Aparxon Pr

Package Leaflet: Information for the User

Aparxon PR, 2 mg, prolonged-release tablets
Aparxon PR, 4 mg, prolonged-release tablets
Aparxon PR, 8 mg, prolonged-release tablets
ropinirole

You should read the contents of the package leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this package leaflet, so you can read it again if you need to.
• 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 as yours.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should tell their doctor or pharmacist. See section 4.

Package Leaflet Contents:

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

1. What Aparxon PR is and what it is used for

The active substance of Aparxon PR 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.

Aparxon PR 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 dopamine in the brain and helps to alleviate the symptoms of Parkinson's disease.

2. Important information before taking Aparxon PR

When not to take Aparxon PR

hypersensitivityto ropinirole hydrochloride or any of the other ingredients of this medicine (listed in section 6).severe kidney disease.liver disease. The patient should inform their doctor if this applies to them.

Warnings and precautions

Before starting to take Aparxon PR, the patient should discuss it with their doctor or pharmacist:

pregnantor thinks they may be pregnant,breast-feeding,under 18 years old,severe heart disease,severe mental health problems,particular tendencies and/or behaviors(such as an uncontrollable urge to gamble or excessive sexual activity) (see section 4),intolerance to sugars(e.g., lactose intolerance).

The patient should inform their doctor if any of these apply to them. The doctor may decide that Aparxon PR is not a suitable medicine for the patient or may recommend additional monitoring during treatment.

While taking Aparxon PR

If the patient experiences symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain (known as 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 inform their doctor if they or their caregivers notice an increased urge or desire to perform behaviors that are unusual for the patient, or if the patient cannot resist the impulse to perform certain actions that may harm themselves or others. These behaviors, known as impulse control disorders, may include: gambling, increased libido, excessive spending, or binge eating. The doctor may adjust the dose or stop the medicine.
The patient should inform their doctor if they or their family/caregivers notice episodes of overactivity, euphoria, or irritability (symptoms of mania). These may occur with or without impulse control disorders (see above). The doctor may need to adjust or reduce the dose.

Smoking and taking Aparxon PR

The patient should inform their doctorif they start or stop smoking while taking Aparxon PR. The doctor may need to adjust the dose of the medicine.

Aparxon PR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
The patient should remember to inform their doctor or pharmacist if they start taking any other medicine while taking Aparxon PR.
Some medicines may affect the way Aparxon PR works or increase the risk of side effects. Aparxon PR may also affect the way other medicines work.
The patient should tell their doctor if they are taking:

• 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
• other medicines used for Parkinson's disease. The patient should inform their doctor if they are taking or have recently taken any of these medicines.

In patients taking Aparxon PR with the following medicines, additional blood tests may be required
blood:

• vitamin K antagonists (used to reduce blood clotting), such as warfarin (coumarin).

Aparxon PR with food, drink, and alcohol

Aparxon PR can be taken with or without food.
Drinking alcohol while taking Aparxon PR is not recommended.

Pregnancy and breast-feeding

If the patient is pregnant or breast-feeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Aparxon PR is not recommended during pregnancy, unless the doctor considers that the benefits to the mother outweigh the risks to the unborn child. Aparxon PR is not recommended during breast-feeding, as it may affect milk production. The doctor will advise if the patient is breast-feeding or plans to breast-feed. The doctor may recommend stopping Aparxon PR.

Driving and using machines

Aparxon PR may cause drowsiness. Sudden, uncontrollable sleep attacksmay also occur, sometimes without any prior warning of drowsiness.
If the patient suspects they may experience such symptoms, they should not drive, operate machinery, or perform tasks that could put themselves or others at risk of serious injury or death. They should not perform such tasks until the symptoms have resolved.
The patient should talk to their doctorif this applies to them.
While taking Aparxon PR, the patient may experience hallucinations(seeing, hearing, or feeling things that are not there). If the patient experiences hallucinations, they should not drive or operate machinery.

Aparxon PR contains lactose

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

Aparxon PR contains hydrogenated castor oil

The medicine may cause stomach upset and diarrhea.

