ROPINIROLE KRKA 8 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Ropinirol Krka 8 mg prolonged-release tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

The active substance of Ropinirol Krka is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists work in a similar way to a natural substance called dopamine in the brain.

Ropinirol Krka prolonged-release tablets are used to treat Parkinson's disease.

People with Parkinson's disease have low levels of dopamine in some parts of their brain. Ropinirole has a similar effect to natural dopamine and helps to reduce the symptoms of Parkinson's disease.

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

Do not take Ropinirol Krka if:

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

Tell your doctor if you think you may have any of these conditions.

Warnings and precautions

Consult your doctor or pharmacist before taking Ropinirol Krka

• if you are pregnant or think you may be pregnant,
• if you are breast-feeding,
• if you are under 18 years old,
• if you have severe heart disease,
• if you have severe mental health problems,
• if you have impulse control disorders and/or compulsive behaviour (see section 4)
• if you have an intolerance to some sugars (e.g. lactose).

Tell your doctor if you think you may have any of these conditions. Your doctor will decide if your treatment with Ropinirol Krka is suitable for you, or if you need any additional monitoring while taking it.

Tell your doctor if you or your family/carer notice that you are developing unusual behaviours such as an excessive interest in gambling, or if you are unable to resist the impulse, carry out or have a temptation to carry out certain activities that could be harmful to yourself or others. This is called impulse control disorders and can include behaviours such as excessive gambling, eating, shopping, or an increased sex drive. Your doctor may need to adjust or stop your treatment.

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

Tell your doctor if you or your family/carer notice that you are developing episodes of excessive excitement, euphoria, or irritability (symptoms of mania). These can occur with or without impulse control disorders (see above). Your doctor may need to adjust or stop your treatment.

While taking Ropinirol Krka

Tell your doctor if you or your family notice that you are developing any unusual behaviour (such as an excessive interest in gambling or an increased sex drive) while taking Ropinirol Krka. Your doctor may need to adjust or stop your treatment.

Smoking and Ropinirol Krka

Tell your doctorif you start or stop smoking while taking Ropinirol Krka.

Your doctor may need to adjust your dose.

Other medicines and Ropinirol Krka

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

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

Some medicines may affect the way ropinirole works, or make it more likely that you will have side effects. Ropinirole may also affect the way other medicines work.

These medicines include:

• the antidepressant fluvoxamine,
• medicines for mental health problems, 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.

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

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

• Vitamin K antagonists (used to prevent 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 breast-feeding

Ropinirole should not be used during pregnancy unless your doctor advises that the benefits outweigh the risks. Ropinirole should not be used during breast-feeding as it may affect milk production.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will advise you to stop taking Ropinirol Krka if you are breast-feeding.

Driving and using machines

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

If this happens: do not drive, do not use machines, and do notput yourself in situations where feeling drowsy or falling asleep could put you or others at risk of serious harm or death. Do not engage in 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 some sugars, contact them before taking this medicine.

3. How to take Ropinirol Krka

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Use in children and adolescents

Do not give Ropinirol Krka to children.Ropinirole is not normally prescribed for people under 18 years old.

You may have been prescribed ropinirole on its own to treat your Parkinson's disease symptoms, or you may have been prescribed ropinirole as well as another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience some uncontrollable movements (dyskinesias) when you first start taking ropinirole. If this happens, talk to your doctor, as they may need to adjust the doses of the medicines you are taking.

Ropinirol Krka tablets are designed to release the active substance over a 24-hour period. If you have a condition that makes the medicine pass through your body too quickly, such as diarrhoea, the tablets may not work properly. You may see the tablets in your stool. If this happens, talk to your doctor as soon as possible.

What dose of Ropinirol Krka should you take?

It may take some time to find the best dose of ropinirole for you.

The recommended starting doseof ropinirole prolonged-release tablets is 2 mg once daily for the first week. Your doctor may then increase your dose to 4 mg of ropinirole prolonged-release tablets once daily in the second week of treatment. In elderly people, your doctor may increase your dose more slowly. After this, your doctor may adjust your dose to the best dose for you. Some people may take up to 24 mg of ropinirole prolonged-release tablets each day.

If you experience side effects that you cannot tolerate when you start treatment, talk to your doctor. Your doctor may advise you to switch to a lower dose of ropinirole immediate-release tablets, which you will take three times a day.

