ROLPRYNA SR

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Rolpryna SR (Ropinirolo Krka 4 mg)
4 mg, prolonged-release tablets
Ropinirolum
Rolpryna SR and Ropinirolo Krka 4 mg are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

The active substance in Rolpryna 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.
Rolpryna SR prolonged-release tablets are used in the treatment of Parkinson's disease.
In patients with Parkinson's disease, certain areas of the brain have low levels of dopamine. Ropinirole acts similarly to naturally occurring dopamine in the brain and thus helps to relieve the symptoms of Parkinson's disease.

2. Important information before using Rolpryna SR

When not to use Rolpryna SR

• if the patient has hypersensitivity 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. You should inform the doctor if any of the above situations apply to the patient.

Warnings and precautions
Before starting treatment with Rolpryna SR, discuss the following 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, Page 1 of 7
• if the patient has severe heart disease,
• if the patient has severe psychiatric disorders,
• if the patient has particular urges and/or behaviors (see section 4),
• if the patient has an intolerance to sugars (such as lactose). Inform the doctor if any of the above situations apply to the patient. The doctor may decide that Rolpryna SR is not suitable for the patient or may recommend additional monitoring during treatment.

Tell the doctor if the patient or their family/caregiver notices that the patient begins to feel urges or desires to behave in an unusual way, or if the patient cannot resist impulses, urges, or temptations to engage in activities that could harm themselves or others. These phenomena are known as impulse control disorders and may manifest as compulsive gambling, excessive appetite or spending, increased sexual drive, or heightened frequency and intensity of sexual thoughts or feelings. The doctor may consider adjusting the dose or discontinuing the medicine.

Inform the doctor if symptoms such as depression, apathy, anxiety, fatigue, excessive sweating, or pain occur after stopping or reducing the dose of ropinirole [known as dopamine agonist withdrawal syndrome (DAWS)]. If these symptoms persist for more than a few weeks, the doctor may modify the treatment.

Inform the doctor if the patient, a family member, or caregiver observes the development of episodes of hyperactivity, euphoria, or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorders (see above). The doctor may consider it necessary to adjust the dose or discontinue the medicine.

While taking Rolpryna SR
Contact the doctor if the patient or a family member observes any unusual behaviors (such as uncontrollable gambling tendencies or increased sexual drive and/or excessive sexual activity) during treatment with Rolpryna SR. The doctor may recommend adjusting the dose or discontinuing the medicine.

Smoking and using Rolpryna SR
Tell the doctor about starting or stopping smoking while taking Rolpryna SR. The doctor may need to adjust the dose.

Rolpryna SR and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal remedies and over-the-counter medicines, as well as any medicines the patient plans to take.

Remember to inform your doctor or pharmacist if starting any new medicine while taking Rolpryna SR.

Some medicines may affect the action of Rolpryna SR or increase the risk of adverse effects. Rolpryna SR may also affect the action of other medicines.

These include:

• fluvoxamine (an antidepressant),
• medicines used to treat other psychiatric disorders, e.g. sulpiride,
• hormone replacement therapy (HRT),
• metoclopramide, used to treat nausea and heartburn,
• antibiotics: ciprofloxacin or enoxacin,
• any other medicine used in Parkinson’s disease. Inform the doctor if the patient is taking or has recently taken any of the above medicines.

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Additional blood tests may be required if the patient is taking Rolpryna SR together with:

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

Rolpryna SR with food and drink
Rolpryna SR may be taken with or without food.

Pregnancy and breastfeeding
Rolpryna SR is not recommended during pregnancy unless the doctor determines that the benefits to the patient outweigh the risks to the unborn child. Rolpryna SR is not recommended during breastfeeding, as it may affect milk production.

Inform the doctor immediately if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant. The doctor will also advise if the patient is breastfeeding or plans to breastfeed. The doctor may recommend discontinuing Rolpryna SR.

Driving and operating machinery
Rolpryna SR may cause drowsiness. Sudden, uncontrollable sleepiness may occur, including sudden and unexpected sleep attacks without prior warning.

Ropinirole may cause hallucinations (seeing, hearing, or sensing things that do not exist). If hallucinations occur, the patient must not drive or operate machinery.

If you suspect 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 symptoms have resolved.

Talk to your doctor if this situation causes difficulties for the patient.

Rolpryna SR contains monohydrate lactose
If the patient has intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to use Rolpryna SR

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult 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 must not be used in children. Rolpryna SR is generally not prescribed to patients under
18 years of age.
Rolpryna SR may be used in the treatment of Parkinson's disease symptoms either as monotherapy or
in combination with another medicine called L-dopa (also known as levodopa). If you are taking L-dopa,
involuntary movements (dyskinesias) may occur when starting treatment with Rolpryna SR. If such
symptoms occur, inform your doctor, who may adjust the dose of your medicines.
Rolpryna SR is an extended-release tablet formulation, which ensures release of ropinirole over a 24-hour period. If you have a condition causing rapid elimination of the medicine from the body, such as diarrhoea, the tablets may not dissolve completely and may not work properly. In such cases, remnants of the tablet may be visible in the stool. If this occurs, you should contact your doctor as soon as possible.
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What dose of Rolpryna SR should be used?
Determining the appropriate dose of Rolpryna SR may take some time.
The usual recommended starting dose of 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 elderly, your doctor may increase the dose more slowly.
Your doctor may then adjust the dose until the optimal dose for you is reached. Some patients take up
to 24 mg of Rolpryna SR per day.
If you experience intolerable side effects at the beginning of treatment, inform your doctor. Your doctor
may recommend switching therapy to a lower dose of ropinirole in the form of immediate-release
tablets, to be taken three times daily.
Do not take a higher dose of Rolpryna SR than prescribed by your doctor.
It may take several weeks before the therapeutic effect of the medicine becomes apparent.
How to take Rolpryna SR
Rolpryna SR should be taken once daily at the same time each

