Ropinirole Krka 8 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ropinirol Krka 8 mg prolonged-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ropinirol Krka is and what it is used for
2. What you need to know before taking Ropinirol Krka
3. How to take Ropinirol Krka
4. Possible side effects
5. How to store Ropinirol Krka
6. Contents of the pack and other information

1. What is Ropinirol Krka and what is it used for?

The active substance in Ropinirol Krka is ropinirole, 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. Ropinirole has an effect similar to natural dopamine and thereby reduces the symptoms of Parkinson's disease.

2. What you need to know before starting to take Ropinirol Krka

DO NOT TAKE Ropinirol Krka if:

• you are allergic to ropinirol or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney disease,
• if you have 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 starting to take Ropinirol Krka

• if you are pregnant or think you might be pregnant,
• if you are breastfeeding,
• if you are under 18 years of age,
• if you have serious heart problems,
• if you have severe mental disorders,
• if you experience impulse control disorders and/or abnormal behavior (see section 4),
• if you have an intolerance to certain sugars (e.g.: lactose).

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

Inform your doctor if you or your family members/caregiver notice that you are developing any abnormal behavior or if you are unable to resist impulses, or feel urges or temptations to carry out certain activities that could be harmful to yourself 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 abnormally increased desire and/or sexual 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 ropinirol (called 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 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 need to adjust or stop your treatment.

While taking Ropinirol Krka

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 increased desire and/or sexual behaviors) while taking Ropinirol Krka. Your doctor may need to adjust or stop your dosage.

Smoking and Ropinirol Krka

Inform your doctor if 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 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 on Ropinirol Krka.

Some medicines may affect the action of ropinirol, or make it more likely that you will experience 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, 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 may need additional blood tests if you are taking these medicines with Ropinirol Krka:

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

Taking Ropinirol Krka with food, drinks, and alcohol

You may take Ropinirol Krka with or without food.

Pregnancy and breastfeeding

The use of ropinirol during pregnancy is not recommended unless your doctor considers that the benefit to you outweighs 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will advise you on what to do if you are breastfeeding or plan to breastfeed. Your doctor may recommend that you stop treatment with Ropinirol Krka.

Driving and using machines

Ropinirol Krka may make you feel sleepy. In very rare cases, Ropinirol Krka may make you feel extremely sleepy, and occasionally may cause you to fall asleep suddenly without warning.

If this happens: do not drive, do not use machines, and do not engage in activities where feeling sleepy or falling asleep could put you (or others) at risk of serious injury or death. Avoid such 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 him before taking this medicine.

3. How to take Ropinirol Krka

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 Ropinirol Krka to children. Ropinirol is normally not prescribed for patients under 18 years of age.

You may have been prescribed ropinirol 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 may experience some involuntary movements (dyskinesias) when you start taking ropinirol. Consult your doctor if this occurs, as you may need adjustments in the doses of the medicines you are taking.

Ropinirol Krka tablets are designed to release the drug over a 24-hour period. If you have any 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 Ropinirol Krka should you take?

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

The recommended starting dose of ropinirol prolonged-release tablets is 2 mg once daily during the first week. From there, your doctor may increase the dose to 4 mg of ropinirol prolonged-release tablets once daily during the second week of treatment. In elderly patients, the doctor may increase the dose more slowly. Afterwards, your doctor may adjust the dose until reaching the most appropriate dose for you. Some patients may take up to 24 mg of ropinirol 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 ropinirol film-coated tablets (immediate-release) which you would take three times daily.

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

It may take several weeks before ropinirol starts to work.

How to take your dose of Ropinirol Krka

Take Ropinirol Krka once daily, at the same time each day.

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

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

Your doctor will adjust your dose of ropinirole 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 ropinirole prolonged-release tablets the following morning, and do not take any further ropinirole film-coated tablets (immediate-release).

If you take more Ropinirol Krka than you should

If you have taken more ropinirole than you should, contact your doctor or go immediately to the nearest hospital, or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medication and the amount taken. If possible, show the package.

Someone who has overdosed on ropinirole may experience one or more of the following symptoms: nausea, vomiting, dizziness, somnolence, fatigue (mental or physical tiredness), feeling faint, hallucinations.

If you forget to take Ropinirol Krka

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

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

If you stop taking Ropinirol Krka

Do not stop treatment with Ropinirol Krka without consulting your doctor.

Take Ropinirol Krka for as long as your doctor prescribes. Do not discontinue treatment unless instructed by your doctor.

If you stop treatment with Ropinirol Krka abruptly, symptoms of your Parkinson's disease may worsen rapidly.

Do not stop taking Ropinirol Krka suddenly without consulting your doctor.

An abrupt discontinuation could lead to the development of 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 treatment with Ropinirol Krka, 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 Ropinirol Krka 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 (sleepiness),
• 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 (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 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 swelling 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 by blood tests,
• acting aggressively,
• excessive use of Ropinirol Krka (impulse to take more than the required dose of dopaminergic medication 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 concern to you or others, such as excessive sexual drive,
• compulsive shopping,
• binge eating (excessive eating within a short period of time) or compulsive eating (eating more than normal and more than needed to satisfy appetite).
• after stopping or reducing treatment with Ropinirol Krka: 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 ways to manage or reduce the symptoms.

If you are taking ropinirol with L-dopa

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to 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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ropinirol Krka

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ropinirol Krka 8 mg prolonged-release tablets

• The active substance is ropinirol. Each prolonged-release tablet contains 8 mg of ropinirol (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 “Ropinirol Krka contains lactose”.

Nature of the product and contents of the container

Ropinirol Krka 8 mg are prolonged-release tablets, brownish-red in colour, biconvex and oval-shaped.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 further information about 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 most recent review 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/)