Polpix Sr

Leaflet attached to the packaging: patient information

Polpix SR, 2 mg, prolonged-release tablets

Polpix SR, 4 mg, prolonged-release tablets

Polpix SR, 8 mg, prolonged-release tablets

Ropinirole

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept to be re-read if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Polpix SR and what is it used for

The active substance of Polpix SR is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists work in the brain similarly to a naturally occurring substance called dopamine.

Polpix SR is used to treat Parkinson's disease.

In patients with Parkinson's disease, there is a low concentration of dopamine in some parts of the brain. Ropinirole works similarly to natural dopamine and helps alleviate the symptoms of Parkinson's disease.

2. Important information before taking Polpix SR

When not to take Polpix SR:

• if the patient is allergicto ropinirole or any of the other ingredients of this medicine (listed in section 6)
• if the patient has severe kidney disease
• if the patient has liver disease.

The doctor or nurse should be informedin case of these circumstances.

Warnings and precautions

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

• if the patient is pregnantor thinks they may be pregnant
• if the patient is breast-feeding
• if the patient is under 18 years old
• if the patient has severe heart disease
• if the patient has severe mental disorders
• if the patient has particular tendencies and (or) behaviors(see section 4)
• if the patient has intolerance to some sugars(such as lactose).

The doctor should be informed if the patient experiences symptoms such as depression, apathy, anxiety, lack of energy, sweating, or painafter stopping or reducing the dose of ropinirole (called dopamine agonist withdrawal syndrome, DAWS). If the symptoms persist for more than a few weeks, the doctor may decide to adjust the treatment. The doctor should be informed if the patient or their relatives notice unusual behaviors resulting from an irresistible impulse, compulsion, or urge to perform certain actions, which may be harmful to the patient or others. Such behaviors are called impulse control disorders and may include gambling, overeating, or excessive spending. The doctor may decide to adjust the treatment or stop the medicine. The doctor should be informed if the patient or their family or caregiver notices episodes of excessive restlessness, excitement, or irritability. These may occur with or without symptoms of impulse control disorders (see above). The doctor may decide to adjust the dose or stop the medicine. The doctor or nurse should be informedin case of these circumstances. The doctor or nurse may decide that Polpix SR is not a suitable medicine for the patient or may recommend additional monitoring during treatment.

During treatment with Polpix SR

The patient should contact their doctor if they or a family member notice the patient experiencing any particular behaviorswhile taking Polpix SR (such as uncontrollable urge to gamble or increased libidoand (or) excessive sexual activity). The doctor may recommend adjusting the dose or stopping the medicine.

Smoking and taking Polpix SR

The patient should inform their doctor or nurse if they start or stop smoking while taking Polpix SR. The doctor may decide to adjust the dose.

Polpix SR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. The patient should remember to inform their doctor or pharmacist if they start taking any other medicine while taking Polpix SR. Some medicines may affect the action of Polpix SR or increase the risk of side effects. Polpix SR may also affect the action of other medicines. These medicines include:

• the antidepressant fluvoxamine
• medicines used in other mental disorders, such as sulpiride
• HRT (hormone replacement therapy)
• metoclopramide, which is used to treat nausea and heartburn
• antibiotics ciprofloxacin and enoxacin
• any other medicines used to treat Parkinson's disease.

The doctor or nurse should be informedif the patient is taking or has recently taken any of these medicines. Additional blood tests should be performedif the patient is taking any of the following medicines with Polpix SR:

• medicines that belong to the group of vitamin K antagonists (used to reduce blood clotting), such as warfarin (Coumadin).

Polpix SR with food and drink

Polpix SR can be taken with or without food, as preferred by the patient.

Pregnancy and breast-feeding

Polpix SR is not recommended during pregnancy, unless the doctor decides that the benefits of the medicine outweigh the risks to the unborn child. Polpix SR is not recommended during breast-feeding, as it may affect milk production. The doctor should be informed immediatelyif the patient is pregnant, thinks they may be pregnant, or plans to become pregnant. The doctor will also advise if the patient is breast-feeding or plans to breast-feed. The doctor may recommend stopping Polpix SR.

