REQUIP 0.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

REQUIP 0.5 mg film-coated tablets

ropinirole (as hydrochloride)

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.See section 4.

Contents of the pack and other information

1. What is REQUIP and what is it used for
2. What you need to know before you take REQUIP
3. How to take REQUIP
4. Possible side effects
5. Storing REQUIP

1. Contents of the pack and further information

1. What is REQUIP and what is it used for

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

REQUIP is used to treat Parkinson's disease.

People with Parkinson's disease have low levels of dopamine in some parts of the brain. Ropinirole has a similar effect to natural dopamine and reduces the symptoms of Parkinson's disease.

2. What you need to know before you take REQUIP

Do not take REQUIP

• if you are allergicto ropinirole 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 doctorif you think you may have any of these conditions.

Warnings and precautions

Talk to your doctor or pharmacist before starting REQUIP:

• 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(such as an excessive need to gamble or an increased sex drive)
• if you have intolerance to some sugars(such as lactose).

Tell your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating or painwhen you stop or reduce 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/carer notice that you are developing impulses or desires to behave in ways that are unusual for you and that you cannot resist the impulse, desire or temptation to perform certain activities that could harm yourself or others. This is called impulse control disorders and can include behaviours such as binge eating, compulsive shopping, or an increased sex drive. 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 (mania symptoms). These can occur with or without impulse control disorders (see above). Your doctor may need to adjust or stop your treatment.

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

While taking REQUIP

Tell your doctor if you or your family notice that you are developing unusual behaviour (such as an abnormal need to gamble or increased sexual desires) while taking REQUIP.

Your doctor may need to adjust your dose.

Driving and using machines

REQUIP can make you feel drowsy. Some people may feel extremely drowsyand may fall asleep suddenly without warning.

REQUIP can 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 harm or death. Do not do these activities until you are no longer affected.

Ask your doctorif this could affect you.

Smoking and REQUIP

Tell your doctorif you start or stop 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 take any other medicines, including those obtained without a prescription. Remember to tell your doctor or pharmacist if you start taking a new medicine while taking REQUIP.

Some medicines may affect the way REQUIP works, or make it more likely that you will have side effects. REQUIP 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, used to treat nausea and vomitingand heartburn
• the antibiotics ciprofloxacin or 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, you may need to have extra blood tests:

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

Taking REQUIP with food and drink

If you take REQUIP with food, it may reduce the chance of you feeling sick (nausea) or being sick (vomiting). It is best to take it with food if you can.

Pregnancy and breast-feeding

REQUIP 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 discuss with you whether you should continue to take REQUIP if you are breast-feeding.

REQUIP contains lactose and sodium

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

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

3. How to take REQUIP

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

You may have been prescribed REQUIP on its own to treat the symptoms of your Parkinson's disease, or you may have been prescribed REQUIP as well as another medicine called L-dopa (levodopa).

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

What dose of REQUIP should you take?

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

The usual starting dose is 0.25 mg three times a day for the first week. After this, your doctor will increase your dose every week for the next three weeks. After that, your doctor will gradually increase your dose until you reach the dose that is best for you. The usual dose is 1 mg to 3 mg three times a day (which makes a total daily dose of 3 to 9 mg). If your symptoms of Parkinson's disease do not improve enough, your doctor may decide to gradually increase your 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 medicines for Parkinson's disease, your doctor may advise you to gradually reduce the dose of these medicines. If you are taking L-dopa, you may experience some uncontrolled movements (dyskinesias) when you first start taking REQUIP. Tell your doctor if this happens, as your doctor may need to adjust the dose of the medicines you are taking.

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

It may take several weeks for REQUIP to start working.

How to take your dose of REQUIP

Take REQUIP three times a day.

Swallow the REQUIP tabletswith a glass of water. It is best to take REQUIP with food, as this reduces the chance of you feeling sick (nausea).

If you take more REQUIP than you should

If you or someone else has taken too much REQUIP, contact a doctor or pharmacist immediatelyor call the national poison centre on 91 562 04 20, quoting the medicine and the amount taken.

Someone who has taken an overdose of REQUIP may have some of the following symptoms: nausea, vomiting, dizziness (spinning sensation), drowsiness, 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 a forgotten dose. Take your next dose at the usual time.

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

If you stop taking REQUIP

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

Take REQUIP for as long as your doctor has told you. Do not stop taking it unless your doctor tells you to. If you suddenly stop taking REQUIP, your symptoms of Parkinson's disease may quickly get much worse. Stopping treatment suddenly can also 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 (such as coma).

If you need to stop taking REQUIP, your doctor will reduce your dose gradually.

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.

It is more likely that you will have side effects when you first start taking REQUIP, or when your dose is increased. These are usually mild and may become 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 peoplewho take REQUIP:

• feeling faint
• drowsiness
• nausea.

Common side effects

These may affect up to 1 in 10 peoplewho take REQUIP:

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

Uncommon side effects

These may affect up to 1 in 100 peoplewho take REQUIP:

• dizziness or fainting, especially when standing up quickly (this is due to a drop in blood pressure)
• low blood pressure (hypotension)
• feeling extremely drowsy during the day (excessive daytime sleepiness)
• suddenly falling asleep without feeling sleepy first (sudden sleep episodes)
• 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 which may cause difficulties in swallowing or breathing, rash or intense itching (see section 2)
• aggression
• overuse of REQUIP (anxiety to take more doses of dopaminergic medicines than needed 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 can be detected with blood tests
• spontaneous erections.

You may experience the following side effects:

• inability to resist the impulse, drive or temptation to perform certain activities that may be harmful to you or to others, which may include:

• strong impulse to gamble excessively, despite significant personal or family problems
• altered or increased sexual interest or behaviour, and disturbing behaviour to you or others, for example, an increased libido
• uncontrollable shopping or spending
• binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than you need to satisfy your hunger)

• episodes of overactivity, euphoria or irritability.

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

If you are taking REQUIP with L-dopa

People who take REQUIP with L-dopa may develop other side effects after some time:

• very common side effects are uncontrolled movements (dyskinesias). If you are taking L-dopa, you may experience some uncontrolled movements (dyskinesias) when you first start taking REQUIP. Tell your doctor if this happens, as your doctor may need to adjust the dose of the medicines you are taking
• a common side effect is confusion.

Reporting of side effects

If you get 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 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. Storing REQUIP

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 carton. The expiry date refers to the last day of the month shown.

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Container Content and Additional Information

Composition of REQUIP

The active ingredient of REQUIP is ropinirol.

Each film-coated tablet contains 0.5 mg of ropinirol (as hydrochloride).

The other components are:

• Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
• Coating film: hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine (indigo dye) (E132).

Appearance of the Product and Container Content

REQUIP 0.5 mg is presented in the form of film-coated tablets, yellow in color, pentagonal in shape, marked with "SB" on one side and with "4891" on the other.

REQUIP 0.5 mg is supplied in packs containing 21 tablets in blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

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

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

Date of the Last Revision of this Leaflet:June 2023

Detailed and updated 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/