Ristidic

Package Leaflet: 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

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, please tell your 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 pack 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 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, Ristidic allows the levels 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 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 Ristidic

When not to take Ristidic

• if you are allergic to rivastigmine (the active substance of Ristidic) or any of the other ingredients of this medicine (listed in section 6);
• if you have had a skin reaction to rivastigmine patches that spread beyond the skin area covered by the patch, if the local reaction worsens (e.g., blisters, exacerbation of skin inflammation, swelling) and if these changes do not resolve within 48 hours after removing the patch.

If this situation applies to you, you should inform your doctor and not take Ristidic.

Warnings and precautions

Before starting treatment with Ristidic, you should discuss this with your doctor:

• if you have or have had an irregular or slow heart rate;
• if you have or have had an active stomach ulcer;
• if you have or have had difficulty urinating;
• if you have or have had seizures;
• 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 experience stomach and 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 applies to you, your doctor may need to monitor you more closely during treatment.
If you have stopped taking Ristidic for more than three days, you should not take the next dose until you have talked to your doctor.

Children and adolescents

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

Ristidic and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Ristidic should not be taken with other similar-acting medicines. 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 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 you need to undergo surgery during treatment with Ristidic, you should tell your doctor before undergoing general anesthesia, as Ristidic may increase the action of certain muscle relaxants used during general anesthesia.
Caution should be exercised 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 slow heart rate (bradycardia) leading to fainting or loss of consciousness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
If you are pregnant, your doctor will need to assess the benefits of taking Ristidic against the possible effects of the medicine on the unborn child. Ristidic should not be taken during pregnancy unless it is absolutely necessary.
You should not breastfeed while taking Ristidic.

Driving and using machines

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

3. How to take Ristidic

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should ask your doctor, pharmacist, or nurse.

How to start treatment

Your doctor will inform you what dose of Ristidic to take.

• Treatment usually starts with a low dose.
• Your doctor will gradually increase the dose depending on your response to treatment.
• The maximum dose that can be taken is 6.0 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 body weight.
If you have stopped taking Ristidic for more than three days, you should not take the next dose until you have talked to your doctor.

Patient taking this medicine

• Should inform their caregiver that they are taking Ristidic.
• Should take the medicine every day to achieve the desired therapeutic effect.
• Ristidic should be taken twice a day (morning and evening) with food.
• The capsules should be swallowed whole with a liquid.
• Do not open or crush the capsules.

Taking a higher dose of Ristidic than recommended

In case of accidental ingestion of a higher dose of Ristidic than recommended, you should inform your doctor, as medical attention may be necessary. In some people who have accidentally taken too much Ristidic, nausea (vomiting), 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 missing of a dose of Ristidic, you should 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 about taking this medicine, you should ask your 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 (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 (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 moving, and muscle weakness

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

• Sudden severe vomiting, which may lead to tearing of the esophagus (the tube connecting the mouth to the stomach)
• Dehydration (loss of too much fluid)
• Liver problems (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

Patient 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 moving, and muscle weakness

Uncommon(may affect up to 1 in 100 people)

• Irregular heartbeat and poor control over movements

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

Common(may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to control 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 reactions after taking the patch, such as blisters on the skin or skin inflammation. If you experience any of these symptoms, you should 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, you should tell your doctor, pharmacist, or nurse. 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 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ristidic

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the month stated.
• No special precautions for storage of the medicinal product are necessary.
• Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Ristidic contains

Contents of the capsule:

• The active substance of Ristidic is rivastigmine in the form of rivastigmine hydrogentartrate.
• 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 the 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 contents of the pack

Ristidic 1.5 mg: yellow/yellow, hard gelatin capsules with the imprint “RIVA 1.5 mg” 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 imprint “RIVA 3mg” 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 imprint “RIVA 4.5mg” 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 imprint “RIVA 6 mg” 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