Leaflet: information for the user

Rolpryna SR 4 mg prolonged-release tablets EFG

ropinirol

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you and must not be given to others, even if they have the same symptoms as you, as it may harm them.
• Ifyou experienceside effects, consult your doctor or pharmacist,evenifthey are not listed in this leaflet. See section 4.

The active ingredient of Rolpryna SR is ropinirol, which belongs to a group of medications called dopamine agonists. Dopamine agonists act in the same way as a natural substance found in the brain, called dopamine.

Rolpryna SR prolonged-release tablets are used for the treatment of Parkinson's disease.

People with Parkinson's disease have low levels of dopamine in certain parts of the brain. Ropinirol has a similar effect to natural dopamine and, in this way, reduces the symptoms of Parkinson's disease.

DO NOT TAKERolpryna SRIF:

• you are allergic to the active ingredient or any of the other components of this medication (listed in section 6),
• you have any severe kidney disease,
• you have any liver disease.

Inform your doctor if you think you may be in any of these situations.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Rolpryna SR:

• if you are pregnant or think you may be pregnant,
• if you are breastfeeding,
• if you are under 18 years old,
• if you have any severe heart disease,
• if you have any severe mental disorder,
• if you have any impulsive behavior or abnormal behavior (see section 4),
• if you have intolerance to some sugars (e.g. lactose).

Inform your doctor if you think you may be in any of these situations. Your doctor will decide if your treatment with Rolpryna SR is suitable for you, or if you need additional monitoring while taking it.

Inform your doctor if you or your family/caregiver notice that you are developing any abnormal behavior or if you cannot resist impulses, or if you have temptations to perform certain activities that may be harmful to you or others. This is known as impulse control disorder and may include behaviors such as an abnormal need to gamble, eat excessively or compulsively, compulsive buying, or an abnormal increase in sexual desires and/or behaviors.Your doctor may need to adjust or stop your treatment.

Inform your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with ropinirol (called dopamine agonist withdrawal syndrome or SAAD).If the problems persist after a few weeks, your doctor may need to adjust your treatment.

Inform your doctor if you or your family/caregiver notice that you are developing episodes of hyperactivity, euphoria, or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorder (see above).Your doctor may need to adjust or stop your treatment.

While Taking Rolpryna SR

Inform your doctor if you or your family members notice that you are developing any abnormal behavior (such as an abnormal need to gamble or an increase in sexual desires and/or behaviors) while taking Rolpryna SR. Your doctor may need to adjust or stop your treatment.

Smoking and Rolpryna SR

Inform Your Doctorif you have started or stopped smoking while taking Rolpryna SR.Your doctor may need to adjust your dose.

Other Medications and Rolpryna SR

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including herbal or over-the-counter medications.

Remember to inform your doctor or pharmacist if you start taking a new medication while taking Rolpryna SR.

Some medications may affect the effect of Rolpryna SR or make it more likely that you will experience side effects. Rolpryna SR may also alter the way other medications work.

These medications include:

• the antidepressant fluvoxamine,
• medications for mental disorders, such as sulpiride,
• hormone replacement therapy (also called HRT),
• metoclopramide, used to treat nausea and stomach acid,
• the antibiotics ciprofloxacin or enoxacin,
• any other medication for Parkinson's disease.

Inform your doctor if you are taking, or have taken recently, any of these medications.

You will need to undergo additional blood tests if you are taking these medications with Rolpryna SR:

• Anticoagulant vitamin K antagonists (used to reduce blood clotting) such as warfarin (Coumadin).

Taking Rolpryna SR with Food and Drinks

You can take Rolpryna SR with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

It is not recommended to use Rolpryna SR during pregnancy, unless your doctor tells you that the benefits for you outweigh any possible risks to the fetus. Rolpryna SR should not be used during breastfeeding, as milk production may be affected.

Inform your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will recommend what you should do if you are breastfeeding or plan to breastfeed. Your doctor may recommend that you stop taking Rolpryna SR.

Driving and Operating Machinery

Rolpryna SR may make you feel drowsy. In rare cases, Rolpryna SR may make you feel extremely drowsy, and you may fall asleep suddenly without warning. It may also cause hallucinations.

If you experience this:do not drive, do not operate machinery, anddo notput yourself in situations where feeling drowsy or falling asleep may put you (or others) at risk of serious harm or death. Do not engage in these activities until you are no longer affected.

Rolpryna SR Contains Lactose

This medication contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken exactly as directed by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Use in children and adolescents

Do not give Rolpryna SR to children.Rolpryna SR is not normally prescribed to individuals under 18 years old.

You may have been prescribed Rolpryna SR only for the treatment of your Parkinson's disease symptoms, or you may also have been prescribed another medication called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience some uncontrollable sudden movements (dyskinesias) when you start taking rolprinirol. Consult your doctor if this occurs, as you may need to adjust the doses of L-dopa and other medications you are taking.

The Rolpryna SR tablets have been designed to release the medication over a period of 24 hours. If you have any condition that makes the medication pass through your body too quickly, such as diarrhea, it is possible that the tablets will not dissolve completely and will not act correctly. You may see the tablets in your stool. If this occurs, inform your doctor as soon as possible.

What dose of Rolpryna SR should you take?

You may need some time to determine what dose of Rolpryna SR is best for you.

Initial recommended doseof Rolpryna SR prolonged-release tablets is 2 mg once a day during the first week.From there, your doctor may increase the dose to 4 mg of Rolpryna SR prolonged-release tablets once a day, during the second week of treatment. In older individuals, your doctor may increase the dose more slowly. After that, your doctor may adjust the dose to reach the most suitable dose for you. Some people may take up to 24 mg of Rolpryna SR prolonged-release tablets each day.

