Aropilo

Leaflet accompanying the packaging: patient information

Aropilo, 5 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 pack 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 natural dopamine and thus helps to alleviate the symptoms of Parkinson's disease.

2. Important information before taking Aropilo

When not to take Aropilo

• if the patient has been diagnosed with allergyto 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 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 disorders;
• if you have a history of impulse control disorders (e.g., pathological gambling or increased sexual desire);
• if you have intolerance to sugars (e.g., lactose).

If you experience any of the following symptoms after stopping or reducing the dose of ropinirole, such as depression, apathy, anxiety, lack of energy, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS), tell your doctor. If the symptoms persist for more than a few weeks, your doctor may decide to adjust the dose of the medicine. Tell your doctor if you or your family/caregiver notice any unusual behavior resulting from an irresistible impulse, compulsion, or repetitive behavior that may be harmful to you or others. Such behaviors are called impulse control disorders and may include addiction to gambling, overeating, or spending money, or increased sexual desire. Your doctor may decide to adjust the dose or stop the medicine. Tell your doctor if any of the above conditions apply to you. Your doctor may decide that Aropilo is not a suitable medicine for you or may recommend additional monitoring during 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 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
• any other medicines used in Parkinson's disease. Tell your doctor if you are taking or have recently taken any of these medicines. Your doctor may recommend additional blood tests if you are taking any of these medicines with Aropilo:
• Medicines that belong to the group of vitamin K antagonists (used to reduce blood clotting), such as warfarin (Coumadin).

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 and breastfeeding

Aropilo is not recommended during pregnancy, unless your doctor decides that the benefits of taking the medicine outweigh the potential risks to the fetus. Aropilo is not recommended for breastfeeding women, as it may affect lactation. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Your doctor may recommend stopping Aropilo.

Driving and using machines

Aropilo may cause drowsiness. In very rare cases, it may cause uncontrollable drowsiness, and sometimes also sudden and unexpected attacks of sleep, not preceded by drowsiness. During treatment with Aropilo, 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). Discuss this with your doctor if it is a problem for you.

Smoking and taking Aropilo

Tell your doctor if you start or stop smoking while taking Aropilo. Your doctor may decide to adjust the dose.

Aropilo contains lactose

If you have previously 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 notice any unusual behavior (such as a strong impulse to gamble or increased sexual desire) while taking Aropilo. Your doctor may change the dose of the medicine or stop treatment. Aropilo should not be given to children. Aropilo is not usually prescribed for people under 18 years old.

Recommended dose

It may take some time to find the optimal dose of Aropilo. The usual starting dose is 0.25 mg three times a day for the first week. Then, your doctor will increase the dose every week for the next three weeks. After that, your 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 you do not get enough relief from your Parkinson's symptoms, your 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, your doctor may recommend gradually reducing the doses of those medicines. If you are taking L-dopa, you may experience involuntary movements (dyskinesias) when you start taking Aropilo. If you experience these symptoms, tell your doctor, who may adjust the doses of your medicines.

Do not take more Aropilo than your doctor has recommended

It may take several weeks for Aropilo to start working.

Method of administration

Aropilo should be taken 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.

Taking a higher dose of Aropilo than recommended

Immediately consult your doctor or pharmacist. Show them the packaging of Aropilo. A person who has taken too much medicine 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 treatment.

Stopping treatment with Aropilo

Do not stop taking the medicine unless your doctor tells you to. Aropilo should be taken for as long as your doctor recommends. If you suddenly stop taking Aropilo, your Parkinson's symptoms may worsen significantly. Stopping treatment suddenly may 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 decreased level of consciousness (e.g., coma). If you need to stop taking Aropilo, your doctor will gradually reduce the dose you are taking. 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
• 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 standing up quickly (related to low blood pressure)
• very strong drowsiness during the day (uncontrollable drowsiness)
• sudden sleep attacks not preceded by drowsiness
• mental disorders, such as delirium (severe confusion), delusions (unreasonable 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 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)
• aggression
• overuse of Aropilo (uncontrollable desire to take high doses of dopaminergic medicines, greater 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 (known as dopamine agonist withdrawal syndrome or DAWS)
• changes in liver function, which have been detected in blood tests
• spontaneous erections

The following side effects may occur:

• inability to resist an impulse, temptation, or compulsion to perform actions that may be harmful to you or others; this includes:
• strong impulse to gamble uncontrollably, despite significant personal or family consequences
• changed or increased sexual interests and behaviors of importance to you or others, e.g., activities related to increased sexual desire
• 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.

Taking Aropilo with L-dopa (levodopa)

In patients taking Aropilo with L-dopa, the following side effects may occur over 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 Aropilo. If you experience these symptoms, tell your doctor, who may adjust the doses of your medicines.
• feeling disoriented is a common side effect

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 of Monitoring of Adverse Reactions to Medicinal Products, 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 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. 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 Aropilo contains

The active substance is ropinirole (Ropinirolum). One Aropilo 5 mg coated tablet contains 5 mg of ropinirole in the form of ropinirole hydrochloride. The other ingredients are:

Core:

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

Coating:

Opadry 03B20462 blue: indigo carmine (E132), lacquer, hypromellose, macrogol 400, titanium dioxide (E171).

What Aropilo looks like and contents of the pack

Aropilo 5 mg coated tablets are round, light blue. Blisters of PVC/PCTFE/PVC/Aluminum: 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