Requip-modutab

Leaflet accompanying the packaging: information for the user

Requip-Modutab, 2 mg, prolonged-release tablets

Requip-Modutab, 4 mg, prolonged-release tablets

Requip-Modutab, 8 mg, prolonged-release tablets

Ropinirole

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

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This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
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You should keep this leaflet, so you can read it again if you need to.
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If you have any further questions, you should ask your doctor or pharmacist.
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If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or

pharmacist.See section 4.

Table of contents of the leaflet

• 1. What is Requip-Modutab and what is it used for
• 2. Important information before taking Requip-Modutab
• 3. How to take Requip-Modutab
• 4. Possible side effects
• 5. How to store Requip-Modutab
• 6. Contents of the packaging and other information

1. What is Requip-Modutab and what is it used for

The active substance of Requip-Modutab 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-Modutab prolonged-release tablets are 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 natural dopamine in the brain and helps to alleviate the symptoms of Parkinson's disease.

2. Important information before taking Requip-Modutab

When not to take Requip-Modutab:

• if the patient has been diagnosed with hypersensitivityto 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 doctor if these circumstances occur.

Warnings and precautions

Before starting to take Requip-Modutab, the patient should discuss it 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(see section 4)
• if the patient has intolerance to sugars(e.g., lactose). If the patient experiences symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain (called dopamine agonist withdrawal syndrome (DAWS)) after stopping or reducing the dose of ropinirole, they should tell their doctor. If the symptoms persist for more than a few weeks, the doctor may decide to modify the dose of the medicine. The patient should tell their doctor if they, a family member, or caregiver notice the occurrence of tendencies or behaviors that were not previously observed in the patient and that the patient cannot resist the urge, drive, or temptation to perform certain actions that may harm them or others. This condition is called impulse control disorders and may include behaviors such as compulsive gambling, overeating, or excessive spending, as well as an increased sex drive or intensification of thoughts or feelings related to sex. The doctor may consider it necessary to adjust the dose or stop the medicine.

The patient should inform their doctorif these circumstances occur. The doctor may decide that Requip-Modutab is not a suitable medicine for the patient or may recommend additional monitoring during treatment.

During treatment with Requip-Modutab

The patient should contact their doctor if they or a family member observe the occurrence of particular behaviorsin the patient during treatment with Requip-Modutab (such as uncontrolled urge to gamble or increased sex drive and (or) excessive sexual activity). The doctor may recommend adjusting the dose or stopping the medicine.

Smoking and taking Requip-Modutab

The patient should inform their doctorabout starting or stopping smoking while taking Requip-Modutab. The doctor may consider it necessary to adjust the dose.

Requip-Modutab and other medicines

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

currently or recently, as well as any medicines they plan to take, including herbal products and other medicines available without a prescription.
The patient should remember to inform their doctoror pharmacist about starting to take any other medicine during treatment with Requip-Modutab.
Some medicines may affect the action of Requip-Modutab or increase the risk of side effects. Requip-Modutab 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 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. Additional blood tests should be performedif the patient is taking the following medicines with Requip-Modutab:
• Medicines from the group of vitamin K antagonists (used to reduce blood clotting), such as warfarin (Coumadin).

Requip-Modutab with food and drink

Requip-Modutab can be taken with or without food, as the patient prefers.

Pregnancy and breastfeeding

Requip-Modutab is not recommended during pregnancyunless the doctor considers that the benefits of taking Requip-Modutab outweigh the risks to the unborn child. Requip-Modutab is not recommended during breastfeedingas 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-Modutab.

Driving and using machines

Requip-Modutab may cause drowsiness. Uncontrolled drowsiness may occur, and sometimes sudden and unexpected episodes of sleep without prior drowsiness. During treatment with Requip-Modutab, 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 these symptoms may occur: they should not drive, operate machinery, or perform activitieswhere drowsiness or falling asleep may put the patient (or others) at risk of serious injury or death. The patient should not perform such activities until the symptoms have resolved.
The patient should talk to their doctorif this situation is a problem for them.

