Requip 0.25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

REQUIP 0.25 mg film-coated tablets

ropinirole (as hydrochloride)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What REQUIP is and what it is used for

2. What you need to know before taking REQUIP

3. How to take REQUIP

4. Possible side effects

5. How to store REQUIP

6. Contents of the pack and other information

1. What REQUIP is and what it is used for

The active substance in REQUIP is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists work in the same way as a natural substance found in the brain called dopamine.

REQUIP is used to treat Parkinson's disease.

People with Parkinson's disease have low levels of dopamine in certain parts of the brain. Ropinirol has an effect similar to natural dopamine and thus helps reduce the symptoms of Parkinson's disease.

2. What you need to know before starting REQUIP

Do not take REQUIP

• if you are allergic to ropinirole or to 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 are in any of these situations.

Warnings and precautions

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

• if you are pregnant or think you may be pregnant
• if you are breastfeeding
• if you are under 18 years of age
• if you have a serious heart condition
• if you have a severe mental disorder
• if you experience impulsive behavior and/or abnormal behavior (such as an overwhelming urge to gamble or excessive sexual behavior)
• if you have intolerance to certain sugars (such as lactose).

Tell your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with REQUIP (called dopamine agonist withdrawal syndrome or DAWS). If symptoms persist after a few weeks, your doctor may need to adjust your treatment.

Tell your doctor if you or your family/caregiver notice that you are developing impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, urge, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorders and may include behaviors such as pathological gambling, compulsive 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/caregiver notice 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.

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

While taking REQUIP

Tell your doctor if you or your family notice that you are developing any abnormal behavior (such as an unusual urge to gamble or increased sexual desires and/or behaviors) while taking REQUIP.

Your doctor may need to adjust or stop your dosage.

Driving and using machines

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

REQUIP may cause hallucinations (seeing, hearing, or feeling things that are not there). If this occurs, do not drive or operate machinery.

If you experience this: do not drive, do not use machines, and do not engage in activities where feeling sleepy or falling asleep could place you or others at serious risk or risk of death. Do not perform these activities until you are no longer affected.

? Talk to your doctor if this could affect you.

Smoking and REQUIP

Tell your doctor if you have started or stopped smoking while taking REQUIP. Your doctor may need to adjust your dose.

Other medicines and REQUIP

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines or those obtained without a prescription. Remember to inform your doctor or pharmacist if you start taking a new medicine while on REQUIP.

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

These medicines include:

• the antidepressant fluvoxamine
• medicines for mental disorders, such as sulpiride
• hormone replacement therapy (also called HRT)
• metoclopramide, used to treat nausea and stomach acid
• the antibiotics ciprofloxacin or enoxacin
• any other medicines for Parkinson's disease.

? Tell your doctor if you are taking or have recently taken any of these medicines.

If you are taking the following medicines with REQUIP, you may need additional blood tests:

• Vitamin K antagonists (used to reduce blood clotting) such as Warfarin.

Taking REQUIP with food and drink

Taking REQUIP with food may reduce the likelihood of experiencing nausea or vomiting. It is preferable to take it with food whenever possible.

Pregnancy and breastfeeding

REQUIP is not recommended during pregnancy, unless your doctor determines that the benefit to you outweighs any potential risk to the fetus. REQUIP must not be used during breastfeeding, as milk production may be affected.

Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will advise you on what to do if you are breastfeeding or planning to breastfeed. Your doctor may recommend that you discontinue treatment with REQUIP.

REQUIP contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially "sodium-free".

3. How to take REQUIP

Follow exactly the instructions for administering this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Do not give REQUIP to children. REQUIP is normally not prescribed for individuals under 18 years of age.

What dose of REQUIP should you take?

It may take some time to determine the most appropriate dose of REQUIP for you.

The usual starting dose is 0.25 mg three times a day during the first week. From there, your doctor will increase your dose each week over the next three weeks. Afterwards, your doctor will gradually increase the dose until you are taking the most suitable dose for you. The usual dose is 1 mg to 3 mg three times a day (which gives a total daily dose of 3 to 9 mg). If your Parkinson's disease symptoms do not improve sufficiently, your doctor may decide to gradually increase the dose to higher levels. Some people take up to 8 mg of REQUIP three times a day (a total of 24 mg daily).