Driving and using machines

Polpix SR may cause drowsiness. Ropinirole may cause hallucinations (seeing, hearing, or feeling things that are not there). If the patient experiences hallucinations, they should not drive or operate machinery. Sudden onset of sleepinessmay occur, as well as sudden and unanticipated episodes of sleepwithout prior warning of sleepiness. During treatment with ropinirole, hallucinations (seeing, hearing, or feeling things that are not there) may occur. If the patient experiences hallucinations, they should not drive or operate machinery. The doctor or nurse should be consultedif the patient experiences such symptoms. The doctor or nurse may decide that Polpix SR is not a suitable medicine for the patient or may recommend additional monitoring during treatment.

Polpix SR 2 mg contains lactose

Polpix SR 2 mg contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Polpix SR 4 mg contains orange yellow S (E110)

Polpix SR 4 mg contains a coloring agent called orange yellow S (E110), which may cause allergic reactions.

Polpix SR contains sodium

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

3. How to take Polpix SR

This medicine should always be taken exactly as prescribed by the doctor or pharmacist.In case of doubts, the doctor or pharmacist should be consulted. Polpix SR can be used to treat the symptoms of Parkinson's disease as a single medicine or in combination with another medicine called L-dopa (also known as levodopa). If the patient is taking L-dopa, they may experience involuntary movements (dyskinesias) when starting to take Polpix SR. If such symptoms occur, the patient should inform their doctor, who may adjust the doses of the medicines taken by the patient.

In case of switching treatment from ropinirole immediate-release tablets

The doctor or nurse will determine the dose of Polpix SR prolonged-release tablets based on the previously taken dose of ropinirole immediate-release tablets. The patient should take the previously taken dose of ropinirole immediate-release tablets on the day before switching treatment. The next morning, the patient should take Polpix SR prolonged-release tablets and not take any more ropinirole immediate-release tablets.

What doses of Polpix SR should be taken

It may take some time to determine the suitable dose of Polpix SR for the patient. The recommended initial doseis 2 mg once daily for the first week. The doctor may increase the dose to 4 mg of Polpix SR from the second week of treatment. If the patient is elderly, the doctor may increase the dose more slowly. The doctor may then adjust the dose until the optimal dose for the patient is reached. Some patients take up to 24 mg of Polpix SR per day. If the patient experiences intolerable side effects at the beginning of treatment, they should inform their doctor. The doctor may recommend changing the treatment to a lower dose of ropinirole immediate-release tablets, which the patient will take three times a day.

The patient should not take more than the recommended dose of Polpix SR.

It may take several weeks for the beneficial effect of the medicine to occur.

Taking the dose of Polpix SR

Polpix SR should be taken once daily, at the same time every day.

The prolonged-release tablet(s) of Polpix SR should be swallowed whole, with a glass of water.

The tablet(s) should not be broken, chewed, or crushed -

if this happens, there is a risk of overdose due to the rapid release of the medicine in the body. The Polpix SR tablet is designed to release the medicine over 24 hours. If the patient experiences a condition where the medicine passes through the body too quickly, such as diarrhea, the tablet may not dissolve completely and may not work properly. In such a case, the tablet may be visible in the stool. If the patient experiences such a condition, they should inform their doctor as soon as possible.

Use in children and adolescents

Polpix SR should not be used in children.Polpix SR is not intended for use in patients under 18 years old.

Taking a higher dose of Polpix SR than recommended

The doctor, pharmacist, or nurse should be contacted immediately.If possible, the patient should show them the packaging of Polpix SR. If a person takes a higher dose of Polpix SR than recommended, they may experience: nausea, vomiting, dizziness (feeling of spinning), drowsiness, mental or physical fatigue, fainting, or hallucinations.

Missing a dose of Polpix SR

The patient should not take more tablets or a double dose to make up for a missed dose. If the patient misses a dose of Polpix SR for a day or longer,they should consult their doctor or nurse for advice on restarting treatment.

Stopping treatment with Polpix SR

The patient should not stop taking Polpix SR without consulting their doctor.

