ROLPRYNA SR 2 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Rolpryna SR

DO NOT TAKERolpryna SRif:

• you are allergicto the active substance 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 Rolpryna SR:

• if you are pregnantor think you may be pregnant,
• if you are breast-feeding,
• if you are under 18 years old,
• if you have a serious heart condition,
• if you have a serious mental health problem,
• if you have a history of 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 Rolpryna SR 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 behaviour (such as an unusual urge to gamble or increased sexual urges or behaviours). This is called impulse control disorders and can include behaviours such as excessive eating or shopping. 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 you stop or reduce your treatment with ropinirole (called dopamine agonist withdrawal syndrome or DAWS).If the 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 enthusiasm, overactivity 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 Rolpryna SR

Tell your doctor if you or your family notice that you are developing unusual behaviour (such as an unusual urge to gamble or increased sexual urges or behaviours) while taking Rolpryna SR. Your doctor may need to adjust or stop your treatment.

Smoking and Rolpryna SR

Tell your doctorif you start or stop 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 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 Rolpryna SR.

Some medicines can affect the way Rolpryna SR works, or make it more likely that you will have side effects. Rolpryna SR can also affect the way some 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 Rolpryna SR:

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

Taking Rolpryna SR with food and drink

You can take Rolpryna SR with or without food.

Pregnancy and breast-feeding

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.

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

Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to become pregnant. Your doctor will advise you what to do if you are breast-feeding or think you may be pregnant.

Driving and using machines

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

If this happens to you: 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.

Rolpryna SR 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 Rolpryna SR

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 giveRolpryna SRto children.Rolpryna SR is not normally prescribed for people under 18 years old.

You may have been prescribed Rolpryna SR alone for the treatment of your Parkinson's disease symptoms, or you may have been prescribed Rolpryna SR in addition to another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience some uncontrolled movements (dyskinesias) when you first start taking ropinirole. If this happens, talk to your doctor, as you may need to have your L-dopa dose adjusted.

The Rolpryna SR 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, tell your doctor as soon as possible.

What dose of Rolpryna SR should you take?

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

The recommended starting doseof Rolpryna SR prolonged-release tablets is 2 mg once daily for the first week. After this, your doctor may increase your dose to 4 mg of Rolpryna SR prolonged-release tablets once daily, during the second week of treatment. In elderly people, the doctor may increase the 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 Rolpryna SR prolonged-release tablets each day.

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

Do not take more Rolpryna SR tablets than your doctor hasprescribed.

It may take several weeks for ropinirole to start working.

How to take your dose of Rolpryna SR

Take Rolpryna SR once a day, 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. If you do, you may be at risk of getting too much medicine at once, because the medicine will be released into your body too quickly.

If you switch 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) that you are taking.

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

If you take more Rolpryna SR than you should

If you have taken more Rolpryna SR than you should, talk to a doctor or pharmacist immediately, go to the nearest hospital casualty department or call the Poisons Information Service on 91 562 04 20, quoting the medicine and the amount you have taken. If possible, show them the pack.

Someone who has taken an overdose of Rolpryna SR may experience some of the following symptoms: nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical), feeling faint, hallucinations.

If you forget to take Rolpryna SR

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

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

If you stop taking Rolpryna SR

Do not stop taking Rolpryna SR without talking to your doctor.

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

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

Do not stop taking Rolpryna SR suddenly without talking to your doctor.

Suddenly stopping treatment may cause a condition called neuroleptic malignant syndrome, which can be life-threatening. The symptoms include: muscle stiffness, fever, unstable blood pressure, rapid heartbeat, confusion, reduced level of consciousness (e.g. coma).

If you need to stop taking Rolpryna SR, 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.

Rolpryna SR 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 become less troublesome 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):

• suddenly falling asleep without feeling sleepy first (sudden sleep episodes),
• 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 extremely drowsy during the day (excessive daytime sleepiness),
• mental problems such as severe confusion (delirium), irrational ideas (delusions) 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 rash 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 with blood tests,
• aggressive behaviour,
• excessive use of Rolpryna SR (a desire for higher doses of dopaminergic drugs than needed to control motor symptoms, known as dopamine dysregulation syndrome),
• inability to resist the impulse to perform an action that could be harmful, which may include:

• an abnormal desire to gamble despite serious personal or family consequences,
• a significant increase in sexual desires or behaviours that cause concern to you or others, such as an increased sexual drive,
• compulsive shopping,
• binge eating (eating large amounts of food in a short time) or compulsive eating (eating more than normal and more than needed 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 excessive enthusiasm, overactivity or irritability,
• spontaneous erection.

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

If you are taking Rolpryna SR with L-dopa

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

• uncontrolled movements (dyskinesias) are a very common side effect. If you are taking L-dopa, you may experience some uncontrolled movements when you first start taking Rolpryna SR. If this happens, talk to your doctor, as you may need to have your L-dopa dose adjusted,
• confusion is a common side effect.

Reporting of side effects

If you get 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 Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rolpryna SR

Keep out of the sight and reach of children.

Do not use Rolpryna SR after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

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 to protect the environment.

6. Package Contents and Additional Information

Composition ofRolpryna SR 2 mgprolonged-release tablets

• The active substance is ropinirol. Each prolonged-release tablet contains 2 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). See section 2 "Rolpryna SR contains lactose".

Appearance and Package Contents of the Product

Rolpryna SR 2 mg are pink, biconvex, and oval prolonged-release tablets.

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

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 strasse, 5 D-27472 Cuxhaven, Germany

You can request more information about this medicinal product by contacting 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/