Requip

Leaflet accompanying the packaging: information for the user

REQUIP 0.25 mg coated tablets

REQUIP 0.5 mg coated tablets

REQUIP 1 mg coated tablets

REQUIP 2 mg coated tablets

REQUIP 5 mg coated tablets

Ropinirole

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.See section 4.

Table of contents of the leaflet

1. What is REQUIP and what is it used for

2. Important information before taking REQUIP

3. How to take REQUIP

4. Possible side effects

5. How to store REQUIP

6. Contents of the packaging and other 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 the brain in a similar way to a naturally occurring substance called dopamine.

REQUIP is used to treat Parkinson's disease.

In patients with Parkinson's disease, there is a low level of dopamine in some parts of the brain. Ropinirole works in a similar way to dopamine and helps to alleviate the symptoms of Parkinson's disease.

2. Important information before taking REQUIP

When not to take REQUIP:

• if the patient is allergicto the active substance or any of the other ingredients of this medicine (listed in section 6)
• if the patient has severe kidney disease
• if the patient has liver disease

The patient should inform their doctorif any of these conditions occur.

Warnings and precautions

Before starting to take REQUIP, the patient should discuss with their doctor or pharmacist:

• if the patient is pregnantor thinks they may be pregnant,
• if the patient is breastfeeding,
• if the patient is under 18 years old,
• if the patient has severe heart disease,
• if the patient has severe mental disorders,
• if the patient has particular tendencies and/or behaviors(e.g. uncontrolled urge to gamble or excessive sexual activity),
• if the patient has intolerance to sugars(e.g. lactose intolerance).

If the patient experiences any of the following symptoms after stopping or reducing the dose of ropinirole, they should inform their doctor: depression, apathy, anxiety, fatigue, sweating, or pain(known as dopamine agonist withdrawal syndrome, or DAWS). If the symptoms persist for more than a few weeks, the doctor may decide to adjust the dose of the medicine. The patient should inform their doctor if they, their family, or caregiver notice any unusual behaviors during treatment with REQUIP (such as uncontrolled urge to gamble or increased sexual desire). The doctor may adjust the dose or stop the medicine. The patient should inform their doctor if they or their family or caregiver notice any episodes of excessive restlessness, excitement, or irritability. The doctor may adjust the dose or stop the medicine.

While taking REQUIP

The patient should contact their doctor if they or their family member notice any unusual behaviors in the patient while taking REQUIP (such as uncontrolled urge to gamble or increased sexual desire). The doctor may adjust the dose or stop the medicine.

Driving and using machines

REQUIP may cause drowsiness. Uncontrolled drowsiness may occur, as well as sudden and unexpected attacks of sleep, not preceded by drowsiness. While taking REQUIP, hallucinations (seeing, hearing, or feeling things that are not there) may occur. If the patient experiences hallucinations, they should not drive or operate machinery. If the patient suspects that they may experience such symptoms: they should not drive, operate machinery, orperform tasks that require alertness, as drowsiness or falling asleep may put the patient or others at risk of serious injury or death. The patient should not perform such tasks until the symptoms have resolved. The patient should discuss this with their doctorif it is a problem for them.

Taking REQUIP and smoking

The patient should inform their doctor if they start or stop smoking while taking REQUIP. The doctor may decide to adjust the dose.

REQUIP and other medicines

The patient should inform their doctor or pharmacist about all medicines they are taking

currently or recently, and about any medicines they plan to take, including herbal medicines and other medicines available without a prescription. The patient should remember to inform their doctor about starting to take any other medicine while taking REQUIP. Some medicines may affect the action of REQUIP or increase the risk of side effects. REQUIP may also affect the action of other medicines. These medicines include:

• fluvoxamine (an antidepressant)
• medicines used in other mental disorders, such as sulpiride
• HRT (hormone replacement therapy)
• metoclopramide, which is used to treat nausea and heartburn
• antibiotics ciprofloxacin and enoxacin
• any other medicines used to treat Parkinson's disease. The patient should inform their doctor if they are taking or have recently taken any of these medicines.

