Rivaldo

Package Leaflet: Information for the Patient

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 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 or pharmacist.
• 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 inform your doctor or pharmacist. See section 4.

Contents of the Package 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 pack 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 dementia, certain brain cells die, which leads to a decrease in the concentration 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, 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 dementia. 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 you, you should tell your doctor and not take Rivaldo.

Warnings and precautions

Before starting treatment with Rivaldo, you should discuss it with your doctor or pharmacist:

If you have stopped taking Rivaldo for a few days, you should not take the next dose until you have talked to your doctor.

Children and adolescents

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

Rivaldo and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Rivaldo should not be taken with other medicines that have a similar effect. Rivaldo may affect the action of anticholinergic medicines (medicines used to relieve stomach cramps, treat Parkinson's disease, or prevent motion sickness). Rivaldo 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 have surgery, you should tell your doctor that you are taking Rivaldo before receiving general anesthesia, as Rivaldo may increase the effect of some muscle relaxants used for general anesthesia. You should be careful when taking Rivaldo 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 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 become pregnant, you should consult your doctor or pharmacist before taking this medicine. If you are pregnant, your doctor will assess the benefits of taking Rivaldo against the possible effects of the medicine on the unborn child. Rivaldo should not be taken during pregnancy unless it is absolutely necessary. You should not breastfeed while taking Rivaldo.

Driving and using machines

Your doctor will inform you whether your condition allows you to drive or use machines safely. Rivaldo may cause dizziness and drowsiness, mainly at the beginning of treatment or when increasing the dose. If you feel dizzy or drowsy, you should not drive, operate machinery, or perform other tasks that require concentration.

3. How to take Rivaldo

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

How to start treatment

Your doctor will inform you what dose of Rivaldo 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 weight. If you have stopped taking Rivaldo for more than three days, you should not take the next dose until you have talked to your doctor.

Patient taking this medicine

• Should tell their caregiver that they are taking Rivaldo.
• Should take the medicine every day to get the desired therapeutic effect.
• Should take Rivaldo twice a day (in the morning and in the evening) with food.
• Should swallow the capsules whole with a liquid.
• Should not open or crush the capsules.

Taking a higher dose of Rivaldo than recommended

In case of unintentional ingestion of a higher dose of Rivaldo than recommended, you should inform your 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 you have missed a dose of Rivaldo, you should wait and take the next dose at the usual scheduled time. You should 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, Rivaldo can cause side effects, although not everybody gets them. Side effects usually occur during the initial treatment period or when increasing the dose. Side effects will gradually resolve as your body gets used 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 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

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 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 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 heartbeat 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. 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 inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaldo

Keep 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 that month. There are no special precautions for storage. 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 Rivaldo contains

• The active substance 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 content: 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); soy lecithin; Antifoam DC; titanium dioxide (E 171); Allura Red, aluminum lake (E 129), propylene glycol.

Rivaldo 3.0 mg

Capsule content: 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); soy lecithin; Antifoam DC; titanium dioxide (E 171); Allura Red, aluminum lake (E 129), propylene glycol.

Rivaldo 4.5 mg

Capsule content: 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 content: 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); soy lecithin; Antifoam DC; titanium dioxide (E 171); Allura Red, aluminum lake (E 129), propylene glycol.

What Rivaldo looks like and contents of the pack

Rivaldo 1.5 mg: yellow capsule with red print "R 1.5" on the body, containing white or off-white powder.
Rivaldo 3.0 mg: orange capsule with red print "R 3.0" on the body, containing white or off-white powder.
Rivaldo 4.5 mg: red capsule with white print "R 4.5" on the body, containing white or off-white powder.
Rivaldo 6.0 mg: red-orange capsule with red print "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
Single pack contains 28 capsules.
Rivaldo 3 mg, 4.5 mg, 6 mg hard capsules
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 revision of the leaflet:03.2019