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)

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

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

You should inform your doctor if any of these conditions occur.

Warnings and precautions

Before starting to take Ceurolex SR, you should discuss it with your doctor or pharmacist:

• if you are pregnant or think you may be pregnant
• if you are breastfeeding
• if you are under 18 years old
• if you have severe heart disease
• if you have severe mental health problems
• if you have a history of certain behaviors or impulses (see section 4)
• if you have an intolerance to some sugars (such as lactose).

You should inform your doctorif any of these conditions occur. Your doctor may decide that Ceurolex SR is not a suitable medicine for you or may recommend additional monitoring during treatment. You should inform your doctor if you or your family notice any unusual behaviors in you, such as an inability to resist the impulse to gamble, or an increased sexual drive, and you are unable to control these behaviors. This behavior is called impulse control disorder and can include behaviors such as: gambling, overeating, spending sprees, or an increased sexual drive. Your doctor may adjust your dose or stop your treatment. You should inform your doctor if you or your family/caregiver notice episodes of mania or hypomania (abnormally elevated or irritable mood). These can occur with or without impulse control disorders (see above). Your doctor may adjust or reduce your dose.

During treatment with Ceurolex SR

You should inform your doctor if you or your family notice any unusual behaviors in you, such as an inability to resist the impulse to gamble, or an increased sexual drive, while taking Ceurolex SR. Your doctor may adjust your dose or stop your treatment.

Ceurolex SR and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or

have recently taken, as well as any medicines you plan to take, including herbal medicines or other medicines obtained without a prescription.You should remember to inform your doctor or 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 for other mental health problems, such as sulpiride
• HRT (hormone replacement therapy)
• metoclopramide, which is used to treat nausea and vomiting
• 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 required:

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

You should inform your doctorif you 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 is not recommended while taking Ceurolex SR. You should tell your doctorif you start or stop smoking during treatment with Ceurolex SR. Your doctor or nurse may adjust your dose.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine. Your doctor may recommend stopping Ceurolex SR. Ceurolex SR is not recommended during pregnancy, unless your doctor considers that the benefits to you outweigh the risks to your unborn baby. Ceurolex SR is not recommended during breastfeeding, as it may affect milk production.

Driving and using machines

Ceurolex SR can cause drowsiness. You may experience excessive drowsinessor sudden sleep attackswithout feeling drowsy beforehand. If you experience these symptoms, you should not drive or operate machineryor perform tasks that may put you or others at risk of serious injury or death. You should not perform these tasks until the symptoms have resolved. During treatment with ropinirole, you may experience hallucinations (seeing, hearing, or feeling things that are not there). If you experience hallucinations, you should not drive or operate machinery. You should discuss this with your doctorif it applies to you.

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 you have been diagnosed with an intolerance to some sugars, you should contact your 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.

Other excipients

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

3. How to take Ceurolex SR

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist. This 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 you are taking L-dopa, you may experience involuntary movements (dyskinesias) when you start taking Ceurolex SR. If you experience these symptoms, you should inform your doctor, who may adjust your doses.

How much Ceurolex SR to take

It may take some time to find the right dose of Ceurolex SR for you. The recommended starting doseof Ceurolex SR is 2 mg once daily for the first week. Your doctor may increase your dose of Ceurolex SR to 4 mg once daily from the second week onwards. If you are elderly, your doctor may increase your dose more slowly. Your doctor will then adjust your dose until you reach the dose that is right for you. Some patients may take up to 24 mg of Ceurolex SR. If you experience side effects that are difficult to tolerate at the start of treatment, you should inform your doctor. Your doctor may recommend switching to a lower dose of ropinirole in the form of immediate-release tablets, which you will take three times a day.

Do not take more Ceurolex SR than your doctor has recommended.

It may take several weeks for the full effect of the medicine to develop.

Taking your dose of Ceurolex SR

Ceurolex SR should be taken once daily, at the same time each 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 you do, there is a risk of overdose due to the rapid release of the medicine in the body. The tablets of Ceurolex SR are designed to release the medicine slowly over a period of more than 24 hours. If the medicine moves through your body too quickly, the tablets may not dissolve completely and may not work as they should. You may see the tablets in your stool. In this situation, you should contact your doctor as soon as possible.

If you are switching from ropinirole immediate-release tablets to Ceurolex SR prolonged-release tablets

Your doctor will determine your dose of Ceurolex SR based on the dose of ropinirole immediate-release tablets you were taking previously. You should take your previous dose of ropinirole immediate-release tablets as usual on the day before you switch to Ceurolex SR. The next day, you should take Ceurolex SR and not take any more ropinirole immediate-release 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.

If you take more Ceurolex SR than you should

You should contact your doctor or pharmacist immediately. If possible, you should show them the Ceurolex SR packaging. If you take more Ceurolex SR than you should, you may experience nausea, vomiting, dizziness, drowsiness, mental fatigue, or fainting.

If you forget to take Ceurolex SR

Do not take an extra prolonged-release tablet or a double dose to make up for a forgotten dose.

If you forget to take a dose of Ceurolex SR for a day or longer, you should consult your doctor about restarting treatment with Ceurolex SR.

Stopping treatment with Ceurolex SR

You should not stop taking Ceurolex SR suddenly without discussing it with your doctor. Ceurolex SR should be taken for as long as your doctor recommends. You should not stop taking it unless your doctor advises you to. If you stop taking Ceurolex SR suddenly, your Parkinson's disease symptoms may worsen rapidly. Stopping treatment suddenly may also cause a condition called neuroleptic malignant syndrome, which can be life-threatening. Symptoms include: akinesia (loss of movement), muscle stiffness, fever, unstable blood pressure, rapid heartbeat, confusion, and altered consciousness (such as coma). If your doctor needs to stop your treatment with Ceurolex SR, they will reduce your dose gradually. If you have any further questions about taking Ceurolex SR, you should ask your doctor or pharmacist.

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 usually mild and may become less troublesome after a few days of treatment. If you are concerned about side effects, you should talk to your 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 feeling drowsy beforehand
• 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 up to 1 in 100 people)

• dizziness or fainting, especially when standing up (related to low blood pressure)
• low blood pressure (hypotension)
• excessive drowsiness during the day
• mental health problems, 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 swallowing or breathing, rashor intense itching (see section 2)
• changes in liver function, which have been detected in blood tests
• aggressive behavior
• inability to resist the impulse to perform certain actions that could be harmful to you or others, including:
• strong urge to gamble, regardless of the serious consequences this may have for you or your family
• altered or increased sexual interest and behavior that causes concern for you or others, such as increased sexual drive
• uncontrolled spending or buying sprees
• binge eating (eating large amounts of food in a short period) 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, you may experience: depression, apathy, anxiety, lack of energy, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS)
• spontaneous erections.

You should inform your doctor about any of the above symptoms; your doctor will discuss the possibilities and ways to reduce the symptoms with you.

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:

• involuntary movements (dyskinesias) are a very common side effect. If you are taking L-dopa, you may experience involuntary movements when you start taking Ceurolex SR. If you experience these symptoms, you should inform your doctor, who may adjust your doses
• disorientation is a common side effect.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the national reporting system (see below for contact information). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceurolex SR

The medicine should be kept 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 stated. Store in a temperature below 25°C. Do not open the bottle until you are ready to start taking the tablets. If there are any tablets left in the bottle after 90 days, do not take them. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. 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, or 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 Ceurolex SR are available in blisters of PVC/PCTFE/Aluminum and bottles of HDPE 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 further information about this medicine, you 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