The patient should have additional blood testsif they are taking any of the following medicines with REQUIP:

• Medicines that reduce blood clotting, such as warfarin (Coumadin).

Taking REQUIP with food and drink

Taking REQUIP with food may reduce the likelihood of nausea and vomiting. Therefore, it is recommended to take REQUIP with food.

Pregnancy and breastfeeding

REQUIP is not recommended during pregnancy, unless the doctor considers that the benefits of taking REQUIP outweigh the risks to the unborn child. REQUIP is not recommended during breastfeeding, as it may affect milk production. The patient should inform their doctor immediatelyif they are pregnant, think they may be pregnant, or plan to become pregnant. The doctor will also advise if the patient is breastfeeding or plans to breastfeed. The doctor may recommend stopping REQUIP.

Important information about some ingredients of REQUIP

REQUIP contains a small amount of sugar called lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking REQUIP. REQUIP contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is considered "sodium-free".

3. How to take REQUIP

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist again. REQUIP can be used to treat the symptoms of Parkinson's disease as a single medicine or in combination with another medicine called L-dopa (also known as levodopa).

What dose of REQUIP should be taken?

It may take some time to determine the optimal dose. The usual starting dose is 0.25 mg of ropinirole three times a day for the first week. Then, the doctor will increase the dose every week for three weeks. After that, the doctor will gradually increase the dose until the optimal dose for the patient is reached. The usual dose is 1 mg to 3 mg three times a day (total daily dose 3 mg to 9 mg). If the symptoms of Parkinson's disease are not adequately controlled, the doctor may decide to gradually increase the dose. Some patients may take a dose of up to 8 mg of REQUIP three times a day (a total of 24 mg per day). If the patient is taking other medicines for Parkinson's disease, the doctor may recommend gradually reducing the doses of these medicines. If the patient is taking L-dopa, they may experience involuntary movements (dyskinesias) when starting to take REQUIP. If these symptoms occur, the patient should inform their doctor, who may adjust the doses of the medicines they are taking.

The patient should not take more REQUIP than the dose recommended by their doctor.

It may take several weeks for the beneficial effect of REQUIP to occur.

Taking the dose of REQUIP

REQUIP should be taken three times a day. The tablet(s) should be swallowed with a glass of water. It is recommended to take REQUIP with food, as this may reduce the likelihood of nausea.

Taking more REQUIP than recommended

The patient should immediately consult their doctor or pharmacist. If possible, they should show the packaging of the medicine. If the patient takes more REQUIP than recommended, they may experience: nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical), fainting, or hallucinations.

Missing a dose of REQUIP

The patient should not take extra tablets or a double dose to make up for a missed dose.

The patient should take the next dose at the usual time. If the patient has not taken REQUIP for a day or longer, they should consult their doctor about restarting treatment with REQUIP.

Stopping treatment with REQUIP

The patient should not stop taking REQUIP unless their doctor recommends it.

REQUIP should be taken for as long as the doctor recommends. The patient should not stop taking REQUIP unless their doctor recommends it. If the patient suddenly stops taking REQUIP, their symptoms of Parkinson's disease may worsen significantly. Stopping treatment suddenly may cause 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, tachycardia (rapid heart rate), confusion, and decreased level of consciousness (e.g. coma). If the doctor needs to stop treatment with REQUIP, they will gradually reduce the dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, REQUIP can cause side effects, although not everybody gets them. The side effects of REQUIP may occur most frequently when starting treatment or shortly after increasing the dose. The side effects are usually mild and become less troublesome after a short time of taking the dose. If the patient is concerned about side effects, they should consult their doctor.

