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

Read 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 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

• if the patient has been diagnosed with hypersensitivityto ropiniroleor 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

Tell your doctor if any of these situations apply to you.

Warnings and precautions

Before starting to take Aropilo, discuss it with your doctor or pharmacist.

• 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 severe mental disorders;
• if the patient has a history of certain tendencies and (or) behaviors (uncontrolled urge to gamble or excessive sexual activity),
• if the patient has intolerance to sugars (e.g. lactose).

If the patient experiences symptoms such as depression, apathy, anxiety, lack of energy, sweating, or pain (called dopamine agonist withdrawal syndrome or 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 adjust the dose of the medicine. Tell your doctor if you or your family/ caregiver notice any unusual behaviors (such as a strong urge to gamble or increased desire and/ or sexual behavior) while taking Aropilo. The doctor may adjust the dose or stop the treatment. If you or your family/ caregiver notice any unusual behaviors that are the result of an irresistible impulse, compulsion, or urge to perform certain actions that may be harmful to you or others, tell your doctor. Such behaviors are called impulse control disorders and may include addiction to gambling, overeating, or excessive spending, or increased sexual drive or intense sexual thoughts and feelings. The doctor may adjust the dose or stop the treatment.

Aropilo and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including herbal preparations or other medicines bought without a prescription. Tell your doctor or pharmacist if you start taking any new medicines while taking 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

Tell your doctor if you are taking or have recently taken any of these medicines. Additional blood tests should be performed if you are taking the following medicines with Aropilo:

• medicines from 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 decides 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 you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine. The doctor may advise you to stop taking Aropilo.

Driving and using machines

Aropilo may cause drowsiness. In very rare cases, it may cause uncontrollable drowsiness, and sometimes even sudden and unexpected sleep attacks, not preceded by drowsiness. During treatment with ropinirole, hallucinations (seeing, hearing, or feeling things that are not there) may occur. If you experience hallucinations, do not drive or operate machinery. If you experience such symptoms, do not drive or perform tasks that require attention, as reduced alertness may put you or others at risk of serious injury or death (e.g., operating machinery). Consult your doctor if this situation is a problem for you.

Smoking and taking Aropilo

Tell your doctor if you start or stop 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 the symptoms starting earlier or becoming more intense. Symptoms may also appear in limbs that were previously unaffected, such as the arms, or the symptoms may shift to the early morning hours. If you experience any of these symptoms, consult your doctor.

Aropilo contains lactose

If you have been diagnosed with intolerance to some sugars, consult your 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

Always take Aropilo exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. Aropilo 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). Tell your doctor if you or your family/ caregiver notice any unusual behaviors (such as a strong urge to gamble or increased desire and/ or sexual behavior) while taking Aropilo. The doctor may adjust the dose or stop the treatment. Aropilo should not be given to children. Aropilo is not usually prescribed for people under 18 years old.

Recommended dose:

For Parkinson's disease:

Finding the optimal dose of Aropilo may take time. The usual starting 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 you. The usual dose is 1 mg to 3 mg three times a day (total daily dose: 3 mg to 9 mg). If the symptoms of Parkinson's disease are not sufficiently alleviated, the doctor may decide to gradually increase the dose. Some patients may take a dose of up to 8 mg of Aropilo three times a day (a total of 24 mg per day). If you are taking other medicines for Parkinson's disease, the doctor may advise you to gradually reduce the doses of these medicines. When taking L-dopa, you may experience involuntary movements (dyskinesia) when starting to take Aropilo.

Do not take more Aropilo than your doctor has recommended.

It may take a few weeks for Aropilo to start working.

Taking Aropilo

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

For restless legs syndrome:

Finding the optimal dose of Aropilo may take time. The starting 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 the symptoms of restless legs syndrome are not sufficiently alleviated, the dose may be gradually increased to a maximum dose of 4 mg once a day. After three months of treatment with Aropilo, depending on the symptoms and the patient's condition, the doctor may adjust the dose or consider stopping the treatment. If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist. Do not take more tablets than your doctor has recommended. Continue the treatment even if you 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. 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 you have taken more Aropilo than recommended, tell your doctor or pharmacist immediately. Show them the packaging of the medicine. If you have taken more Aropilo than recommended, you may experience: nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical), fainting, or hallucinations.

Missing a dose of Aropilo

If you miss a dose of Aropilo, do not take a double dose to make up for the missed dose. If you remember to take the dose, take the next dose at the usual time. If you miss a dose of Aropilo for one or more days, consult your doctor about restarting the treatment.

Stopping treatment with Aropilo

Do not stop taking Aropilo unless your doctor tells you to. Take Aropilo for as long as your doctor has recommended. If you suddenly stop taking Aropilo, the symptoms of Parkinson's disease may worsen significantly. Stopping the treatment suddenly may cause 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 heartbeat), confusion, and decreased level of consciousness (e.g., coma). If you need to stop taking Aropilo, your doctor will gradually reduce the dose. If you have any doubts about taking the medicine, consult your 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 you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.

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
• abdominal pain
• swelling of the feet, ankles, or hands

Uncommon side effects (occurring in up to 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)
• sudden sleep attacks without feeling drowsy (sudden sleep episodes)
• mental disorders, such as delirium (severe confusion), delusions (nonsensical thoughts), or paranoia (unfounded suspicion)
• hiccups

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

• allergic reactions such as red, itchy swelling 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, larger 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 erection

The following side effects may occur:

• inability to resist impulses, urges, or compulsions to perform actions that may be harmful to you 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 you 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)

Tell your doctor if you experience any of these behaviors, so you can discuss ways to control or limit these symptoms.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Aropilo

Keep the medicine out of the 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 that month. Do not store above 25°C. Keep in the original packaging to protect from light and moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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. The other ingredients are:

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), lacquer, 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), lacquer, 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