Rolpryna SR 4 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rolpryna SR 4 mg prolonged-release tablets EFG

ropinirole

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could be harmful to them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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 a similar way to a naturally occurring substance 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. Ropinirole has an effect similar to natural dopamine and thus reduces the symptoms of Parkinson's disease.

2. What you need to know before taking Rolpryna SR

Do NOT take Rolpryna SR if:

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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Rolpryna SR:

• if you are pregnant or think you may be pregnant,
• if you are breastfeeding,
• if you are under 18 years of age,
• if you have a serious heart condition,
• if you have a severe mental disorder,
• if you experience any impulsive behavior and/or abnormal behavior (see section 4),
• if you have intolerance to certain sugars (e.g., lactose).

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

Tell your doctor if you or your family members/caregivers notice that you are developing any behavior that is unusual for you, or if you cannot resist impulses, or feel urges or temptations to carry out certain activities that could be harmful to you or others. This is known as impulse control disorders and may include behaviors such as an abnormal urge to gamble, binge or compulsive eating, compulsive shopping, or an abnormal increase in sexual urges and/or behaviors. Your doctor may need to adjust or stop your treatment.

Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with ropinirole (known as dopamine agonist withdrawal syndrome or DAWS). If these 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 overactivity, 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 urge to gamble or an increase in sexual urges and/or behaviors) while taking Rolpryna SR. Your doctor may need to adjust or stop your dosage.

Smoking and Rolpryna SR

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

Other medicines and Rolpryna SR

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines or those obtained without a prescription.

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

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

These medicines include:

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

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

You will need additional blood tests if you are taking these medicines with Rolpryna SR:

• Vitamin K antagonists (used to reduce blood clotting), such as warfarin (Coumadin).

Taking Rolpryna SR with food and drink

You may take Rolpryna SR with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of Rolpryna SR during pregnancy is not recommended unless your doctor determines that the benefit to you outweighs any possible risk 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 are pregnant, or plan to become pregnant. Your doctor will advise you on what to do if you are breastfeeding or plan to breastfeed. Your doctor may recommend that you discontinue treatment with Rolpryna SR.

Driving and using machines

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

If this happens: do not drive, do not use machinery, and do not put yourself in situations where feeling sleepy or falling asleep could place 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 medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Rolpryna SR

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in children and adolescents

Do not give Rolpryna SR to children. Rolpryna SR is normally not prescribed for individuals under 18 years of age.

You may have been prescribed Rolpryna SR alone for the treatment of your Parkinson's disease symptoms, or you may also have been prescribed another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, you might experience some uncontrolled sudden movements (dyskinesias) when you start taking ropinirole. Consult your doctor if this occurs, as you may need adjustments to your L-dopa dosage or other medications you are taking.

Rolpryna SR tablets are designed to release the drug over a 24-hour period. If you have a condition that causes the medicine to pass through your body too quickly, such as diarrhea, the tablets may not dissolve completely and may not work properly. You may see the tablets in your stools. If this happens, inform your doctor as soon as possible.

What dose of Rolpryna SR should you take?

It may take some time to determine which dose of Rolpryna SR is best for you.

The recommended starting dose of Rolpryna SR prolonged-release tablets is 2 mg once daily for the first week. From there, your doctor may increase the dose to 4 mg of Rolpryna SR prolonged-release tablets once daily during the second week of treatment. In elderly patients, your doctor may increase the dose more slowly. Afterwards, your doctor may adjust the dose until reaching the most appropriate dose for you. Some people may take up to 24 mg of Rolpryna SR prolonged-release tablets daily.

If you experience adverse effects at the beginning of your treatment that you cannot tolerate, consult your doctor. Your doctor may advise you to switch to a lower dose of ropinirole film-coated tablets (immediate-release) to be taken three times daily.

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

It may take several weeks before ropinirole starts to take effect.

How to take your dose of Rolpryna SR

Take Rolpryna SR once daily, at the same time each day.

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

DO NOT break, chew, or crush the prolonged-release tablets. Doing so may result in an overdose, as the medicine would be released too quickly into your body.

If switching from ropinirole film-coated tablets (immediate-release)

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

Take your ropinirole film-coated tablets (immediate-release) as usual the day before the switch. Then, take your first dose of Rolpryna SR prolonged-release tablets the following morning, and do not take any further doses of ropinirole film-coated tablets (immediate-release).

If you take more Rolpryna SR than you should

If you have taken more Rolpryna SR than prescribed, contact your doctor or pharmacist, go to the nearest hospital immediately, or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount ingested. If possible, show the package.

Symptoms of Rolpryna SR overdose may include: nausea, vomiting, dizziness, somnolence, fatigue (mental or physical tiredness), feeling faint, hallucinations.

If you forget to take Rolpryna SR

Do not take extra tablets or a double dose to make up for missed doses.

If you have forgotten to take Rolpryna SR for one or more days, consult your doctor for advice on how to restart treatment.

If you stop taking Rolpryna SR

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

Take Rolpryna SR for as long as your doctor instructs. Do not discontinue treatment unless advised by your doctor.

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

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

An abrupt discontinuation could lead to a condition called neuroleptic malignant syndrome, which may pose a serious risk to your health. Symptoms include akinesia (loss of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, and depressed level of consciousness (e.g., coma).

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects with Rolpryna SR are more likely to occur at the beginning of treatment or when the dose is increased. These are generally mild and may become less bothersome over time. Inform your doctor if you are concerned about any adverse effects.

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

• feeling faint,
• somnolence,
• nausea.

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

• falling asleep suddenly without feeling sleepy 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 adverse effects (may affect up to 1 in 100 people):

• dizziness or fainting, especially when standing up suddenly (due to a drop in blood pressure),
• feeling very sleepy during the day (excessive somnolence),
• low blood pressure (hypotension),
• mental problems such as delirium (severe confusion), delusional thoughts (irrational beliefs), or paranoia (irrational suspicions),
• hiccups.

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

• allergic reactions such as redness, skin inflammation with itching (urticaria), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing, rash or intense itching (see section 2),

• changes in liver function, which may be detected through blood tests,

• acting aggressively,

• excessive use of Rolpryna SR (desire for higher doses of dopaminergic drugs than needed to control motor symptoms, known as dopamine dysregulation syndrome),

• inability to resist impulses, urges, or temptations to carry out activities that may be harmful to yourself or others, which may include:

• abnormal urge to gamble despite serious personal or family consequences,

• abnormally increased desire and/or sexual behaviors causing significant distress to you or others, such as excessive sexual drive,

• compulsive buying,

• binge eating (excessive eating within a short period of time) or compulsive eating (eating more than normal and more than necessary to satisfy hunger).

• 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 overactivity, euphoria, or irritability,

• spontaneous penile erection.

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

If you are taking Rolpryna SR with L-dopa

People who take Rolpryna SR with L-dopa may develop other adverse effects over time:

• uncontrolled, sudden movements (dyskinesias) are a very common adverse effect. If you are taking L-dopa, you may experience some involuntary 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 your medications.
• a common adverse effect is confusion.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rolpryna SR

Keep out of the reach and sight of children.

Do not use Rolpryna SR after the expiry date stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Rolpryna SR 4 mg prolonged-release tablets

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

Tablet core: hypromellose 2208, lactose monohydrate, colloidal anhydrous silica, carbomer 4.000-11.000 mPa.s, hydrogenated castor oil, magnesium stearate.

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

Appearance of the product and contents of the pack

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

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: July 2023

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/