use of Rivastigmine Aurovitas

If the patient stops using the patch, they should inform their doctor or pharmacist.
If the patient has any further doubts about using the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivastigmine Aurovitas can cause side effects, although not everybody gets them.
Side effects may occur more frequently during the initial period of using the medicine or during the dose increase. Side effects usually resolve slowly as the patient's body adapts to the treatment.

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

Common(may affect less than 1 in 10 people)

• Loss of appetite
• Dizziness
• Agitation or drowsiness
• Urinary incontinence (inability to properly retain urine)

Uncommon(may affect less than 1 in 100 people)

• Heart rhythm disorders, such as slow heart rate
• Seeing things that are not there (hallucinations)
• Stomach ulcers
• Dehydration (loss of too much fluid)
• Excessive restlessness (high level of activity, agitation)
• Aggression

Rare(may affect less than 1 in 1,000 people)

• Falls

Very rare(may affect less than 1 in 10,000 people)

• Stiffness of the arms or legs
• Hand tremors

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

• Allergic reaction at the patch application site, such as blisters or skin inflammation
• Worsening of Parkinson's disease symptoms, such as tremors, stiffness, or dragging of the legs
• Pancreatitis - including severe abdominal pain, often with nausea (vomiting) or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Seizures (convulsions)
• Liver function disorders (jaundice, yellowing of the eyes, unusual dark urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)
• Changes in liver function test results
• Agitation
• Nightmares

If any of the above side effects occur, the patient should remove the patch and immediately tell their doctor.

Other side effects reported after taking rivastigmine in capsule or oral solution form, which may also occur after using rivastigmine, transdermal system, patch:

Common(may affect less than 1 in 10 people)

• Excessive salivation
• Loss of appetite
• Agitation
• General malaise
• Tremors or confusion
• Excessive sweating

Uncommon(may affect less than 1 in 100 people)

• Heart rhythm disorders (e.g., fast heartbeat)
• Difficulty sleeping
• Accidental falls

Rare(may affect less than 1 in 1,000 people)

• Seizures (convulsions)
• Ulcerative disease of the intestines
• Chest pain - may be caused by a heart attack

Very rare(may affect less than 1 in 10,000 people)

• High blood pressure
• Pancreatitis - including severe abdominal pain, often with nausea (vomiting) or vomiting
• Gastrointestinal bleeding - blood in the stool or vomit
• Seeing things that are not there (hallucinations)
• Severe vomiting, which can lead to a tear in the esophagus (the tube connecting the mouth to the stomach).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Rivastigmine Aurovitas

• This medicine should be stored out of the sight and reach of children.
• Rivastigmine Aurovitas should not be used after the expiry date stated on the carton and sachet after EXP. "EXP" means the last day of the month stated.
• Before use, the transdermal system, patch should be stored in the sachet.
• The medicine should be stored in its original packaging to protect it from light.
• 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 surface inwards and press firmly. The used patch should be placed in the sachet and then disposed of 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. If local regulations regarding environmental protection require the incineration of household waste, the patch can be thrown into the trash. Otherwise, used patches should be returned to the pharmacy, preferably in their original packaging.

6. Contents of the packaging and other information

What Rivastigmine Aurovitas contains

The active substance is rivastigmine.
Rivastigmine Aurovitas, 4.6 mg/24 h: each patch releases 4.6 mg of rivastigmine over 24 hours. Each patch has an area of 5 cm and contains 9 mg of rivastigmine.
Rivastigmine Aurovitas, 9.5 mg/24 h: each patch releases 9.5 mg of rivastigmine over 24 hours. Each patch has an area of 10 cm and contains 18 mg of rivastigmine.
Other ingredients are:
Active substance layer:
Acrylic adhesive layer
Butyl methacrylate and methyl methacrylate copolymer
Adhesive layer:
Silicone adhesive layer
Outer layers:
Polyester
Polyester coated with fluorine

What Rivastigmine Aurovitas looks like and what the pack contains.

Each transdermal system, patch is a thin patch consisting of three layers. The outer part of the adhesive layer is semi-transparent, white with the inscription: "Rivastigmine Aurovitas" and "4.6 mg/24 h" or "Rivastigmine Aurovitas" and "9.5 mg/24 h".
Each transdermal system, patch is in a separate, sealed sachet. Patches are available in packs containing 30 sachets.
Not all pack sizes may be marketed.
Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland
Manufacturer

Eurofins PHAST GmbH

Kardinal-Wendel-Strasse 16
66424 Homburg
Germany

ACC GmbH Analytical Clinical Concepts

Schöntalweg 9
63849 Leidersbach
Germany

Date of last revision of the leaflet: 09.2020