Polpix Sr
How to use 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 package leaflet, they should tell 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 package 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, there is a low level of dopamine in some parts of the brain. 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:
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:
Tell your doctor if you experience any of the following symptoms after stopping or reducing the dose of ropinirole: depression, apathy, anxiety, lack of energy, sweating, or pain(known as dopamine agonist withdrawal syndrome, or DAWS). If the symptoms persist for more than a few weeks, your doctor may decide to adjust your treatment. Tell your doctor if you or your family notice any unusual behaviors, such as irresistible impulses, compulsions, or excessive behaviors that may be harmful to you or others. These behaviors are known as impulse control disorders and may include gambling, eating, or excessive shoppingor increased sex drive. Your doctor may decide to adjust your treatment or stop the medicine. Tell your doctor if you or your family notice episodes of excessive restlessness, excitement, or irritability. These may occur with or without impulse control disorders (see above). Your doctor may decide to adjust the dose or stop the medicine. Tell your doctor or nurseif any of these conditions apply. Your doctor or nurse may decide that Polpix SR is not a suitable medicine for you or may recommend additional monitoring during treatment.
During treatment with Polpix SR
Contact your doctor if you or a family member notice any unusual behaviors in you while taking Polpix SR, such as uncontrollable gambling or increased sex drive. Your doctor may recommend adjusting the dose or stopping the medicine.
Smoking and taking Polpix SR
Tell your doctor or nurse if you start or stop smoking while taking Polpix SR. Your doctor may need to adjust the dose.
Polpix SR and other medicines
Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. Remember to tell your doctor or pharmacist if you start taking any other medicine while taking Polpix SR. Some medicines may affect the way Polpix SR works, or may increase the risk of side effects. Polpix SR may also affect the way other medicines work. These medicines include:
- fluvoxamine, an antidepressant
- medicines used to treat other mental health problems, such as sulpiride
- HRT (hormone replacement therapy)
- metoclopramide, used to treat nausea and vomiting
- antibiotics such as ciprofloxacin and enoxacin
- any other medicines used to treat Parkinson's disease
Tell your doctor or nurseif you are taking, or have recently taken, any of these medicines. Additional blood tests may be neededif you are taking any of the following medicines with Polpix SR:
- medicines that prevent blood clotting, such as warfarin (Coumadin)
Polpix SR with food and drink
Polpix SR can be taken with or without food, as you prefer.
Pregnancy and breast-feeding
Polpix SR is not recommended during pregnancy, unless your doctor considers that the benefits to you outweigh the risks to your unborn baby. Polpix SR is not recommended during breast-feeding, as it may affect milk production. Tell your doctor immediatelyif you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will also advise you if you are breast-feeding or plan 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 you experience hallucinations, do not drive or operate machinery. Excessive drowsiness may occur, and sometimes sudden and unexplained episodes of sleepwithout feeling drowsy beforehand. During treatment with ropinirole, hallucinations may occur (seeing, hearing, or feeling things that are not there). If you experience hallucinations, do not drive or operate machinery. If you think you may experience these symptoms, do not drive, operate machinery, or perform taskswhere drowsiness or sleep may put you or others at risk of serious injury or death. Do not perform these tasks until you are sure that these symptoms do not occur. Talk to your doctor or nurseif this applies to you.
Polpix SR 2 mg contains lactose
Polpix SR 2 mg contains a sugar called lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this 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 essentially '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 taken alone or with another medicine called L-dopa (also known as levodopa) to treat the symptoms of Parkinson's disease. If you are taking L-dopa, you may experience involuntary movements (dyskinesias) when you start taking Polpix SR. If you experience these symptoms, tell your doctor, who may adjust the doses of your medicines.
Switching from ropinirole immediate-release tablets to Polpix SR prolonged-release tablets
Your doctor or nurse will determine the dose of Polpix SR based on the dose of ropinirole immediate-release tablets you were taking. Take your usual dose of ropinirole immediate-release tablets on the day before you switch to Polpix SR. The next morning, take Polpix SR and do not take any more ropinirole immediate-release tablets.
What dose of Polpix SR to take
It may take some time to find the right dose of Polpix SR for you. The recommended starting doseis 2 mg once daily for the first week. Your doctor may increase the dose to 4 mg of Polpix SR from the second week of treatment. If you are elderly, your doctor may increase the dose more slowly. Your doctor will then adjust the dose until you reach the dose that is right for you. Some patients take up to 24 mg of Polpix SR per day. If you experience side effects that are difficult to tolerate at the start of treatment, tell your doctor. Your doctor may recommend changing your treatment to a lower dose of ropinirole immediate-release tablets, which you would take three times a day.
