Rolprina Sr

Leaflet accompanying the packaging: patient information

Rolpryna SR, 2 mg, prolonged-release tablets

Rolpryna SR, 4 mg, prolonged-release tablets

Rolpryna SR, 8 mg, prolonged-release tablets

ropinirole

You should carefully read the contents of 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.
• In case of 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 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 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 patient should inform their doctor if any of the above situations apply to them.

Warnings and precautions

Before starting to take Rolpryna SR, the patient should discuss it with their 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 disorders,
• if the patient has particular tendencies and (or) behaviors(see section 4),
• if the patient has intolerance to sugars (such as lactose). The patient should inform their doctor if any of the above situations apply to them. The doctor may decide that Rolpryna SR is not a suitable medicine for the patient or may recommend additional monitoring during treatment.

The patient should tell their doctor if they or their family/caregiver notice that the patient starts to feel the urge or desire to behave in an unusual way and when 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 patient should inform their 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, the doctor may modify the treatment.
The patient should inform their doctor if they, a family member, or caregiver notice that the patient is developing episodes of overactivity, euphoria, or irritability (mania symptoms). These may occur with impulse control disorders or without (see above). The doctor may consider it necessary to adjust the dose or discontinue the medicine.

During treatment with Rolpryna SR

The patient should contact their doctor if they or their family member observe the occurrence of any unusual behavior in the patient (such as uncontrollable 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 patient should tell their doctorabout starting or stopping smoking while taking Rolpryna SR. The doctor may decide to adjust the dose.

Rolpryna SR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including herbal products and other medicines available without a prescription.
The patient should remember to tell their doctor or pharmacist if they 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. The patient should inform their doctor if they are taking or have recently taken any of these medicines.

Additional blood tests will be necessaryif the patient takes Rolpryna SR at the same time as:

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

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 considers 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 patient should inform their doctor immediately if they are pregnant, think they may be pregnant, or plan 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. Uncontrollable drowsinessmay occur, as well as sudden and unexpected sleep attackswithout any clear warning.
Ropinirole may cause hallucinations (seeing, hearing, or feeling things that do not exist). If hallucinations occur, the patient should not drive or operate machinery.
If the patient suspects that such symptoms may occur, they should not drive, operate machinery, or perform
taskswhere drowsiness or falling asleep may put them (or others) at risk of serious injury or death. The patient should not perform such tasks until the symptoms have resolved.
The patient should discuss this with their doctor if this situation is a problem for them.

Rolpryna SR contains lactose

If the patient has intolerance to some 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. In case of doubt, the patient should consult their doctor or pharmacist

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 the patient is taking L-dopa, they may experience involuntary movements (dyskinesia) when starting to take Rolpryna SR. The patient should inform their doctor if this occurs, as they may need to adjust the dose of their medicines.
Rolpryna SR is a prolonged-release tablet that releases 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 tablet may not dissolve completely and may not work properly. In this case, the remains of the tablet may be visible in the stool. If this happens, the patient should contact their doctor as soon as possible.

What dose of Rolpryna SR should be taken?

It may take some time to determine the correct dose of Rolpryna SR.
The recommended starting 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 patient should take the previously taken dose of ropinirole immediate-release tablets on the day before switching treatment. The next morning, the patient should take Rolpryna SR, prolonged-release tablets and not take any more ropinirole immediate-release tablets.

Taking more Rolpryna SR than prescribed

The patient should contact their doctor or pharmacist immediately. If possible, the patient should show them the packaging of Rolpryna SR.
If a person has taken more Rolpryna SR than prescribed, they may experience nausea, vomiting, dizziness (feeling of spinning), drowsiness, mental or physical fatigue, fainting, or hallucinations.

Missing a dose of Rolpryna SR

The patient should not take more tablets or a double dose to make up for a missed dose.
If the patient has not taken Rolpryna SR for a day or longer, they should consult their doctor about restarting treatment with Rolpryna SR.

Stopping treatment with Rolpryna SR

The patient should not stop taking Rolpryna SR without consulting their doctor.

Rolpryna SR should be taken for as long as the doctor recommends. The patient should not stop taking it unless their doctor tells them to.
If the patient suddenly stops taking Rolpryna SR, the symptoms of Parkinson's disease may worsen rapidly. Suddenly 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, blood pressure fluctuations, tachycardia (increased heart rate), disorientation, decreased level of consciousness (e.g., coma).
If the patient needs to stop taking Rolpryna SR, their doctor will gradually reduce the dose they are taking.
If the patient has any further doubts about taking this medicine, they should consult their 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 often when starting 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 the patient is concerned about side effects, they should talk to their 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 (uncontrollable drowsiness)
• 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 swellingof the skin (hives), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing, rashor severe itching (see section 2),
• changes in liver function, which have been shown in blood tests,
• 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 serious 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 overeating or eating compulsively (eating more food than usual and more than needed to satisfy hunger);
• uncontrollable shopping or spending money;

The patient should tell their doctor if they experience 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 patient should inform their doctor if this occurs, as they may need to adjust the dose of their medicines.
• disorientation (common side effect).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected 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 blister and carton after EXP. 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.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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. Rolpryna SR, 2 mg, prolonged-release tabletsEach prolonged-release tablet contains 2 mg of ropinirole (as ropinirole hydrochloride). Rolpryna SR, 4 mg, prolonged-release tabletsEach prolonged-release tablet contains 4 mg of ropinirole (as ropinirole hydrochloride). Rolpryna SR, 8 mg, prolonged-release tabletsEach prolonged-release tablet contains 8 mg of ropinirole (as ropinirole hydrochloride).
• Rolpryna SR also contains: Rolpryna SR, 2 mg, prolonged-release tabletsHypromellose type 2208, lactose monohydrate, colloidal anhydrous silica, carbomers 4000-11000 mPas, hydrogenated castor oil, magnesium stearate in the tablet core, and hypromellose type 2910, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), iron oxide yellow (E 172) in the coating. See section 2 "Rolpryna SR contains lactose".
• Rolpryna SR, 4 mg, 8 mg, prolonged-release tablets

Rolpryna SR, 4 mg, 8 mg, prolonged-release tablets
Hypromellose type 2208, lactose monohydrate, colloidal anhydrous silica, carbomers 4000-11000 mPas, hydrogenated castor oil, magnesium stearate in the tablet 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. See section 2 "Rolpryna SR contains lactose".

What Rolpryna SR looks like and contents of the pack

Rolpryna SR, 2 mg, prolonged-release tablets:The tablets are pink, biconvex, and oval.
Rolpryna SR, 4 mg, prolonged-release tablets:The tablets are light brown, biconvex, and oval.
Rolpryna SR, 8 mg, prolonged-release tablets:The tablets are brown-red, biconvex, and oval.
Packaging: 28 or 84 prolonged-release tablets in blisters, in a carton box

Marketing authorization holder

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

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

To obtain more detailed information on the names of the medicinal products in other Member States of the European Economic Area, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:26.07.2023