Prospecto: information for the user

REQUIP-PROLIB 4 mg prolonged-release tablets

ropinirol

Read the entire prospect carefully before starting to take the medicine, because it contains important information for you.

• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• Ifyou experience adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect.See section 4.

1. What is REQUIP-PROLIB and what it is used for

2. What you need to knowbeforestarting totake REQUIP-PROLIB

3. How to take REQUIP-PROLIB

4. Possible adverse effects

5. Storage of REQUIP-PROLIB

6. Contents of the pack and additional information

The active ingredient of REQUIP-PROLIB is ropinirol, whichbelongs to a group of medications called dopamine agonists.Dopamine agonists act in the same way as a natural substance found in the brain, called dopamine.

REQUIP-PROLIB 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. Ropinirol hasa similar effect to natural dopamine and, in this way, reduces the symptoms of Parkinson's disease.

Do not take REQUIP-PROLIB

• if you areallergicto ropinirol or any of the other components of this medication(listed in section 6)
• if you have anyserious kidney disease
• if you have anyliver disease
• • Inform your doctor if you think you are in any of these situations.

Warnings and precautions

Consult your doctoror pharmacist before starting to take REQUIP-PROLIB:

• if you arepregnantor think you may be pregnant
• if you are inlactation
• if you areunder 18 years old
• if you have anyserious heart disease
• if you have anyserious mental disorder
• if you experience anyimpulsive behavior and/or abnormal behavior(see section 4)
• if you haveintolerance to some sugars(e.g. lactose).

Inform your doctor if you notice symptoms such asdepression, apathy, anxiety, fatigue, sweating or painwhen stopping or reducing treatment with REQUIP-PROLIB(known as dopamine agonist withdrawal syndrome or DAWS). If the problems persist after a few weeks,your doctor may need to adjust your treatment.

Inform your doctor if you or your family/caregiver notice that you are developingimpulses or desires to behave in an unusual way 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 asimpulse control disorders and may include behaviors such as pathological gambling, excessive eating or spending, abnormally elevated sexual desire or an increase in sexual thoughts or feelings.Your doctor may need to adjust or stop your treatment.

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

?Inform 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 additional monitoring while taking it.

While taking REQUIP-PROLIB

Inform your doctor if you or your family members notice that you are developing anyabnormal behavior(such as anabnormal need to gambleor anincrease in desires and/or sexual behaviors) while taking REQUIP-PROLIB. Your doctor may need to adjust or stop your treatment.

Smoking and REQUIP-PROLIB

Inform your doctorif you have started or stopped smoking while taking REQUIP-PROLIB. Your doctor may need to adjust your dose.

Other medications and REQUIP-PROLIB

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, including medications based on plants or those obtained without a prescription.

Remember to inform your doctoror pharmacist if you start taking a new medication while taking REQUIP-PROLIB.

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

These medications include:

• theantidepressantfluvoxamine
• medications formental disorders, such as for examplesulpiride
• hormone replacement therapy (HRT)
• metoclopramide, which is used to treatnauseaandstomach acid
• theantibiotics ciprofloxacinorenoxacin
• any othermedication for Parkinson's disease

?Inform your doctorif you are taking or have taken recently any of these medications.

If you are taking the following medications with REQUIP-PROLIB, you may need additional blood tests:

• anticoagulant medications (used to reduce blood clotting) such as Warfarin.

Taking REQUIP-PROLIB with food and drinks

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

Pregnancy and lactation

REQUIP-PROLIB is not recommended during pregnancy, unless your doctor tells you that the benefits for you are greater than any possible risk to the fetus.REQUIP-PROLIB should not be used during lactation, as milk production may be affected.

Inform your doctorimmediately if you are pregnant, think you may be pregnant, or think you may become pregnant. Your doctor will recommend what you should do if you are breastfeeding or plan to breastfeed. Your doctor may recommend that you stop taking REQUIP-PROLIB.

Driving and operating machinery

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

REQUIP-PROLIBmay cause hallucinations (seeing, hearing or feeling things that are not present). If this happens, do not drive or operate machinery.

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

?Consult your doctorif this may affect you.

REQUIP-PROLIB contains lactose, sunset yellow, sodium and hydrogenated ricin oil

This medicationcontainslactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause allergic reactions because it containssunset yellow FCF (E110).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

This medication may cause stomach discomfort and diarrhea because it containshydrogenated ricin oil.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

You may have been prescribed only REQUIP-PROLIB for the treatment of your Parkinson's disease symptoms, or you may also have been prescribed another medication called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience some uncontrollable movements (dyskinesias) when you start taking REQUIP-PROLIB. Inform your doctor if this occurs, as you may need to adjust the doses of the medications you are taking.

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

What dose of REQUIP-PROLIB should you take?

You may need some time to determine what dose of REQUIP-PROLIB is best for you.

The recommended initial doseof REQUIP-PROLIB prolonged-release tablets is 2 mg once a day for the first week. From here, your doctor may increase the dose to 4 mg of REQUIP-PROLIB prolonged-release tablets once a day, during the second week of treatment. In very elderly people, the doctor may increase the dose more slowly. Then, your doctor may adjust the dose to reach the most suitable dose for you. Some people take up to 24 mg of REQUIP-PROLIB prolonged-release tablets each day.

