Pronoran

Package leaflet: Information for the patient

PRONORAN
50 mg
prolonged-release coated tablets
Piribedil
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 personally. Do not give it to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Pronoran is and what it is used for
2. What you need to know 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 Pronoran is and what it is 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 vasodilatory effect on peripheral blood vessels.
The effect of the medicine lasts for more than 24 hours.
Pronoran is indicated in the treatment of Parkinson's disease:

• as monotherapy – used alone (especially in tremor-dominant forms);
• in combination therapy with levodopa, either from the beginning or added later, particularly in tremor-dominant forms.

2. Important information before using Pronoran

When not to use Pronoran:

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

Warnings and precautions
Somnolence and sudden sleep attacks have been observed during treatment with piribedil, particularly in patients with Parkinson's disease. Sudden daytime sleep episodes, sometimes without awareness or warning signs, have been observed very rarely.
Patients must be informed about this and advised to exercise caution when 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 physician may consider reducing the dose or discontinuing treatment with Pronoran.
In patients treated with piribedil, the risk of falls due to sudden sleep attacks, hypotension, or confusion (disorientation) increases with age.
Inform the physician if the patient or their caregivers notice unusual behaviors resulting from irresistible urges or compulsions, or obsessive performance of certain actions harmful to the patient or others. These behaviors are known as impulse control disorders and may include gambling addiction, compulsive eating or spending, increased sexual drive, or intensified sexual thoughts and feelings. The physician may decide to adjust the treatment or discontinue the medicine.

Before taking Pronoran, inform the physician:

• if the patient has (or has had) or develops certain conditions or symptoms, especially: kidney disease, liver disease, swelling of the legs, feet, or fingers;
• if the patient, their caregiver, or a family member notices that the patient develops: disorientation, agitation, aggression, or certain psychiatric disorders such as delirium, hallucinations, or illusions. The physician may adjust the dose of Pronoran or recommend discontinuation of the medicine.

The patient should regularly monitor blood pressure, especially at the beginning of treatment. This will help prevent orthostatic hypotension (a drop in blood pressure upon standing).

Children and adolescents
Pronoran is not recommended for use in children and adolescents under 18 years of age.

Pronoran with other medicines
Inform the physician about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concomitant use of piribedil with dopamine antagonists—neuroleptics (except clozapine)—and with certain medicines used to prevent nausea and vomiting is contraindicated.
Concomitant use of piribedil with tetrabenazine is not recommended.
Due to the potential for enhanced sedative effects, caution should be exercised when using piribedil together with other sedative medicines.

Pronoran and alcohol
Drinking alcohol is not recommended during treatment with Pronoran.

Pregnancy and breastfeeding
Before taking any medicine, consult a physician or pharmacist.
Due to lack of significant data, use of this medicine during pregnancy or breastfeeding is not recommended.

Driving and operating machinery
Patients treated with Pronoran who experience somnolence and/or sudden sleep attacks must be advised to refrain from driving or performing activities where impaired alertness could place themselves or others at risk of serious accidents or death (e.g., operating machinery), until such recurrent attacks and drowsiness resolve.

Pronoran contains sucrose and a colouring agent – cochineal red (E124)
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their physician before taking this medicine.
The colouring agent – cochineal red (E124) – may cause allergic reactions.

Pronoran contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release coated tablet; therefore, this medicine is considered "sodium-free".

3. How to take Pronoran

This medicine should always be taken as directed by the physician.
In case of doubt, consult your doctor.
Pronoran is taken orally.
Treatment of Parkinson's disease:

• as monotherapy: 150 to 250 mg, i.e. 3 to 5 tablets daily in 3–5 divided doses;
• in combination with levodopa: 100 to 150 mg daily in 2–3 divided doses. Tablets should be swallowed with half a glass of water after a meal. The dose should be gradually increased, as directed by the physician: by one tablet every 3 days.

To avoid the risk of impulse control disorders (see section 2), the physician may adjust the dose
of the medicine 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
lack of data on safety and efficacy.
Taking more Pronoran than recommended
At very high doses, the emetic effect of piribedil becomes apparent. Because of this, tablets
are expelled, which explains the lack of data on overdose.
Nevertheless, due to the action of the medicine, the following symptoms of overdose may be expected:

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

In case of overdose, seek immediate medical advice.
If you forget to take Pronoran
Do not take a double dose to make up for a missed dose; take the next dose as usual.
Stopping Pronoran
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Do not stop taking Pronoran without first consulting your doctor. If it is necessary to discontinue treatment with this medicine, the doctor will gradually reduce the dose. This will reduce the risk of worsening symptoms. Do not abruptly stop treatment with Pronoran. Sudden discontinuation of this medicine may lead to a condition called neuroleptic malignant syndrome, which may be a serious health risk. Symptoms of this syndrome include:

• akinesia - lack of movement (absence of muscle movements);
• muscle rigidity;
• fever;
• unstable arterial blood pressure;
• tachycardia (rapid heartbeat);
• disorientation;
• disturbances of consciousness (e.g. coma).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been observed:

• Common: mild gastrointestinal disturbances (nausea, vomiting, bloating), which may resolve after individual dose adjustment.
• Somnolence has been observed during treatment with piribedil; very rarely, excessive daytime sleepiness and sudden sleep attacks have been reported.
• Common: psychiatric disturbances such as disorientation, hallucinations, agitation, or dizziness, which resolve after discontinuation of treatment.
• Uncommon: hypotension, orthostatic hypotension (a drop in blood pressure related to a change in body position from lying or sitting to standing, or blood pressure fluctuations) with fainting or malaise, or unstable blood pressure.
• Due to the presence of the colouring agent - carmine red - there is a risk of allergic reactions.

The following adverse effects may also occur:

• Inability to resist an impulse, urge, or compulsion to perform actions that may be harmful to the patient or others; this includes:
• A strong impulse to engage in uncontrollable gambling, despite serious personal or family consequences;
• Altered or increased sexual interests and behaviours of significance to the patient or others, e.g. activities related to heightened sexual drive;
• Compulsive, uncontrolled spending or shopping;
• Binge eating (consuming large amounts of food in a short time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger);
• Aggression;
• Psychiatric disturbances (delusions, confusion, hallucinations - visual, auditory, mixed);
• Swelling of the legs, feet, or fingers;
• Dyskinesias (involuntary movements of limbs or body caused by abnormal muscle contractions).

You should inform the doctor if the patient exhibits any of these behaviours, so that ways of managing or reducing these symptoms can be discussed.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in the leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to collect more information on the safety of using the medicine.

5. How to store the medicine Pronoran

Keep the medicine out of sight and reach of children.
Store at a temperature below 25°C.
Do not use Pronoran after the expiry date stated on the cardboard box and blister pack following the abbreviation "EXP" (the abbreviation used to indicate the expiry date). The expiry date refers to the last day of the stated month. The abbreviation "Lot" printed on the cardboard box and blister pack is used to indicate the batch number. The entry following it represents the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This practice helps protect the environment.

6. Contents of the packaging and other information

What Pronoran contains

• The active substance is piribedil. Each prolonged-release coated tablet contains 50 mg of piribedil.
• Other components of the medicine are: magnesium stearate, povidone, talc. Coating ingredients: sodium carboxymethylcellulose, polysorbate 80, cochineal red (E124), povidone, colloidal anhydrous silica, 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France
Manufacturer
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
Annopol 6 B Street
03-236 Warsaw
For further information, please contact the representative of the Marketing Authorisation Holder:
Servier Polska Sp. z o.o.
Telephone number: (22) 594-90-00