Important information about some ingredients of Requip-Modutab

Requip-Modutab contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

The 4 mg prolonged-release tablets contain a colorant called orange yellow FCF (E110), which may cause allergic reactions.
Requip-Modutab contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Requip-Modutab

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist.
Requip-Modutab should not be taken by children. Requip-Modutab is not intended for use in patients under 18 years old.
Requip-Modutab 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). If the patient is taking L-dopa, they may experience involuntary movements (dyskinesia) when starting to take Requip-Modutab. If the patient experiences these symptoms, they should inform their doctor, who may adjust the doses of the medicines the patient is taking.
Requip-Modutab tablets are designed to release the medicine slowly over a period of more than 24 hours. If the patient's condition (e.g., during diarrhea) causes the medicine to pass through the body too quickly, the tablets may not dissolve completely and may not work as they should. It is possible that the patient may see the tablets in their stool. In such a situation, the patient should contact their doctor as soon as possible.

What doses of Requip-Modutab should be taken?

It may take some time to determine the correct dose of Requip-Modutab for the patient.
The recommended initial doseof Requip-Modutab prolonged-release tablets is 2 mg once daily for the first week. The doctor may increase the dose to 4 mg of Requip-Modutab once daily from the second week of treatment. If the patient is elderly, the doctor may increase the dose more slowly. The doctor will then adjust the dose until the optimal dose for the patient is reached. Some patients take up to 24 mg of Requip-Modutab prolonged-release tablets per day.
If the patient experiences intolerable side effects at the start of treatment, they should inform their doctor. The doctor may recommend changing the treatment to a lower dose of ropinirole in the form of immediate-release tablets, which the patient will take three times a day.

Do not take more than the recommended dose of Requip-Modutab.

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

Taking the dose of Requip-Modutab

Requip-Modutab should be taken once daily, at the same time every day.

The prolonged-release tablet(s) of Requip-Modutab should be swallowed whole,

with a glass of water.

Do not break, chew, or crush the prolonged-release tablet(s)

of Requip-Modutab- if this happens, there is a risk of overdose due to the rapid release of the medicine in the body.

In case of switching treatment in patients taking ropinirole in the form of immediate-release tablets

The doctor will determine the dose of Requip-Modutab prolonged-release tablets based on the previously used dose of ropinirole in the form of immediate-release tablets.
The patient should take the previously used dose of ropinirole in the form of immediate-release tablets on the day before switching treatment. The next morning, the patient should take Requip-Modutab prolonged-release tablets and not take any more ropinirole in the form of immediate-release tablets.

Taking a higher dose of Requip-Modutab than recommended

The patient should contact their doctor or pharmacist immediately. If possible, the patient should show the packaging of Requip-Modutab.
If a person takes a higher dose of Requip-Modutab than recommended, they may experience:
nausea, vomiting, dizziness, drowsiness, mental fatigue, or fainting, hallucinations.

Missing a dose of Requip-Modutab

Do not take more tablets or a double dose

to make up for a missed dose.
If the patient has not taken Requip-Modutab for a day or longer, they should consult their doctor about restarting treatment with Requip-Modutab.

Stopping treatment with Requip-Modutab

Do not stop taking Requip-Modutab unless the doctor recommends it.

Requip-Modutab should be taken for as long as the doctor recommends. The patient should not stop taking it unless the doctor recommends it.
If the patient suddenly stops taking Requip-Modutab, the symptoms of Parkinson's disease may worsen rapidly. Stopping treatment suddenly may cause the patient to experience a condition called neuroleptic malignant syndrome, which can be life-threatening. The symptoms include: akinesia (loss of muscle mobility), muscle stiffness, fever, unstable blood pressure, tachycardia (rapid heart rate), confusion, decreased level of consciousness (e.g., coma).
If the doctor needs to stop treatment with Requip-Modutab, they will gradually reduce the dose taken by the patient.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Requip-Modutab can cause side effects, although not everybody gets them.
The side effects of Requip-Modutab 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 period of taking the medicine. If the patient is concerned about side effects, they should consult their doctor.

Very common side effects

May occur in more than 1 in 10 patientstaking Requip-Modutab:

• fainting
• drowsiness
• nausea.

