Rivaldo

Leaflet attached to the packaging: patient information

Rivaldo, 1.5 mg hard capsules

Rivaldo, 3.0 mg hard capsules

Rivaldo, 4.5 mg hard capsules

Rivaldo, 6.0 mg hard capsules

Rivastigmine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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 the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Rivaldo and what is it used for

The active substance of Rivaldo is rivastigmine.
Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with Alzheimer's disease or 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).
Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking the action of these enzymes, Rivaldo allows the concentration of acetylcholine in the brain to increase, which helps to alleviate the symptoms of Alzheimer's disease and Parkinson's disease.
Rivaldo is used to treat adult patients with mild to moderate Alzheimer's disease.
Rivaldo is used to treat dementia in adult patients with Parkinson's disease.

2. Important information before taking Rivaldo

When not to take Rivaldo

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

Warnings and precautions

Before starting to take Rivaldo, the patient should discuss it with their doctor or pharmacist:

If the patient has stopped taking Rivaldo for a few days, they should not take the next dose until they have spoken to their doctor.

Children and adolescents

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

Rivaldo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Rivaldo should not be taken at the same time as other medicines with similar effects. Rivaldo may affect the action of anticholinergic medicines (used to relieve stomach cramps, treat Parkinson's disease, or prevent motion sickness).
Rivaldo 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 the patient needs to undergo surgery, they should inform their doctor about taking Rivaldo before receiving general anesthesia, as Rivaldo may enhance the effect of some muscle relaxants used for general anesthesia.
Care should be taken when Rivaldo is used with beta-adrenergic blockers (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 using Rivaldo should be weighed against the potential effects of the medicine on the unborn child. Rivaldo should not be used during pregnancy unless it is absolutely necessary.
The patient should not breastfeed while taking Rivaldo.

Driving and using machines

The doctor will inform the patient whether their condition allows for safe driving and use of machines. Rivaldo may cause dizziness and drowsiness, mainly at the beginning of treatment or during dose increases. If the patient experiences dizziness or drowsiness, they should not drive, operate machines, or perform other tasks that require concentration.

3. How to take Rivaldo

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

How to start treatment

The doctor will inform the patient about the dose of Rivaldo 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 Rivaldo 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 Rivaldo.
• They should take the medicine every day to achieve the desired therapeutic effect.
• Rivaldo 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 Rivaldo than recommended

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

Missing a dose of Rivaldo

If a dose of Rivaldo is missed, 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 further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaldo can cause side effects, although not everybody gets them.
Side effects usually occur during the initial period of treatment or during dose increases. Side effects will gradually resolve 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, diarrhea

Common(may affect up to 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 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
• hallucinations
• heart rhythm disorders, such as fast or slow heart rate
• 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 occurrence of similar symptoms - such as muscle stiffness, difficulty moving

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

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 moving, and muscle weakness

Uncommon(may affect up to 1 in 100 people)

• irregular heart rhythm and poor movement control

Other side effects of Rivaldo that may also occur when taking hard 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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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, email: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Rivaldo

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton.
The expiry date refers to the last day of the given month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Rivaldo contains

• The active substance of Rivaldo is rivastigmine. Each capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine.
• The other ingredients are:

Rivaldo 1.5 mg

Capsule contents: hypromellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.
Coating: gelatin, sodium lauryl sulfate, titanium dioxide (E 171), yellow iron oxide (E 172).
Red ink: shellac; red iron oxide (E 172); soybean lecithin; Antifoam DC; titanium dioxide (E 171); Allura Red, aluminum lake (E 129), propylene glycol.

Rivaldo 3.0 mg

Capsule contents: hypromellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.
Coating: gelatin, sodium lauryl sulfate, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171).
Red ink: shellac; red iron oxide (E 172); soybean lecithin; Antifoam DC; titanium dioxide (E 171); Allura Red, aluminum lake (E 129), propylene glycol.

Rivaldo 4.5 mg

Capsule contents: hypromellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.
Coating: gelatin, sodium lauryl sulfate, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171).
White ink: shellac, titanium dioxide (E 171).

Rivaldo 6.0 mg

Capsule contents: hypromellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.
Coating: gelatin, sodium lauryl sulfate, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171).
Red ink: shellac; red iron oxide (E 172); soybean lecithin; Antifoam DC; titanium dioxide (E 171); Allura Red, aluminum lake (E 129), propylene glycol.

What Rivaldo looks like and what the pack contains

Rivaldo 1.5 mg: yellow capsule with red printing "R 1.5" on the body, containing white or off-white powder.
Rivaldo 3.0 mg: orange capsule with red printing "R 3.0" on the body, containing white or off-white powder.
Rivaldo 4.5 mg: red capsule with white printing "R 4.5" on the body, containing white or off-white powder.
Rivaldo 6.0 mg: red-orange capsule with red printing "R 6.0" on the body, containing white or off-white powder.
Rivaldo is packaged in blisters of 14 capsules.
Rivaldo 1.5 mg hard capsules
The single pack contains 28 capsules.
Rivaldo 3 mg, 4.5 mg, 6 mg hard capsules
The single pack contains 28 or 56 capsules.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

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

Poland:
Rivaldo
Date of leaflet approval:03.2019