Pronoran

Leaflet attached to the packaging: patient information

PRONORAN

50 mg

prolonged-release coated tablets
Piribedil

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Pronoran and what is it used for

Pronoran contains piribedil, which belongs to a group of medicines called dopamine receptor agonists.
It stimulates dopamine receptors in the brain and has a vasodilating effect on peripheral blood vessels.
The effect of the medicine lasts for more than 24 hours.
Pronoran is indicated for the treatment of Parkinson's disease:

• as monotherapy - as the only medicine (especially in cases with tremors);
• in combination with levodopa; from the beginning or later, especially in cases with tremors.

2. Important information before taking Pronoran

When not to take Pronoran:

• if the patient is allergic to piribedil or any of the other ingredients of this medicine (listed in section 6);
• if the patient has cardiovascular shock;
• if the patient has acute phase of myocardial infarction;
• if the patient is taking neuroleptics (except clozapine).

Warnings and precautions

During treatment with piribedil, somnolence and sudden sleep attacks have been observed, especially in patients with Parkinson's disease. Sudden sleep onset during the day, in some cases without warning signs, has been observed very rarely.
Patients must be informed about this and advised to exercise caution while driving or operating machinery during treatment with piribedil.
Patients who experience somnolence and/or sudden sleep attacks must refrain from driving or operating machinery. The doctor may recommend reducing the dose or discontinuing Pronoran.
In patients treated with piribedil, the risk of falls due to sudden sleep attacks, hypotension, or confusion (disorientation) increases with age.
The doctor should be informed if the patient or their relatives notice unusual behaviors resulting from irresistible impulse, compulsion, or repetitive behavior, which may be harmful to the patient or others. Such behaviors are called impulse control disorders and may include gambling addiction, overeating, or excessive spending, increased sexual drive, or intense sexual thoughts and feelings. The doctor may decide to adjust the treatment or discontinue the medicine.
Before taking Pronoran, the doctor should be informed:

• if the patient has (had) or has experienced certain conditions or symptoms, especially: kidney disease, liver disease, swelling of the feet, ankles, or toes.
• if the patient, their caregiver, or a family member notices that the patient has experienced: disorientation, agitation, aggression, certain mental disorders, such as delirium, hallucinations, or delusions. The doctor may adjust the dose of Pronoran or recommend discontinuing it.

The patient should regularly check their blood pressure, especially at the beginning of treatment. This will help avoid orthostatic hypotension (a drop in blood pressure when changing position from lying or sitting to standing).
Children and adolescents
Pronoran is not recommended for use in children and adolescents under 18 years of age.

Pronoran and other medicines

The doctor should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking piribedil in combination with dopamine antagonists - neuroleptics (except clozapine) and with certain medicines used to prevent nausea and vomiting is contraindicated.
Taking piribedil in combination with tetrabenazine is not recommended.
Due to the possible increased sedative effect, caution should be exercised when taking piribedil with other sedative medicines.

Pronoran and alcohol

It is not recommended to drink alcohol while taking Pronoran.

Pregnancy and breastfeeding

Before taking any medicine, consult a doctor or pharmacist.
Due to the lack of significant data, it is not recommended to use the medicine during pregnancy or breastfeeding.

Driving and operating machinery

Patients treated with Pronoran and experiencing somnolence and/or sudden sleep attacks must be informed to refrain from driving or operating machinery until such recurring attacks and somnolence have stopped.

Pronoran contains sucrose and a colorant - carmoisine (E124)

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The colorant - carmoisine (E124) may cause allergic reactions.

Pronoran contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release coated tablet, which means the medicine is considered "sodium-free".

3. How to take Pronoran

This medicine should always be taken according to the doctor's recommendations.
In case of doubts, consult a doctor.
Pronoran is taken orally.
Treatment of Parkinson's disease:

• as monotherapy: from 150 to 250 mg, i.e., from 3 to 5 tablets per day in 3-5 divided doses;
• in combination with levodopa: from 100 to 150 mg per day in 2-3 divided doses. The tablets should be swallowed with half a glass of water after a meal. The dose, on the doctor's recommendation, should be gradually increased: by one tablet every 3 days.