If you experience adverse effects at the start of your treatment that you cannot tolerate, consult your doctor. Your doctor may advise you to change to a lower dose of REQUIP immediate-release tablets that you will take three times a day.

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

You may need several weeks for REQUIP-PROLIB to take effect.

How to take your dose of REQUIP-PROLIB

Take REQUIP-PROLIB once a day, at the same time of day.

Swallow the prolonged-release tablets of REQUIP-PROLIB whole, with a glass of water.

Do not break, chew, or crush the prolonged-release tablets. If you do, there may be a risk of you receiving an excessive dose, because the medication will be released into your body too quickly.

If you change from REQUIP immediate-release tablets

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

Take your REQUIP immediate-release tablets as usual the day before the change. Then, take your REQUIP-PROLIB prolonged-release tablets in the morning, and do not take any more REQUIP immediate-release tablets.

If you take more REQUIP-PROLIB than you should

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

Someone who has experienced 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 forgot to take REQUIP-PROLIB

Do not take extra tablets or a double dose to compensate for the missed doses.

If you have forgotten to take REQUIP-PROLIB for one or several days, consult your doctor to have them recommend how to start taking it again.

If you interrupt the treatment with REQUIP-PROLIB

Do not interrupt the treatment with REQUIP-PROLIB without having consulted beforehand.

Take REQUIP-PROLIB for the time your doctor tells you.Do not suspend the treatment unless your doctor tells you to.

If you suddenly stop the treatment with REQUIP-PROLIB, your Parkinson's disease symptoms may worsen rapidly. A sudden interruption of treatment may cause the appearance of a condition known as neuroleptic malignant syndrome, which can represent a serious risk to your health. The symptoms include: akinesia (loss of muscular movement), muscular rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, decreased level of consciousness (for example, coma).

If you need to stop your REQUIP-PROLIB treatment, your doctor will gradually reduce the dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Reactions to REQUIP-PROLIB usually occur more frequently at the beginning of treatment or when the dose is increased. Side effects are generally mild and may be less bothersome over time. Inform your doctor if you are concerned about side effects.

Very common side effects

These may affectmore than 1 in 10 peoplewho take REQUIP-PROLIB:

• dizziness
• drowsiness
• unpleasantness (nausea).

Common side effects

These may affectup to 1 in 10 peoplewho take REQUIP-PROLIB:

• falling asleep suddenly without feeling sleepy beforehand (sudden sleep episodes)
• hallucinations (seeing things that are not really there)
• vomiting
• dizziness (sensation of spinning)
• heartburn
• stomach pain
• constipation
• swelling of the legs, feet, or hands.

Rare side effects

These may affectup to 1 in 100 peoplewho take REQUIP-PROLIB:

• dizziness or fainting, especially when standing up quickly (this is due to a drop in blood pressure)

• low blood pressure (hypotension)

• excessive daytime somnolence (excessive sleepiness)
• mental problems such as delirium (severe confusion), delusional ideas (irrational ideas) or paranoia (irrational suspicions)
• hypotension.

Some patients may experience the following side effects (frequency not known: cannot be estimated from available data)

• allergic reactions such as redness, inflammation of the skin with itching (hives), swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing, intense itching or hives (see section 2)
• changes in liver function, which can be detected by blood tests
• aggressive behavior
• excessive use of REQUIP-PROLIB (anxiety about taking an excessive dose of dopaminergic medications compared to the necessary dose 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 sex drive, and very concerning behavior for you or others, for example, excessive sexual behavior
• uncontrollable spending or excessive, uncontrolled purchases
• binges (eating large amounts of food in a short period of time) or compulsive eating (eating more food than necessary to satisfy hunger)

• episodes of hyperactivity, 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.

Inform your doctor if you experience any of these behaviors; they will indicate ways to manage or reduce symptoms.

When taking REQUIP-PROLIB with L-dopa

People taking REQUIP-PROLIB with L-dopa may develop other side effects over time:

• very common side effects are involuntary movements (dyskinesias). If you are taking L-dopa, you may experience some involuntary movements (dyskinesias) when starting REQUIP-PROLIB. Inform your doctor if this occurs, as they may need to adjust the doses of the medications you are taking
• a common side effect is confusion.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medicationafter the expiration date that appears on the blister pack and on the packaging. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of REQUIP-PROLIB

The active ingredient of REQUIP-PROLIB is ropinirol.

A prolonged-release tablet contains 4 mg of ropinirol (as hydrochloride).

The other components 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), dibehenato of glycerol.
• Coating film:OPADRY light brown OY-27207 (hypromellose, titanium dioxide (E171), macrogol 400, sunset yellow lake FCF (E110), indigo carmine lake (E132)).

Appearance of the product and contents of the package

REQUIP-PROLIB 4 mg is presented in the form of light brown, prolonged-release tablets, in capsule shape, engraved with “GS” on one face and “WXG” on the other.

REQUIP-PROLIB 4 mg is supplied in packages with blisters of 28 or 84 prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Procedure number: FR/H/111/008

This medicine is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet:June 2023

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