Aparxon Pr

Leaflet attached to the packaging: 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 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 you need to.
• 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 as yours.
• 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 Aparxon PR and what is it 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 packaging and other information

1. What is Aparxon PR and what is it 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 that occurs naturally 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 disorders,particular tendencies and (or) behaviors(such as uncontrolled urge to gamble or excessive sexual activity) (see section 4),intolerance to sugars(e.g. lactose).

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 tests during treatment.

While taking Aparxon PR

If the patient experiences symptoms such as depression, apathy, anxiety, fatigue, 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 inform their doctor if they or their caregivers notice an increased urge or desire to perform unusual behaviors for the patient, or if the patient cannot resist the urge to perform certain actions that may harm themselves or others. These behaviors, called impulse control disorders, may include: gambling, increased appetite, excessive spending, unusually high sexual drive, and increased sexual thoughts and behaviors. 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 symptoms of 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 decide 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 action of Aparxon PR or increase the risk of side effects. Aparxon PR may also affect the action of other medicines.
The patient should tell their doctor about taking:

• fluvoxamine (an antidepressant)
• medicines used for other mental disorders, 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 patient 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 and unexplained episodes of sleepmay also occur.
If the patient suspects that they may experience these symptoms, they should not drive, operate machinery, or perform tasks where drowsiness or falling asleep may put them 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 situation 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 intolerance to some sugars, they should contact their doctor before taking the medicine.

Aparxon PR contains hydrogenated castor oil

The medicine may cause indigestion and diarrhea.

3. How to take Aparxon PR

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should consult 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 involuntary movements (dyskinesias) when they start taking Aparxon PR. If the patient experiences these symptoms, they should inform their doctor, who may adjust the doses of the medicines they are taking.
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 this situation, the patient 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 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 side effects that are difficult to tolerate at the start 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 Aparxon PR than prescribed by the doctor.

It may take a few 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 medicine being released too quickly 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 Aparxon PR prolonged-release tablets based on the dose of ropinirole immediate-release tablets previously taken.
The patient should take their usual dose of ropinirole immediate-release tablets on the day before switching treatment. The next morning, they should take Aparxon PR prolonged-release tablets and not take any more ropinirole immediate-release tablets.

Taking more Aparxon PR than prescribed

The patient should contact their doctor or pharmacist immediately. If possible, they should show them the packaging of Aparxon PR.
If someone takes more Aparxon PR than prescribed, they may experience: nausea, vomiting, dizziness, drowsiness, mental fatigue or physical fatigue, fainting, 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 treatment with 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 quickly.
Suddenly stopping Aparxon PR 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, impaired consciousness (e.g. coma).
If the doctor needs to stop the patient's treatment with Aparxon PR, they will gradually reduce the dose.
If the patient has any further questions about taking this medicine, they should contact their doctor or pharmacist.

4. Possible side effects

Like all medicines, Aparxon PR can cause side effects, although not everybody gets them.
The side effects of Aparxon PR are most likely to occur when the patient first starts taking the medicine or when the dose is increased. The 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 consult 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 swelling of the skin (hives), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing, rash, or intense itching. These are very serious side effects with a frequency that is not known. Emergency medical treatment or hospitalization may be required.

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

Aparxon PR

• fainting
• feeling sleepy
• nausea

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

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

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

Aparxon PR

• dizziness or fainting, especially when the patient gets up quickly (related to low blood pressure)
• low blood pressure (hypotension)
• very strong feeling of sleepiness during the day (excessive daytime sleepiness)
• psychiatric disorders, 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

• liver function changes, which have been seen in blood tests
• spontaneous erections
• aggressive behavior
• excessive use of Aparxon PR (desire for high doses of dopaminergic drugs exceeding the amounts required to control motor symptoms, known as dopamine dysregulation syndrome)
• inability to resist the urge, drive, or temptation to perform actions that may harm the patient or others. Symptoms may include:
• Uncontrolled urge to gamble, despite significant consequences for the patient or their family.
• Change or increased interest in sex and behaviors that are particularly disturbing to the patient or others, such as increased sexual drive.
• Uncontrolled, excessive eating or binge eating.
• 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 they can determine the best course of treatment or alleviate the symptoms.

Taking Aparxon PR with L-dopa

In patients taking Aparxon PR in combination with L-dopa, the following side effects may occur after some time:

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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
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 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 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 use. This will help protect the environment.

6. Contents of the packaging 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 medicine also contains

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 tablet 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 tablet 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
Brownish-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
Medicinal product name
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)
SPIROCO XL 2/4/8 mg prolonged-release tablets

Date of last revision of the leaflet: May 2023