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

It may take several weeks for ropinirole to start working.

How to take your dose of Ropinirol Krka

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

Do not break, chew or crushthe prolonged-release tablets. If you do, you may be at risk of receiving a dose that is too high, because the medicine will be released into your body too quickly.

If you switch from ropinirol immediate-release tablets

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

Take your ropinirol immediate-release tablets as usual on the day before you switch. Then, take your ropinirol prolonged-release tablets the next morning, and do not take any more ropinirol immediate-release tablets.

If you take more Ropinirol Krka than you should

If you have taken more ropinirole than you should, talk to a doctor or go to a hospital casualty department straight away, or call the national poison centre on 91 562 04 20, quoting the medicine and the amount taken. If possible, show them the pack.

Someone who has taken an overdose of ropinirole may experience some of the following symptoms: nausea, vomiting, dizziness, drowsiness, fatigue, feeling faint, hallucinations.

If you forget to take Ropinirol Krka

Do not take extra tablets or a double doseto make up for a forgotten dose.

If you have forgotten to take Ropinirol Krka for one or more days, talk to your doctor for advice on how to start taking it again.

If you stop taking Ropinirol Krka

Do not stop taking Ropinirol Krka without talking to your doctor first.

Take Ropinirol Krka for as long as your doctor has told you to. Do not stop taking Ropinirol Krka without talking to your doctor first.

If you suddenly stop taking Ropinirol Krka, your Parkinson's disease symptoms may quickly get much worse.

Do not stop taking Ropinirol Krka suddenly without talking to your doctor first.

A sudden stop could lead to a condition called neuroleptic malignant syndrome, which can be life-threatening. The symptoms include: muscle stiffness, fever, unstable blood pressure, a fast heart rate, confusion, reduced consciousness (e.g. coma).

If you need to stop taking Ropinirol Krka, your doctor will reduce your dose gradually.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Ropinirol Krka side effects are most likely to happen when you first start taking the medicine, or when your dose is increased. These are usually mild and may reduce after a while. If you are concerned about side effects, talk to your doctor.

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

• feeling faint,
• drowsiness,
• nausea.

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

• falling asleep suddenly without feeling sleepy first (sudden onset of sleep),

• hallucinations (seeing, hearing, or feeling things that are not 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 quickly (this is due to low blood pressure),
• low blood pressure (hypotension),

• feeling very drowsy during the day (excessive daytime somnolence),
• mental problems such as delirium (severe confusion), delusional thoughts (irrational thoughts) or paranoia (irrational suspicions),
• drooling.

Some patients may have the following side effects(frequency not known: cannot be estimated from the 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 in swallowing or breathing, rash or intense itching (see section 2),

• changes in liver function, which can be detected by blood tests,
• aggressive behaviour,
• excessive use of Ropinirol Krka (anxiety about taking an excessive dose of dopaminergic medicines in relation to the dose needed to control motor symptoms, known as dopamine dysregulation syndrome),
• inability to resist the impulse, realisation or temptation to perform acts that could be harmful to yourself or others, which may include:
• an excessive interest in gambling, despite serious personal or family consequences,
• an abnormal increase in sex drive or sexual behaviour that causes you or others distress,
• compulsive shopping,
• binge eating (eating large amounts of food in a short time) or compulsive eating (eating more than normal and more than is needed 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 DAWS),
• episodes of excessive excitement, euphoria, or irritability,
• spontaneous erections.

Tell your doctor if you experience any of these behaviours.Your doctor will advise you on ways to manage or reduce the symptoms.

If you are taking ropinirole with L-dopa

People who take ropinirole with L-dopa may develop other side effects after some 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 ropinirole. Talk to your doctor if this happens, as they may need to adjust the dose of the medicines you are taking,
• a common side effect is confusion.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ropinirol Krka

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional 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 ingredients 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, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172). See section 2 "Ropinirol Krka contains lactose".

Appearance and Packaging of the Product

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

biconvex and oval.

The tablets are available in packs of 10, 21, 28, 30, 42, 60, 84 and 90 prolonged-release tablets

in blisters (OPA/Al/PVC//Al).

Only some 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

Further information about this medicinal product can be obtained from 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 on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/