RIVASTIGMIN 4.5 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Rivastigmin Orion, 3 mg, hard capsules Rivastigmin Orion, 4.5 mg, hard capsules
   2. Rivastigmin Orion, 6 mg, hard capsules
   3. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   4. Table of Contents of the Leaflet:
2. What is Rivastigmin Orion and what is it used for
3. Important information before taking Rivastigmin Orion
   1. When not to take Rivastigmin Orion
   2. Warnings and precautions
   3. Children and adolescents
   4. Rivastigmin Orion and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
4. How to take Rivastigmin Orion
   1. How to start treatment
   2. Patients taking this medicine
   3. Taking a higher dose of Rivastigmin Orion than recommended
   4. Missing a dose of Rivastigmin Orion
5. Possible side effects
   1. Patients with dementia and Parkinson's disease
   2. Other side effects observed with rivastigmine transdermal system, which may also occur with Rivastigmin Orion capsules:
   3. Reporting side effects
6. How to store Rivastigmin Orion
7. Contents of the pack and other information
   1. What Rivastigmin Orion contains
   2. What Rivastigmin Orion looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Rivastigmin Orion, 1.5 mg, hard capsules

Rivastigmin Orion, 3 mg, hard capsules Rivastigmin Orion, 4.5 mg, hard capsules

Rivastigmin Orion, 6 mg, hard capsules

Rivastigmine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet:

• 1. What is Rivastigmin Orion and what is it used for
• 2. Important information before taking Rivastigmin Orion
• 3. How to take Rivastigmin Orion
• 4. Possible side effects
• 5. How to store Rivastigmin Orion
• 6. Contents of the pack and other information

1. What is Rivastigmin Orion and what is it used for

The active substance of Rivastigmin Orion is rivastigmine.
Rivastigmin Orion belongs to a group of medicines called cholinesterase inhibitors. In patients
with Alzheimer's disease or Parkinson's disease dementia, certain brain cells die, which reduces the levels of the neurotransmitter
acetylcholine (a substance that enables nerve cells to communicate with each other).
The action of rivastigmine is to block the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking the action of these enzymes, Rivastigmin Orion
allows the levels of acetylcholine in the brain to increase, which helps to alleviate the symptoms of Alzheimer's disease and Parkinson's disease dementia.
Rivastigmin Orion is used to treat adult patients with mild to moderate Alzheimer's disease, a progressive brain disorder that causes
gradual disturbances in memory, intellectual abilities, and behavior. The capsules can also be used to treat dementia in adult patients with Parkinson's disease.

2. Important information before taking Rivastigmin Orion

When not to take Rivastigmin Orion

• if you are allergic to rivastigmine (the active substance of Rivastigmin Orion) or any of the other ingredients of this medicine (listed in section 6)
• if you have had a skin reaction, indicating contact dermatitis, associated with the use of rivastigmine.

If this applies to you, tell your doctor and do not take Rivastigmin Orion.

Warnings and precautions

Before starting treatment with Rivastigmin Orion, discuss this with your doctor:

• if you have or have had heart diseases, such as irregular or slow heart rhythm, prolonged QT interval, family history of prolonged QT interval, Torsades de Pointes, or low potassium or magnesium levels in the blood;
• if you have or have had an active stomach ulcer
• if you have or have had difficulties in urinating
• if you have or have had seizures (fits or convulsions)
• if you have or have had asthma or severe respiratory disease
• if you have or have had kidney problems
• if you have or have had liver problems
• if you have muscle tremors
• if you have a low body weight
• if you have stomach or intestinal reactions, such as nausea (vomiting), vomiting, and diarrhea. You may become dehydrated (lose too much fluid) if vomiting or diarrhea persists for a longer period.

If any of the above apply to you, your doctor may need to monitor you more closely while taking the medicine.
If you have stopped taking Rivastigmin Orion for more than three days, do not take the next dose until you have talked to your doctor.

Children and adolescents

Rivastigmin Orion should not be used in children and adolescents for the treatment of Alzheimer's disease.

Rivastigmin Orion and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Rivastigmin Orion should not be given with other medicines that have similar effects.
Rivastigmin Orion may interact with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson's disease, or to prevent motion sickness).
Rivastigmin Orion should not be taken with 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 tremors of the hands.
If you need to undergo surgery while taking Rivastigmin Orion, tell your doctor about the use of rivastigmine before receiving any anesthetics, as Rivastigmin Orion may increase the effect of certain muscle relaxants during anesthesia.
Caution should be exercised when Rivastigmin Orion is used with beta-adrenergic blocking agents (medicines such as atenolol, used to treat high blood pressure, angina, and other heart diseases). Taking these two medicines together may cause side effects such as slow heart rate (bradycardia) leading to fainting or loss of consciousness.
Caution should be exercised when Rivastigmin Orion is used with other medicines that may affect heart rate or the heart's conduction system (prolonged QT interval).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, your doctor will assess the benefits of taking Rivastigmin Orion against the possible effects on the unborn baby. Rivastigmin Orion should not be used during pregnancy unless absolutely necessary.
Do not breastfeed while taking Rivastigmin Orion.

Driving and using machines

Your doctor will inform you whether your condition allows you to drive or use machines. Rivastigmin Orion may cause dizziness and drowsiness, mainly during the initial treatment period or when increasing the dose. If you experience dizziness or drowsiness, do not drive, operate machinery, or perform any other tasks that require concentration.

3. How to take Rivastigmin Orion

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

How to start treatment

• Your doctor will decide what dose of Rivastigmin Orion you should take.
• Treatment usually starts with a low dose.
• Your doctor will gradually increase the dose, depending on your response to the treatment.
• The maximum dose you can take is 6 mg, twice a day.

