Polpix Sr

Package Leaflet: Information for the Patient

Polpix SR, 2 mg, prolonged-release tablets

Polpix SR, 4 mg, prolonged-release tablets

Polpix SR, 8 mg, prolonged-release tablets

Ropinirole

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

• Keep this package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• 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 as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 pack 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 in a similar way to a naturally occurring substance called dopamine.

Polpix SR is used to treat Parkinson's disease.

In patients with Parkinson's disease, some parts of the brain have a low concentration of dopamine. Ropinirole works in a similar way to natural dopamine and helps to 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

Tell your doctor or nurseif any of these conditions apply.

Warnings and precautions

Before starting to take Polpix SR, discuss the following with your 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 health problems
• if the patient has particular tendencies or behaviors(see section 4)
• if the patient has intolerance to some sugars(such as lactose)

Tell your doctor if the patient has experienced symptoms such as depression, apathy, anxiety, lack of energy, sweating, or painafter stopping or reducing the dose of ropinirole (called dopamine agonist withdrawal syndrome, or DAWS). If the symptoms persist for more than a few weeks, the doctor may decide to adjust the treatment.

During treatment with Polpix SR

If the patient or their family members notice any particular behaviorswhile taking Polpix SR (such as uncontrollable urge to gamble or increased libido), the doctor should be informed. The doctor may adjust the dose or stop the treatment.

Smoking and taking Polpix SR

Tell your doctor or nurse if you start or stop smoking while taking Polpix SR. The doctor may need to adjust the dose.

Polpix SR and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. 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.

• the antidepressant fluvoxamine
• medicines used for other mental health problems, 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

Tell your doctor or nurseif the patient is taking or has recently taken any of these medicines.

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 considers that the benefits of the treatment outweigh the risks to the unborn child.

Polpix SR is not recommended during breast-feeding, as it may affect milk production. Tell your doctor 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.

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.

Polpix SR 2 mg contains lactose

Polpix SR 2 mg contains a sugar called lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult 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 is considered to be sodium-free.

3. How to take Polpix SR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Polpix SR can be used to treat the symptoms of Parkinson's disease, either alone or in combination with another medicine called L-dopa (also known as levodopa).

If switching from ropinirole immediate-release tablets

The doctor or nurse will determine the dose of Polpix SR based on the dose of ropinirole immediate-release tablets previously taken.

What dose of Polpix SR to take

It may take some time to find the right dose of Polpix SR for the patient.

The recommended starting 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.

Do not take more than the recommended dose of Polpix SR

It may take several weeks for the full effect of the medicine to develop.

How to take the dose of Polpix SR

Take Polpix SR once daily, at the same time each day.

Swallow the prolonged-release tablet(s) whole, with a glass of water.

Do not break, chew, or crush the prolonged-release tablet(s) -

this could lead to overdose, as the medicine would be released too quickly into the body.

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.

What to do if you take more Polpix SR than you should

Seek medical advice immediately. If possible, show the package leaflet to your doctor, pharmacist, or nurse.

What to do if you forget to take Polpix SR

Do not take a double dose to make up for a forgotten dose.

What to do if you stop taking Polpix SR

Do not stop taking Polpix SR without consulting your doctor.

Take Polpix SR for as long as your doctor or nurse recommends. Do not stop taking the medicine unless your doctor or nurse tells you to.

4. Possible side effects

Like all medicines, Polpix SR can cause side effects, although not everybody gets them.

Very common(may affect more than 1 in 10 people):

• orthostatic hypotension
• drowsiness
• nausea

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

• sudden onset of sleep without warning (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 people):

• 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 health problems such as confusion (severe confusion), delusions (unrealistic thoughts), or paranoia (unfounded suspicion)
• hiccups

Other side effects

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

• allergic reactions such as red, itchy hiveson the skin (urticaria), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing, rash, or intense itching (see section 2)
• changes in liver function, which have been seen in blood tests
• aggressive behavior
• overuse of Polpix SR (uncontrollable urge to take higher doses of dopaminergic medicines than needed to control motor symptoms, called dopamine dysregulation syndrome)
• inability to resist an impulse, drive, or temptation to perform an action that could be harmful to the patient or others. Symptoms may include: uncontrollable urge to gamble, despite significant consequences for the patient or their family, increased interest in sex, and behavior that is disturbing to the patient or others, such as increased libido, uncontrollable and excessive shopping or spending, or binge eating(eating large amounts of food in a short time)
• episodes of excessive movement, 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)

Tell your doctor if you experience any of these behaviors, so you can discuss ways to control or limit these symptoms.

Taking Polpix SR with L-dopa

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

• involuntary movements (dyskinesia) are a very common side effect. When taking L-dopa, starting treatment with Polpix SR may cause dyskinesia. If these symptoms occur, tell your doctor, who may adjust the doses of the medicines you are taking.
• feeling disoriented is a common side effect

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your 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.

5. How to store Polpix SR

Keep the medicine out of the sight and reach of children.

Do not use the medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Polpix SR contains

• The active substance 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