Ropodrin

Leaflet accompanying the packaging: patient information

Ropodrin, 2 mg, prolonged-release tablets

Ropodrin, 4 mg, prolonged-release tablets

Ropodrin, 8 mg, prolonged-release tablets

Ropinirole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others.
• The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ropodrin and what is it used for

The active substance of Ropodrin 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. Ropodrin 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 thus helps to alleviate the symptoms of Parkinson's disease.

2. Important information before taking Ropodrin

When not to take Ropodrin

if the patient is allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6), if the patient has severe kidney disease without regular hemodialysis, if the patient has liver disease. The doctor should be informed if this applies to the patient.

Warnings and precautions

Before starting to take Ropodrin, the doctor or pharmacist should be consulted. Before starting to take Ropodrin, the doctor should be consulted:

• if the patient is pregnant or thinks she 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 serious mental disorders
• if the patient has particular tendencies and (or) behaviors (such as uncontrolled urge to gamble or excessive sexual activity)
• if the patient has intolerance to certain sugars (e.g. lactose).

If the patient experiences any of the following symptoms after stopping or reducing the dose of ropinirole, such as depression, apathy, anxiety, fatigue, sweating, or pain (called dopamine agonist withdrawal syndrome, DAWS), they should inform their doctor. If the symptoms persist for more than a few weeks, the doctor may decide to modify the dose of the medicine. If the patient, a relative, or caregiver notices that the patient starts to feel an overwhelming, irresistible urge to behave in a completely different way from their previous behavior and cannot resist such an impulse, even if the behaviors may harm the patient or others, they should inform the doctor as soon as possible. Such irresistible urges and unusual behaviors are due to so-called impulse control disorders. They may manifest as, for example, compulsive gambling, binge eating, shopping addiction, or excessive sexual drive. The doctor will decide whether to reduce the dose of the medicine or discontinue it altogether. The doctor should be informed if this applies to the patient. The doctor may decide that Ropodrin is not a suitable medicine for the patient or may recommend additional control tests during treatment.

During treatment with Ropodrin

The doctor should be informed if the patient or their family notices any unusual behavior (such as an unusual urge to gamble or increased sexual activity) while taking Ropodrin. The doctor will decide whether to reduce the dose of the medicine or discontinue it altogether.

Smoking and Ropodrin

The doctor should be informedabout starting or stopping smoking while taking Ropodrin. The doctor may decide to adjust the dose of the medicine.

Other medicines and Ropodrin

The doctor or pharmacist should be told about all medicines the patient is taking, has recently taken, or plans to take. The doctor or pharmacist should be remindedabout starting to take any other medicine while taking Ropodrin. Some medicines may affect the action of Ropodrin or increase the risk of side effects. Ropodrin may also affect the action of other medicines. These include:

• fluvoxamine (an antidepressant)
• medicines used for other mental disorders, such as sulpiride
• hormone replacement therapy (HRT)
• metoclopramide, which is used to treat nausea and heartburn
• antibiotics: ciprofloxacin and enoxacin
• other medicines used for Parkinson's disease.

The doctor should be informed if the patient is taking or has recently taken any of these medicines. The patient may need to have additional blood tests if they are taking Ropodrin with the following medicines:

• vitamin K antagonists (used to reduce blood clot formation), such as warfarin (coumarin), acenocoumarol.

Ropodrin with food

Ropodrin can be taken with or without food.

Pregnancy and breastfeeding

Ropodrin is not recommended during pregnancy, unless the doctor decides that the benefits of taking Ropodrin outweigh the risks to the unborn child. Ropodrin is not recommended during breastfeeding, as it may affect milk production. If the patient is pregnant, breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine. The doctor will also advise if the patient is breastfeeding or plans to breastfeed. The doctor may recommend discontinuing Ropodrin.