3. How to take Aparxon PR

The patient should always take Aparxon PR exactly as their doctor or pharmacist has told them. If they are unsure, they should ask their doctor or pharmacist.
Aparxon PR should not be taken by children. Aparxon PR is not intended for use in patients under 18 years old.
Aparxon PR can be used to treat the symptoms of Parkinson's disease, either alone or in combination with another medicine called L-dopa (also known as levodopa). If the patient is taking L-dopa, they may experience uncontrollable movements (dyskinesia) when they start taking Aparxon PR. If they experience such symptoms, they should inform their doctor, who may adjust the doses of their medicines.
Aparxon PR prolonged-release tablets are designed to release the medicine slowly over a period of more than 24 hours. If the patient's condition (e.g., during diarrhea) causes the medicine to pass through their body too quickly, the tablets may not dissolve completely and may not work as they should. The patient may see the tablets in their stool. In such cases, they should contact their doctor as soon as possible.

What dose of Aparxon PR should be taken?

It may take some time to find the right dose of Aparxon PR for the patient.
The recommended starting doseis 2 mg once daily for the first week. The doctor may increase the dose of Aparxon PR prolonged-release tablets to 4 mg once daily, starting from the second week of treatment. If the patient is elderly, the doctor may increase the dose more slowly. The doctor will then adjust the dose until they find the optimal dose for the patient. Some patients may take up to 24 mg of Aparxon PR prolonged-release tablets per day.
If the patient experiences intolerable side effects at the start of treatment, they should inform their doctor. The doctor may recommend switching 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 Aparxon PR than the doctor has recommended.

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

Taking the dose of Aparxon PR

Aparxon PR should be taken once daily, at the same time each day.

The Aparxon PR prolonged-release tablet(s) should be

swallowed whole, with a glass of water.

Do not break, chew, or crushthe prolonged-release tablet(s)
- if this happens, there is a risk of overdose, due to the rapid release of the medicine in the body.

If the patient is switching from ropinirole immediate-release tablets

The doctor will determine the dose of Aparxon PR prolonged-release tablets based on the dose of ropinirole immediate-release tablets the patient was taking previously.
The patient should take their usual dose of ropinirole immediate-release tablets on the day before switching to Aparxon PR. The next morning, they should take Aparxon PR prolonged-release tablets and not take any more ropinirole immediate-release tablets.

What to do if too much Aparxon PR is taken

The patient should contact their doctor or pharmacist immediately. If possible, they should show the doctor or pharmacist the Aparxon PR packaging.
If someone takes more Aparxon PR than recommended, they may experience: nausea, vomiting, dizziness, drowsiness, mental fatigue or physical fatigue, fainting, or hallucinations.

Missing a dose of Aparxon PR

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

If the patient misses a dose of Aparxon PR for a day or longer, they should consult their doctor about restarting Aparxon PR.

Stopping treatment with Aparxon PR

Do not stop taking Aparxon PR without consulting a doctor.

Aparxon PR should be taken for as long as the doctor recommends. The patient should not stop taking it unless their doctor tells them to.
If the patient stops taking Aparxon PR suddenly, their Parkinson's disease symptoms may worsen rapidly.
Suddenly stopping Aparxon PR may cause a condition called neuroleptic malignant syndrome, which can be life-threatening. Symptoms include: akinesia (loss of movement), muscle stiffness, fever, unstable blood pressure, tachycardia (rapid heart rate), confusion, and impaired consciousness (e.g., coma).
If the doctor needs to stop Aparxon PR, they will gradually reduce the dose.

4. Possible side effects

Like all medicines, Aparxon PR can cause side effects, although not everybody gets them.
Aparxon PR side effects are most likely to occur when the patient first starts taking the medicine or when the dose is increased. Side effects are usually mild and become less troublesome after a short time taking the medicine. If the patient is concerned about side effects, they should talk to their doctor.

The patient should stop taking Aparxon PR and contact their doctor or go to the emergency department of their nearest hospital immediately if they experience any of the following symptoms:

• allergic reactions, such as a red, itchy rash (hives), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing, rash, or intense itching. These are very serious side effects with an unknown frequency. Emergency medical treatment or hospitalization may be required.

