Rolprina Sr

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Rolpryna SR (Ropinirole Krka 4 mg)

4 mg, prolonged-release tablets

Ropinirole
Rolpryna SR and Ropinirole Krka 4 mg are different trade names for the same medicine.

You should carefully read the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• 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 you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

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

The active substance of Rolpryna 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.

Rolpryna SR, prolonged-release tablets are 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 dopamine that occurs naturally in the brain and thus helps to alleviate the symptoms of Parkinson's disease.

2. Important information before taking Rolpryna SR

When not to take Rolpryna SR

• if you are allergicto ropinirole or any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney disease,
• if you have liver disease. You should inform your doctor if any of the above situations apply to you.

Warnings and precautions

Before starting to take Rolpryna SR, you should discuss it with your doctor or pharmacist:

• if you are pregnantor think you may be pregnant,
• if you are breast-feeding,
• if you are under 18 years old, Page 1 7
• if you have severe heart disease,
• if you have severe mental disorders,
• if you have particular tendencies and (or) behaviors(see section 4),
• if you have intolerance to sugars (such as lactose). You should inform your doctor if any of the above situations apply to you. Your doctor may decide that Rolpryna SR is not a suitable medicine for you or may recommend additional monitoring during treatment.

You should tell your doctor if you or your family/caregiver notice that you start to feel the urge or desire to behave abnormally and if you cannot resist the impulse, drive, or temptation to engage in activities that may harm you or others. These phenomena are called impulse control disorders and may manifest as behaviors such as compulsive gambling, excessive appetite, or a desire to spend money, excessive sexual drive, or an increase in the frequency and intensity of thoughts or feelings about sexual topics. Your doctor may consider it appropriate to change the dose or discontinue the medicine.
You should inform your doctor about the occurrence of symptoms such as depression, apathy, anxiety, fatigue, excessive sweating, or pain after stopping treatment or reducing the dose of ropinirole [called dopamine agonist withdrawal syndrome (DAWS)]. If these symptoms persist for more than a few weeks, your doctor may modify the treatment.
You should inform your doctor if you, a family member, or caregiver notice that you are developing episodes of overactivity, euphoria, or irritability (mania symptoms). They may occur with impulse control disorders or without (see above). Your doctor may consider it necessary to adjust the dose or discontinue the medicine.

During treatment with Rolpryna SR

You should contact your doctor if you or a family member observe any unusual behavior in you (such as an uncontrollable urge to gamble or increased sexual drive) during treatment with Rolpryna SR. Your doctor may recommend adjusting the dose or discontinuing the medicine.

Smoking and taking Rolpryna SR

You should tell your doctorif you start or stop smoking while taking Rolpryna SR. Your doctor may decide to adjust the dose.

Rolpryna SR and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, including herbal products and other medicines available without a prescription.
You should remember to tell your doctor or pharmacist if you start taking any other medicine while taking Rolpryna SR.
Some medicines may affect the action of Rolpryna SR or increase the risk of side effects. Rolpryna SR may also affect the action of other medicines.
These medicines include:

• fluvoxamine (an antidepressant),
• medicines used to treat other mental disorders, such as sulpiride,
• hormone replacement therapy (HRT),
• metoclopramide, which is used to treat nausea and heartburn,
• antibiotics: ciprofloxacin or enoxacin,
• any other medicine used to treat Parkinson's disease. You should inform your doctor if you are taking or have taken any of these medicines recently.

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Additional blood tests will be necessaryif you are taking Rolpryna SR at the same time as:

• vitamin K antagonists (used to thin the blood), such as warfarin.

Taking Rolpryna SR with food and drink

Rolpryna SR can be taken with or without food.

Pregnancy and breast-feeding

Rolpryna SR is not recommended during pregnancy unless your doctor considers that the benefit of taking Rolpryna SR for you outweighs the risk to the unborn baby. Rolpryna SR is not recommended during breast-feeding, as it may affect milk production.
You should inform your doctor immediately if 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. Your doctor may recommend discontinuing Rolpryna SR.

Driving and using machines

Rolpryna SR may cause drowsiness. Sudden drowsinessmay occur, as well as sudden and unexpected sleep attackswithout any clear warning.
Ropinirole may cause hallucinations (seeing, hearing, or feeling things that are not real). If you experience hallucinations, you should not drive or operate machinery.
If you suspect that these symptoms may occur: do not drive, operate machinery, or perform tasks where drowsiness or falling asleep may put you (or others) at risk of serious injury or death. Do not perform such tasks until the symptoms have resolved.
You should discuss this with your doctor if this situation is a problem for you.

Rolpryna SR contains lactose monohydrate

If you have intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Rolpryna SR

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
Rolpryna SR is available in doses of 2 mg, 4 mg, and 8 mg.

Use in children and adolescents

Rolpryna SR should not be used in children. Rolpryna SR is not usually prescribed for patients under 18 years old.
Rolpryna SR may 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 you are taking L-dopa, you may experience involuntary movements (dyskinesia) when you start taking Rolpryna SR. You should inform your doctor if this happens, as they may need to adjust the dose of your medicines.
Rolpryna SR has a prolonged-release formulation, which ensures the release of ropinirole over a 24-hour period. If you have a condition that may cause the medicine to be removed from your body too quickly, such as diarrhea, the tablets may not dissolve completely and may not work properly. In this case, the remains of the tablet may be visible in your stool. If this happens, you should contact your doctor as soon as possible.
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What dose of Rolpryna SR should you take?

