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
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Ristidic is and what it is used for
2. What you need to know 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 Ristidic is and what it is used for

The active substance in Ristidic is rivastigmine.
Rivastigmine belongs to a group of substances known as cholinesterase inhibitors. In patients
with Alzheimer's-type dementia or dementia associated with Parkinson's disease, certain brain
cells degenerate, leading to a reduction in 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 blocking these enzymes, Ristidic increases the concentration of acetylcholine in the brain, which helps alleviate symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.
Ristidic is used in the treatment of adult patients with mild to moderate Alzheimer's-type dementia, a progressive brain disorder causing gradual impairments in memory, intellectual abilities, and behavior. The capsules may also be used in the treatment of dementia in adult patients with Parkinson's disease.

2. Important information before using Ristidic

When not to use RISTIDIC

• if the patient is allergic to rivastigmine (the active substance in Ristidic) or to any of the other ingredients of this medicine (listed in section 6);
• if during treatment with rivastigmine in the form of transdermal systems (patches), the patient develops a skin reaction extending beyond the patch area, if local reactions worsen (e.g. blisters occur, skin inflammation intensifies, swelling appears), or if these changes do not resolve within 48 hours after removing the patch.

If this situation applies to the patient, inform the doctor and do not use Ristidic.
Warnings and precautions
Before starting treatment with Ristidic, discuss the following with the doctor:

• if the patient currently has or has ever had heart conditions, such as irregular or slow heartbeat, QT interval prolongation, familial QT prolongation, torsade de pointes, or low levels of potassium or magnesium in the blood;
• if the patient currently has or has ever had an active peptic ulcer;
• if the patient currently has or has ever had difficulties in passing urine;
• if the patient currently has or has ever had seizures;
• if the patient currently has or has ever had bronchial asthma or severe respiratory disease;
• if the patient currently has or has ever had kidney function disorders;
• if the patient currently has or has ever had liver function disorders;
• if the patient has muscle tremors;
• if the patient has low body weight;
• if the patient experiences gastrointestinal side effects such as nausea, vomiting, or diarrhoea. The patient may become dehydrated (losing too much fluid) if vomiting or diarrhoea persists for a prolonged period.

If any of the above apply, the doctor may need to monitor the patient more closely during treatment.
If the patient has stopped taking Ristidic for more than three days, they should not take the next dose without first discussing it with their doctor.
Children and adolescents
Ristidic is not indicated for the treatment of Alzheimer-type dementia in children and adolescents.
Ristidic and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Ristidic should not be used concomitantly with other medicines of similar action. Ristidic may affect the action of anticholinergic medicines (medicines used to relieve stomach spasms, in the treatment of Parkinson's disease, or to prevent motion sickness).
Ristidic should not be used together with metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Concomitant use of these two medicines may cause adverse effects such as limb stiffness and hand tremors.
If surgery requiring general anaesthesia becomes necessary during treatment with Ristidic, inform the doctor about taking this medicine beforehand, because Ristidic may enhance the effect of certain muscle relaxants used during general anaesthesia.
Exercise caution when Ristidic is used together with beta-blockers (medicines such as atenolol, used in the treatment of hypertension, angina pectoris, and other heart conditions). Concomitant use of these two medicines may cause adverse effects such as slowing of the heart rate (bradycardia), leading to fainting or loss of consciousness.
Exercise caution when Ristidic is used together with other medicines that may affect heart rhythm or the cardiac conduction system (QT interval prolongation).
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
If the patient is pregnant, the benefits of using Ristidic should be weighed against the potential risks to the unborn child. Ristidic should not be used during pregnancy unless absolutely necessary.
Breastfeeding is not recommended while taking Ristidic.
Driving and operating machinery
The doctor will advise the patient whether their condition allows safe driving and operating of machinery. Ristidic may cause dizziness and drowsiness, particularly during the initial phase of treatment or during dose escalation.
If the patient experiences dizziness or drowsiness, they should not drive, operate machinery, or perform any other tasks requiring concentration.

3. How to use Ristidic

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor, pharmacist, or nurse.
Starting 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 daily.

Your doctor will regularly monitor whether the medicine is working for you. While taking this medicine, your doctor will also monitor your body weight.
If you have stopped taking Ristidic for more than three days, do not take another dose until you have spoken to your doctor.
Patients using 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 daily (in the morning and evening) with food.
• Capsules must be swallowed whole with liquid.
• Do not open or crush the capsules.

