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
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, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on 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, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Polpix SR is and what it is used for
2. What you need to know 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 Polpix SR is and what it is used for

The active substance in Polpix SR is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists act in the brain similarly to a naturally occurring substance called dopamine.
Polpix SR is used in the treatment of Parkinson's disease.
In patients with Parkinson's disease, certain parts of the brain have low levels of dopamine. Ropinirole works similarly to naturally occurring dopamine and thus helps to relieve the symptoms of Parkinson's disease.

2. Important information before using Polpix SR

When not to use Polpix SR:

• if the patient is allergic to 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.

Please inform your doctor or nurse if any of these circumstances apply.
Warnings and precautions
Before starting treatment with Polpix SR, discuss this with your doctor or pharmacist:

• if the patient is pregnant or suspects she may be pregnant
• if the patient is breastfeeding
• if the patient is under 18 years of age
• if the patient has severe heart disease
• if the patient has severe mental health disorders
• if the patient has specific urges and (or) behaviours (see section 4)
• if the patient has intolerance to certain sugars (such as lactose).

Tell your doctor if symptoms such as depression, apathy, anxiety, lack of energy, sweating, or pain (known as dopamine agonist withdrawal syndrome (DAWS)) occur after stopping or reducing the dose of ropinirole. If symptoms persist for longer than a few weeks, your doctor may decide to adjust the treatment.

Inform your doctor if the patient or their family members notice unusual behaviours caused by irresistible impulses, compulsions, or obsessive performance of certain activities, which may be harmful to the patient or others. These behaviours are known as impulse control disorders and may include gambling addiction, binge eating, excessive spending, increased sexual drive, or intense sexual thoughts and feelings. Your doctor may decide to adjust the treatment or discontinue the medicine.

Tell your doctor if the patient or their family or caregiver notice episodes of excessive physical activity, excitement, or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorders (see above). Your doctor may decide to adjust the dose or discontinue the medicine.

Please inform your doctor or nurse if any of these circumstances apply.
Your doctor or nurse may decide that Polpix SR is not suitable for the patient or may recommend additional monitoring tests during treatment.

While taking Polpix SR
Contact your doctor if the patient or a family member observes any unusual behaviours during treatment with Polpix SR (such as uncontrollable urge to gamble or increased sexual drive and/or excessive sexual activity). Your doctor may recommend adjusting the dose or discontinuing the medicine.

Smoking and Polpix SR
Inform 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Remember to inform your doctor or pharmacist if starting 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 include:

• the antidepressant fluvoxamine
• medicines used for other mental health disorders, such as sulpiride
• HRT (hormone replacement therapy)
• metoclopramide, a medicine used to treat nausea and heartburn
• the antibiotics ciprofloxacin and enoxacin
• any other medicines used in Parkinson’s disease

Please inform your doctor or nurse if the patient is taking or has recently taken any of these medicines.

Additional blood tests should be performed if the patient is taking the following medicines together with Polpix SR:

• vitamin K antagonists (used to reduce blood clotting), such as warfarin (Coumadin).

Polpix SR with food and drink
Polpix SR may be taken with or without food, according to the patient’s preference.

Pregnancy and breastfeeding
Polpix SR is not recommended during pregnancy, unless the doctor decides that the benefit to the patient outweighs the risk to the unborn child.

Polpix SR is not recommended during breastfeeding, as it may affect milk production.

Contact your doctor immediately if the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant.

Your doctor will also advise if the patient is breastfeeding or planning to breastfeed. The doctor may recommend discontinuing Polpix SR.

Driving and operating machinery
Polpix SR may cause drowsiness. Ropinirole may cause hallucinations (seeing, hearing, or feeling things that are not actually present). If the patient experiences hallucinations, they should not drive or operate machinery.

Sudden and overwhelming drowsiness may occur, and sometimes sudden, unexpected sleep attacks without prior warning of drowsiness.

Hallucinations (seeing, hearing, or feeling things that are not actually present) may occur during treatment with ropinirole. If the patient experiences hallucinations, they should not drive or operate machinery.

If there is suspicion that such symptoms may occur: do not drive, operate machinery, or perform any activity in which drowsiness or falling asleep could put the patient (or others) at risk of serious injury or death.

Do not perform such activities until it is certain that these symptoms do not occur.

Talk to your doctor or nurse if this applies to the patient.

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

Polpix SR 4 mg contains sunset yellow (E110)
Polpix SR 4 mg contains a colouring agent called sunset yellow (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, meaning the medicine is considered "sodium-free".

