RIVASTIGMIN 1.5 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. You should carefully read the contents of this leaflet 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 rivastigmine 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

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not give it 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 inform their 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 level of the neurotransmitter acetylcholine (a substance that enables 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, Rivastigmin Orion allows the increase of acetylcholine levels in the brain, 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 disease that causes gradual memory, intellectual, and behavioral disorders. 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 this situation applies to the patient, they should inform their doctor and not take Rivastigmin Orion.

Warnings and precautions

Before starting treatment with Rivastigmin Orion, the patient should discuss the following with their doctor:

Torsades de Pointes, or low potassium or magnesium levels in the blood;

If any of the above applies to the patient, the doctor may need to monitor them more closely during treatment. If the patient has stopped taking Rivastigmin Orion for more than three days, they should not take the next dose until they have consulted their doctor.

Children and adolescents

Rivastigmin Orion should not be used in children and adolescents to treat Alzheimer's disease.

Rivastigmin Orion and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they 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 disorders such as stiffness of the limbs and hand tremors. If the patient needs to undergo surgery while taking Rivastigmin Orion, they should inform their doctor about the use of rivastigmine before receiving any anesthetics, as Rivastigmin Orion may enhance the effect of certain muscle relaxants during anesthesia. Caution should be exercised when Rivastigmin Orion 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. Caution should be exercised when Rivastigmin Orion is used with other medicines that may affect heart rhythm or the heart conduction system (prolonged QT interval).

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 taking this medicine. If the patient is pregnant, the benefits of using Rivastigmin Orion should be weighed against the possible effects of the medicine on the unborn child. Rivastigmin Orion should not be used during pregnancy unless it is absolutely necessary. The patient should not breastfeed while taking Rivastigmin Orion.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive or use machines safely. Rivastigmin Orion may cause dizziness and drowsiness, mainly during the initial treatment period or when increasing the dose. If the patient feels dizzy or drowsy, they should not drive, use machines, or perform any other tasks that require concentration.

3. How to take Rivastigmin Orion

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor, pharmacist, or nurse.

How to start treatment

• The doctor will determine the dose of Rivastigmin Orion to be taken.
• Treatment usually starts with a low dose.
• The doctor will gradually increase the dose, depending on the patient's response to treatment.
• The maximum dose that can be taken is 6 mg, twice a day.

The doctor will regularly check if the medicine is working for the patient. During treatment with this medicine, the doctor will also monitor the patient's weight. If the patient has stopped taking Rivastigmin Orion for more than three days, they should not take the next dose until they have consulted their doctor.

Patients taking this medicine

• They should inform their caregiver that they are taking Rivastigmin Orion.
• They should take the medicine every day to achieve the desired therapeutic effect.
• Rivastigmin Orion should be taken twice a day (morning and evening) with food.
• The capsules should be swallowed whole, with a drink of liquid.
• The capsules should not be opened or crushed.

Taking a higher dose of Rivastigmin Orion than recommended

In case of unintentional ingestion of a higher dose of Rivastigmin Orion than recommended, the patient should inform their doctor, as medical attention may be necessary. In some individuals 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 the patient has missed a dose of Rivastigmin Orion, they should wait and take the next dose at the usual scheduled time. They should not take a double dose to make up for the missed dose. If the patient has any further doubts about taking this medicine, they should consult their 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 adapts to 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 a tear in the tube connecting the mouth to the stomach (esophagus)
• dehydration (loss of too much fluid)
• liver function disorders (yellowing of the skin, yellowing of the whites of the eyes, unusual dark color of urine or unexplained nausea, vomiting, fatigue, and loss of appetite)
• aggression, restlessness
• irregular heart rhythm
• 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 control over movements
• 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 heart rhythm and poor control over movements

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 rivastigmine capsules:

Common ( may affect up to 1 in 10 people)

• fever
• severe confusion
• urinary incontinence (inability to properly hold urine)

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 patch site, such as blisters or skin inflammation

If the patient experiences any of these symptoms, they should contact their doctor, as medical attention may be necessary.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, 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, more information can be gathered on the safety of the medicine.

5. How to store Rivastigmin Orion

• The medicine should be stored out of sight and reach of children.
• The medicine should not be used after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month.
• This medicine does not require special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This 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 of rivastigmine as rivastigmine hydrogen tartrate. Each Rivastigmin Orion hard capsule contains 3.0 mg of rivastigmine as rivastigmine hydrogen tartrate. Each Rivastigmin Orion hard capsule contains 4.5 mg of rivastigmine as rivastigmine hydrogen tartrate. Each Rivastigmin Orion hard capsule contains 6.0 mg of rivastigmine as rivastigmine hydrogen tartrate.
• The other ingredients of the capsule are: magnesium stearate, hypromellose, microcrystalline cellulose, colloidal anhydrous 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, only for Rivastigmin Orion 3 mg, 4.5 mg, and 6 mg hard capsules - a pack of 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. For further information on this medicine, the patient should 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