Rolprina Sr

Leaflet attached to the packaging: patient information

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

Rolpryna SR (Rolpryna EP)

4 mg, prolonged-release tablets

Ropinirole
Rolpryna SR and Rolpryna EP are different trade names for the same medicine.

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 so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist 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 illness 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 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 packaging 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 concentration of dopamine in some parts of the brain.
Ropinirole works in a similar way to natural dopamine 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 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 should be informed if any of the above situations apply to the patient.

Warnings and precautions

Before starting to take Rolpryna SR, the doctor or pharmacist should be consulted:

• if the patient is pregnantor thinks they may be pregnant,
• if the patient is breast-feeding, Page 1 8
• 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 sugars (such as lactose). The doctor should be informed if any of the above situations apply to the patient. The doctor may decide that Rolpryna SR is not a suitable medicine for the patient or may recommend additional monitoring during treatment.

The doctor should be told if the patient or their family/caregiver notices that the patient starts to feel the urge or desire to behave in an unusual way and if the patient cannot resist the impulse, drive, or temptation to engage in activities that may harm them or others. These phenomena are called impulse control disorders and may manifest as behaviors such as compulsive gambling, excessive appetite, or the need to spend money, excessive sexual drive, or increased frequency and intensity of thoughts or feelings about sex. The doctor may consider it appropriate to change the dose or discontinue the medicine.
The doctor should be informed if symptoms such as depression, apathy, anxiety, fatigue, excessive sweating, or pain occur after stopping or reducing the dose of ropinirole [called dopamine agonist withdrawal syndrome (DAWS)]. If these symptoms persist for more than a few weeks, the doctor may modify the treatment.
The doctor should be informed if the patient, a family member, or caregiver notices that the patient is developing episodes of overactivity, euphoria, or irritability (mania symptoms). These may occur with or without impulse control disorders (see above). The doctor may consider it necessary to adjust the dose or discontinue the medicine.

During treatment with Rolpryna SR

The doctor should be contacted if the patient or their family member observes the occurrence of any unusual behaviors in the patient (such as uncontrolled urge to gamble or increased sexual drive) during treatment with Rolpryna SR. The doctor may recommend adjusting the dose or discontinuing the medicine.

Smoking and taking Rolpryna SR

The doctor should be toldabout starting or stopping smoking while taking Rolpryna SR. The doctor may decide to adjust the dose.

Rolpryna SR and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, including herbal products and other medicines available without a prescription.
It should be remembered to tell the doctor or pharmacist if the patient starts 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. The doctor should be informed if the patient is taking or has recently taken any of these medicines. Page 2 8

Additional blood tests will be necessaryif the patient is 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 the doctor decides that the benefits of taking Rolpryna SR outweigh the risks to the unborn child. Rolpryna SR is not recommended during breast-feeding, as it may affect milk production.
The doctor should be informed immediately if 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 discontinuing Rolpryna SR.

Driving and using machines

Rolpryna SR may cause drowsiness. Sudden drowsinessmay occur, as well as sudden and unexpected sleep attackswithout any warning.
Ropinirole may cause hallucinations (seeing, hearing, or feeling things that are not real). If hallucinations occur, the patient should not drive or operate machinery.
If it is suspected that such symptoms may occur: do not drive, operate
machines or perform
activitieswhere drowsiness or falling asleep may put the patient (or others) at risk of serious injury or death. Such activities should not be performed until the symptoms have resolved.
The doctor should be consulted if such a situation is a problem for the patient.

Rolpryna SR contains lactose monohydrate

If the patient has intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to take Rolpryna SR

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If there are any doubts, the doctor or pharmacist should be consulted.
Rolpryna SR is available in 2 mg, 4 mg, and 8 mg strengths.

Use in children and adolescents

Rolpryna SR should not be used in children.Rolpryna SR is not usually prescribed to 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 the patient is taking L-dopa, they may experience involuntary movements (dyskinesia) when starting to take Rolpryna SR. The doctor should be informed if these symptoms occur, as it may be necessary to adjust the dose of the medicines being taken.
Rolpryna SR has a prolonged-release formulation, which ensures the release of ropinirole over a 24-hour period. If the patient has a condition that may cause the medicine to be removed from the body too quickly, such as diarrhea, the tablets may not dissolve completely and may not work properly. In such cases, the remains of the tablet may be visible in the stool. If this happens, the doctor should be contacted as soon as possible.

