Rivastigmine Sandoz GmbH

Package leaflet: Information for the user

Rivastigmina Sandoz GmbH 4.6 mg/24 hours transdermal patch, 9.5 mg/24 hours transdermal patch, 13.3 mg/24 hours transdermal patch

Generic medicine
Please read all of this 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 other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rivastigmina Sandoz GmbH is and what it is used for

Rivastigmina Sandoz GmbH contains the active substance 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 the
neurotransmitter 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, Rivastigmina Sandoz GmbH increases acetylcholine levels in the brain, helping to reduce the symptoms of Alzheimer's disease.
Rivastigmina Sandoz GmbH is used to treat adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, learning ability, and behaviour.

2. What you need to know before using Rivastigmina Sandoz GmbH

Do not use Rivastigmina Sandoz GmbH

• if you are allergic to rivastigmine (the active substance in Rivastigmina Sandoz GmbH) or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction to medicines of a similar type (carbamate derivatives).
• if you have had a skin reaction spreading beyond the area where the patch was applied, or if you experienced a more severe local reaction (such as blisters, increased skin inflammation, swelling) that did not improve within 48 hours after removing the patch. If this applies to you, inform your doctor and do not apply Rivastigmina Sandoz GmbH transdermal patches.

Warnings and precautions
Talk to your doctor before using Rivastigmina Sandoz GmbH:

• if you have or have ever had a heart condition such as slow heartbeat (bradycardia),
  prolonged QTc interval, family history of prolonged QTc interval,
  torsades de pointes, or if you have 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 feeling unwell (nausea), being sick (vomiting), and diarrhea. If vomiting and diarrhea are persistent, you may become dehydrated (excessive fluid loss).
• if you have impaired liver function. If any of these conditions apply to you, your doctor may monitor you more frequently during treatment with this medicine.

If you have not applied a patch for more than three days, consult your doctor before applying the next one.
Children and adolescents
There is no indication for the specific use of Rivastigmina Sandoz GmbH in the pediatric population for the treatment of Alzheimer's disease.
Other medicines and Rivastigmina Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Rivastigmina Sandoz GmbH may interact with anticholinergic medicines, including those used to relieve stomach cramps or spasms (e.g. dicyclomine), for the treatment of Parkinson's disease (e.g. amantadine), or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).
The Rivastigmina Sandoz GmbH patch must 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 side effects such as stiffness of the limbs and hand tremors.
If you are scheduled for surgery and are being treated with Rivastigmina Sandoz GmbH transdermal patches, inform your doctor, as they may enhance the effects of certain muscle relaxants during anesthesia.
Caution is recommended when using the Rivastigmina Sandoz GmbH patch together with beta-blockers (medicines such as atenolol, used to treat high blood pressure, angina, and other heart conditions). Taking both medicines together may cause side effects such as slowing of the heartbeat (bradycardia), which may lead to fainting or loss of consciousness.
Caution is also recommended when Rivastigmina Sandoz GmbH is taken together with other medicines that may affect heart rhythm or the heart's electrical system (prolongation of the QT interval).
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, the benefits of using Rivastigmina Sandoz GmbH must be weighed against the possible risks to the unborn child. Rivastigmina Sandoz GmbH should not be used during pregnancy unless strictly necessary.
You must not breastfeed while using Rivastigmina Sandoz GmbH transdermal patches.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Rivastigmina Sandoz GmbH transdermal patches may cause fainting or severe confusion. If you feel faint or confused, do not drive, do not use machines, and avoid any other activities requiring alertness.

3. How to use Rivastigmina Sandoz GmbH

Use Rivastigmina Sandoz GmbH transdermal patches exactly as directed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.
IMPORTANT:

• Remove the previous patch before applying a NEW one.
• Only one patch per day.
• Do not cut the patch into pieces.
• Press firmly on the patch with the palm of your hand for at least 30 seconds.

Starting treatment
Your doctor will tell you which Rivastigmina Sandoz GmbH transdermal patch is most suitable for you.

• Treatment usually starts with Rivastigmina Sandoz GmbH 4.6 mg/24 hours.
• The normally recommended daily dose is Rivastigmina Sandoz GmbH 9.5 mg/24 hours. If well tolerated, your doctor may consider increasing the dose to 13.3 mg/24 hours.
• Apply only one Rivastigmina Sandoz GmbH 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 more than three days, do not apply the next one without first consulting your doctor. Treatment may be resumed with the same dose of transdermal patches if therapy has not been interrupted for more than 3 days; otherwise, your doctor will restart treatment with Rivastigmina Sandoz GmbH 4.6 mg/24 hours.
Rivastigmina Sandoz GmbH may be used while eating, drinking, or consuming alcohol.