Taking more Ristidic than recommended
If you accidentally take more Ristidic than recommended, inform your doctor immediately, as medical assistance may be required. In some people who have accidentally taken too much Ristidic, nausea, vomiting, diarrhoea, high blood pressure, and hallucinations have been observed. Slow heart rate and fainting may also occur.
Missing a dose of Ristidic
If you accidentally miss a dose of Ristidic, wait and take the next dose at your usual scheduled time. Do not take a double dose to make up for a missed dose.
If you have any further 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 everyone gets them.
Side effects may occur more frequently during the initial period of treatment or when the dose is being increased. Side effects usually gradually diminish as the body adapts to the treatment.

Very common (may affect more than 1 in 10 people)

• Dizziness
• Loss of appetite
• Stomach problems such as nausea or vomiting, diarrhoea

Common (may affect less than 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Abdominal pain
• Restlessness
• Feeling tired or weak
• General malaise
• Tremor or confusion
• Reduced appetite
• Nightmares
• Drowsiness

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 (fits)
• Peptic ulcer of the stomach or intestines

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 heartbeat
• Gastrointestinal bleeding – blood in stool or vomit
• Pancreatitis – symptoms include severe pain in the upper abdomen, often with nausea or vomiting
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty performing voluntary movements

Unknown frequency (frequency cannot be estimated from available data)

• Severe vomiting, which may lead to rupture of the oesophagus (the tube connecting the mouth to the stomach)
• Dehydration (loss of too much fluid)
• Liver function disorders (yellowing of the skin, yellowing of the whites of the eyes, abnormal dark urine, or unexplained nausea, vomiting, fatigue and loss of appetite)
• Aggression, restlessness
• Irregular heartbeat
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal tilting of the body and head to one side)

Patients with dementia and Parkinson's disease
In these patients, certain side effects occur more frequently. Other additional symptoms may also occur:

Very common (may affect more than 1 in 10 people)

• Tremor
• Accidental falls

Common (may affect less than 1 in 10 people)

• Anxiety
• Restlessness
• Slow and fast heartbeat
• Difficulty sleeping
• Excessive salivation and dehydration
• Abnormal slowing of movements or poor control of movements
• Worsening of Parkinson's disease symptoms or development of similar symptoms – such as muscle stiffness, difficulty performing voluntary movements, and muscle weakness
• Seeing things that are not there (hallucinations)
• Depression
• High blood pressure

Uncommon (may affect less than 1 in 100 people)

• Irregular heartbeat and poor control of movements
• Low blood pressure

Unknown frequency (frequency cannot be estimated from available data)

• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal tilting of the body and head to one side)
• Skin rash

Other side effects following administration of the medicinal product Ristidic which may also occur after taking hard capsules:

Common (may affect less than 1 in 10 people)

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

Uncommon (may affect less than 1 in 100 people)

• Hyperkinesia (excessive activity, restlessness)

Unknown frequency (frequency cannot be estimated from available data)

• Allergic reaction at the site of the patch application, such as blisters or skin inflammation. If any of the above symptoms occur, contact your doctor, as medical help may be needed.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ristidic

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
• No special precautions regarding storage of the medicinal product are required.
• Medicines must not be disposed of via the sewage system or in 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 Ristidic contains
Contents of the capsule:

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

Capsule shell:

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

Printing ink:

• Shellac, propylene glycol, concentrated ammonia, iron oxide black (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” printed in black ink on the lower part, containing white or almost white granular powder corresponding to 1.5 mg of rivastigmine.
Ristidic 3.0 mg: light orange/light orange hard gelatin capsules with the imprint “RIVA 3mg” printed in black ink on the lower part, containing white or almost white granular powder corresponding to 3.0 mg of rivastigmine.
Ristidic 4.5 mg: caramel/caramel hard gelatin capsules with the imprint “RIVA 4.5mg” printed in black ink on the lower part, containing white or almost white granular powder corresponding to 4.5 mg of rivastigmine.
Ristidic 6.0 mg: light orange/caramel hard gelatin capsules with the imprint “RIVA 6 mg” printed in black ink on the lower part, containing white or almost white granular powder corresponding to 6.0 mg of rivastigmine.

The capsules are packed in blisters. Three different pack sizes are available (28, 56 and 112 capsules).
Not all pack sizes may be marketed.

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

Manufacturer
Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice
Poland

Genepharm S.A.
18th km Marathonos Avenue,
153 51 Pallini Attikis
Greece

This medicinal product is authorised 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 hard capsules