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 8 mg)
8 mg, prolonged-release tablets
Ropinirolum
Rolpryna SR and Ropinirolo Krka 8 mg are different trade names for the same medicinal product.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions 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. What you need to know 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 like 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 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 if any of the above situations apply to you.

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 impulses and (or) behaviours (see section 4),
• if the patient has intolerance to sugars (such as lactose). Please inform your doctor if any of the above situations apply to you. Your doctor may decide that Rolpryna SR is not suitable for you or may recommend additional monitoring tests during treatment.

Please tell your doctor if you or your family/carer notice that you
are beginning to feel an urge or desire to behave in an unusual way, or if you
are unable to resist an impulse, drive, or temptation to carry out an activity that could harm you
or others. These phenomena are known as impulse control disorders and may manifest as
behaviours such as compulsive gambling, excessive appetite or spending, increased sexual drive,
or heightened frequency and intensity of sexual thoughts or feelings.
Your doctor may consider it necessary to adjust the dose or discontinue the medicine.
Inform your 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, your doctor may modify your treatment.
Inform your doctor if you, a family member, or carer notice 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). Your doctor may consider it necessary to adjust the dose or discontinue the medicine.
While taking Rolpryna SR
Contact your doctor if you or a family member observe any unusual behaviours (such as uncontrollable gambling tendencies or increased and/or excessive sexual activity) during treatment with Rolpryna SR. Your doctor may recommend adjusting the dose or discontinuing the medicine.
Smoking and taking Rolpryna SR
Tell your doctor if you start or stop smoking while taking Rolpryna SR. Your doctor may need to adjust your dose.
Rolpryna SR and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including herbal medicines and over-the-counter medicines.
Remember to inform your doctor or pharmacist if you start taking any other medicine while being treated with 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 to treat Parkinson's disease. Inform your doctor if you are taking or have recently taken any of the medicines listed above.

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Additional blood tests may be required if you are taking Rolpryna SR
concurrently:

• 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 your doctor decides that the benefit to you outweighs the risk to the unborn child. Rolpryna SR is not recommended during breastfeeding because it may affect milk production.
Inform your doctor immediately if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will also advise you if you are breastfeeding or plan to breastfeed. Your doctor may recommend discontinuing Rolpryna SR.
Driving and operating machinery
Rolpryna SR may cause drowsiness. Sudden and uncontrollable drowsiness may occur, as well as sudden and unexpected sleep attacks without prior warning.
Ropinirole may cause hallucinations (seeing, hearing, or feeling things that do not exist). If hallucinations occur, do 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 you (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 you.
Rolpryna SR contains monohydrate lactose
If you have intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Rolpryna SR

This medicine should always be used exactly as your doctor or pharmacist has advised.
If in doubt, consult your doctor or pharmacist.
Rolpryna SR is available in strengths 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 symptoms of Parkinson's disease either as monotherapy or in combination with another medicine called L-dopa (also known as levodopa). When a patient is taking L-dopa, involuntary movements (dyskinesias) may occur upon starting treatment with Rolpryna SR. If such symptoms occur, inform your doctor, who may adjust the dose of the medicines being taken.
Rolpryna SR is available as prolonged-release tablets, which provide release of ropinirole over a 24-hour period. If a patient has 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, contact your doctor as soon as possible.
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What dose of Rolpryna SR should be used?
Finding the appropriate dose of Rolpryna SR may take 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 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 Rolpryna SR per day.
If the patient experiences intolerable side effects at the beginning of treatment, inform the doctor. The 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 that 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 prolonged-release tablet(s) of Rolpryna SR must be swallowed whole with a glass of water.
Prolonged-release tablets must NOT be divided, chewed, or crushed. Doing so may result in overdose due to 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 prolonged-release tablets based on the previously used dose of ropinirole immediate-release tablets.
Continue taking your current dose of ropinirole immediate-release tablets on the day before switching treatment. The next morning, take Rolpryna SR prolonged-release tablets and do not take any further doses of ropinirole immediate-release 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.
If you miss a dose of Rolpryna SR
Do not take a larger number of prolonged-release tablets or a double dose to make up for a missed dose.
If Rolpryna SR has not been taken for one day or longer, consult your doctor before resuming treatment with Rolpryna SR.
Stopping Rolpryna SR
Do not stop taking Rolpryna SR without consulting your doctor.
Rolpryna SR should be taken for as long as your doctor recommends. Do not stop unless instructed by your doctor.
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If treatment with Rolpryna SR is suddenly stopped, symptoms of Parkinson's disease may rapidly worsen. Abruptly stopping Rolpryna SR may lead to a condition called neuroleptic malignant syndrome, which may be life-threatening. Symptoms include: akinesia (inability to perform movement), muscle rigidity, fever, fluctuations in blood pressure, tachycardia (increased heart rate), disorientation, and decreased level of consciousness (e.g. coma).
If it becomes necessary to discontinue Rolpryna SR, your doctor will gradually reduce the dose.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Side effects with Rolpryna SR may most commonly occur when starting treatment
or shortly after increasing the dose. These side effects are usually mild and become less
bothersome after a short period of taking the medicine. If you have any concerns about side effects, you should
talk to your doctor.

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

• fainting
• feeling sleepy
• nausea

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

• sudden onset of sleep without prior warning of sleepiness (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 side effects (may affect up to 1 in 100 people)

• dizziness or fainting, especially when changing position suddenly to standing (related to low blood pressure)
• low blood pressure (hypotension)
• very strong feeling of daytime sleepiness (irresistible sleepiness)
• psychiatric disorders such as delirium (severe disorientation), delusions (irrational thoughts) or paranoia (unfounded suspicion)
• hiccups

In some patients the following side effects may occur (frequency unknown:
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 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 medicines than required to control motor symptoms, known as dopamine dysregulation syndrome),
• inability to resist the impulse, drive or temptation to carry out an activity which may harm the patient or others, including behaviours such as:
• strong impulse to gamble excessively despite serious personal or family consequences;
• changed or increased interest in sexual activity and behaviours significantly distressing to the patient or others, e.g. increased sexual drive;
• uncontrolled excessive shopping or spending;
• uncontrolled overeating (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, 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.

Tell your doctor if you experience any of these types of behaviour; your doctor will discuss with you
ways to manage or reduce these symptoms.

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

• involuntary movements (dyskinesias) – this is a very common side effect. If you are taking L-dopa, you may develop involuntary movements (so-called dyskinesia) when starting treatment with Rolpryna SR. Inform your doctor if this occurs, as it may be necessary to reduce the dose of your medicines.
• feeling of disorientation (common side effect).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also 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
Reporting side effects helps provide more information on the safe use of this medicine.

5. How to store Rolpryna SR

Keep this medicine out of the 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.
Keep in the original packaging to protect from moisture.
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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 8 mg of ropinirole (as ropinirole hydrochloride).
• Other ingredients in the core of the tablet: Hypromellose type 2208, lactose monohydrate, colloidal anhydrous silica, carbomers 4000-11000 mPas, hydrogenated castor oil, magnesium stearate.
• Other ingredients in the coating: Hypromellose type 2910, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172).

What Rolpryna SR looks like and contents of the pack
The prolonged-release tablets are brownish-red, biconvex and oval.
Packaging: 28 or 84 prolonged-release tablets in blisters, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Italy, 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in Italy, the country of export: 040525192
Parallel import licence number: 89/24
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

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