What doses of Rolpryna SR should be taken?

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

Do not take more Rolpryna SR than prescribed by the doctor.

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

Taking the dose of Rolpryna SR

Rolpryna SR should be taken 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.

In case of switching treatment from ropinirole immediate-release tablets

The doctor will determine the dose of Rolpryna SR, prolonged-release tablets based on the previously taken dose of ropinirole immediate-release tablets.
The previously taken dose of ropinirole immediate-release tablets should be taken on the day before the treatment is switched. The next morning, Rolpryna SR, prolonged-release tablets should be taken, and no more ropinirole immediate-release tablets should be taken.

Taking more Rolpryna SR than prescribed

The doctor or pharmacist should be contacted immediately.If possible, the packaging of Rolpryna SR should be shown.
In a person who has taken more Rolpryna SR than prescribed, nausea, vomiting, dizziness (feeling of spinning), drowsiness, mental or physical fatigue, fainting, or hallucinations may occur.

Missing a dose of Rolpryna SR

Do not take more tablets or a double dose to make up for a missed dose.
If a dose of Rolpryna SR is missed for a day or longer, the doctor should be consulted for advice on how to restart treatment with Rolpryna SR.

Stopping treatment with Rolpryna SR

Do not stop taking Rolpryna SR without consulting a doctor.

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Rolpryna SR should be taken for as long as the doctor recommends. Do not stop taking it unless the doctor advises to do so.
If treatment with Rolpryna SR is stopped suddenly, the symptoms of Parkinson's disease may worsen rapidly. Stopping treatment with Rolpryna SR may lead to a condition called malignant neuroleptic syndrome, which can be life-threatening. Its symptoms include: akinesia (inability to move), muscle stiffness, fever, changes in blood pressure, tachycardia (increased heart rate), disorientation, decreased level of consciousness (e.g., coma).
If it is necessary to stop treatment with Rolpryna SR, the doctor will gradually reduce the dose being taken.
If there are any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

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 initial treatment period or shortly after the dose is increased. These side effects are usually mild and become less troublesome after a short period of treatment with the medicine. If there are any concerns about side effects, the doctor should be consulted.

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

• fainting
• feeling drowsy
• 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)
• excessive 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, Page 5 8
• aggressive behavior,
• abuse of Rolpryna SR (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 the patient or others, including behaviors such as:
• strong impulse to gamble excessively despite significant personal or family consequences;
• altered or increased interest in sex and behaviors that significantly disturb the patient 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.

The doctor should be told if the patient experiences any of these behaviors; the doctor will discuss ways to treat or reduce these symptoms.

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 the patient is taking L-dopa, they may experience involuntary movements (dyskinesia) when starting treatment with Rolpryna SR. The doctor should be informed if these symptoms occur, as it may be necessary to reduce the dose of the medicines being taken.
• feeling disoriented (common side effect).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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, more information can be gathered on the safety of the 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.
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. The pharmacist should be asked 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 Rolpryna SR contains

• The active substance of Rolpryna SR is ropinirole. Each prolonged-release tablet contains 4 mg of ropinirole (as ropinirole hydrochloride).
• The medicine also contains: hypromellose type 2208, lactose monohydrate, colloidal anhydrous silica, carbomer 4000-11000 mPas, hydrogenated castor oil, magnesium stearate in the core of the tablet, 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 what the pack contains

The prolonged-release tablets are light brown, biconvex, and oval.
Packaging: 21, 28, 42, or 84 prolonged-release tablets in blisters, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Romania, the country of export:

Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer:

Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 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
Authorization number in Romania, the country of export:
10183/2017/01
10183/2017/02
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10183/2017/03
10183/2017/04

Parallel import authorization number: 25/19

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

Date of leaflet approval: 23.11.2023

[Information about the trademark]

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