ROLPRYNA SR 8 mg PROLONGED-RELEASE TABLETS

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

DO NOT TAKE Rolpryna 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 starting treatment with 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 severe heart disease,
• if you have severe mental health problems,
• if you have impulsive behaviour and/or abnormal behaviour(see section 4),
• if you have 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 members/caregivers notice that you are developing any abnormal behaviour for you or if you cannot resist impulses, perform or have temptations to perform certain activities that may be harmful to you or others. This is known as impulse control disorders and may include behaviours such as an abnormal need to gamble, eat excessively or compulsively, make compulsive purchases, an abnormal increase in sexual desires and/or behaviours. 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 the problems persist after a few weeks, your doctor may need to adjust your treatment.

Tell your doctor if you or your family members/caregivers notice that you are developing episodes of overactivity, 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 Rolpryna SR

Tell your doctor if you or your family members observe that you are developing any abnormal behaviour (such as an abnormal need to gamble money or an increase in sexual desires and/or behaviours) while taking Rolpryna SR. Your doctor may need to adjust or stop your treatment.

Smoking and Rolpryna SR

Tell your doctorif 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 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 may affect the effect of Rolpryna SR or make it more likely that you will have side effects. Rolpryna SR 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 Rolpryna SR:

• Vitamin K antagonists (used to reduce 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 is not recommended during pregnancy, unless your doctor advises you that the benefit for you is greater than the possible risk to the fetus. Rolpryna SR should not be used during breast-feeding, as milk production may be affected.

Tell your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will advise you what to do if you are breast-feeding or plan to breast-feed. Your doctor may recommend that you stop treatment with Rolpryna SR.

Driving and using machines

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

If you experience this: 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, consult your doctor before taking this medicine.

3. How to take Rolpryna SR

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Use in children and adolescents

Do not give Rolpryna SR to 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 another medicine called L-dopa (also called levodopa) as well. If you are taking L-dopa, you may experience some uncontrolled movements (dyskinesias) when you first start taking ropinirole. Consult your doctor if this happens, as you may need to have your L-dopa dose adjusted.

The Rolpryna SR tablets are designed to release the medicine 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 dissolve completely and may not work properly. You may see the tablets in your stools. 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 initial doseof Rolpryna SR prolonged-release tablets is 2 mg once daily for the first week. From then on, 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 people, the doctor may increase the dose more slowly. After that, your doctor may adjust the dose until you reach the dose that is best 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 start treatment, consult your doctor. Your doctor may advise you to switch to a lower dose of ropinirole film-coated tablets (immediate release) that you will take three times a day.

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

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 receiving a higher dose, 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) you are taking.

Take your ropinirole film-coated tablets (immediate release) as usual 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, consult your doctor or pharmacist, go to the nearest hospital immediately or call the Poison Information Service. Telephone: 91 562 04 20 indicating the medicine and the amount taken. If possible, show the packaging.

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

If you forget to take Rolpryna SR

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

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

If you stop taking Rolpryna SR

Do not stop taking Rolpryna SR without consulting your doctor.

Take Rolpryna SR for as long as your doctor tells you to. Do not stop treatment unless your doctor tells you to.

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

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

A sudden stop could cause the development of a condition called neuroleptic malignant syndrome, which can be a serious risk to your health. The symptoms are akinesia (loss of muscle movement), muscle stiffness, fever, unstable blood pressure, rapid heart rate, confusion, decreased level of consciousness (e.g. coma).

If you need to stop your treatment with Rolpryna SR, your doctor will gradually reduce your dose.

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

4. Possible side effects

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

The side effects of Rolpryna SR are more likely to happen when you first start treatment, or when your dose is increased. These are usually mild and may be less troublesome after a while. Tell your doctor if you are worried about side effects.

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

• feeling of fainting,
• drowsiness,
• nausea.

Common side 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 side effects (may affect up to 1 in 100 people):

• dizziness or fainting, especially when standing up quickly (this is due to a drop in blood pressure),
• low blood pressure (hypotension),
• feeling very drowsy during the day (excessive daytime sleepiness),
• mental problems such as delirium (severe confusion), delusional thoughts (irrational thoughts) or paranoia (irrational suspicions),
• hypo.

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 that may cause difficulty 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 (desire for higher doses of dopaminergic drugs than needed to control motor symptoms, known as dopamine dysregulation syndrome),
• inability to resist impulses, performing or having temptations to perform activities that may be harmful to you or others, which may include:

• abnormal need to gamble money despite serious personal or family consequences,
• an abnormal increase in sexual desires and/or behaviours that cause you or others great concern, such as an exaggerated sexual impulse,
• compulsive shopping,
• binge eating (eating excessively in a short period) 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 (called dopamine agonist withdrawal syndrome or DAWS),

• episodes of overactivity, euphoria or irritability,
• spontaneous penile erection.

Tell your doctor if you experience any of these behaviours, he 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 side effects after a while:

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

Keep out of the reach and sight of children.

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

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rolpryna SR 8 mg prolonged-release tablets

• The active ingredient 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 "Rolpryna SR contains lactose".

Appearance and Package Contents of the Product

Rolpryna SR 8 mg are prolonged-release tablets of reddish-brown color, biconvex and oval.

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 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

TAD PHARMA GmbH Heinz Lohmann strasse, 5 D-27472 Cuxhaven, Germany

You can request more information about this medication by contacting 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 medication is authorized 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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/