REQUIP 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

1. Contents of the pack and further information

1. What REQUIP is and what it is 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 their brain. Ropinirole has a similar effect to natural dopamine and helps to reduce 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 taking 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 serious mental health problems
• if you have impulsive behaviourand/or abnormal behaviour(such as an excessive desire to gamble or an increased sexual desire)
• 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 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 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 a strong desire to gamble.

Tell your doctor if you or your family/carer notice that you are developing episodes of excessive excitement, euphoria or irritability (symptoms of mania). 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 your 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 behaviours (such as an excessive desire to gamble or an increased sexual desire) while taking REQUIP.

Your doctor may need to adjust or stop 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 engage in these activities until you are no longer affected.

Consult your doctorif this may 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 experience 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 (HRT)
• metoclopramide, used to treat nausea and heartburn
• the antibiotics ciprofloxacin or enoxacin
• any other medicines 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 additional 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 or being sick. It is best to take REQUIP with food if possible.

Pregnancy and breast-feeding

REQUIP should not be used during pregnancy

Tell your doctor immediatelyif 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

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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 in combination with 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. Your doctor will then increase your dose by 0.25 mg three times a day every week for the next three weeks. After this, your doctor may increase your dose further, up to a maximum of 1 mg to 3 mg three times a day (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 increase your dose to more than 3 mg three times a day (a total daily dose of more than 9 mg). Some people take up to 8 mg of REQUIP three times a day (a total daily dose of 24 mg).

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 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.

If you take more REQUIP than you should

If you have taken too much REQUIP, contact a doctor or pharmacist immediatelyor call the national poison centre, telephone 91 562 04 20, and quote the medicine and the amount taken.

Someone who has taken an overdose of REQUIP may have some of the following symptoms: feeling sick, being sick, dizziness (feeling like the room is spinning), drowsiness, 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 REQUIP 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 may cause you to develop a condition called neuroleptic malignant syndrome, which can be life-threatening. The symptoms include: loss of muscle movement (akinesia), muscle stiffness, fever, unstable blood pressure, fast heart rate (tachycardia), confusion, decreased 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.

Side effects of REQUIP are more likely to happen when you first start taking it, 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 peopletaking REQUIP:

• feeling faint
• drowsiness
• feeling sick

Common side effects

These may affect up to 1 in 10 peopletaking REQUIP:

• hallucinations (seeing things that are not really there)
• being sick
• dizziness (feeling like the room is spinning)
• heartburn
• stomach pain
• swelling of the legs, feet or hands

Uncommon side effects

These may affect up to 1 in 100 peopletaking REQUIP:

• dizziness or fainting, especially when standing up quickly (this is due to low blood pressure)
• low blood pressure (hypotension)
• feeling extremely drowsy during the day (excessive daytime sleepiness)
• suddenly falling asleep without warning (sudden sleep episodes)
• mental problems such as delirium (severe confusion), delusions (irrational thoughts) or paranoia (irrational suspicions)
• hypo.

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

• allergic reactions such as redness, skin rash, itching (urticaria), swelling of the face, lips, tongue or throat that may cause difficulty in swallowing or breathing, intense itching (pruritus)
• aggression
• excessive use 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 could be harmful to you or 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 for you or others, for example, an increased libido
• uncontrollable shopping or spending
• binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than you need to satisfy your hunger)

• episodes of excessive excitement, 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 taking 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 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. Storage of 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 that month.

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 protect the environment.

6. Container Content and Additional Information

Composition of REQUIP

The active ingredient of REQUIP is ropinirol.

Each film-coated tablet contains 1 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), indigo carmine (indigo dye) (E132).

Appearance of the Product and Container Content

REQUIP 1 mg is presented in the form of film-coated tablets, green in color, pentagonal, marked with "SB" on one face and with "4892" on the other.

REQUIP 1 mg is supplied in packages containing 21 or 84 tablets in blisters.

Only some package 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/