It may take some time to find the right dose of Rolpryna SR for you.
The recommended starting doseof Rolpryna SR is 2 mg once daily for the first week. Your doctor may increase the dose of Rolpryna SR to 4 mg once daily from the second week of treatment. If you are very elderly, your doctor may increase the dose more slowly.
Then, your doctor may adjust the dose until they find the best dose for you.
Some patients may take up to 24 mg of Rolpryna SR per day.
If you experience side effects that are difficult to tolerate at the start of treatment, you should inform your doctor. Your doctor may recommend changing the treatment to a lower dose of ropinirole in the form of immediate-release tablets, which you will take three times a day.

Do not take more Rolpryna SR than your doctor has recommended.

It may take several weeks before you feel the therapeutic effect of the medicine.

Taking your dose of Rolpryna SR

You should take Rolpryna SR once a dayat the same time every day.

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

The prolonged-release tablet(s) of Rolpryna SR should not be divided, chewed, or crushed. If this happens, there is a risk of overdose due to the rapid release of the medicine in the body.

If you are changing treatment from ropinirole immediate-release tablets

Your doctor will determine the dose of Rolpryna SR, prolonged-release tablets based on the dose of ropinirole immediate-release tablets you were taking previously.
You should take the previously prescribed dose of ropinirole immediate-release tablets on the day before the change in treatment. The next morning, you should take Rolpryna SR, prolonged-release tablets and not take any more ropinirole immediate-release tablets.

If you take more Rolpryna SR than you should

You should contact a doctor or pharmacist immediately. If possible, you should show them the packaging of Rolpryna SR.
If you take more Rolpryna SR than you should, you may experience nausea, vomiting, dizziness (feeling of spinning), drowsiness, mental or physical fatigue, fainting, or hallucinations.

If you forget to take Rolpryna SR

You should not take more tablets or a double dose to make up for a forgotten dose.
If you miss a dose of Rolpryna SR for a day or longer, you should consult your doctor about restarting treatment with Rolpryna SR.

If you stop taking Rolpryna SR

You should not stop taking Rolpryna SR without consulting your doctor.
You should take Rolpryna SR for as long as your doctor recommends. You should not stop taking it unless your doctor tells you to.

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If you suddenly stop taking Rolpryna SR, your Parkinson's disease symptoms may worsen rapidly. Suddenly stopping Rolpryna SR may lead to a condition called neuroleptic malignant syndrome, which can be life-threatening. Its symptoms include: akinesia (inability to move), muscle stiffness, fever, blood pressure fluctuations, tachycardia (increased heart rate), disorientation, decreased level of consciousness (e.g., coma).
If you need to stop taking Rolpryna SR, your doctor will gradually reduce your dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rolpryna SR can cause side effects, although not everybody gets them.
The side effects of Rolpryna SR may occur most frequently during the start of treatment or shortly after increasing the dose. These side effects are usually mild and become less troublesome after a short period of taking the medicine. If you are concerned about side effects, you should talk to your doctor.

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

• fainting
• drowsiness
• nausea

Common side effects (may affect up to 1 in 10 people)

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

Uncommon side effects (may affect up to 1 in 100 people)

• dizziness or fainting, especially when standing up quickly (related to low blood pressure)
• low blood pressure (hypotension)
• very strong drowsiness during the day (excessive daytime sleepiness)
• mental disorders, such as confusion (severe disorientation), delusions (irrational thoughts), or paranoia (unfounded 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 swellingson the skin (hives), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing, rashor severe itching (see section 2),
• changes in liver function, which have been shown in blood tests,
• aggressive behavior,

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• abuse of Rolpryna SR (a desire to take higher doses of dopaminergic medicines than required to control motor symptoms, called dopamine dysregulation syndrome),
• inability to resist the impulse, drive, or temptation to engage in activities that may harm you or others, including behaviors such as:
• a strong urge to gamble excessively despite significant personal or family consequences;
• altered or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive;
• uncontrolled excessive shopping or spending;
• uncontrolled eating (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger).
• depression, apathy, anxiety, fatigue, excessive sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS) may occur after stopping or reducing the dose of Rolpryna SR.
• episodes of overactivity, euphoria, or irritability
• spontaneous erections.

You should tell your doctor if you experience any of these behaviors; your doctor will discuss ways to treat or reduce these symptoms with you.

Taking Rolpryna SR with L-dopa

In patients taking Rolpryna SR in combination with L-dopa, other side effects may occur after some time:

• involuntary movements (dyskinesia) are a very common side effect. If you are taking L-dopa, you may experience involuntary movements (dyskinesia) when you start taking Rolpryna SR. You should inform your doctor if this happens, as they may need to adjust the dose of your medicines.
• feeling disoriented (common side effect).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rolpryna SR

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
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Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Rolpryna SR contains

• The active substance of Rolpryna SR is ropinirole. Each prolonged-release tablet contains 4 mg of ropinirole (as ropinirole hydrochloride).
• The other ingredients are: hypromellose type 2208, lactose monohydrate, colloidal anhydrous silica, carbomers 4000-11000 mPas, hydrogenated castor oil, magnesium stearate in the core and hypromellose type 2910, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172) in the coating.

What Rolpryna SR looks like and contents of the pack

The prolonged-release tablets are light brown, biconvex, and oval.
Packaging: 28 or 84 prolonged-release tablets in blisters, in a cardboard box.
For more detailed information, you should consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Italy, in the country of export:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Italy, in the country of export: 040525115
040525154

Parallel import authorization number: 154/24

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of revision of the leaflet: 12.04.2024

[Information about the trademark]

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