Very common side effects: may affect more than 1 in 10 people taking Aparxon PR

• fainting
• feeling drowsy
• nausea

Common side effects: may affect up to 1 in 10 people taking Aparxon PR

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

Uncommon side effects: may affect up to 1 in 100 people taking Aparxon PR

• dizziness or fainting, especially when standing up quickly (related to low blood pressure)
• low blood pressure (hypotension)
• very strong feeling of drowsiness during the day (excessive daytime sleepiness)
• mental health problems, such as confusion (severe disorientation), delusions (irrational thoughts), or paranoia (unfounded suspicion)
• hiccups

Some patients may experience the following side effects

Frequency not known:frequency cannot be estimated from the available data

• changes in liver function, which have been seen in blood tests
• spontaneous erections
• aggressive behavior
• excessive use of Aparxon PR (a desire for large doses of dopaminergic drugs that exceed the amounts needed to control motor symptoms, known as dopamine dysregulation syndrome)
• inability to resist an impulse, drive, or temptation to perform an action that could harm the patient or others. Symptoms may include:
• Uncontrollable urge to gamble, despite significant consequences for the patient or their family.
• Change or increase in sexual interest and behaviors that are particularly disturbing to the patient or others, such as increased libido.
• Uncontrolled, excessive shopping or spending.
• Binge eating (eating large amounts of food in a short time), compulsive eating (eating more than needed to satisfy hunger).
• Episodes of overactivity, euphoria, or irritability
• Depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS) after stopping or reducing the dose of Aparxon PR.

The patient should tell their doctor if they experience any of these behaviors so that the doctor can determine the best course of treatment or alleviate the symptoms.

Taking Aparxon PR with L-dopa (levodopa)

In patients taking Aparxon PR with L-dopa, other side effects may occur after some time:

• uncontrollable movements (dyskinesia) are a very common side effect. If the patient is taking L-dopa, they may experience uncontrollable movements (dyskinesia) when they start taking Aparxon PR. If they experience such symptoms, they should inform their doctor, who may adjust the doses of their medicines
• feeling disoriented (common side effect).

Reporting side effects

If the patient experiences any side effects, including any not listed in the package leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.
By reporting side effects, more information can be gathered on the safety of medicines.

5. How to store Aparxon PR

The medicine should be stored out of 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 the month stated.
Do not store above 30°C.
The medicine should be stored in its original packaging to protect it from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Aparxon PR contains

• The active substance of Aparxon PR is ropinirole. Each prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirole (as hydrochloride).
• The other ingredients are

Aparxon PR 2 mg prolonged-release tablets
hypromellose, lactose monohydrate, colloidal anhydrous silica, carbomer 4,000 – 11,000 mPa.s, hydrogenated castor oil, magnesium stearate in the core and hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), iron oxide yellow (E 172) in the coating.
Aparxon PR 4 mg and 8 mg prolonged-release tablets
hypromellose, lactose monohydrate, colloidal anhydrous silica, carbomer 4,000 – 11,000 mPa.s, hydrogenated castor oil, magnesium stearate in the core and hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172) in the coating.

What Aparxon PR looks like and contents of the pack

Aparxon PR 2 mg prolonged-release tablets
Pink, oval, biconvex, film-coated tablets.
Aparxon PR 4 mg prolonged-release tablets
Light brown, biconvex, oval, film-coated tablets.
Aparxon PR 8 mg prolonged-release tablets
Brown-pink, biconvex, oval, film-coated tablets.
Packaging containing 21, 28, 42, or 84 prolonged-release tablets in OPA/Aluminum/PVC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters, which may be divided into single doses, in a cardboard box
Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Poland

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren
Germany
Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Teva Operations Poland Sp. z o. o.
ul. Mogilska 80
31-546 Kraków

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Member State
Marketing authorization holder
Germany
Ropinirol-ratiopharm 2/4/8 mg Retardtabletten
Hungary
Ropinirol Teva 2/4/8 mg retard tabletta
Poland
Aparxon PR
Sweden
Ropinirole Teva 2/4/8 mg depottabletter
United Kingdom (Northern Ireland)
SPYROCO XL 2/4/8 mg prolonged-release tablets

Date of last revision of the package leaflet: May 2023