Package Insert: Information for the User

REQUIP 5 mg Film-Coated Tablets

ropinirol (as hydrochloride)

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• Ifyou experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

6. Contents of the pack and additional information

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

REQUIP is 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 has a similar effect to natural dopamine and, in this way, reduces the symptoms of Parkinson's disease.

Do not take REQUIP

• if you areallergicto ropinirol or any of the other components of this medication (listed in section6)
• if you have anyserious kidney disease
• if you have anyliver disease

?Inform your doctorif you think you have any of these conditions.

Warnings and precautions

Consult your doctor or pharmacist before starting to take REQUIP:

• 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(such as an excessive need to gamble or excessive sexual behavior)
• if you haveintolerance to some sugars(such as lactose).

Inform your doctor if you notice symptoms such asdepression, apathy, anxiety, fatigue, sweating, or painwhen stopping or reducing treatment with REQUIP(called dopamine agonist withdrawal syndrome or SAAD). 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 developing impulses 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 (see above).Your doctor may need to adjust or stop your treatment.

?Inform your doctor,if you think you have any of these conditions. Your doctor will decide if your treatment with REQUIP is suitable for you, or if you need additional monitoring while taking it.

While taking REQUIP

Inform your doctor if you or your family members notice that you are developing any abnormal behavior (such as an abnormal need to gamble or an increase in sexual desires and/or behaviors) while taking REQUIP.

Your doctor may need to adjust or stop your dosage.

Driving and operating machines

REQUIP may make you feel drowsy.Some people may feel extremely drowsy, and occasionally fall asleep suddenly without warning.

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

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

?Consult your doctorif this may affect you.

Smoking and REQUIP

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

Other medications andREQUIP

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including herbal remedies or those obtained without a prescription. Remember to inform your doctor or pharmacist if you start taking a new medication while taking REQUIP.

Some medications may affect the way REQUIP works, or make it more likely that you will experience side effects. REQUIP may also alter the way other medications work.

These medications include:

• theantidepressantfluvoxamine
• medications formental disorders, such assulpiride
• hormone replacement therapy (also calledTHS)
• metoclopramide, which is used to treatnauseaandheartburn
• theantibioticsciprofloxacin or enoxacin
• 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,you may need additional blood tests:

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

Taking REQUIP with food and drinks

If you take REQUIP with food, it may reduce the likelihood of experiencing nausea or vomiting. It is best to take it with food whenever possible.

Pregnancy and lactation

REQUIP is not recommended during pregnancy, unless your doctor tells you that the benefits for you outweigh any possible risks to the fetus.REQUIP 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.

REQUIP contains lactose and sodium

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

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

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

You may have been prescribed REQUIP only for the treatment of your Parkinson's disease symptoms, or you may also have been prescribed another medication called L-dopa (levodopa).

Do not give REQUIP to children. REQUIP is usually not prescribed to minors under 18 years old.

What dose of REQUIP should you take?

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

The initial normal doseis 0.25 mg three times a day during the first week. From here, your doctor will increase your dose each week, for the next three weeks. Then, your doctor will gradually increase the dose until you take the most suitable dose for you. The normal dose is 1 mg to 3 mg three times a day (which makes a total daily dose of 3 to 9 mg). If your Parkinson's disease symptoms do not improve enough, your doctor may decide to gradually increase the dose to higher doses. Some people take up to 8 mg of REQUIP three times a day (a total of 24 mg per day).

If you are also taking other medications for Parkinson's disease, your doctor may advise you to gradually reduce the dose of these. If you are taking L-dopa you may experience some involuntary movements (dyskinesias) when you start treatment with REQUIP. Inform your doctor if this happens, as your doctor may need to adjust the dose of the medications you are taking.

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

You may need several weeks for REQUIP to take effect.

How to take your REQUIP dose

Take REQUIP three times a day.

Swallow the REQUIP tablets,with a glass of water.It is better to take REQUIP with food, as this reduces the likelihood of nausea.

If you take more REQUIP than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Someone who has suffered a REQUIP overdose may have some of the following symptoms: nausea, vomiting, dizziness (feeling of spinning), drowsiness, fatigue (mental or physical tiredness), feeling of fainting, hallucinations.

If you forgot to take REQUIP

Do not take extra tablets or a double dose to make up for the missed doses.Take the next dose at the usual time.

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

If you interrupt the treatment with REQUIP

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

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

If you suddenly stop treatment with REQUIP, your Parkinson's disease symptoms may worsen rapidly.A sudden interruption of treatment could 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 suspend your REQUIP treatment, your doctor will gradually reduce your dose.

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

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

It is more likely that the side effects of REQUIP will appear at the beginning of treatment or when the dose is increased. These 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 patientswho take REQUIP:

• dizziness
• drowsiness
• nausea

Common side effects

These may affectup to 1 in 10 patientswho take REQUIP:

• hallucinations (seeing things that are not really there)
• vomiting
• dizziness (feeling like you are spinning)
• heartburn
• stomach pain
• swelling of the legs, feet, or hands.

Rare side effects

These may affectup to 1 in 100 patientswho take REQUIP:

• dizziness or fainting, especially when standing up quickly (this is due to a drop in blood pressure)
• low blood pressure (hypotension)
• excessive daytime sleepiness (excessive somnolence)
• sudden onset of sleep (sleep episodes)
• 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 unknown:cannot be estimated from available data)

• allergic reactions such as redness, inflammation of the skin with itching (urticaria), swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing, hives, or intense itching (see section 2)
• aggression
• excessive use of REQUIP (anxiety about taking an excessive dose of dopaminergic medications compared to the necessary dose to control motor symptoms, known as dopamine dysregulation syndrome)

• after stopping or reducing treatment with REQUIP: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopaminergic agonist withdrawal syndrome or SAAD)
• liver function alterations, which can be detected with blood tests
• spontaneous penile erection.

You may experience the following side effects:

• inability to resist the impulse, desire, or temptation to perform certain actions that may be harmful to you or others, which may include:
• • excessive urge to gamble, 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 excessive spending or 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.

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

When taking REQUIP with L-dopa

Patients taking REQUIP 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 treatment with REQUIP. Inform your doctor if this happens, as your doctor may need to adjust the dose 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 about the safety of this medicine.

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

Do not use this medication after 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 at a temperature above 25 °C. Store in the original packaging to protect it from light.

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

Composition of REQUIP

The active ingredient of REQUIP is ropinirol.

Each film-coated tablet contains 5 mg of ropinirol (as hydrochloride).

The other components are:

• Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• Film coating: hypromellose, macrogol 400, titanium dioxide (E171), indigotin (indigo carmine) (E132), poloxamer 80 (E433).

Appearance of the product and contents of the packaging

REQUIP 5 mg is presented in the form of film-coated tablets, blue in color, pentagonal, marked with “SB” on one face and with “4894” on the other.

REQUIP 5 mg is supplied in packaging containing 21 or 84 tablets in a blister.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Procedure number FR/H/111/01-05:

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

Germany, Austria, Belgium, Spain, France, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, and Sweden:Requip.

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/