Aropilo Sr

Package Leaflet: Information for the Patient

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 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, please inform your 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 natural 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, helping to alleviate the symptoms of Parkinson's disease.

2. Important information before taking AROPILO SR

When not to take AROPILO SR:

• if you are allergic to the active substance 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 you have any of these conditions.

Warnings and precautions

Before starting to take AROPILO SR, you should discuss with your doctor or pharmacist:
if you are pregnant or think you may be pregnant
if you are breast-feeding
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 particular tendencies and/or behaviors(see section 4)
if you have an intolerance to some sugars (e.g. lactose).
If you experience any of the following symptoms after stopping or reducing the dose of ropinirol, such as depression, apathy, anxiety, lack of energy, sweating, or pain(known as dopamine agonist withdrawal syndrome or DAWS), you should inform your doctor. If the symptoms persist for more than a few weeks, your doctor may decide to adjust the dose of the medicine.
You should inform your doctor if you or a family member notice that you have developed any of these behaviors or if you are unable to resist the impulse, drive, or temptation to perform certain activities that could harm you or others. This condition is called impulse control disorders and may include behaviors such as compulsive gambling, excessive eating, or spending, or an increased sexual drive or sexual thoughts. Your doctor may need to adjust the dose or stop the treatment.

While taking AROPILO SR

You should contact your doctor if you or a family member notice any particular behaviorswhile taking AROPILO SR (such as uncontrollable gamblingor increased sexual drive and/or activity). Your doctor may need to adjust the dose or stop the treatment.

Smoking and taking AROPILO SR

You should inform your doctorif you start or stop smoking while taking AROPILO SR. Your doctor may need to adjust the dose.

AROPILO SR and other medicines

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

and about any medicines you plan to take, including those obtained without a prescription, herbal products, and other medicines available without a prescription.
You should remember to inform your doctoror pharmacist if you start taking any other medicine while taking AROPILO SR.
Some medicines may affect the action of ropinirol or increase the risk of side effects. Ropinirol may also 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 heartburn
antibiotics ciprofloxacin and enoxacin
any other medicines used for Parkinson's disease.
You should inform your doctorif you are taking or have recently taken any of these medicines. You may need to have additional blood testsif you are taking any of these medicines with ropinirol:

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

AROPILO SR can be taken with or without food.

Pregnancy and breast-feeding

AROPILO SR is not recommended during pregnancy, unless your doctor considers that the benefits of taking the medicine outweigh the risks to the unborn baby. AROPILO SR is not recommended during breast-feeding, as it may affect milk production.
You should inform your doctor immediatelyif you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will also advise you if you are breast-feeding or plan to breast-feed.

Driving and using machines

AROPILO SR may cause drowsiness. Sudden sleepiness may occur, and sometimes sudden and unexpected episodes of sleep without warning.
While taking AROPILO SR, you may experience hallucinations (seeing, hearing, or feeling things that are not there). If you experience hallucinations, you should not drive or operate machinery.
If you suspect that you may experience these symptoms, do not drive, operate machinery, or perform activitieswhere drowsiness or falling asleep may put you or others at risk of serious injury or death. Do not perform such activities until the symptoms have resolved.
You should discuss this with your doctorif this is a problem for you.

AROPILO SR contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.

AROPILO SR contains sodium

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

3. How to take AROPILO SR

This medicine should always be taken exactly as advised by your doctor. If you are unsure, you should ask your 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 you are taking L-dopa, you may experience involuntary movements (dyskinesias) when you start taking AROPILO SR. If you experience these symptoms, you should inform your doctor, who may need to adjust the doses of your medicines.
AROPILO SR tablets are designed to release the medicine slowly over a period of more than 24 hours. If, due to your condition (e.g. during diarrhea), the medicine passes 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 such a situation, you should contact your doctor as soon as possible.

What dose of AROPILO SR should you take?

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

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

It may take several weeks for the medicine to start working.

Taking your dose of AROPILO SR

You should take AROPILO SR once daily, at the same time each day.