day.
The extended-release tablet(s) of Rolpryna SR must be swallowed whole with a glass of water.
Extended-release tablets must NOT be divided, chewed, or crushed. If this occurs, there is a risk of
overdose due to too rapid release of the medicine into the body.
Switching treatment in patients currently taking ropinirole immediate-release tablets
Your doctor will determine the dose of Rolpryna SR extended-release tablets based on your previous
dose of immediate-release ropinirole tablets.
Take your usual dose of immediate-release ropinirole tablets on the day before switching treatment.
The next morning, take Rolpryna SR extended-release tablets and do not take any further immediate-release ropinirole tablets.
Taking more Rolpryna SR than prescribed
Seek immediate advice from your doctor or pharmacist. If possible, show the Rolpryna SR packaging.
In a person who has taken more than the prescribed dose of Rolpryna SR, symptoms such as nausea,
vomiting, dizziness (spinning sensation), drowsiness, mental or physical fatigue, fainting, or hallucinations may occur.
Missing a dose of Rolpryna SR
Do not take a larger number of extended-release tablets or a double dose to make up for a missed dose.
If you miss taking Rolpryna SR for one day or longer, consult your doctor before resuming treatment.
Stopping treatment with Rolpryna SR
Do not stop taking Rolpryna SR without consulting your doctor.
Continue taking Rolpryna SR for as long as your doctor recommends. Do not discontinue unless instructed by your doctor.
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If treatment with Rolpryna SR is suddenly stopped, Parkinson's disease symptoms may rapidly worsen. Abrupt discontinuation of Rolpryna SR may lead to a condition called neuroleptic malignant syndrome, which may pose a serious health risk. Symptoms include: akinesia (inability to initiate movement), muscle rigidity, fever, fluctuations in blood pressure, tachycardia (increased heart rate), disorientation, and decreased level of consciousness (e.g. coma).
If discontinuation of Rolpryna SR is necessary, your doctor will gradually reduce the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions to Rolpryna SR may occur most frequently when starting treatment
or shortly after increasing the dose. These adverse reactions are usually mild and become less
bothersome after a short period of taking the medicine. If you have any concerns about adverse reactions, you should
speak with your doctor.

Very common adverse reactions (may affect more than 1 in 10 people)

• fainting
• drowsiness
• nausea

Common adverse reactions (may affect up to 1 in 10 people)

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

Uncommon adverse reactions (may affect up to 1 in 100 people)

• dizziness or fainting, especially upon sudden change to an upright position (related to low blood pressure)
• low blood pressure (hypotension)
• excessive daytime sleepiness (irresistible sleepiness)
• psychiatric disorders such as delirium (severe disorientation), delusions (irrational thoughts), or paranoia (unfounded suspicion)
• hiccups

In some patients, the following adverse reactions may occur (frequency unknown:
cannot be estimated from available data)

• allergic reactions such as red, itchy swellings on the skin (urticaria), facial swelling, swelling of the lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing, rash, or severe itching (see section 2),
• changes in liver function observed in blood tests,
• aggressive behaviour,

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• misuse of Rolpryna SR (desire to take higher doses of dopaminergic medications than required to control motor symptoms, known as dopamine dysregulation syndrome),
• inability to resist the impulse, drive, or temptation to engage in activities that may harm the patient or others, including behaviours such as:
• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased interest in sexual activity and behaviours significantly troubling to the patient or others, for example increased sexual drive;
• uncontrolled excessive shopping or spending;
• uncontrolled overeating (consuming 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, lack of energy, sweating, or pain (referred to as dopamine agonist withdrawal syndrome or DAWS) may occur after stopping or reducing the dose of Rolpryna SR.
• episodes of hyperactivity, euphoria, or irritability
• spontaneous erection

You should inform your doctor if such behaviours occur in the patient; the doctor will discuss
treatment options or ways to reduce these symptoms with the patient.

Taking Rolpryna SR together with L-dopa
In patients taking Rolpryna SR in combination with L-dopa, other adverse reactions may occur over time:

• involuntary movements (dyskinesias) – this is a very common adverse reaction. If a patient is taking L-dopa, involuntary movements (so-called dyskinesia) may occur during initiation of treatment with Rolpryna SR. You should inform your doctor if this occurs, as it may be necessary to reduce the dose of the medicines being taken.
• feeling of disorientation (common adverse reaction).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions 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.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store the medicine Rolpryna SR

Keep this medicine 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 stated month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
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Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Rolpryna SR contains

• The active substance is ropinirole. Each prolonged-release tablet contains 4 mg of ropinirole (as ropinirole hydrochloride).
• Other ingredients in the medicine are: 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.

What Rolpryna SR looks like and contents of the pack
The prolonged-release tablets are light brown, biconvex and oval.
Packs: 28 or 84 prolonged-release tablets in blisters, packed in a cardboard box.
For more detailed information, please contact the marketing authorization holder or parallel importer.
Marketing Authorization Holder in Italy, 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorization Number in Italy, country of export: 040525115
Parallel Import Authorization Number: 154/24
This medicinal product is authorized for sale in the European Economic Area under the following names:

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