Do not take more Polpix SR than your doctor or nurse has recommended.
It may take several weeks for the full effect of the medicine to develop.
Taking your 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) -
Using Polpix SR 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 more Polpix SR than recommended
Contact your doctor, pharmacist, or nurse immediately. If possible, show them the Polpix SR packaging. If you take more Polpix SR than recommended, you may experience: nausea, vomiting, dizziness (feeling like the room is spinning), drowsiness, mental fatigue or physical fatigue, fainting, or hallucinations.
Missing a dose of Polpix SR
Do not take more tablets or a double dose to make up for a missed dose. If you miss a dose of Polpix SR for a day or longer, consult your doctor or nurse for advice on restarting treatment.
Stopping treatment with Polpix SR
Do not stop taking Polpix SR without consulting your doctor.
Take Polpix SR for as long as your doctor or nurse tells you. Do not stop taking it unless your doctor or nurse tells you to. If you suddenly stop taking Polpix SR, your Parkinson's disease symptoms may quickly get much worse. Stopping the medicine suddenly 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, rapid heartbeat, confusion, and changes in mental state (such as coma). If your doctor needs to stop your treatment with Polpix SR, they will reduce your dose gradually. If you have any further questions about your treatment, ask your 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 are usually mild and may become less troublesome after a few days of treatment. If you are concerned about side effects, talk to your doctor or nurse. Very common(may affect more than 1 in 10 people):
- fainting
- feeling drowsy
- nausea
Common(may affect up to 1 in 10 people):
- sudden onset of sleep without feeling drowsy beforehand (sudden sleep attacks)
- hallucinations (seeing things that are not there)
- vomiting
- dizziness (feeling like the room is spinning)
- heartburn
- stomach 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)
- excessive drowsiness during the day (extreme drowsiness)
- low blood pressure (hypotension)
- mental health problems, 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, shown by blood tests
- aggressive behavior
- excessive use of Polpix SR (uncontrollable desire to take more of the medicine than is needed to control symptoms, known as dopamine dysregulation syndrome)
- inability to resist an impulse, drive, or temptation to perform an action that could harm you or others. Symptoms may include: uncontrollable gambling, despite significant consequences for you or your family, increased interest in sex, and behaviors that are particularly worrying for you or others, such as increased sex drive, uncontrolled eating(eating large amounts of food in a short time), or compulsive eating(eating more than you need to satisfy your hunger)
- episodes of excessive restlessness, excitement, or 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(known as 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
Patients taking Polpix SR with L-dopa may experience other side effects:
- involuntary movements (dyskinesias) are a very common side effect. If you are taking L-dopa, you may experience involuntary movements when you start taking Polpix SR. If you experience these symptoms, tell your doctor, who may adjust the doses of your medicines.
- feeling disoriented is a common side effect.
Reporting side effects
If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, 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. You can also report side effects 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 Polpix SR
Keep the medicine out of the 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 the month. The packaging is marked with the expiry date and batch number. 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. These measures will help protect the environment.
6. Contents of the package 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:
| 2 mg prolonged-release tablets | lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide red (E172) |
| 4 mg prolonged-release tablets | titanium dioxide (E171), hypromellose, macrogol 400, indigo carmine (E132), orange yellow S (E110) |
| 8 mg prolonged-release tablets | titanium dioxide (E171), hypromellose, macrogol 400, iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172) |
What Polpix SR looks like and contents of the pack
Polpix SR, 2 mg, prolonged-release tablets: pink, round, biconvex tablets, 6.8 ± 0.1 mm in diameter and 5.5 ± 0.2 mm in thickness. Polpix SR, 4 mg, prolonged-release tablets: light brown, oval, biconvex tablets, 12.6 x 6.6 ± 0.1 mm in diameter and 5.3 ± 0.2 mm in thickness. Polpix SR, 8 mg, prolonged-release tablets: red, oval, biconvex tablets, 19.2 x 10.2 ± 0.2 mm in diameter and 5.2 ± 0.2 mm in thickness. All strengths:Polpix SR is packaged in PVC/PCTFE/Aluminum blisters.
Pack sizes:
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 package leaflet:June 2023
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterPharmathen International S.A. Pharmathen S.A. Zakłady Farmaceutyczne POLPHARMA S.A.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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