Package Leaflet: Information for the User

Ropinirol Krka 8 mg prolonged-release tablets EFG

Read this 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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

Ropinirol Krka 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 TAKE Ropinirol Krka if:

• you are allergic to ropinirol or any of the other ingredients of this medicine (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 Ropinirol Krka.

• 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 severe 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 Ropinirol Krka is suitable for you, or if you need any additional monitoring while taking it.

Inform your doctor if you or your family/caregiver notice that you are developing any abnormal behavior for you, or if you cannot resist impulses, or if you make or have temptations to make 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, an abnormal increase in desires and/or sexual 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 DAWS). 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 Ropinirol Krka

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

Smoking and Ropinirol Krka

Inform your doctorif you have started or stopped smoking while taking Ropinirol Krka.

Your doctor may need to adjust your dose.

Other medicines and Ropinirol Krka

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including medicines based on plants or those obtained without a prescription.

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

Some medicines may affect the way ropinirol works, or make it more likely that you will have side effects. Ropinirol 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, which is used to treat nausea and stomach acid,
• the antibiotics ciprofloxacin or enoxacin,
• any other medicine for Parkinson's disease.

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

You will need to have additional blood testsif you are taking these medicines with Ropinirol Krka:

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

Taking Ropinirol Krka with food, drinks and alcohol

You can take Ropinirol Krka with or without food.

Pregnancy and breastfeeding

Ropinirol should not be used during pregnancy, unless your doctor tells you that the benefits for you are greater than any possible risk to the fetus. Ropinirol should not be used during breastfeeding, as milk production may be affected.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will recommend what you should do if you are breastfeeding or plan to breastfeed. Your doctor may recommend that you stop treatment with Ropinirol Krka.

Driving and operating machines

Ropinirol Krkamay make you feel drowsy. In rare cases Ropinirol Krkamay make you feel extremely drowsy, and sometimes you may fall asleep suddenly without warning.

If you experience this:do not drive, do not use machines, 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 perform these activities until you are no longer affected.

Ropinirol Krka contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in children and adolescents

Do not give Ropinirol Krka to children.Ropinirol is not normally prescribed to minors under 18 years old.

You may have been prescribed only ropinirol 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 movements (dyskinesias) when you start taking ropinirol. Consult your doctor if this occurs, as you may need to adjust the doses of the medications you are taking.

The Ropinirol Krka tablets have been designed to release the drug 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 work correctly. You may see the tablets in your stool. If this occurs, inform your doctor as soon as possible.

What dose of Ropinirol Krka should you take?

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

Initial recommended doseof ropinirol prolonged-release tabletsis 2 mg once a day for the first week. From here, your doctor may increase the dose to 4 mg of ropinirol prolonged-release tablets once a day, during the second week of treatment. In older people, the doctor may increase the dose more slowly. Your doctor may then adjust the dose to reach the most suitable dose for you. Some people may take up to 24 mg of ropinirol prolonged-release tablets each day.

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

Do not take more Ropinirol Krka tablets than your doctor has prescribed.

You may need several weeks for ropinirol to take effect.

How to take your Ropinirol Krka dose

Take Ropinirol Krka once a day, at the same time of day.

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

If you change from ropinirol film-coated tablets (immediate-release)

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

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

If you take more Ropinirol Krka than you should

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

Someone who has suffered a ropinirol overdose may have some of the following symptoms: nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical exhaustion), feeling of fainting, hallucinations.

If you forget to take Ropinirol Krka

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

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

If you interrupt the treatment with Ropinirol Krka

Do not interrupt the treatment with Ropinirol Krka without consulting your doctor.

Take Ropinirol Krka for the time your doctor tells you. Do not suspend the treatment unless your doctor tells you to.

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

Do not stop taking Ropinirol Krka 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 Ropinirol Krka 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 Ropinirol Krka are more likely to occur at the start 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 affectmore than 1 in 10 people):

• dizziness,
• drowsiness,
• nausea.

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

• falling asleep suddenly without feeling tired beforehand (sudden onset of sleep),

• 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 affectup to 1 in 100 people):

• dizziness or fainting, especially when standing up suddenly (this is due to a drop in blood pressure),
• low blood pressure (hypotension),

• excessive daytime sleepiness (excessive somnolence),
• 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 Ropinirol Krka (anxiety about taking an excessive dose of dopaminergic medications compared to the necessary dose 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,
• binge eating (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 Ropinirol Krka: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or SAAD) may occur,
• episodes of hyperactivity, euphoria, or irritability,
• spontaneous penile erection.

Inform your doctor if you experience any of these behaviors,they will indicate ways to manage or reduce symptoms.

When taking ropinirol with L-dopa

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

• uncontrollable 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 Ropinirol Krka. 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:www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

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

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Ropinirol Krka 8 mg prolonged-release tablets composition

• The active ingredient is ropinirol. Each prolonged-release tablet contains 8 mg of ropinirol (as hydrochloride).
• The other components are:

Tablet core:hypromellose 2208, lactose monohydrate, anhydrous colloidal silica, carbomer 4.000-11.000 mPa.s, hydrogenated ricin oil, magnesium stearate.Capsule coating:hypromellose 2910, titanium dioxide (E171), macrogol 400, iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172). See section 2 “Ropinirol Krka contains lactose”.

Appearance of the product and contents of the package

Ropinirol Krka 8 mg are prolonged-release tablets of reddish-brown color,

biconvex and oval.

The tablets are available in packages of 10, 21, 28, 30, 42, 60, 84, and 90 prolonged-release tablets in blister (OPA/Al/PVC//Al).

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

or

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more information about this medicine, please contact 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

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/)