Very common side effects:

May occur in more than 1 in 10patients taking REQUIP:

• fainting
• drowsiness
• nausea

Common side effects:

May occur in up to 1 in 10patients taking REQUIP:

• hallucinations (seeing things that are not there)
• vomiting
• dizziness
• heartburn
• abdominal pain
• swelling of the legs, feet, and hands

Uncommon side effects:

May occur in up to 1 in 100patients taking REQUIP:

• dizziness or fainting, especially when standing up quickly (related to low blood pressure)
• low blood pressure (hypotension)
• very strong drowsiness during the day (uncontrolled drowsiness)
• sudden and unexpected attacks of sleep, not preceded by drowsiness
• mental disorders such as confusion (acute state of confusion), delusions (irrational thoughts), or paranoia (unjustified suspicion)
• hiccups

The following side effects may occur in some patients (frequency not known: cannot be estimated from the available data):

• allergic reactions such as red, itchy swelling of the skin (hives), 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 (uncontrolled desire to take large doses of dopaminergic medicines, larger than necessary to control motor symptoms, known as dopamine dysregulation syndrome)
• after stopping or reducing the dose of REQUIP, the following symptoms may occur: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS)
• changes in liver function, which have been shown in blood tests
• spontaneous erections

The following side effects may occur:

• inability to resist impulses, urges, and desires to perform actions that may be harmful to the patient or others, including: o Strong urge to gamble despite serious personal or family consequences. o Changed or increased interest in sex and behaviors that cause concern for the patient and others, e.g. increased sexual desire. o Uncontrolled urge to shop and spend. o Excessive eating (eating large amounts of food in a short time) or compulsive eating (eating more than needed to satisfy hunger).
• episodes of excessive restlessness, excitement, and irritability

The patient should contact their doctor immediately if they experience any of these behaviors, to discuss ways to limit or eliminate these symptoms.

Taking REQUIP with L-dopa

In patients taking REQUIP with L-dopa, the following side effects may occur over time:

• involuntary movements (dyskinesias) are a very common side effect. If the patient is taking L-dopa, they may experience involuntary movements (dyskinesias) when starting to take REQUIP. If these symptoms occur, the patient should inform their doctor, who may adjust the doses of the medicines they are taking.
• feeling disoriented is a common side effect.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store REQUIP

The medicine should be stored out of sight and reach of children. The patient should not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. The patient should not store the medicine at temperatures above 25°C. The patient should store the medicine in its original packaging to protect it from light. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What REQUIP contains

The active substance of REQUIP is ropinirole. Each coated tablet contains 0.25 mg, 0.5 mg, 1 mg, 2 mg, or 5 mg of ropinirole (as hydrochloride). The other ingredients of the medicine are:

• tablet core:lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate.
• coating:0.25 mg tablets:hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 (E433). 0.5 mg tablets:hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine (E132). 1 mg tablets:hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine (E132). 2 mg tablets:hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

5 mg tablets:hypromellose, macrogol 400, titanium dioxide (E171), indigo carmine (E132), polysorbate 80 (E433).

What REQUIP looks like and contents of the packaging

The tablets are pentagonal in shape with the letters "SB" embossed on one side. REQUIP 0.25 mg:white tablets with the code "4890" embossed on the other side. REQUIP 0.5 mg:yellow tablets with the code "4891" embossed on the other side. REQUIP 1 mg:green tablets with the code "4892" embossed on the other side. REQUIP 2 mg:pink tablets with the code "4893" embossed on the other side. REQUIP 5 mg:blue tablets with the code "4894" embossed on the other side. 0.25 mg tablets:packs containing 21, 84, or 210 tablets in blisters. 0.5 mg tablets:packs containing 21 tablets in blisters. 1 mg, 2 mg, and 5 mg tablets:packs containing 21 or 84 tablets in blisters. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Manufacturer:

Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain

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

Austria, Belgium, France, Germany, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Spain, and Sweden: REQUIP.
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
tel. +48 22 576 90 00
Date of last revision:January 2025