REQUIP-PROLIB 8 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take REQUIP-PROLIB

Do not take REQUIP-PROLIB

• if you are allergicto ropinirol or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney disease
• if you have liver disease.
• • Tell your doctor if you think you have any of these conditions.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take REQUIP-PROLIB:

• 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 or abnormal behaviour(see section 4)
• if you have intolerance to some sugars(e.g. lactose).

Tell your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating or painwhen you stop or reduce treatment with REQUIP-PROLIB (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 impulses or desires to behave abnormally for you and that you cannot resist the impulse, desire or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorders and can include behaviours such as pathological gambling, excessive eating or spending, abnormally increased sexual desire or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your treatment.

Tell your doctor if you or your family/carer notice that you are developing episodes of overactivity, 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.

Tell your doctorif you think you are in any of these situations. Your doctor will decide if your treatment with REQUIP-PROLIB is suitable for you, or if you need any additional monitoring while taking it.

While taking REQUIP-PROLIB

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

Smoking and REQUIP-PROLIB

Tell your doctorif you start or stop smoking while taking REQUIP-PROLIB. Your doctor may need to adjust your dose.

Other medicines and REQUIP-PROLIB

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 doctoror pharmacist if you start taking a new medicine while taking REQUIP-PROLIB.

Some medicines may affect the effect of REQUIP-PROLIB, or make it more likely that you will have side effects. REQUIP-PROLIB may also affect the way other medicines work.

These medicines include:

• the antidepressantfluvoxamine
• 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 ciprofloxacinor enoxacin
• any other medicine for Parkinson's disease.

Tell your doctorif you are taking or have recently taken any of these medicines.

If you are taking the following medicines with REQUIP-PROLIB, you may need to have extra blood tests:

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

Taking REQUIP-PROLIB with food and drink

You can take REQUIP-PROLIB with or without food, as you prefer.

Pregnancy and breast-feeding

REQUIP-PROLIB is not recommended during pregnancy

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

Driving and using machines

REQUIP-PROLIB may make you feel drowsy. Some people may feel extremely drowsyor fall asleep suddenly without warning.

REQUIP-PROLIB may cause hallucinations (seeing, hearing or feeling things that are not there). If this happens, do not drive or use machines.

If you experience this: do not drive, do not use machinesand do notput yourself in situations where feeling drowsy or falling asleep could put you or others at risk of serious injury or death. Do not do these activities until you are no longer affected.

Ask your doctorif this could affect you.

REQUIP-PROLIBcontains lactose, sodium and hydrogenated castor oil

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially, “sodium-free”.

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

3. How to take REQUIP-PROLIB

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist.If you are not sure, ask your doctor or pharmacist again.

Do not give REQUIP-PROLIB to children. REQUIP-PROLIB is not normally prescribed for people under 18 years old.

You may have been prescribed REQUIP-PROLIB alone for the treatment of your Parkinson's disease symptoms, or you may have been prescribed REQUIP-PROLIB 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 start taking REQUIP-PROLIB. Tell your doctor if this happens, as they may need to adjust the doses of the medicines you are taking.

The prolonged-release tablets of REQUIP-PROLIB have been designed to release the active substance over a 24-hour period. If you are in a state where medicines pass through your body very quickly, for example with diarrhea, the tablet may not dissolve completely and may not work properly. You may see tablets in your stools. If this happens, tell your doctor as soon as possible.

What dose of REQUIP-PROLIB should you take?

It may take some time to find the best dose of REQUIP-PROLIB for you.

The recommended initial doseof REQUIP-PROLIB 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 REQUIP-PROLIB 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 to the level that is best for you. Some people take up to 24 mg of REQUIP-PROLIB prolonged-release tablets each day.

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

Do not take more REQUIP-PROLIB tablets than your doctor has recommended.

It may take several weeks for REQUIP-PROLIB to work.

How to take your dose of REQUIP-PROLIB

Take REQUIP-PROLIB once daily, at the same time each day.

Swallow the REQUIP-PROLIB 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 high dose, because the medicine will be released into your body too quickly.

If you are switching from REQUIP film-coated tablets (immediate release)

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

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

If you take more REQUIP-PROLIB than you should

Contact your doctor or pharmacist immediately. If possible, show them the REQUIP-PROLIB pack.