Common side effects

May occur in up to 1 in 10 patientstaking Requip-Modutab:

• sudden sleepiness without prior drowsiness ( sudden sleep attacks)
• hallucinations (seeing things that are not real)
• vomiting
• dizziness
• heartburn
• abdominal pain
• constipation
• swelling of the legs, feet, or hands.

Uncommon side effects

May occur in up to 1 in 100 patientstaking Requip-Modutab:

• dizziness or fainting, especially when standing up quickly (related to low blood pressure)
• low blood pressure (hypotension)
• extreme drowsiness during the day ( excessive daytime sleepiness)
• mental disorders such as delirium (confusion), delusions (irrational thoughts), or paranoia (unfounded suspicion)
• hiccups.

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

• allergic reactionssuch as red, itchy swellingof the skin (hives), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing, rashor intense itching (see section 2).
• liver function changesshown in blood tests.
• aggressive behavior.
• excessive use of Requip-Modutab (uncontrolled desire to take high doses of dopaminergic medicines, higher than necessary to control motor symptoms, called dopamine dysregulation syndrome).
• inability to resist the urge, drive, or temptation to perform actions that may harm the patient or others. Symptoms may include: o Uncontrolled urge to gamble, despite significant consequences for the patient or their family. o Change or increase in interest in sex and behavior that is particularly disturbing to the patient or others, such as increased sex drive or excessive sexual activity. o Uncontrolled, excessive eating or spending. o Sudden episodes of overeating (consuming large amounts of food in a short time), compulsive eating (consuming more food than needed to satisfy hunger).
• episodes of excessive restlessness, excitement, and irritability.
• after stopping or reducing the dose of Requip-Modutab, the following may occur: depression, apathy, anxiety, fatigue, sweating, or pain (called dopamine agonist withdrawal syndrome or DAWS).
• spontaneous erections.

The patient should tell their doctor if they experience any of these behaviors to determine the course of treatment or alleviate symptoms.

Taking Requip-Modutab with L-dopa

In patients taking Requip-Modutab with L-dopa, the following side effects may occur:

• involuntary movements (dyskinesia) are a very common side effect. If the patient is taking L-dopa, they may experience involuntary movements (dyskinesia) when starting to take Requip-Modutab. If the patient experiences these symptoms, they should inform their doctor, who may adjust the doses of the medicines the patient is taking.
• disorientation is a common side effect.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Requip-Modutab

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Requip-Modutab contains

The active substance of Requip-Modutab is ropinirole.

One prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirole (as hydrochloride).

Other ingredients of the medicine are:

• prolonged-release tablet core: hypromellose, hydrogenated castor oil, sodium carmellose, povidone (K29-32), maltodextrin, magnesium stearate, lactose monohydrate, silicon dioxide, anhydrous, mannitol (E 421), yellow iron oxide (E 172), glycerol dibehenate
• 2 mg prolonged-release tablet coating: Opadry Pink OY-S-24900 (hypromellose, yellow iron oxide (E 172), titanium dioxide (E 171), macrogol 400, red iron oxide (E 172)) 4 mgprolonged-release tablet coating: Opadry Light Brown OY-27207 (hypromellose, titanium dioxide (E 171), macrogol 400, orange yellow FCF, as a lake (E 110), indigo carmine, as a lake (E 132)) 8 mgprolonged-release tablet coating: Opadry Red 03B25227 (hypromellose, yellow iron oxide (E 172), titanium dioxide (E 171), black iron oxide (E 172), macrogol 400, red iron oxide (E 172))

What Requip-Modutab looks like and contents of the pack

Requip-Modutab (all strengths) is a prolonged-release tablet in the shape of a capsule, marked with "GS" on one side.
Requip-Modutab 2 mg: pink prolonged-release tablets marked with '3V2' on the other side.
Requip-Modutab 4 mg: light brown prolonged-release tablets marked with 'WXG' on the other side.
Requip-Modutab 8 mg: red prolonged-release tablets marked with '5CC' on the other side.
All strengths: packaging containing 28 or 84 prolonged-release tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

The marketing authorization holderis GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland.
The manufactureris 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:

France: Ropinirole GSK LP
Malta, Lithuania, and Poland: Requip-Modutab
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 of the leaflet:January 2025