Polpix SR should be taken for as long as the doctor or nurse recommends.The patient should not stop taking the medicine unless their doctor or nurse advises them to do so. If the patient suddenly stops taking Polpix SR, their Parkinson's disease symptoms may worsen rapidly. Suddenly stopping the medicine may cause a condition called neuroleptic malignant syndrome, which can be life-threatening. Symptoms include: akinesia (loss of muscle movement), muscle stiffness, fever, unstable blood pressure, tachycardia (rapid heart rate), confusion, and impaired consciousness (e.g., coma). If the doctor needs to stop the treatment with Polpix SR, they will gradually reduce the dose. If the patient has any further doubts about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Polpix SR can cause side effects, although not everybody gets them. The side effects of Polpix SR may occur most frequently at the beginning of the first treatment or shortly after increasing the dose. Side effects are usually mild and become less troublesome after a short time of taking the medicine. If the patient is concerned about side effects, they should consult their doctor or nurse. Very common(may affect more than 1 in 10 patients) :

• fainting
• feeling of drowsiness
• nausea.

Common(may affect up to 1 in 10 patients) :

• sudden onset of sleep without prior warning of sleepiness (sudden sleep attacks)
• hallucinations (seeing things that are not there)
• vomiting
• dizziness (feeling of spinning)
• heartburn
• abdominal pain
• constipation
• swelling of the legs, feet, or hands.

Uncommon(may affect up to 1 in 100 patients) :

• dizziness or fainting, especially when standing up quickly (related to low blood pressure)
• extreme drowsiness during the day (excessive daytime sleepiness)
• low blood pressure (hypotension)
• mental disorders such as confusion (severe confusion), delusions (unreasonable thoughts), or paranoia (unreasonable suspicion)
• hiccups.

Some patients may experience the following side effects

Frequency not known (cannot be estimated from the available data):

• allergic reactions such as red, itchy swellingof the skin (hives), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing, rash, or intense itching (see section 2)
• changes in liver function, which have been detected in blood tests
• aggressive behavior
• excessive use of Polpix SR (uncontrollable desire to take higher doses of dopaminergic medicines than necessary to control motor symptoms, called dopamine dysregulation syndrome)
• inability to resist an impulse, drive, or temptation to perform actions that may harm the patient or others. Symptoms may include: o uncontrollable urge to gamble, despite significant consequences for the patient or their family o change or increase in sexual interest and behaviors that are particularly disturbing to the patient or others, such as increased libido o uncontrollable, excessive shopping or spending o binge eating (consuming large amounts of food in a short time), compulsive eating (consuming more food than needed to satisfy hunger)
• episodes of excessive restlessness, excitement, and irritability
• spontaneous erections
• after stopping or reducing the dose of Polpix SR, the following may occur: depression, apathy, anxiety, lack of energy, sweating, or pain (called dopamine agonist withdrawal syndrome or DAWS).

The doctor should be informed if the patient experiences any of these behaviors to discuss ways to control or limit these symptoms.

Taking Polpix SR with L-dopa

In patients taking Polpix SR with L-dopa, other side effects may occur:

• involuntary movements (dyskinesias) are a very common side effect. If the patient is taking L-dopa, they may experience involuntary movements (dyskinesias) when starting to take Polpix SR. If such symptoms occur, the patient should inform their doctor, who may adjust the doses of the medicines taken by the patient.
• feeling of disorientation is a common side effect.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Polpix SR

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number. The medicine should not be stored above 25°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Polpix SR contains

• The active substance of Polpix SR is ropinirole. Each prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirole (as hydrochloride).
• The other ingredients are: Tablet core:ammonio methacrylate copolymer (type B), hypromellose, sodium lauryl sulfate, copovidone, magnesium stearate.

Tablet coating:

What Polpix SR looks like and contents of the pack

Polpix SR, 2 mg, prolonged-release tablets: pink, round, biconvex tablets with a diameter of 6.8 ± 0.1 mm and a thickness of 5.5 ± 0.2 mm. Polpix SR, 4 mg, prolonged-release tablets: light brown, oval, biconvex tablets with a diameter of 12.6 x 6.6 ± 0.1 mm and a thickness of 5.3 ± 0.2 mm. Polpix SR, 8 mg, prolonged-release tablets: red, oval, biconvex tablets with a diameter of 19.2 x 10.2 ± 0.2 mm and a thickness of 5.2 ± 0.2 mm. All strengths:Polpix SR is packaged in PVC/PCTFE/Aluminum blisters.

Available packs:

Polpix SR, 2 mg: 21 and 28 tablets Polpix SR, 4 mg and 8 mg: 28 tablets Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01, Poland

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Poland Pharmathen International S.A, Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece Pharmathen S.A, 6 Dervenakion str., 153 51, Pallini, Attiki, Greece Date of last revision of the leaflet:June 2023