Someone who has taken an overdose of REQUIP-PROLIB 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 REQUIP-PROLIB

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

If you have forgotten to take REQUIP-PROLIB for one or more days, talk to your doctor to find out how to start taking it again.

If you stop taking REQUIP-PROLIB

Do not stop taking REQUIP-PROLIB without talking to your doctor first.

Take REQUIP-PROLIB for as long as your doctor recommends.Do not stop treatment unless your doctor tells you to.

If you stop taking REQUIP-PROLIB suddenly, your Parkinson's disease symptoms may quickly get worse. Stopping treatment suddenly may cause you to develop a condition called neuroleptic malignant syndrome, which can be life-threatening. The symptoms include: 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 taking REQUIP-PROLIB, your doctor will reduce your dose gradually.

If you have any other questions about 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.

REQUIP-PROLIB side effects are more likely to happen when you first start taking the medicine or when your dose is increased. The side effects 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

These may affect more than 1 in 10 peopletaking REQUIP-PROLIB:

• fainting
• drowsiness
• nausea.

Common side effects

These may affect up to 1 in 10 peopletaking REQUIP-PROLIB:

• sudden onset of sleep (sudden sleep episodes)
• hallucinations (seeing things that are not really there)
• vomiting
• dizziness (feeling of spinning)
• heartburn
• stomach pain
• constipation
• swelling of the legs, feet or hands.

Uncommon side effects

These may affect up to 1 in 100 peopletaking REQUIP-PROLIB:

• 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), delusions (irrational ideas) or paranoia (irrational suspicions)
• hypothermia.

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 (hives), 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 REQUIP-PROLIB (anxiety about taking too much of the dopaminergic medication needed to control motor symptoms, known as dopamine dysregulation syndrome)
• inability to resist the impulse, desire or temptation to perform certain actions that may be harmful to you or others, which may include:

• strong impulse to gamble excessively, despite significant personal or family consequences
• altered or increased sexual interest and behaviour, and behaviour that is very worrying for you or others, for example excessive sexual behaviour
• uncontrollable shopping or spending
• binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than needed to satisfy hunger)

• episodes of overactivity, euphoria or irritability

• after stopping or reducing treatment with REQUIP-PROLIB: depression, apathy, anxiety, fatigue, sweating or pain (known as dopamine agonist withdrawal syndrome or DAWS)
• spontaneous penile erection.

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

If you are taking REQUIP-PROLIB with L-dopa

People who take REQUIP-PROLIB with L-dopa may develop other side effects after a while:

• very common side effects are uncontrolled movements (dyskinesias). If you are taking L-dopa, you may experience some uncontrolled movements (dyskinesias) when you start taking REQUIP-PROLIB. Tell your doctor if this happens, as they may need to adjust the doses 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, even if they are 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. Storage of REQUIP-PROLIB

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 blister and on the carton. The expiry date is the last day of the month stated.

Do not store above 25°C. Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of REQUIP-PROLIB

The active substance of REQUIP-PROLIB is ropinirole.

One prolonged-release tablet contains 8 mg of ropinirole (as hydrochloride).

The other ingredients are:

• Prolonged-release tablet core:hypromellose, hydrogenated ricin oil, sodium carmellose, povidone (K29-32), maltodextrin, magnesium stearate, lactose monohydrate, anhydrous colloidal silica, mannitol (E421), yellow iron oxide (E172), glycerol dibehenate.
• Coating film:OPADRY red 03B25227 (hypromellose, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), macrogol 400, red iron oxide (E172)).

Appearance and Package Contents of the Product

REQUIP-PROLIB 8 mg is presented in the form of red, capsule-shaped, prolonged-release tablets, engraved with "GS" on one face and "5CC" on the other.

REQUIP-PROLIB 8 mg is supplied in packs with blisters of 28 or 84 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Procedure Number: FR/H/111/009

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany, Austria, Belgium, Ireland, Luxembourg, Netherlands: Requip modutab

Finland and Sweden: Requip Depot

France and Portugal: Requip LP

Greece: Requip XL

Italy: Requip

Spain: Requip Prolib

Date of the Last Revision of this Leaflet:June 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/