Ristidic

Leaflet attached to the packaging: information for the user

Ristidic, 1.5 mg, hard capsules
Ristidic, 3.0 mg, hard capsules
Ristidic, 4.5 mg, hard capsules
Ristidic, 6.0 mg, hard capsules
Rivastigmine

You should carefully read the contents of the leaflet before taking 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.
• If you have 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 Ristidic and what is it used for
• 2. Important information before taking Ristidic
• 3. How to take Ristidic
• 4. Possible side effects
• 5. How to store Ristidic
• 6. Contents of the packaging and other information

1. What is Ristidic and what is it used for

The active substance of Ristidic is rivastigmine.
Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with Alzheimer's-type dementia or dementia caused by Parkinson's disease, certain brain cells die, which reduces the concentration 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, Ristidic allows the concentration of acetylcholine in the brain to increase, which helps to alleviate the symptoms of Alzheimer's disease.
Ristidic is used to treat adult patients with mild to moderately severe Alzheimer's-type dementia, 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 Ristidic

When not to take Ristidic

If this situation applies to the patient, they should inform their doctor and not take Ristidic.

Warnings and precautions

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

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 Ristidic for more than three days, they should not take the next dose until they have spoken to their doctor.

Children and adolescents

Ristidic should not be used in children and adolescents to treat Alzheimer's-type dementia.

Ristidic 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.
Ristidic should not be taken at the same time as other medicines with similar effects. Ristidic may affect the action of anticholinergic medicines (medicines used to relieve stomach cramps, treat Parkinson's disease, or prevent motion sickness).
Ristidic should not be taken 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 surgery is required during treatment with Ristidic, the patient should tell their doctor before undergoing general anesthesia, as Ristidic may enhance the effect of certain muscle relaxants used during general anesthesia.
Care should be taken when Ristidic 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 slowed heart rate (bradycardia) leading to fainting or loss of consciousness.

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 taking Ristidic should be weighed against the possible effects of the medicine on the unborn child. Ristidic should not be taken during pregnancy unless it is absolutely necessary.
The patient should not breastfeed while taking Ristidic.

Driving and using machines

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

3. How to take Ristidic

This medicine should always be taken according to the doctor's instructions. If the patient has any doubts, they should consult their doctor, pharmacist, or nurse.

How to start treatment

The doctor will inform the patient about the dose of Ristidic they should take.

• 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 6.0 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 body weight.
If the patient has stopped taking Ristidic for more than three days, they should not take the next dose until they have spoken to their doctor.

Patients taking this medicine

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

Taking a higher dose of Ristidic than recommended

In case of accidental ingestion of a higher dose of Ristidic than recommended, the patient should inform their doctor, as medical attention may be necessary. In some people who have accidentally taken too much Ristidic, nausea (nausea), vomiting, diarrhea, high blood pressure, and hallucinations have been observed. Slow heart rate and fainting may also occur.

Missing a dose of Ristidic

In case of accidental omission of a dose of Ristidic, the patient 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, Ristidic 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 resolve 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 (nausea) or vomiting, diarrhea

Common(may affect less than 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Abdominal pain
• Agitation
• Feeling tired or weak
• General malaise
• Tremors or confusion
• Decreased appetite
• Nightmares

Uncommon(may affect less than 1 in 100 people)

• Depression
• Difficulty sleeping
• Fainting or accidental falls
• Changes in liver function

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

• Chest pain
• Rash, itching
• Seizures (convulsions)
• Stomach or intestinal ulcers

Very rare(may affect less than 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 moving, and muscle weakness

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

• Sudden vomiting, which can lead to a tear in the part of the digestive tract 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 heartbeat

Patients with dementia and Parkinson's disease

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

• Tremors
• Fainting
• Accidental falls

Common(may affect less than 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 moving, and muscle weakness

Uncommon(may affect less than 1 in 100 people)

• Irregular heartbeat and poor movement control

Other side effects of Ristidic that may also occur after taking the hard capsules:

Common(may affect less than 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to properly hold urine)

Uncommon(may affect less than 1 in 100 people)

• Excessive restlessness (high level of activity, restlessness)

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

• Allergic reactions after taking the medicine in the form of a patch, such as blisters on the skin 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 the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 22 49 21 301
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ristidic

• The medicine should be stored out of sight and reach of children.
• The medicine should not be taken after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the stated month.
• There are no special precautions for storing the medicinal product.
• Medicines should not be thrown away 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 packaging and other information

What Ristidic contains

Contents of the capsule:

• The active substance of Ristidic is rivastigmine in the form of rivastigmine hydrochloride.
• Other ingredients of the medicine are: hypromellose 5cp, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica.

Capsule shell:

• Gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), red iron oxide (E 172) (only for 3/4.5/6 mg capsule shells) and printing ink.

Printing ink:

• Shellac, propylene glycol, concentrated ammonia, black iron oxide (E 172), and potassium hydroxide.

Each Ristidic 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Ristidic 3.0 mg capsule contains 3.0 mg of rivastigmine.
Each Ristidic 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Ristidic 6.0 mg capsule contains 6.0 mg of rivastigmine.

What Ristidic looks like and what the pack contains

Ristidic 1.5 mg: yellow/yellow, hard gelatin capsules with the inscription "RIVA 1.5 mg" printed in black ink on the lower part, containing a white or almost white, granular powder equivalent to 1.5 mg of rivastigmine.
Ristidic 3.0 mg: light orange/light orange, hard gelatin capsules with the inscription "RIVA 3mg" printed in black ink on the lower part, containing a white or almost white, granular powder equivalent to 3.0 mg of rivastigmine.
Ristidic 4.5 mg: caramel/caramel, hard gelatin capsules with the inscription "RIVA 4.5mg" printed in black ink on the lower part, containing a white or almost white, granular powder equivalent to 4.5 mg of rivastigmine.
Ristidic 6.0 mg: light orange/caramel, hard gelatin capsules with the inscription "RIVA 6 mg" printed in black ink on the lower part, containing a white or almost white, granular powder equivalent to 6.0 mg of rivastigmine.
The capsules are packaged in blisters. Three different pack sizes are available (28, 56, and 112 capsules). Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
Genepharm S.A.
18th km Marathonos Avenue,
153 51 Pallini Attikis
Greece
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
NL: Ristidic 1.5 / 3 / 4.5 / 6 mg capsules, hard
PL: Ristidic
SK: Ristidic 1.5 / 3/ 4.5 / 6 mg tvrdé kapsule

Date of last revision of the leaflet: December 2021