Where to apply the Rivastigmina Sandoz GmbH transdermal patch

• Before applying a patch, make sure the skin is clean, dry, and hair-free, without powders, oils, moisturizers, or lotions that could 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 medication, which could be potentially dangerous.
• Apply ONE patch per day to ONE of the following possible sites shown in the figures below:
  • upper left arm or upper right arm
  • upper left chest or upper right chest (avoid the breast)
  • 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 before applying a new one each time at a different site (for example, right side of the body one day and left side the next day, upper part of the body one day and lower part the next). Do not reapply a new patch to the same spot on the skin until at least 14 days have passed.
How to apply the Rivastigmina Sandoz GmbH transdermal patch
Rivastigmina Sandoz GmbH patches are thin, opaque, plastic-based 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 immediately before application.

Carefully remove any existing patch before applying a new one.
For patients starting treatment for the first time or resuming treatment with Rivastigmina Sandoz GmbH 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 dotted line with scissors and remove the patch from the pouch.

• A protective liner covers the adhesive side of the patch. Peel off one side of the protective liner and avoid touching the adhesive surface 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 (e.g., 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 the Rivastigmina Sandoz GmbH transdermal patch
Gently lift one corner of the patch and slowly peel it off the skin. If adhesive residue remains on the skin, gently but thoroughly moisten the area with warm water and mild soap, or use baby oil to remove it. Alcohol or other solvents (such as nail polish remover or similar types) must not be used.
After removing the patch, wash your hands with soap and water. If you get the medication in 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 Sandoz GmbH transdermal patch while bathing,
swimming, or sunbathing?

• Bathing, swimming, or showering should not interfere with the patch. Make sure the patch remains securely attached 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 to complete the day’s treatment, then replace the patch at the usual time the next day.
When and for how long to apply the Rivastigmina Sandoz GmbH transdermal patch

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

If you use more Rivastigmina Sandoz GmbH 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 require medical treatment. Some people who accidentally took an excessive amount of Rivastigmina Sandoz GmbH experienced feeling unwell (nausea), vomiting, diarrhea, high blood pressure, and hallucinations. Slowing of the heart rate and fainting may also occur.
If you forget to use Rivastigmina Sandoz GmbH
If you realize you have forgotten to apply a patch, apply one immediately. You may apply the next patch at the usual time the following day. Do not apply two patches to make up for the missed one.
If you stop using Rivastigmina Sandoz GmbH
If you discontinue treatment with the patch, inform your doctor or pharmacist.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get 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 that any of the following
side effects may become severe:

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Dizziness
• Feeling agitated or drowsy
• Urinary incontinence (inability to properly retain urine)

Uncommon (may affect up to 1 in 100 people)

• Heart rhythm disorders such as slow heartbeat
• Seeing things that are not really there (hallucinations)
• Stomach ulcer
• Dehydration (excessive loss of fluids)
• Hyperactivity (high level of activity, 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
• Hand tremors

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

• Allergic reactions at the patch application site, such as blisters or inflamed skin
• Worsening of Parkinson’s disease symptoms – such as tremor, stiffness, and shuffling gait
• Pisa syndrome (a condition involving involuntary muscle contraction causing abnormal sideways bending of the body and head)
• Inflammation of the pancreas – manifested by severe pain in the upper abdomen, often accompanied by nausea or vomiting
• Fast or irregular heartbeat
• High blood pressure
• Seizures
• Liver disorders (yellowing of the skin and whites of the eyes, abnormally dark urine, unexplained nausea, vomiting, fatigue, and loss of appetite)
• Changes in liver function test results
• Feeling restless
• Nightmares

Remove the patch and contact your doctor immediately if you notice any of the side effects listed above.

Other side effects observed with rivastigmine capsules or oral solution that may also occur with the patch:

Common (may affect up to 1 in 10 people)

• Excessive salivation
• Loss of appetite
• Feeling restless
• General feeling of being unwell
• Tremors or confusion
• Increased sweating

Uncommon (may affect up to 1 in 100 people)

• Irregular heartbeat (e.g. fast heartbeat)
• Sleep disorders
• Accidental falls

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

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

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

• High blood pressure
• Inflammation of the pancreas – manifested by severe pain in the upper abdomen, often accompanied by nausea or vomiting
• Gastrointestinal bleeding – manifested by blood in stools or vomit
• Seeing things that are not there (hallucinations)
• In some people who experienced severe vomiting, rupture of the tube connecting the mouth to the stomach (esophagus) has occurred

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
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 Sandoz GmbH

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and on the pouch. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Keep the transdermal patch in its pouch 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 firmly. Return the used patch to its original pouch 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 water and soap 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 in use. This will help protect the environment.

