Aropilo Sr

Leaflet attached to the packaging: patient information

AROPILO SR, 2 mg, prolonged-release tablets
AROPILO SR, 4 mg, prolonged-release tablets
AROPILO SR, 8 mg, prolonged-release 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.
• In case of 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 those 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 SR and what is it used for
• 2. Important information before taking AROPILO SR
• 3. How to take AROPILO SR
• 4. Possible side effects
• 5. How to store AROPILO SR
• 6. Contents of the pack and other information

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

The active substance of AROPILO 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.
AROPILO SR, prolonged-release tablets are used to treat Parkinson's disease.
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 thus helps to alleviate the symptoms of Parkinson's disease.

2. Important information before taking AROPILO SR

When not to take AROPILO SR:

• if the patient has been diagnosed with hypersensitivityto the active substance 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 diseaseThe patient should inform their doctor if such circumstances occur.

Warnings and precautions

Before starting to take AROPILO 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 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.
The patient should tell their doctor if they, a family member, or caregiver notice the occurrence of tendencies or behaviors that the patient has not previously experienced and that they cannot resist the urge, drive, or temptation to perform certain actions that may harm them or others. This condition is called impulse control disorders and may include behaviors such as compulsive gambling, overeating, or excessive spending, or an increased sexual drive or intensification of thoughts or feelings related to sex. The doctor may consider it necessary to adjust the dose or stop the treatment.
The patient should inform their doctorif such circumstances occur. The doctor may decide that AROPILO SR is not a suitable medicine for the patient or may recommend additional monitoring during treatment.

During treatment with AROPILO SR

The patient should contact their doctor if they or a family member notice the occurrence of particular behaviorsduring treatment with AROPILO SR (such as uncontrolled urge to gambleor increased sexual drive and (or) excessive sexual activity). The doctor may recommend adjusting the dose or stopping the treatment.

Smoking and taking AROPILO SR

The patient should inform their doctorabout starting or stopping smoking while taking AROPILO SR. The doctor may consider it necessary to adjust the dose.

AROPILO SR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken

and about medicines they plan to take, including herbal products and other medicines available without a prescription.
The patient should remember to inform their doctoror pharmacist about starting to take any other medicine while taking AROPILO SR.
Some medicines may affect the action of ropinirole or increase the risk of side effects. Ropinirole may also 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 nausea and heartburn
antibiotics ciprofloxacin and enoxacin
any other medicines used in Parkinson's disease.
The patient should inform their doctorif they are taking or have recently taken any of these medicines. Additional blood tests should be performedif the patient is taking any of the following medicines with ropinirole:

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

Taking AROPILO SR with food and drink

AROPILO SR can be taken with or without food, as the patient prefers.

Pregnancy and breast-feeding

AROPILO SR is not recommended during pregnancy, unless the doctor considers that the benefits of taking AROPILO SR outweigh the risks to the unborn child. AROPILO SR is not recommended during breast-feeding, as it may affect milk production.
The patient should inform their doctor immediatelyif they are pregnant, think they may be pregnant, or plan to become pregnant. The doctor will also advise if the patient is breast-feeding or plans to breast-feed. The doctor may recommend stopping AROPILO SR.

Driving and using machines

AROPILO SR may cause drowsiness. Uncontrolled drowsiness may occur, and sometimes also sudden and unexpected attacks of sleep without prior drowsiness.
During treatment with AROPILO SR, hallucinations (seeing, hearing, or feeling things that are not there) may occur. If the patient experiences hallucinations, they should not drive or operate machines.
In case of suspicion that such symptoms may occur: the patient should not drive, operate machines, or perform activitiesin which 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.
The patient should talk to their doctorif such a situation is a problem for them.

AROPILO SR contains lactose

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

AROPILO SR contains sodium

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

3. How to take AROPILO SR

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
AROPILO SR should not be taken by children. AROPILO SR is not intended for use in patients under 18 years old.
AROPILO 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 involuntary movements (dyskinesia) when starting to take AROPILO SR. If such symptoms occur, the patient should inform their doctor, who may adjust the doses of the medicines taken by the patient.
The AROPILO SR tablets are designed for gradual release of the medicine over a period of more than 24 hours. If, due to the patient's condition (e.g. during diarrhea), the medicine passes through the body too quickly, the tablets may not dissolve completely and may not work as they should. It is possible that the tablets may be visible in the stool. In such a situation, the patient should contact their doctor as soon as possible.

What doses of AROPILO SR should be taken?

Determining the appropriate dose of AROPILO SR for the patient may take time.
The recommended initial doseof AROPILO SR prolonged-release is 2 mg once daily for the first week. The doctor may increase the dose to 4 mg of AROPILO SR once daily from the second week of treatment. If the patient is very elderly, the doctor may increase the dose more slowly. Then, the doctor may adjust the dose until the optimal dose for the patient is reached. Some patients take up to 24 mg of AROPILO SR prolonged-release tablets per day.
If the patient experiences intolerable side effects at the beginning 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 AROPILO SR than recommended by the doctor.

It may take several weeks for the beneficial effect of the medicine to occur.

Taking the dose of AROPILO SR

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

The AROPILO SR prolonged-release tablet (tablets) should be swallowed whole,

washed down with a glass of water.

Do not split, chew, or crush the prolonged-release tablet (tablets) –

if this happens, there is a risk of overdose due to the rapid release of the medicine in the body.

In case of switching treatment in patients taking ropinirole in the form of immediate-release tablets

The doctor will determine the dose of AROPILO SR prolonged-release tablets based on the previously used dose of ropinirole in the form of immediate-release tablets.
The patient should take the previously used dose of ropinirole in the form of immediate-release tablets on the day before switching the treatment. The next morning, the patient should take AROPILO SR prolonged-release tablets and not take any more ropinirole in the form of immediate-release tablets.