If you experience side effects at the start of your treatment that you cannot tolerate, consult your doctor. Your doctor may advise you to switch to a lower dose of ropinirol coated tablets (immediate-release) that you will take three times a day.

Do not take more Rolpryna SR tablets than your doctor has prescribed.

You may need several weeks for ropinirol to take effect.

How to take your Rolpryna SR dose

Take Rolpryna SR once a day, at the same time of day.

Swallow the Rolpryna SR tablets whole, with a glass of water.

Do not break, chew, or crush the prolonged-release tablets. If you do, there may be a risk of receiving an excessive dose, as the medication will be released into your body too quickly.

If you switch from ropinirol coated tablets (immediate-release)

Your doctor will adjust your dose of Rolpryna SR prolonged-release tablets based on the dose of ropinirol coated tablets (immediate-release) you are taking.

Take your ropinirol coated tablets (immediate-release) as usual the day before the switch. Then, take your Rolpryna SR prolonged-release tablets in the morning, and do not take any more ropinirol coated tablets (immediate-release).

If you take more Rolpryna SR than you should

If you have taken more Rolpryna SR than you should, consult your doctor or pharmacist, go to the nearest hospital immediately, or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested. If possible, show them the packaging.

Someone who has suffered a Rolpryna SR overdose may experience some of the following symptoms: nausea, vomiting, dizziness, somnolence, fatigue (mental or physical tiredness), feeling of fainting, hallucinations.

If you forget to take Rolpryna SR

Do not take extra tablets or a double dose to compensate for the missed dose.

If you have forgotten to take Rolpryna SR for one or several days, consult your doctor to have them recommend how to start taking it again.

If you interrupt treatment with Rolpryna SR

Do not interrupt treatment with Rolpryna SR without consulting your doctor.

Take Rolpryna SR for the time your doctor indicates. Do not suspend treatment unless your doctor tells you to.

If you suddenly stop taking Rolpryna SR, your Parkinson's disease symptoms may worsen rapidly.

Do not stop taking Rolpryna SR suddenly without consulting your doctor.

A sudden interruption could cause the development of a condition called neuroleptic malignant syndrome, which can pose a significant risk to your health. The symptoms are akinesia (loss of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, depressed level of consciousness (e.g., coma).

If you need to stop your Rolpryna SR treatment, your doctor will gradually reduce the dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

The side effects of Rolpryna SR are more likely to occur at the beginning of treatment, or when the dose is increased. These are generally mild and may be less bothersome over time. Inform your doctor if you are concerned about side effects.

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

• dizziness,
• drowsiness,
• nausea.

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

• falling asleep suddenly without feeling tired beforehand (sudden sleep episodes),
• hallucinations (seeing things that are not really there),
• vomiting,
• dizziness,
• heartburn,
• stomach 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 suddenly (this is due to a drop in blood pressure),
• excessive daytime sleepiness (excessive somnolence),
• low blood pressure (hypotension),
• mental problems such as delirium (severe confusion), delusional ideas (irrational ideas), or paranoia (irrational suspicions),
• hypotension.

Some patients may experience the following side effects(frequency not known:cannot be estimated from available data):

• allergic reactions such as redness, inflammation of the skin with itching (urticaria),swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing, intense itching or hives (see section 2),
• changes in liver function, which can be detected by blood tests,
• aggressive behavior,
• excessive use of Rolpryna SR (desire for higher doses of dopaminergic medications than necessary to control motor symptoms, known as dopamine dysregulation syndrome),
• inability to resist impulses, realization or temptations to perform activities that may be harmful to you or others, which may include:

• abnormal need to gamble despite severe personal or family consequences,
• an abnormal increase in sexual desires and/or behaviors that cause you great concern for yourself or others, such as excessive sexual impulse,
• compulsive buying,
• binges (eating excessively in a short period of time) or compulsively (eating more than normal and more than necessary to satisfy your appetite).
• after stopping or reducing treatment with Rolpryna SR: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS),

• episodes of hyperactivity, euphoria, or irritability,
• spontaneous penile erection.

Inform your doctor if you experience any of these behaviors, he will advise you on how to manage or reduce symptoms.

If you are taking Rolpryna SR with L-dopa

People taking Rolpryna SR with L-dopa may develop other side effects over time:

• uncontrollable sudden movements (dyskinesias) are a very common side effect. If you are taking L-dopa, you may experience some uncontrollable movements (dyskinesias) when you first start taking Rolpryna SR. Inform your doctor if this occurs, as it may be necessary to adjust the dose of the medications you are taking,
• a common side effect is confusion.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not use Rolpryna SR after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from humidity.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and the

medicines that you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medicines that you no longer need. In this way, you will help protect the environment.

Composition of Rolpryna SR 4 mg prolonged-release tablets

• The active ingredient is ropinirole. Each prolonged-release tablet contains 4 mg of ropinirole (as hydrochloride).
• The other components are:

Core tablet : hypromellose 2208, lactose monohydrate, anhydrous colloidal silica, carbomer 4,000-11,000 mPa.s, hydrogenated castor oil, magnesium stearate.

Covering : hypromellose 2910, titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172). See section 2 “Rolpryna SR contains lactose” .

Appearance of the product and contents of the package

Rolpryna SR 4 mg are prolonged-release tablets of light brown color, biconvex, and oval-shaped.

The tablets are available in blister packs (OPA/Al/PVC-Al) of 21, 28, 42, and 84 prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

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

Responsible manufacturer:

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

TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: : July 2023

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/