If you are also taking other Parkinson's disease medications, 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 starting treatment with REQUIP. Inform your doctor if this occurs, 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.

It may take several weeks for REQUIP to take effect.

How to take your dose of REQUIP

Take REQUIP three times a day.

Swallow the REQUIP tablets with a glass of water. It is best to take REQUIP with food, as this reduces the likelihood of experiencing 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 at 91 562 04 20, indicating the medicine and the amount ingested.

Someone who has suffered an overdose of REQUIP may experience one or more of the following symptoms: nausea, vomiting, dizziness (a spinning sensation), somnolence, fatigue (mental or physical tiredness), feeling faint, hallucinations.

If you forget to take REQUIP

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

If you have forgotten to take REQUIP for one or more days, consult your doctor for advice on how to restart treatment.

If you stop taking REQUIP

Do not stop treatment with REQUIP without first consulting your doctor.

Take REQUIP for as long as your doctor tells you to. Do not stop treatment unless instructed by your doctor.

If you stop treatment with REQUIP abruptly, your Parkinson's disease symptoms may worsen rapidly. A sudden interruption of treatment could cause a condition known as neuroleptic malignant syndrome, which may pose a serious health risk. Symptoms include: akinesia (loss of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, and decreased level of consciousness (e.g., coma).

If you need to discontinue treatment with REQUIP, your doctor will gradually reduce your dose.

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

4. Possible adverse effects

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

Adverse effects with REQUIP are more likely to occur at the beginning of treatment or when the dose is increased. These are generally mild and may become less bothersome over time. Inform your doctor if you are concerned about any adverse effects.

Very common adverse effects

These may affect more than 1 in 10 patients taking REQUIP:

• dizziness or lightheadedness
• drowsiness
• nausea

Common adverse effects

These may affect up to 1 in 10 patients taking REQUIP:

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

Uncommon adverse effects

These may affect up to 1 in 100 patients taking REQUIP:

• dizziness or fainting, especially when standing up suddenly (due to a drop in blood pressure)
• low blood pressure (hypotension)
• excessive daytime sleepiness (somnolence)
• falling asleep suddenly without warning (sudden sleep episodes)
• mental disturbances such as delirium (severe confusion), delusional thoughts (irrational beliefs), or paranoia (irrational suspicions)
• hiccups

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

• allergic reactions such as redness, skin inflammation with itching (urticaria), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing, rash, or intense itching (see section 2)
• aggression
• excessive use of REQUIP (compulsive urge to take more than the required dose of dopaminergic medication 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 dopamine agonist withdrawal syndrome or DAWS)
• changes in liver function, which may be detected in blood tests
• spontaneous penile erection

You may experience the following adverse effects:

• inability to resist the impulse, desire, or temptation to carry out certain actions that could be harmful to yourself or others, which may include:

• strong urge to gamble excessively, despite significant personal or family consequences

• altered or increased sexual interest, and behavior that is troubling to you or others, such as excessive sexual behavior

• uncontrollable excessive shopping or spending

• binge eating (consuming 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

If you experience any of these behaviors, inform your doctor; they will advise you on ways to manage or reduce the symptoms.

If you are taking REQUIP with L-dopa

People taking REQUIP with L-dopa may develop additional adverse effects over time:

• very common adverse 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 occurs, as your doctor may need to adjust the dose of your medications
• a common adverse effect is confusion

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of REQUIP

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

Do not use this medicine after the expiry date stated on the blister pack and outer packaging. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of REQUIP

The active substance of REQUIP is ropinirole.

Each film-coated tablet contains 0.25 mg of ropinirole (as hydrochloride).

The other components are:

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

Appearance of the product and contents of the pack

REQUIP 0.25 mg is presented as white, pentagonal, film-coated tablets, marked with “SB” on one side and “4890” on the other.

The 0.25 mg tablets are supplied in blister packs containing 21, 84 or 210 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
[To be completed according to the country-specific information]

Responsible for Manufacturing:
[To be completed according to the country-specific information]

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

This medicinal product is authorized in the European Economic Area member states under the following names:

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

Date of latest review of this leaflet: June 2023

Detailed and up-to-date 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/