Ceurolex Sr

PATIENT INFORMATION LEAFLET: USER INFORMATION

Ceurolex SR, 2 mg, prolonged-release tablets

Ceurolex SR, 4 mg, prolonged-release tablets

Ceurolex SR, 8 mg, prolonged-release tablets

(Ropinirole)

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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.
• 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 Ceurolex SR and what is it used for
• 2. Important information before taking Ceurolex SR
• 3. How to take Ceurolex SR
• 4. Possible side effects
• 5. How to store Ceurolex SR
• 6. Contents of the pack and other information

1. What is Ceurolex SR and what is it used for

Ceurolex SR, prolonged-release tablets are used to treat Parkinson's disease.

Parkinson's disease.

The active substance of Ceurolex SR 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. 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 Ceurolex SR

When not to take Ceurolex SR

• if the patient is allergicto ropinirole 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 in case of these circumstances.

Warnings and precautions

Before starting to take Ceurolex SR, the patient should discuss it with their doctor or pharmacist:

• if the patient is pregnantor thinks they may be pregnant
• if the patient is breast-feeding
• 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 some sugars(such as lactose).

The patient should inform their doctorin case of these circumstances. The doctor may decide that Ceurolex SR is not a suitable medicine for the patient or may recommend additional monitoring tests during treatment. The patient should inform their doctor if they or their family notice any sudden or unusual behaviors in the patient, and the patient cannot control the impulse or desire to perform certain actions that may harm the patient or others. This behavior is called impulse control disorder and may include behaviors such as: gambling addiction, overeating, tendency to overspend, excessive sexual activity or excessive thinking about sex or increased feelings. The doctor may change the dose or stop the medicine. The patient should inform their doctor if they or their family/caregiver notice episodes of overactivity, euphoria, or irritability (mania symptoms). These may occur with or without impulse control disorder symptoms (see above). The doctor may need to adjust or reduce the dose.

During treatment with Ceurolex SR

The patient should inform their doctor if they or their family notice any unusual behaviors(such as uncontrolled gambling or excessive sexual drive and (or) activity) during treatment with Ceurolex SR. The doctor may change the dose or stop the medicine.

Ceurolex SR and other medicines

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

have recently taken, as well as any medicines they plan to take,including herbal medicines or other medicines obtained without a prescription. The patient should remember to inform their doctoror pharmacist about starting to take any other medicine during treatment with Ceurolex SR. Some medicines may affect the action of Ceurolex SR or increase the risk of side effects. Ceurolex SR may 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 nauseaand heartburn
• antibiotics ciprofloxacin enoxacin
• any other medicines used to treat Parkinson's disease.

In patients taking Ceurolex SR with the following medicines, additional blood tests will be necessary:

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

The patient should inform their doctorif they are taking or have recently taken any of these medicines.

Ceurolex SR with food, drink, and alcohol

Tablets should be swallowed whole with a glass of water. Ceurolex SR can be taken with or without food. Alcohol consumption with Ceurolex SR is not recommended. The patient should tell their doctorif they start or stop smoking during treatment with Ceurolex SR. The doctor or nurse may change the dose.

Pregnancy, breast-feeding, and fertility

If the patient is pregnant or breast-feeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The doctor may recommend stopping Ceurolex SR. Ceurolex SR is not recommended during pregnancy, unless the doctor considers that the benefits of Ceurolex SR outweigh the risks to the unborn child. Ceurolex SR is not recommended during breast-feeding, as it may affect milk production.

Driving and using machines

Ceurolex SR may cause drowsiness. Uncontrolled drowsinessmay occur, and sometimes sudden and unexpected sleep attacks without prior drowsiness. If these symptoms occur, the patient should not drive or operate machinery or performactivities where 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. 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. The patient should discuss this with their doctorif it applies to them.

Ceurolex SR, 2 mg, prolonged-release tablets contain lactose

Ceurolex SR, 2 mg, prolonged-release tablets contain 1.71 mg of lactose (in the form of lactose monohydrate). If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Ceurolex SR, 4 mg, prolonged-release tablets contain orange yellow S

Ceurolex SR, 4 mg, prolonged-release tablets contain 0.81 mg of orange yellow S, which may cause an allergic reaction in the patient.

Other excipients

Ceurolex SR 2 mg, 4 mg, 8 mg contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially 'sodium-free'.

3. How to take Ceurolex SR

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. The medicine is in the form of prolonged-release tablets and should not be taken if the tablet is broken or damaged. Ceurolex SR 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 uncontrolled movements (dyskinesias) when they start taking Ceurolex SR. If these symptoms occur, the patient should inform their doctor, who may adjust the doses of the medicines the patient is taking.

How much Ceurolex SR to take

It may take some time to find the right dose of Ceurolex SR for the patient. The recommended starting doseof Ceurolex SR is 2 mg once daily for the first week. The doctor may increase the dose of Ceurolex SR to 4 mg once daily from the second week of treatment. If the patient is very elderly, the doctor may increase the dose more slowly. The doctor will then adjust the dose until they find the best dose for the patient. Some patients may take up to 24 mg of Ceurolex SR. 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 Ceurolex SR than prescribed by the doctor.

It may take several weeks before the beneficial effects of the medicine are seen.

Taking the dose of Ceurolex SR

Ceurolex SR should be taken once daily, at the same time every day.

The prolonged-release tablet(s) of Ceurolex SR should be swallowed whole, with a glass of water.

Do not break, chew, or crush the prolonged-release tablet(s)– if this happens, there is a risk of overdose, due to the rapid release of the medicine in the body. The Ceurolex SR tablets are designed to release the medicine slowly over a period of more than 24 hours. If the patient's condition, such as 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 tablets will be visible in the stool. In this situation, the patient should contact their doctor as soon as possible.