Driving and using machines

Ropodrin may cause drowsiness. Sudden, uncontrollable drowsiness may occur, sometimes accompanied by sudden, unexpected sleep attacks without prior drowsiness. During treatment with ropinirole, 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 such symptoms may occur, they should not drive, operate machinery, or perform activities that may put them (or others) at risk of serious injury or death. They should not perform such activities until the symptoms have resolved. The patient should discuss this with their doctor. Ropodrin 2 mg prolonged-release tablets contain a sugar called lactose. If the doctor has told the patient that they have an intolerance to some sugars, they should contact their doctor before taking this medicinal product.

Ropodrin 4 mg prolonged-release tablets contain an orange-yellow colorant (E110)

which may cause allergic reactions. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Ropodrin

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted. Ropodrin can be used to treat the symptoms of Parkinson's disease, either alone or in combination with another medicine called L-dopa (or levodopa). If the patient is taking L-dopa, they may experience involuntary movements (dyskinesias) when starting to take Ropodrin. If such symptoms occur, the doctor should be informed, and they may adjust the doses of the medicines the patient is taking. Ropodrin tablets are designed to release the medicine over 24 hours. If the patient has a disease that causes the medicine to pass through the body too quickly, such as diarrhea, the tablet(s) may not dissolve completely and may not work properly. The patient may notice the tablet(s) in their stool. If this happens, they should inform their doctor as soon as possible. What dose of Ropodrin should be takenThe dose of Ropodrin that is right for the patient may need to be determined over time. The recommended starting doseof Ropodrin prolonged-release tablets is 2 mg once daily for the first week. The doctor may increase the dose of Ropodrin prolonged-release tablets to 4 mg once daily from the second week of treatment onwards. If the patient is very 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 may take up to 24 mg of Ropodrin 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 switching to a lower dose of ropinirole in the form of immediate-release tablets, which the patient will take three times a day.

Use in children and adolescents

Ropodrin should not be given to children. Ropodrin is not prescribed to patients under 18 years old. The patient should not take more Ropodrin than prescribed by their doctor.It may take several weeks for the beneficial effect of the medicine to appear.

Taking the dose of Ropodrin

Ropodrin should be taken once daily, at the same time every day. The Ropodrin prolonged-release tablet(s) should be swallowed whole, with a glass of water. The tablet(s) should not be broken, chewed, or crushed. If this happens, there is a risk of overdose due to the rapid release of the medicine in the body. In the case of switching treatment in patients taking ropinirol in the form of film-coated tablets (immediate release)The doctor will determine the dose of Ropodrin prolonged-release tablets based on the previously taken dose of ropinirol in the form of film-coated tablets (immediate release). The patient should take the previously taken dose of ropinirol in the form of film-coated tablets (immediate release) on the day before switching treatment. The next morning, they should take Ropodrin prolonged-release tablets and not take any more ropinirol in the form of film-coated tablets (immediate release).

Taking a higher dose of Ropodrin than recommended

The doctor or pharmacist should be consulted immediately. If possible, the packaging of Ropodrin should be shown. If a person takes a higher dose of Ropodrin than recommended, they may experience: nausea, vomiting, dizziness, drowsiness, mental or physical fatigue, fainting, or hallucinations.

Missing a dose of Ropodrin

A double dose should not be taken to make up for a missed dose. If a dose of Ropodrin is missed for a day or longer, the doctor should be consulted for advice on restarting treatment with Ropodrin.

Stopping treatment with Ropodrin

Ropodrin should not be stopped suddenly without consulting the doctor. If Ropodrin is stopped suddenly, the symptoms of Parkinson's disease may worsen rapidly. Stopping the medicine suddenly may lead to a very serious condition called neuroleptic malignant syndrome (NMS). The symptoms of NMS include: akinesia (loss of movement), muscle stiffness, fever, changes in blood pressure, tachycardia, confusion, and changes in consciousness (up to coma). Ropodrin should be taken for as long as the doctor recommends. The treatment should not be stopped unless the doctor recommends it. If it is necessary to stop treatment with Ropodrin, the doctor will gradually reduce the dose taken. In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Ropodrin can cause side effects, although not everybody gets them. The side effects of Ropodrin 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 medicine. If the patient is concerned about side effects, they should consult their doctor. Very common side effects(may affect at least 1 in 10 people)