Your doctor will regularly check if the medicine is working for you. During treatment with this medicine, your doctor will also monitor your weight.
If you have stopped taking Rivastigmin Orion for more than three days, do not take the next dose until you have talked to your doctor.

Patients taking this medicine

• Should tell their caregiver that they are taking Rivastigmin Orion.
• Should take the medicine every day to get the desired effect.
• Rivastigmin Orion should be taken twice a day (in the morning and in the evening) with food.
• The capsules should be swallowed whole, with a drink of water.
• Do not open or crush the capsules.

Taking a higher dose of Rivastigmin Orion than recommended

If you accidentally take more Rivastigmin Orion than recommended, tell your doctor, as medical attention may be necessary.
In some people who have taken too much Rivastigmin Orion, nausea (vomiting), vomiting, diarrhea, high blood pressure, and hallucinations have been observed. Slow heart rate and fainting may also occur .

Missing a dose of Rivastigmin Orion

If you miss a dose of Rivastigmin Orion, wait and take the next dose at the usual scheduled time. Do not take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivastigmin Orion can cause side effects, although not everybody gets them.
Side effects may occur more frequently during the initial treatment period or when increasing the dose. Side effects usually disappear slowly as the body gets used to the treatment.
Very common ( may affect more than 1 in 10 people)

• dizziness
• loss of appetite
• stomach problems such as nausea (vomiting) or vomiting, diarrhea

Common ( may affect up to 1 in 10 people)

• anxiety
• sweating
• headache
• heartburn
• weight loss
• abdominal pain
• agitation
• feeling tired or weak
• general feeling of being unwell
• tremors or confusion
• decreased appetite
• nightmares

Uncommon ( may affect up to 1 in 100 people)

• depression
• difficulty sleeping
• fainting or accidental falls
• changes in liver function

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

• chest pain
• rash, itching
• seizures (fits or convulsions)
• stomach or intestinal ulcers

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

• high blood pressure
• urinary tract infections
• seeing things that are not there (hallucinations)
• heart rhythm disorders such as fast or slow heart rate
• gastrointestinal bleeding - blood in stool or vomit
• pancreatitis - severe pain in the upper abdomen, often with nausea or vomiting
• worsening of Parkinson's disease symptoms or occurrence of similar symptoms - such as muscle stiffness, difficulty in performing voluntary movements

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

• severe vomiting that may lead to rupture of the esophagus
• dehydration (loss of too much fluid)
• liver problems (yellowing of the skin, yellowing of the whites of the eyes, dark urine, or unexplained nausea, vomiting, fatigue, and loss of appetite)
• aggression, restlessness
• irregular heartbeat
• Pisa syndrome (a condition characterized by involuntary muscle contraction with abnormal tilting of the body and head to one side).

Patients with dementia and Parkinson's disease

In these patients, some side effects occur more frequently. They may also experience additional symptoms:
Very common ( may affect more than 1 in 10 people)

• tremors
• fainting
• accidental falls

Common ( may affect up to 1 in 10 people)

• anxiety
• restlessness
• slow and fast heart rate
• difficulty sleeping
• excessive salivation and dehydration
• abnormal slowing of movement or poor movement control
• worsening of Parkinson's disease symptoms or occurrence of similar symptoms - such as muscle stiffness, difficulty in performing voluntary movements, and muscle weakness

Uncommon ( may affect up to 1 in 100 people)

• irregular heartbeat and poor movement control

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

• Pisa syndrome (a condition characterized by involuntary muscle contraction with abnormal tilting of the body and head to one side).

Other side effects observed with rivastigmine transdermal system, which may also occur with Rivastigmin Orion capsules:

Common ( may affect up to 1 in 10 people)

• fever
• severe confusion
• urinary incontinence (inability to control urination)

Uncommon ( may affect up to 1 in 100 people)

• excessive restlessness (high level of activity, restlessness)

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

• allergic reaction at the application site, such as blisters or skin inflammation

If you experience any of these symptoms, contact your doctor, as medical attention may be necessary.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych,
Al. Jerozolimskie 181 C, 02-222 Warszawa, Tel.: +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 marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivastigmin Orion

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivastigmin Orion contains

• The active substance is rivastigmine. Each Rivastigmin Orion hard capsule contains 1.5 mg rivastigmine as rivastigmine hydrogen tartrate. Each Rivastigmin Orion hard capsule contains 3.0 mg rivastigmine as rivastigmine hydrogen tartrate. Each Rivastigmin Orion hard capsule contains 4.5 mg rivastigmine as rivastigmine hydrogen tartrate. Each Rivastigmin Orion hard capsule contains 6.0 mg rivastigmine as rivastigmine hydrogen tartrate.
• The other ingredients in the capsule are: magnesium stearate, hypromellose, microcrystalline cellulose, anhydrous colloidal silica. The ingredients of the capsule shell (body and cap) are: gelatin, sodium lauryl sulfate, yellow iron oxide (E 172), titanium dioxide (E 171), and red iron oxide (E 172) (in 3.0 mg, 4.5 mg, and 6.0 mg capsules).

What Rivastigmin Orion looks like and contents of the pack

Hard capsule.
Rivastigmin Orion 1.5 mg hard capsule is yellow, 3 mg hard capsule is orange, 4.5 mg hard capsule is red, and 6 mg hard capsule is half red and half orange.
The hard, non-transparent capsules contain a powder that is white to pale yellow in color.
They are packaged in PVC/PVdC/Aluminum blisters. The packs contain 28, 56 hard capsules.
Additionally, for Rivastigmin Orion 3 mg, 4.5 mg, and 6 mg hard capsules, the pack contains 112 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

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

Denmark, Finland, Norway, Poland, Sweden: Rivastigmin Orion
Date of last revision of the leaflet:04.2025