Aropilo

Leaflet attached to the packaging: patient information

Aropilo, 0.25 mg, coated tablets

Aropilo, 0.5 mg, coated tablets

Aropilo, 1 mg, coated tablets

Aropilo, 2 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.

• You should keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, you should consult a 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Aropilo and what is it used for

The active substance of Aropilo 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.

Aropilo is used to treat Parkinson's disease.

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

Aropilo is used to treat symptoms of restless legs syndrome of moderate to severe severity.

Restless legs syndrome is also known as Ekbom's syndrome. People with restless legs syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of their body. This is usually accompanied by unpleasant sensations in the limbs - sometimes described as "skin suffering" or "tingling" - which can start as soon as the patient sits or lies down and only subside after movement. Patients often have trouble sitting, especially sleeping. Aropilo alleviates the unpleasant sensations and reduces the urge to move the limbs.

2. Important information before taking Aropilo

When not to take Aropilo

hypersensitivityto ropiniroleor any of the other ingredients of this medicine (listed in section 6);severe kidney diseaseliver disease

The patient should inform their doctor if any of these situations apply to them.

Warnings and precautions

Before starting to take Aropilo, the patient should discuss it with their doctor or pharmacist.

If the patient experiences any of the following symptoms after stopping or reducing the dose of ropinirole, they should tell their doctor: depression, apathy, anxiety, lack of energy, sweating, or pain (called 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 or their family/caregiver notice any unusual behaviors resulting from an irresistible impulse, compulsion, or urge to perform certain actions, which may be harmful to the patient or others. Such behaviors are called impulse control disorders and may include addiction to gambling, overeating, or spending money, excessive sexual drive, or intense sexual thoughts and feelings. The doctor may decide to adjust the dose or discontinue the medicine. The patient should tell their doctor if any of the above conditions apply to them. The doctor may decide that Aropilo is not a suitable medicine for the patient or may recommend additional monitoring during treatment.

Aropilo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including herbal preparations or other medicines bought without a prescription. The patient should tell their doctor or pharmacist about starting to take any new medicines during treatment with Aropilo. Some medicines may affect the action of Aropilo or increase the risk of side effects. Aropilo may also affect the action of other medicines. These medicines include:

• the antidepressant fluvoxamine
• HRT (hormone replacement therapy)
• antibiotics: ciprofloxacin and enoxacin
• medicines used in other mental disorders, such as sulpiride
• metoclopramide, which is used to treat nausea and heartburn
• cimetidine, used to treat stomach ulcers
• any other medicines used in 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 tests if they are taking the following medicines with Aropilo:

• medicines that belong to the group of vitamin K antagonists (used to reduce blood clotting), such as warfarin (Coumadin).

Taking Aropilo with food and drink

Taking Aropilo with food may reduce the likelihood of vomiting and nausea. If possible, it is recommended to take the medicine with food.

Pregnancy, breastfeeding, and fertility

Aropilo is not recommended during pregnancy, unless the doctor considers that the benefit of taking the medicine outweighs the potential risk to the fetus. Aropilo is not recommended for breastfeeding women, as it may affect lactation. If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. The doctor may recommend discontinuing Aropilo.

Driving and using machines

Aropilo may cause drowsiness. In very rare cases, it may cause uncontrollable drowsiness, and sometimes sudden and unexpected attacks of sleep, not preceded by 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 such symptoms occur, the patient should not drive or perform tasks that require attention, as reduced alertness may put the patient or others at risk of serious injury or death (e.g., operating machinery). The patient should discuss this with their doctor if it becomes a problem.

Smoking and taking Aropilo

The patient should inform their doctor about starting or stopping smoking while taking Aropilo. The doctor may decide to adjust the dose.

Severity of symptoms

During treatment with ropinirole, the symptoms of restless legs syndrome may worsen, with earlier onset of symptoms or increased intensity. Symptoms may also appear in limbs that were previously unaffected, such as the arms, or the time of symptom onset may shift to the early morning hours. If the above symptoms occur, the patient should consult their doctor.