3. How to use Polpix SR

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Polpix SR may be used in the treatment of symptoms of Parkinson's disease either as monotherapy or
in combination with another medicine called L-dopa ( also known as levodopa ) .
If the patient is taking L-dopa, involuntary movements (dyskinesias) may occur when starting Polpix SR
treatment. If such symptoms occur, inform your doctor, who may adjust the doses of medicines the
patient is taking.
Switching treatment in patients previously taking ropinirole tablets (immediate-release)
Your doctor or nurse will determine the dose of Polpix SR extended-release tablets based on the
previously used dose of ropinirole immediate-release tablets.
Take your usual dose of ropinirole immediate-release tablets on the day before switching treatment.
The next morning, start taking Polpix SR extended-release tablets and do not take any further doses of
ropinirole immediate-release tablets.
What dose of Polpix SR should be used
Finding the right dose of Polpix SR for the patient may take some time.
The recommended starting dose is 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 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 may take up to 24 mg of Polpix SR per day.
If intolerable side effects occur at the beginning of treatment, inform your doctor. The doctor may
recommend switching therapy to a lower dose of ropinirole immediate-release tablets, to be taken
three times daily.
Do not take a higher dose of Polpix SR than that prescribed by your doctor or nurse.
It may take several weeks before the beneficial effect of the medicine becomes apparent.
How to take Polpix SR
Polpix SR should be taken once daily, at the same time each day.
The extended-release tablet(s) of Polpix SR should be swallowed whole with a glass of water.
Do not break, chew or crush the extended-release tablet(s) – doing so may lead to overdose due
to rapid release of the active substance in the body.
The Polpix SR tablet is designed to release the medicine over 24 hours. If the patient experiences a
condition causing rapid transit through the body (e.g. diarrhoea), the tablet may not dissolve completely
and may not work properly. In such cases, the tablet may be visible in the stool. If this occurs, inform
your doctor as soon as possible.
Use in children and adolescents
Polpix SR must not be used in children. Polpix SR is not intended for use in patients under 18 years
of age.
Taking more Polpix SR than recommended
Contact your doctor, pharmacist or nurse immediately. If possible, show the Polpix SR packaging.
In a person who has taken more than the recommended dose of Polpix SR, the following may occur:
nausea, vomiting, dizziness (spinning sensation), drowsiness, mental or physical fatigue, fainting,
hallucinations.
If a dose of Polpix SR is missed
Do not take a double dose or extra tablets to make up for a missed dose.
If Polpix SR has not been taken for one day or longer, consult your doctor or nurse before
resuming treatment.
Stopping Polpix SR treatment
Do not stop taking Polpix SR without consulting your doctor.
Polpix SR should be taken for as long as your doctor or nurse recommends. Do not stop unless
instructed by your doctor or nurse.
If Polpix SR is stopped abruptly, Parkinson's disease symptoms may worsen rapidly. Sudden
discontinuation of this medicine may lead to a serious condition called neuroleptic malignant
syndrome, which may be life-threatening. Symptoms include: akinesia (loss of muscle movement),
muscle rigidity, fever, unstable blood pressure, tachycardia (rapid heartbeat), confusion, and
altered consciousness (e.g. coma).
If Polpix SR treatment needs to be discontinued, your doctor or nurse will gradually reduce the dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects of Polpix SR may most commonly occur at the beginning of initial treatment or
shortly after increasing the dose. Adverse effects are usually mild and tend to become less bothersome
after a short period of taking the medicine. If you have any concerns about adverse effects,
you should consult your doctor or nurse.

Very common (may occur in more than 1 in 10 patients):

• fainting
• feeling sleepy
• nausea.

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

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

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

• dizziness or fainting, particularly when changing position suddenly to standing (related to low blood pressure)
• excessive daytime sleepiness (severe drowsiness)
• low blood pressure (hypotension)
• psychiatric disorders such as delirium (severe confusion), delusions (irrational thoughts) or paranoia (unfounded suspicion)
• hiccups.

In some patients, the following adverse effects may occur
Frequency not known (cannot be estimated from available data):

• allergic reactions such as red, itchy swellings on 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)
• liver function abnormalities detected in blood tests
• aggressive behaviour
• compulsive use of Polpix SR (irresistible urge to take large doses of dopaminergic medicines, higher than necessary to control motor symptoms, known as dopamine dysregulation syndrome)
• inability to resist an impulse, drive or temptation to perform actions that may harm the patient or others. Symptoms may include:
  - uncontrollable urge to gamble, despite significant consequences for the patient or their family
  - change or increase in sexual interest and behaviour, particularly disturbing to the patient or others, such as increased libido
  - uncontrolled, excessive shopping or spending
  - binge eating (consuming large amounts of food in a short time), compulsive eating (eating more food than needed to satisfy hunger)
• episodes of excessive motor activity, excitement and irritability
• spontaneous erection
• after stopping treatment with Polpix SR or reducing the dose, symptoms such as depression, apathy, anxiety, lack of energy, sweating or pain (referred to as dopamine agonist withdrawal syndrome or DAWS) may occur.

You should inform your doctor if the patient experiences any of these behaviours, so that ways to manage or reduce these symptoms can be discussed.

Taking Polpix SR in combination with L-dopa
In patients taking Polpix SR with L-dopa, other adverse effects may occur:

• involuntary movements (dyskinesias) are a very common adverse effect. In patients taking L-dopa, involuntary movements (dyskinesias) may occur when starting treatment with Polpix SR. If these symptoms occur, inform your doctor, who may adjust the doses of medicines the patient is taking.
• feeling disoriented is a common adverse effect.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 marketing authorisation holder.
Reporting adverse effects helps 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 stated month.
The marking on the packaging following EXP indicates the expiry date, and that following Lot/LOT indicates the batch number.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging 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: ammonium 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 thickness of 5.5 ± 0.2 mm.
Polpix SR, 4 mg, prolonged-release tablets: light brown, oval, biconvex tablets with dimensions of 12.6 x 6.6 ± 0.1 mm and thickness of 5.3 ± 0.2 mm.
Polpix SR, 8 mg, prolonged-release tablets: red, oval, biconvex tablets with dimensions of 19.2 x 10.2 ± 0.2 mm and thickness of 5.2 ± 0.2 mm.
All strengths: Polpix SR is packed in PVC/PCTFE/Aluminium blisters.
Available 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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