6. Package Contents and Other Information

What Rivastigmina Sandoz GmbH Contains

• The active substance is rivastigmine.
• Rivastigmina Sandoz GmbH 4.6 mg/24 hours transdermal patches: Each 5 cm patch releases 4.6 mg of rivastigmine over 24 hours and contains 9 mg of rivastigmine.
• Rivastigmina Sandoz GmbH 9.5 mg/24 hours transdermal patches: Each 10 cm patch releases 9.5 mg of rivastigmine over 24 hours and contains 18 mg of rivastigmine.
• Rivastigmina Sandoz GmbH 13.3 mg/24 hours transdermal patches: Each transdermal patch releases 13.3 mg of rivastigmine over 24 hours. Each 15 cm transdermal patch contains 27 mg of rivastigmine.
• The other components are coated polyethylene terephthalate film, all-rac-α-tocoferol, poly(butyl methacrylate, methyl methacrylate) copolymer 3:1, acrylic copolymer, silicone oil, dimethicone, fluoropolymer-coated polyester film, resin, pigments, organic polymers/resins.

[13.3 mg]
The other components are:

• Backing layer: coated polyethylene terephthalate film,
• Matrix with active substance: all-rac-α-tocoferol, poly(butyl methacrylate, methyl methacrylate) copolymer (3:1), acrylic copolymer,
• Adhesive matrix: all-rac-α-tocoferol, silicone oil, dimethicone 12,500 cSt,
• Release liner: fluoropolymer-coated polyester film,
• Printing ink: resin, pigments, organic polymers/resins.

Description of the Appearance of Rivastigmina Sandoz GmbH and Package Contents
[4.6 mg]
Each transdermal patch is a thin, matrix-type transdermal patch composed of three layers. The outer side of the backing layer is beige and marked with “RIV”, “4.6 mg/24 h”.
[9.5 mg]
Each transdermal patch is a thin, matrix-type transdermal patch composed of three layers. The outer side of the backing layer is beige and marked with “RIV”, “9.5 mg/24 h”.
[13.3 mg]
Each transdermal patch is a thin, matrix-type transdermal patch composed of three layers.
A circular transdermal system of 15 cm for drug delivery, consisting of an outer layer (beige), a double-layer adhesive matrix, and a large rectangular release liner with pores. The outer side of the patch is marked with “RIV”, “13.3 mg/24 h”.
Each transdermal patch is sealed in an individual pouch. The patches are available in packs containing 7 or 30 pouches, and multipacks containing 60 (2 packs of 30) or 90 (3 packs of 30) pouches.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl (Austria)
Legal representative in Italy: Sandoz S.p.A., Viale Luigi Sturzo 43, 20154 Milan, Italy

Manufacturer
Novartis Pharma GmbH
Roonstrasse 25, D-90429 Nuremberg, Germany
Hexal AG
Industriestrasse 25, 83607 Holzkirchen, Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana, Slovenia
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes 764, 08013 Barcelona, Spain

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Austria
Rivastigmin Sandoz 4.6 mg/24 h transdermal patch
Rivastigmin Sandoz 9.5 mg/24 h transdermal patch
Rivastigmin Sandoz 13.3 mg/24 h transdermal patch

Belgium
Rivastigmin Sandoz 4.6 mg/24 uur transdermal patch for transdermal use
Rivastigmin Sandoz 9.5 mg/24 uur transdermal patch for transdermal use
Rivastigmin Sandoz 13.3 mg/24 uur transdermal patch for transdermal use

Germany
Rivastigmin - 1 A Pharma 4.6 mg/24 hours transdermal patch
Rivastigmin - 1 A Pharma 9.5 mg/24 hours transdermal patch
Rivastigmin - 1 A Pharma 13.3 mg/24 hours transdermal patch

Denmark
Rigmin

Spain
Rivastigmina Sandoz 4.6 mg/24 h transdermal patches EFG
Rivastigmina Sandoz 9.5 mg/24 h transdermal patches EFG
Rivastigmina Sandoz 13.3 mg/24 h transdermal patches EFG

France
RIVASTIGMINE Sandoz 4.6 mg/24 h, transdermal system
RIVASTIGMINE Sandoz 9.5 mg/24 h, transdermal system

Italy
RIVASTIGMINA SANDOZ GmbH

Netherlands
Rivastigmine Sandoz 4.6 mg/24 hours, transdermal patches for transdermal use
Rivastigmine Sandoz 9.5 mg/24 hours, transdermal patches for transdermal use
Rivastigmine Sandoz 13.3 mg/24 hours, transdermal patches for transdermal use

Sweden
Rigmin

United Kingdom
Almuriva 4.6 mg/24 h transdermal patch
Almuriva 9.5 mg/24 h transdermal patch