• fainting
• drowsiness
• nausea

Common side effects(may affect less than 1 in 10 people)

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

Uncommon side effects(may affect less than 1 in 100 people)

• dizziness or fainting, especially when standing up quickly (related to low blood pressure)
• very strong drowsiness during the day (uncontrollable drowsiness)
• mental disorders, such as confusion (severe disorientation), delusions (irrational thoughts), or paranoia (unfounded suspicion or feeling of persecution)
• hiccups

Side effects with unknown frequency(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).
• changes in liver function, which have been shown in blood tests.
• aggressive behavior
• abuse of Ropodrin (desire for large - larger than required to control motor symptoms - amounts of dopaminergic medicines, known as dopamine dysregulation syndrome).
• inability to resist an impulse, desire, or temptation to behave in a way that may be harmful to the patient or others, including:
• strong urge to gamble, despite serious personal or family consequences.
• change or increase in sexual interests and behaviors in a way that concerns the patient or others, e.g., increased sexual drive.
• uncontrolled shopping or spending excessive amounts of money.
• binge eating or compulsive overeating (eating larger amounts of food than normal and more than needed to satisfy hunger).
• episodes of excessive excitement, agitation, or irritability.
• after stopping or reducing the dose of Ropodrin, the following may occur: depression, apathy, anxiety, fatigue, sweating, or pain (called dopamine agonist withdrawal syndrome or DAWS).
• spontaneous erections.

If the patient experiences any of these behaviors, they should inform their doctor: ways to manage or reduce these symptoms will be discussed. Taking Ropodrin with L-dopaIn patients taking Ropodrin in combination with L-dopa, other side effects may occur after some 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 Ropodrin. If such symptoms occur, the doctor should be informed, and they may adjust the doses of the medicines the patient is taking.
• feeling disoriented is a common side effect.

Reporting side effects

If side effects occur, including any not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Ropodrin

The medicine should be stored out of sight and reach of children. This medicine should not be taken after the expiry date (EXP) stated on the blister, bottle, and carton. The expiry date refers to the last day of the month. The medicine should not be stored above 25°C. HDPE bottles: the shelf-life after opening is 60 days. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 Ropodrin contains

• The active substance of Ropodrin is ropinirole. One prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirole (as hydrochloride).
• The other ingredients are:
• ● Core of prolonged-release tablets:ammonio methacrylate copolymer (type B), hypromellose (E464), sodium lauryl sulfate, copovidone, magnesium stearate (E572).
• ● Coating:

What Ropodrin looks like and contents of the pack

Ropodrin 2 mg prolonged-release tablets: pink, round, biconvex tablets with a diameter of 6.8±0.1 mm and a thickness of 5.5±0.2 mm. Ropodrin 4 mg prolonged-release tablets: light brown, oval, biconvex tablets with dimensions of 12.6 x 6.6±0.1 mm and a thickness of 5.3±0.2 mm. Ropodrin 8 mg prolonged-release tablets: red, oval, biconvex tablets with dimensions of 19.2 x 10.2±0.2 mm and a thickness of 5.2±0.2 mm. Ropodrin 2 mg, 4 mg, and 8 mg are packaged in PVC/PCTFE/Aluminum blisters and HDPE bottles with a PP cap and a desiccant, in a cardboard box.

Pack sizes

Blisters: 28, 30, 56, 84 prolonged-release tablets Bottle: 28, 30, 56, 84 prolonged-release tablets Not all pack sizes may be marketed.

Marketing authorization holder

Hungary

Manufacturer

Pharmathen S.A. Hungary

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

Date of last revision of the leaflet 26.05.2023