Aropilo contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Aropilo contains sodium

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

3. How to take Aropilo

Aropilo should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist again. Aropilo may 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). The patient should inform their doctor if they or their family notice any unusual behaviors (such as a strong urge to gamble or increased sexual desire and/or behavior) while taking Aropilo. The doctor may adjust the dose or discontinue the treatment. Aropilo should not be given to children. Aropilo is not usually prescribed to people under 18 years old.

Recommended dose:

In the treatment of Parkinson's disease:

Determining the optimal dosage of Aropilo may take time. The usual initial dose is 0.25 mg three times a day for the first week. Then, the doctor will increase the dose by 0.25 mg three times a day every week for the next three weeks. After that, the doctor will gradually increase the dose to the best dose for the patient. The usual dose is 1 mg to 3 mg three times a day (total daily dose: 3 mg to 9 mg). If sufficient alleviation of Parkinson's disease symptoms is not achieved, the doctor may decide to gradually increase the dose. Some patients may receive a dose of up to 8 mg of Aropilo 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. When taking L-dopa, the patient may experience involuntary movements (dyskinesia) when starting to take Aropilo.

Do not take more Aropilo than recommended by the doctor.

It may take a few weeks before Aropilo starts to work.

Taking the dose of Aropilo

Take Aropilo three times a day. The tablets should be swallowed with a glass of water. Aropilo is best taken with food, as this reduces the likelihood of nausea.

In the treatment of restless legs syndrome:

Determining the optimal dosage of Aropilo may take time. The initial dose of ropinirole is 0.25 mg once a day. After two days, the doctor will probably increase the dose to 0.5 mg once a day for the rest of the week. Then, the doctor may gradually increase the dose to 2 mg once a day over a period of three weeks. If there is not enough improvement in the symptoms of restless legs syndrome, the dose may be gradually increased to a maximum dose of 4 mg once a day for optimal improvement. After three months of treatment with Aropilo, depending on the symptoms of the disease and the patient's well-being, the doctor may adjust the dose or consider discontinuing the treatment. If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist. The patient should not take more tablets than recommended by the doctor. The patient should continue the treatment even if they do not feel any improvement, as the effect of the treatment may only be noticeable after a few weeks.

Method of administration

Take Aropilo once a day. The patient should swallow Aropilo with a glass of water. Aropilo can be taken with or without food. Taking Aropilo with food may reduce the likelihood of nausea. Aropilo is usually taken shortly before bedtime, but the dose can be taken up to 3 hours before bedtime.

Taking a higher dose of Aropilo than recommended

If the patient takes a higher dose than recommended, they should immediately inform their doctor or pharmacist. They should show them the packaging of the medicine. If a person takes a higher dose of Aropilo than recommended, they may experience: nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical), fainting, or hallucinations.

Missing a dose of Aropilo

If the patient misses a dose of Aropilo, they should not take a double dose to make up for the missed dose. If the patient remembers to take the dose, they should take the next dose at the usual time. If the patient misses a dose of Aropilo for one or more days, they should consult their doctor about restarting the treatment.

Stopping treatment with Aropilo

The patient should not stop taking Aropilo unless their doctor recommends it. Aropilo should be taken for as long as the doctor recommends. If the patient suddenly stops taking Aropilo, the symptoms of Parkinson's disease may worsen significantly. Sudden discontinuation of treatment may cause the patient to experience a so-called malignant neuroleptic 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, and decreased level of consciousness (e.g., coma). If the patient needs to stop taking Aropilo, their doctor will gradually reduce the dose. If the patient has any doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Aropilo can cause side effects, although not everybody gets them. The most common side effects of Aropilo occur when some patients first start treatment and/or when the dose is increased. Side effects are usually mild and may decrease after a short period of taking the medicine. If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Parkinson's disease

Very common side effects (occurring in more than 1 in 10 people):

• fainting
• drowsiness
• nausea

Common side effects (occurring in up to 1 in 10 people):

• hallucinations (seeing things that are not there)
• vomiting
• dizziness (feeling of spinning)
• heartburn
• stomach pain
• swelling of the legs, feet, or hands.