If the patient is switching from ropinirole immediate-release tablets to Ceurolex SR prolonged-release tablets

The doctor will determine the dose of Ceurolex SR based on the dose of ropinirole the patient was previously taking. The patient should take their usual dose of ropinirole on the day before the switch. The next day, they should take Ceurolex SR and not take any more of their previous ropinirole tablets.

Use in children and adolescents

Ceurolex SR should not be used in children. Ceurolex SR is not intended for use in patients under 18 years old.

Taking a higher dose of Ceurolex SR than recommended

The patient should contact their doctor or pharmacist immediately. If possible, they should show them the pack of Ceurolex SR. If the patient takes more Ceurolex SR than recommended, they may experience nausea, vomiting, dizziness, drowsiness, mental or physical fatigue, fainting, or hallucinations.

Missing a dose of Ceurolex SR

The patient should not take an extra prolonged-release tablet or double the dose to make up for a missed dose.

If the patient misses a dose of Ceurolex SR for a day or longer, they should consult their doctor about restarting treatment with Ceurolex SR.

Stopping treatment with Ceurolex SR

The patient should not stop taking Ceurolex SR suddenly without consulting their doctor. Ceurolex SR should be taken for as long as the doctor recommends. The patient should not stop taking it unless their doctor advises them to. If the patient stops taking Ceurolex SR suddenly, their Parkinson's disease symptoms may worsen rapidly. Stopping the medicine suddenly may also cause a condition called neuroleptic malignant syndrome, which can be life-threatening. Symptoms include: akinesia (loss of muscle movement), muscle stiffness, fever, unstable blood pressure, tachycardia (rapid heart rate), confusion, and altered consciousness (such as coma). If the doctor needs to stop the treatment, they will gradually reduce the dose.

4. Possible side effects

Like all medicines, Ceurolex SR can cause side effects, although not everybody gets them. The side effects of Ceurolex SR are most likely to occur when the patient first starts taking the medicine or when the dose is increased. 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 more than 1 in 10 people)

• fainting
• drowsiness
• nausea.

Common side effects(may affect up to 1 in 10 people)

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

Uncommon side effects(may affect up to 1 in 100 people)

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

Some patients may experience the following side effects(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 in swallowing or breathing, rashor intense itching (see section 2)
• changes in liver function, which have been seen in blood tests
• aggressive behavior
• inability to control impulses, urges, or behaviors, including:
• uncontrolled urge to gamble, despite the risk of serious consequences for the patient or their family.
• altered or increased sexual interest and behavior, causing concern for the patient or others, such as increased sexual drive.
• uncontrolled urge to shop or spend money.
• binge eating (eating large amounts of food in a short time) or compulsive eating (eating more than normal, more than needed to satisfy hunger).
• excessive intake of Ceurolex SR (excessive desire to take high doses of dopaminergic medicines, higher than needed to control motor symptoms, known as dopamine dysregulation syndrome).
• episodes of overactivity, excitement, or irritability
• after stopping or reducing the dose of Ceurolex SR, the following may occur: depression, apathy, anxiety, lack of energy, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS).
• spontaneous erection.

The patient should inform their doctor about any of the above symptoms; the doctor will discuss the possibilities and ways to reduce the symptoms.

Taking Ceurolex SR with L-dopa (used to treat Parkinson's disease)

In patients taking Ceurolex SR with L-dopa, the following side effects may occur after some time:

• uncontrolled movements (dyskinesias) are a very common side effect. If the patient is taking L-dopa, they may experience uncontrolled movements (dyskinesias) when they start taking Ceurolex SR. If these symptoms occur, the patient 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 any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, 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 Ceurolex SR

The medicine should be stored out of the reach and sight of children. Do not use this medicine after the expiry date stated on the carton, blister, and bottle. The expiry date refers to the last day of the month. Store in a temperature below 25°C. Do not open the bottle until the patient is ready to start taking the tablets. If there are any tablets left in the bottle after 90 days, the patient should not take them. 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 need. This will help protect the environment.

6. Contents of the pack and other information

What Ceurolex SR contains

The active substance of Ceurolex SR is ropinirole. Each prolonged-release tablet contains ropinirole hydrochloride equivalent to 2 mg, 4 mg, and 8 mg of ropinirole. The other ingredients are:

• tablet core: ammonio methacrylate copolymer (type B), hydroxypropyl methylcellulose, sodium lauryl sulfate, copovidone, magnesium stearate.
• tablet coating:

What Ceurolex SR looks like and contents of the pack

Ceurolex SR, 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. Ceurolex SR, 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. Ceurolex SR, 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.

All strengths of the medicine are available in blisters of PVC/PCTFE/Aluminum and bottles of HDPE with a PP cap with a child-resistant closure and a desiccant. Pack sizes: Blisters: 21, 28, 84 tablets. Bottles: 84 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Manufacturer

Orion Corporation, Orion Pharma, Orionintie 1, FI-02200 Espoo, Finland, Orion Corporation, Orion Pharma, Joensuunkatu 7, FI-24100 Salo, Finland, Pharmathen S.A, 6 Dervenakion str., 15351, Pallini, Attiki, Greece, Pharmathen International S.A, Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece. For more information about this medicine, the patient should contact the local representative of the marketing authorization holder: Orion Pharma Poland Sp. z o. o., kontakt@orionpharma.info.pl

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

following names:

Lithuania, Latvia, Hungary: Ropinirole Orion, Poland: Ceurolex SR, Denmark, Finland, Norway: Ropinirol Orion, Date of last revision of the leaflet:19.01.2024