Taking more AROPILO SR than recommended

The patient should contact their doctor or pharmacist immediately. If possible, the patient should show the packaging of AROPILO SR..
In a person who has taken more AROPILO SR than recommended, the following may occur: nausea, vomiting, dizziness, drowsiness, mental fatigue or physical fatigue, fainting, hallucinations.

Missing a dose of AROPILO SR

Do not take more tablets or a double dose to make up for a missed dose.

In case of not taking AROPILO SR for a day or longer, the patient should consult their doctor about restarting the treatment with AROPILO SR.

Stopping treatment with AROPILO SR

Do not stop taking AROPILO SR unless the doctor recommends it.

AROPILO SR should be taken for as long as the doctor recommends. The patient should not stop taking it unless the doctor recommends it.
In case of sudden stopping of AROPILO SR, the symptoms of Parkinson's disease may worsen rapidly. Sudden stopping may cause the patient to experience a so-called malignant neuroleptic syndrome, which can be a serious threat to health. The symptoms include: akinesia (loss of muscle mobility), muscle stiffness, fever, unstable blood pressure, tachycardia (rapid heart rate), confusion, decreased level of consciousness (e.g. coma).
In case of need to stop treatment with AROPILO SR, the doctor will gradually reduce the dose taken by the patient.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, AROPILO SR can cause side effects, although not everybody gets them.
The side effects of ropinirole may occur most frequently during the start of treatment or shortly after increasing the dose. The side effects are usually mild and become less troublesome after a short period of taking the medicine. If the patient has concerns about side effects, they should consult their doctor.

Very common side effects

May occur in more than 1 in 10 patientstaking ropinirole
fainting
feeling drowsy, nausea.

Common side effects

May occur in up to 1 in 10 patientstaking ropinirole

• sudden sleepiness without prior drowsiness ( sudden sleep attacks)
• hallucinations (seeing things that are not real)
• vomiting
• dizziness
• heartburn
• abdominal pain
• constipation
• swelling of the legs, feet, or hands.

Uncommon side effects

May occur in up to 1 in 100 patientstaking ropinirole

• dizziness or fainting, especially when changing position to standing (related to low blood pressure)
• very strong feeling of drowsiness during the day ( excessive daytime sleepiness)
• mental disorders such as delirium (confusion), delusions (irrational thoughts), or paranoia (unfounded suspicion)
• hiccups

In some patients, the following side effects may occur (frequency not known: cannot be estimated from the available data):

allergic reactionssuch as red, itchy swellingof 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).
liver function changesshown in blood tests.

• aggressive behavior.
• excessive intake of ropinirole (uncontrolled desire to take large doses of dopaminergic medicines, larger than necessary to control motor symptoms, called dopamine dysregulation syndrome).
• inability to resist the urge, drive, or temptation to perform actions that may harm the patient or others. Symptoms may include: o Uncontrolled urge to gamble, despite significant consequences for the patient or their family. o Change or increase in interest in sex and behaviors that are particularly disturbing to the patient or others, such as increased sexual drive. o Uncontrolled, excessive eating or spending. o Sudden, intense eating (consuming large amounts of food in a short time), compulsive eating (consuming more food than needed to satisfy hunger).
• after stopping or reducing the dose of ropinirole, the following may occur: depression, apathy, anxiety, lack of energy, sweating, or pain (called dopamine agonist withdrawal syndrome or DAWS).
• spontaneous erection.

The patient should tell their doctor if they experience any of these behaviors in order to determine the treatment or alleviation of symptoms.

Taking AROPILO SR with L-dopa

In patients taking AROPILO SR with L-dopa, the following side effects may occur:

• involuntary movements (dyskinesia) are a very common side effect. If the patient is taking L-dopa, they may experience involuntary movements (dyskinesia) when starting to take AROPILO SR. If such symptoms occur, the patient should inform their doctor, who may adjust the doses of the medicines taken by the patient.
• feeling disoriented is a common side effect.

Reporting side effects

If side effects occur, including those not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of 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
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store AROPILO SR

Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date" or "EXP". The expiry date refers to the last day of the month.
Do not store above 30°C.
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 pack and other information

What AROPILO SR contains

• The active substance of AROPILO SR is ropinirole. Each prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirole (as ropinirole hydrochloride).
• The medicine also contains: hypromellose, sodium croscarmellose, maltodextrin, lactose monohydrate, hydrogenated castor oil, silicon dioxide, magnesium stearate; coloring mixture:[2 mg, prolonged-release tablets]iron oxide red (E 172), iron oxide yellow (E 172), lactose monohydrate; [4 mg and 8 mg, prolonged-release tablets]iron oxide red (E 172), iron oxide yellow (E 172), lactose monohydrate, iron oxide black (E 172).

What AROPILO SR looks like and contents of the pack

AROPILO SR, 2 mg, prolonged-release tablets:
Pink, speckled, oval tablets, 16 mm x 8.2 mm, with embossed marking 2x on one side.
AROPILO SR, 4 mg, prolonged-release tablets:
Brown, speckled, oval tablets, 16 mm x 8.2 mm, with embossed marking 4x on one side.
AROPILO SR, 8 mg, prolonged-release tablets:
Dark pink, speckled, oval tablets, 16 mm x 8.2 mm, with embossed marking 8x on one side.
Pack sizes:
AROPILO SR, prolonged-release tablets are available in blisters, containing 21, 28, 30, 42, 56, 84, or 90 prolonged-release tablets per pack.

Marketing authorization holder and manufacturer

Marketing authorization holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

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

Denmark
Aropilo SR
Czech Republic
Aropilos
Poland
AROPILO SR
Slovakia
Aropilos

Date of last revision of the leaflet: 06/2023