Uncommon side effects (occurring in up to 1 in 100 people)

• dizziness or fainting, especially when changing position to standing (related to low blood pressure)
• very strong drowsiness during the day (uncontrollable sleepiness)
• sudden sleep attacks not preceded by drowsiness (sudden sleep attacks)
• mental disorders, such as delirium (severe confusion), delusions (nonsensical thoughts), or paranoia (unfounded suspicion).
• hiccups

Some patients may experience the following side effects (frequency not known: cannot be estimated from the available data):

• allergic reactions such as red, itchy swellings on 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 Aropilo (uncontrollable urge to take high doses of dopaminergic medicines, higher than necessary to control motor symptoms, called dopamine dysregulation syndrome),
• after stopping or reducing the dose of Aropilo, the following may occur: depression, apathy, anxiety, fatigue, sweating, or pain (called dopamine agonist withdrawal syndrome or DAWS),
• changes in liver function, which have been revealed in blood tests,
• spontaneous erections.

The following side effects may occur:

• inability to resist impulse, temptation, or compulsion to perform actions that may be harmful to the patient or others; this includes:
• strong urge to gamble uncontrollably, despite serious personal or family consequences;
• changed or increased sexual interests and behaviors of significant importance to the patient or others, such as activities related to increased sexual drive;
• compulsive, uncontrolled spending or buying;
• binge eating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger).;
• spontaneous erections.

The patient should inform their doctor if they experience any of these behaviors, so that they can discuss ways to control or limit these symptoms.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Aropilo

The medicine should be stored out of sight and reach of children. Do not use after the expiry date stated on the packaging (blister or container) 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 and moisture. 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 Aropilo contains

The active substance is ropinirole (Ropinirole). One Aropilo 0.25 mg coated tablet contains 0.25 mg of ropinirole in the form of ropinirole hydrochloride. One Aropilo 0.5 mg coated tablet contains 0.5 mg of ropinirole in the form of ropinirole hydrochloride. One Aropilo 1 mg coated tablet contains 1 mg of ropinirole in the form of ropinirole hydrochloride. One Aropilo 2 mg coated tablet contains 2 mg of ropinirole in the form of ropinirole hydrochloride. Other ingredients:

Tablet core:

Microcrystalline cellulose, lactose monohydrate, sodium carmellose, magnesium stearate.

Coating:

Aropilo 0.25 mg coated tablets (white) Opadry 03B28796 white: hypromellose, macrogol 400, titanium dioxide (E171). Aropilo 0.5 mg coated tablets (yellow) Opadry 03B32439 yellow: indigo carmine (E132), lac, hypromellose, iron oxide red (E172), macrogol 400, titanium dioxide (E171), iron oxide yellow (E172). Aropilo 1 mg coated tablets (green) Opadry 03B21634 green: indigo carmine (E132), lac, hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172). Aropilo 2 mg coated tablets (pink) Opadry 03B34666 pink: hypromellose, iron oxide red (E172), macrogol 400, titanium dioxide (E171), iron oxide yellow (E172).

What Aropilo looks like and contents of the pack

Aropilo 0.25 mg coated tablets are round, white or off-white. Aropilo 0.5 mg coated tablets are round, yellow. Aropilo 1 mg coated tablets are round, green. Aropilo 2 mg coated tablets are round, pink. PVC/PCTFE/PVC/Aluminum blisters: packs of 2, 12, 21, 28, 84, 126, 210 coated tablets.

50 ml container with polyethylene cap

84 coated tablets. 50 ml container with polyethylene capwith a desiccant in the cap 84 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

VIPHARM S.A. ul. A. i F. Radziwiłłów 9, 05-850 Ożarów Mazowiecki, Tel.: (+48 22) 679 51 35, Fax: (+48 22) 678 92 87, e-mail: [email protected]

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

Poland: Aropilo

Date of last revision of the leaflet: 28.06.2023