ROLPRYNA SR

Package leaflet: Information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the 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, there is a low concentration of dopamine in certain areas of the brain. Ropinirole acts similarly to naturally occurring dopamine in the brain and thus helps to alleviate 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. 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 , Page 1 of 8
• if the patient is under 18 years of age,
• if the patient has severe heart disease,
• if the patient has severe psychiatric disorders,
• if the patient has impulse control disorders and (or) behaviors (see section 4),
• if the patient has carbohydrate intolerance (such as lactose intolerance). 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 tests 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 unusual ways, 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
behaviors such as compulsive gambling, excessive appetite or spending, increased sexual drive,
or heightened frequency and intensity of sexual thoughts or feelings.
The doctor may consider it necessary to adjust the dose or discontinue 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 longer 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 find it necessary
to adjust the dose or discontinue the medicine.
During treatment with Rolpryna SR
Contact the doctor immediately if the patient or a family member observes
any unusual behaviors (such as uncontrollable gambling urges or increased and/or excessive sexual activity)
during treatment with Rolpryna SR. The doctor may recommend adjusting the dose or discontinuing the medicine.
Smoking and use of Rolpryna SR
Tell the doctor if the patient starts or stops smoking while taking Rolpryna SR.
The doctor may need to adjust the dose.
Rolpryna SR and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take, including herbal remedies and other over-the-counter medicines.
Remember to inform the 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 side 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 for Parkinson's disease. Inform the doctor if the patient is taking or has recently taken any of the above medicines. Page 2 of 8

Additional blood tests may be required if the patient is 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 the doctor determines that the benefits of using Rolpryna SR for the patient outweigh the risks to the unborn child. Rolpryna SR is not recommended during breastfeeding because 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 provide advice 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 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, the patient must not drive or operate machinery.
If there is suspicion that 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. Such activities should not be performed until symptoms resolve.
Talk to the 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 used exactly as directed by your doctor or pharmacist. If in doubt,
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 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 initiation of Rolpryna SR treatment. 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
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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.
What dose of Rolpryna SR should be used?
Determining 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 take up to 24 mg of Rolpryna SR per day.
If intolerable side effects occur at the beginning of treatment, inform your 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 for patients previously taking ropinirole immediate-release tablets
Your doctor will determine the dose of Rolpryna SR prolonged-release tablets based on the previously used dose of immediate-release ropinirole tablets.
Continue taking your previous dose of immediate-release ropinirole tablets on the day before switching treatment. The next morning, take Rolpryna SR prolonged-release tablets and do not take any further doses of immediate-release ropinirole tablets.
Taking more than the recommended dose of Rolpryna SR
Seek immediate advice from your doctor or pharmacist. If possible, show the Rolpryna SR packaging.
In a person who has taken more than the recommended dose of Rolpryna SR, symptoms such as nausea, vomiting, dizziness (spinning sensation), drowsiness, mental or physical fatigue, fainting, or hallucinations may occur.
If a dose of Rolpryna SR is missed
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 treatment with Rolpryna SR
Do not stop taking Rolpryna SR without consulting your doctor.
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Rolpryna SR should be taken for as long as your doctor recommends. Do not stop unless instructed by your doctor.
If Rolpryna SR is stopped abruptly, symptoms of Parkinson's disease may worsen rapidly. Sudden discontinuation of Rolpryna SR may lead to a condition called neuroleptic malignant syndrome, which may pose a serious health risk. Symptoms include: akinesia (lack of ability to perform movement), muscle rigidity, fever, fluctuations in blood pressure, tachycardia (increased heart rate), disorientation, and reduced 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 effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects of Rolpryna SR may occur most frequently when starting treatment
or shortly after increasing the dose. These adverse effects are usually mild and become less
bothersome after a short period of treatment. If you have concerns about adverse effects, you should
consult your doctor.

Very common adverse effects (may affect more than 1 in 10 patients)

• fainting
• drowsiness
• nausea

Common adverse effects (may affect up to 1 in 10 patients)

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

Uncommon adverse effects (may affect up to 1 in 100 patients)

• dizziness or fainting, especially upon sudden change to 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 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),
• liver function abnormalities detected in blood tests, Page 5 of 8
• aggressive behaviour,
• misuse of Rolpryna SR (urge to take higher doses of dopaminergic medications than required to control motor symptoms, known as dopamine dysregulation syndrome),
• inability to resist 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 distressing to the patient or others, e.g. increased sexual drive;
  • uncontrolled excessive shopping or spending;
  • uncontrollable appetite (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

You should inform your doctor if such behaviours occur; 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 adverse effects may occur over time:

• involuntary movements (dyskinesias) – this is a very common adverse effect. 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 these occur, as it may be necessary to reduce the dose of the medicines being taken.
• feeling of disorientation (common adverse effect).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store 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.
Keep 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Rolpryna SR contains

• The active substance is ropinirole. Each prolonged-release tablet contains 4 mg of ropinirole (in the form of ropinirole hydrochloride).
• Other ingredients in the medicine are: hypromellose type 2208, monohydrate lactose, 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
Prolonged-release tablets are light brown, double convex and oval.
Packaging: 21, 28, 42 or 84 prolonged-release tablets in blister packs, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Romania, country of export: 10183/2017/01
10183/2017/02
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10183/2017/03
10183/2017/04
Parallel import authorisation number: 25/19
This medicinal product is authorised in the European Economic Area member states under the following names:

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