You should swallow the tablet(s) whole with a glass of water.

Do not break, chew, or crush the tablet(s) - if you do, there is a risk of overdose due to the rapid release of the medicine in the body.

In case of switching from ropinirol immediate-release tablets

Your doctor will determine the dose of AROPILO SR based on the dose of ropinirol immediate-release tablets you were taking previously.
You should take the same dose of ropinirol immediate-release tablets on the day before switching to AROPILO SR. The next morning, you should take AROPILO SR and not take any more ropinirol immediate-release tablets.

If you take more AROPILO SR than you should

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

If you forget to take AROPILO SR

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

If you miss a dose for a day or longer, you should consult your doctor about restarting treatment with AROPILO SR.

Stopping treatment with AROPILO SR

Do not stop taking AROPILO SR unless your doctor tells you to.

You should keep taking AROPILO SR for as long as your doctor recommends. Do not stop taking it unless your doctor tells you to.
If you suddenly stop taking AROPILO SR, your Parkinson's symptoms may quickly get much worse. Stopping treatment suddenly can also cause a serious problem 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 decreased consciousness (e.g. coma).
If your doctor needs to stop your treatment with AROPILO SR, they will reduce your dose gradually.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, AROPILO SR can cause side effects, although not everybody gets them.
Ropinirole side effects are most likely to happen when you first start taking the medicine or when your dose is increased. The side effects are usually mild and become less troublesome after taking the medicine for a short time. If you are concerned about side effects, you should talk to your doctor.

Very common side effects

May affect more than 1 in 10 peopletaking ropinirole:
fainting
drowsiness
nausea

• fainting
• drowsiness
• nausea

Common side effects

May affect up to 1 in 10 peopletaking ropinirole

• sudden sleepiness without warning (sudden onset of sleep)
• hallucinations (seeing things that are not there)
• vomiting
• dizziness
• heartburn
• stomach pain
• constipation
• swelling of the legs, feet, or hands

Uncommon side effects

May affect up to 1 in 100 peopletaking ropinirole

• dizziness or fainting, especially when standing up quickly (related to low blood pressure)
• excessive drowsiness during the day (excessive daytime sleepiness)
• mental health problems such as delirium (confusion), delusions (irrational 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 reactionssuch 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).
liver function changes, which have been seen in blood tests.

• aggressive behavior
• excessive use of ropinirol (uncontrollable desire to take higher doses of dopaminergic medicines than necessary to control motor symptoms, known as dopaminergic dysregulation syndrome)
• inability to resist the impulse, drive, or temptation to perform certain activities that could harm you or others. These behaviors may include: uncontrollable gambling, despite significant consequences for you or your family; increased interest in sexand sexual thoughts or behaviors that are disturbing to you or others, such as increased sexual drive; uncontrolled, excessive shopping or spending; binge eating(eating large amounts of food in a short time) or compulsive eating(eating more than needed to satisfy hunger); other behaviorsthat are disturbing to you or others.
• after stopping or reducing the dose of ropinirol, you may experience: depression, apathy, anxiety, lack of energy, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS)
• spontaneous erections

You should tell your doctor if you experience any of these behaviors so that your treatment or symptoms can be managed.

Taking AROPILO SR with L-dopa

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

• 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 SR. If you experience these symptoms, you should inform your doctor, who may need to adjust the doses of your medicines.
• disorientation is a common side effect.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects 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 SR

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after 'EXP'. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 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 other ingredients are: 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 the imprint 2x on one side.
AROPILO SR, 4 mg, prolonged-release tablets:
Brown, speckled, oval tablets, 16 mm x 8.2 mm, with the imprint 4x on one side.
AROPILO SR, 8 mg, prolonged-release tablets:
Dark pink, speckled, oval tablets, 16 mm x 8.2 mm, with the imprint 8x on one side.
Pack sizes:
AROPILO SR, prolonged-release tablets are available in blister packs of 21, 28, 30, 42, 56, 84, or 90 prolonged-release tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Vipharm S.A.
A. and F. Radziwiłłów Street 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