In order to avoid the risk of impulse control disorders (see section 2), the doctor may adjust the dose of Pronoran for the patient or discontinue the medicine if such disorders occur.

Use in children and adolescents

Pronoran is not recommended for use in children and adolescents under 18 years of age due to the lack of data on safety and efficacy.

Taking a higher dose of Pronoran than recommended

In very high doses, piribedil has an emetic effect. Therefore, the tablets will be expelled, which explains the lack of data on overdose.
However, due to the effect of the medicine, the following overdose symptoms can be expected:

• blood pressure fluctuations (increase or decrease in blood pressure);
• nausea and vomiting.

In case of overdose, consult a doctor immediately.

Missing a dose of Pronoran

Do not take a double dose to make up for a missed dose, just take the next dose as usual.

Stopping treatment with Pronoran

In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.
Do not stop taking Pronoran without consulting a doctor first. If it is necessary to stop taking this medicine, the doctor will gradually reduce the dose. This will reduce the risk of worsening certain symptoms. Do not stop taking Pronoran abruptly. Abrupt discontinuation of this medicine may cause a condition called neuroleptic malignant syndrome, which can be a serious health risk. The symptoms of this syndrome are:

• akinesia - immobility (lack of muscle movement);
• muscle stiffness;
• fever;
• unstable blood pressure;
• tachycardia (rapid heart rate);
• disorientation;
• altered consciousness (e.g., coma).

4. Possible side effects

Like all medicines, Pronoran can cause side effects, although not everybody gets them.
The following side effects have been observed:

• often: minor gastrointestinal disorders (nausea, vomiting, bloating), which may resolve after individual dose adjustment.
• during treatment with piribedil, somnolence has been observed; very rarely, cases of excessive daytime sleepiness and sudden sleep attacks have been observed.
• often: mental disorders, such as disorientation, hallucinations, agitation, or dizziness, which resolve after discontinuation of treatment.
• not very often: hypotension, orthostatic hypotension (a drop in blood pressure associated with a change in body position from lying or sitting to standing) with fainting or malaise, or unstable blood pressure.
• due to the content of the colorant - carmoisine, there is a risk of allergic reactions.

The following side effects may also occur:

• inability to resist impulse, temptation, or compulsion to perform actions that may be harmful to the patient or others; this includes:
• strong impulse to gamble excessively, despite significant personal or family consequences;
• changed or increased sexual interests and behaviors of great importance to the patient or others, e.g., activities related to increased sexual drive;
• compulsive, uncontrolled spending;
• episodic binge eating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger);
• aggression;
• mental disorders (delusions, hallucinations, delirium - visual, auditory, mixed);
• swelling of the feet, ankles, or toes;
• dyskinesias (uncontrolled movements of the limbs or body, caused by abnormal muscle contractions).

Tell the doctor if the patient experiences any of these behaviors, to discuss ways to control or limit these symptoms.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell the doctor or pharmacist. 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Pronoran

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use Pronoran after the expiry date stated on the carton and blister after the term "EXP" (the term used to describe the expiry date). The expiry date refers to the last day of the month stated.
The batch number stated on the carton and blister is used to describe the batch number. The writing after it indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask a 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 Pronoran contains

• The active substance of Pronoran is piribedil. Each prolonged-release coated tablet contains 50 mg of piribedil.
• The other ingredients of the medicine are: magnesium stearate, povidone, talc. The ingredients of the coating are: sodium carmellose, polysorbate 80, carmoisine (E124), povidone, silica colloidal anhydrous, sodium bicarbonate, sucrose, titanium dioxide (E171), talc, white wax.

What Pronoran looks like and contents of the pack

Pronoran is available in packs containing 30 prolonged-release coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer

Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France
ANPHARM Pharmaceutical Company S.A.
Annopol 6B
03-236 Warsaw
To obtain more detailed information, contact the representative of the marketing authorization holder:
Servier Polska Sp. z o.o.
Phone: (22) 594-90-00

Date of last revision of the leaflet: