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
Please read the entire leaflet before taking this medicine, as it contains important information
for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Aparxon PR is and what it is used for
2. What you need to know 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 in Aparxon PR is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists act in the brain similarly to the naturally occurring substance called dopamine.
Aparxon PR prolonged-release tablets are used in the treatment of Parkinson's disease.
In patients with Parkinson's disease, certain areas of the brain have low levels of dopamine. Ropinirole works similarly to naturally occurring dopamine in the brain and thus helps to relieve the symptoms of Parkinson's disease.

2. Important information before using Aparxon PR

When not to use Aparxon PR

• if the patient has a hypersensitivity to ropinirole hydrochloride 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 disease. The patient should inform the doctor if this applies.

Warnings and precautions
Before starting treatment with Aparxon PR, discuss the following with your doctor or pharmacist:

• if the patient is pregnant or suspects she may be pregnant,
• if the patient is breast-feeding,
• if the patient is under 18 years of age,
• if the patient has severe heart disease,
• if the patient has severe mental disorders,
• if the patient has specific urges and (or) behaviors (such as uncontrollable gambling or excessive sexual activity) (see section 4),
• if the patient has sugar intolerance (e.g. lactose).

The patient should inform the doctor if any of the above apply. The doctor may decide that Aparxon PR
is not the appropriate 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 after stopping or reducing the dose of ropinirole (known as dopamine agonist withdrawal syndrome or DAWS), the doctor should be informed. If symptoms persist for longer than a few weeks, the doctor may decide to modify the dose of the medicine.

The patient or their caregivers should inform the doctor if they notice an increased tendency or desire to engage in unusual behaviors, or if the patient cannot refrain from performing certain actions that could harm themselves or others. These behaviors, known as impulse control disorders, may include gambling, increased appetite, excessive spending, abnormally high sexual drive, and increased sexual thoughts and behaviors. The doctor may change the dose or discontinue the medicine.

The patient or their family/caregivers should inform the doctor if episodes of hyperactivity, euphoria, or irritability (symptoms of mania) occur. These may occur with or without symptoms of impulse control disorders (see above). Dose adjustment or reduction may be necessary.

Smoking and use of Aparxon PR
The patient should inform the doctor about starting or stopping smoking while taking Aparxon PR. The doctor may need to adjust the dose of the medicine.

Aparxon PR and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Remember to inform the doctor or pharmacist about starting any other medicine while taking Aparxon PR.

Some medicines may affect the action of Aparxon PR or increase the risk of adverse effects. Aparxon PR may also affect the action of other medicines.

Inform the doctor if the patient is taking:

• fluvoxamine (an antidepressant),
• medicines used for other psychiatric disorders, for example sulpiride,
• HRT (hormone replacement therapy),
• metoclopramide, a medicine used to treat nausea and vomiting,
• antibiotics: ciprofloxacin and enoxacin,
• other medicines used in Parkinson's disease. The patient should inform the doctor if they are taking or have recently taken any of these medicines.

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

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

Aparxon PR with food, drink and alcohol
Aparxon PR may be taken with or without food.
Consuming alcohol while taking Aparxon PR is not recommended.

Pregnancy and breast-feeding
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Aparxon PR is not recommended during pregnancy unless the doctor determines that the benefit to the patient outweighs the risk to the unborn child. Aparxon PR is not recommended during breast-feeding, as it may affect milk production in the patient.

The doctor will advise if the patient is breast-feeding or planning to breast-feed. The doctor may recommend discontinuing Aparxon PR.

Driving and using machines
Aparxon PR may cause drowsiness. Sudden and uncontrollable sleepiness may occur, and sometimes also sudden and unexpected sleep attacks without prior warning of drowsiness.

If such symptoms are suspected: the patient should not drive, operate machinery, or perform any activity where feeling sleepy or falling asleep could put the patient (or others) at risk of serious injury or death. Such activities should not be performed until symptoms resolve.

The patient should talk to the doctor if this situation applies.

Hallucinations (seeing, hearing, or sensing things that are not present) may occur during treatment with Aparxon PR. If the patient experiences hallucinations, they should not drive or operate machinery.

Aparxon PR contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Aparxon PR contains castor oil
The medicine may cause indigestion and diarrhea.

3. How to use Aparxon PR

This medicine should always be taken exactly as directed by your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Aparxon PR must not be used in children. Aparxon PR is not intended for use in patients under
18 years of age.
Aparxon PR may be used in the treatment of symptoms of Parkinson's disease, either as monotherapy or in combination with another medicine called L-dopa (also known as levodopa). When a patient is taking L-dopa, involuntary movements (dyskinesias) may occur when starting treatment with Aparxon PR. If such symptoms occur, inform your doctor, who may adjust the doses of medicines the patient is taking.
Aparxon PR tablets are designed to release the medicine gradually over a period of more than 24
hours. If, due to the patient's condition (e.g. during diarrhoea), the medicine passes through the body too quickly, the tablets may not dissolve completely and may not work as intended. It is possible that the tablets may be visible in the stool. In such a case, contact your doctor as soon as possible.
What dose of Aparxon PR should be used?
Finding the appropriate dose of Aparxon PR for the patient may take some time.
The recommended starting dose is 2 mg once daily for the first week. Your doctor may increase the dose of Aparxon PR extended-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. Subsequently, the doctor may adjust the dose until the optimal dose for the patient is reached. Some patients take up to 24 mg of Aparxon PR in the form of extended-release tablets per day.
If intolerable side effects occur at the beginning of treatment, inform your doctor. The doctor may recommend switching therapy to a lower dose of ropinirole in coated tablets (immediate-release formulation), to be taken three times daily.
Do not take a higher dose of Aparxon PR than that prescribed by your doctor.
It may take several weeks before the beneficial effect of the medicine becomes apparent.
Taking Aparxon PR dose
Aparxon PR should be taken once daily, at the same time each day.

The extended-release tablet(s) of Aparxon PR should be swallowed whole, with a glass of water.
Do not break, chew or crush the extended-release tablet(s) – doing so may lead to a risk of overdose due to rapid release of the medicine in the body.
Switching treatment in patients taking ropinirole immediate-release coated tablets
Your doctor will determine the dose of Aparxon PR extended-release tablets based on the previously used dose of ropinirole immediate-release coated tablets.
Take your usual dose of ropinirole immediate-release coated tablets on the day before switching treatment. The next morning, take Aparxon PR extended-release tablets and do not take any further doses of ropinirole immediate-release coated tablets.
Taking more Aparxon PR than prescribed
Seek immediate advice from your doctor or pharmacist. If possible, show the Aparxon PR medicine pack.
In a person who has taken more than the prescribed dose of Aparxon PR, symptoms such as nausea, vomiting, dizziness, drowsiness, mental or physical fatigue, fainting, or hallucinations may occur.
If a dose of Aparxon PR is missed
Do not take a larger number of extended-release tablets or a double dose to make up for a missed dose.
If a dose of Aparxon PR is missed for one day or longer, consult your doctor regarding resuming treatment with Aparxon PR.
Stopping Aparxon PR treatment
Do not stop taking Aparxon PR without consulting your doctor.
Aparxon PR should be taken for as long as your doctor recommends. Do not discontinue treatment unless instructed by your doctor.
If Aparxon PR is stopped abruptly, Parkinson's disease symptoms may rapidly worsen significantly.
Sudden discontinuation of Aparxon PR may lead to a condition called neuroleptic malignant syndrome, which may be life-threatening. Symptoms include: akinesia (lack of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (rapid heartbeat), confusion, and disturbances of consciousness (e.g. coma).
If discontinuation of Aparxon PR is necessary, your doctor will gradually reduce the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions to Aparxon PR may most commonly occur when starting treatment
or shortly after increasing the dose. Adverse reactions are usually mild and become less
bothersome after a short period of taking the medicine. If you have any concerns about adverse
reactions, consult your doctor.

Stop taking Aparxon PR and immediately contact your doctor or go to the emergency
department of your nearest hospital if any of the following symptoms occur:

• allergic reactions such as red, itchy skin rash (urticaria), 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 adverse reactions of unknown frequency. Urgent medical assistance or hospitalization may be required.

Very common adverse reactions: may affect more than 1 in 10 people taking Aparxon PR

• fainting
• feeling drowsy
• nausea

Common adverse reactions: may affect up to 1 in 10 people taking Aparxon PR

• sudden onset of sleep without prior drowsiness (episodes of sudden sleep)
• hallucinations (seeing things that are not really there)
• vomiting
• dizziness (spinning sensation)
• heartburn
• abdominal pain
• constipation
• swelling of the legs, feet or hands

Uncommon adverse reactions: may affect up to 1 in 100 people taking Aparxon PR

• dizziness or fainting, especially when the patient stands up suddenly (related to low blood pressure)
• low blood pressure (hypotension)
• very strong feeling of daytime sleepiness (irresistible sleepiness)
• psychiatric disorders such as delirium (severe disorientation), delusions (irrational thoughts) or paranoia (unwarranted suspicion)
• hiccups

The following adverse reactions may occur in some patients
Frequency unknown: frequency cannot be estimated from the available data

• liver function abnormalities detected in blood tests
• spontaneous penile erection
• aggressive behavior
• excessive use of Aparxon PR (craving for large doses of dopaminergic medications exceeding amounts required to control motor symptoms, known as dopamine dysregulation syndrome)
• inability to resist the impulse, urge or temptation to carry out behaviors 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 behavior that is particularly troubling to the patient or others, for example increased libido.
  • Uncontrolled, excessive shopping or spending.
  • Binge eating (consuming large amounts of food in a short time), compulsive eating (consuming more food than needed to satisfy hunger).
  • Episodes of hyperactivity, excitement or irritability.
  • Depression, apathy, anxiety, fatigue, sweating or pain (referred to as dopamine agonist withdrawal syndrome or DAWS) after stopping or reducing the dose of Aparxon PR.

Tell your doctor if the patient experiences any of these behaviors so that appropriate
treatment or symptom relief can be determined.
Taking Aparxon PR together with levodopa (L-dopa)
In patients taking Aparxon PR in combination with levodopa, other adverse reactions may occur after some time:

• involuntary movements (dyskinesias) are a very common adverse reaction. In patients receiving levodopa, involuntary movements (dyskinesias) may occur when starting treatment with Aparxon PR. If these symptoms occur, inform your doctor, who may adjust the doses of the medicines the patient is taking.
• feeling of disorientation (common adverse reaction).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of medicines.

5. How to store Aparxon PR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store the medicine in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Aparxon PR contains

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

Aparxon PR 2 mg prolonged-release tablets
hypromellose, monohydrate lactose, colloidal anhydrous silica, carbomers 4,000 – 11,000 mPa.s, hydrogenated castor oil, magnesium stearate in the tablet core and hypromellose, titanium dioxide (E 171), macrogol 400, red iron oxide (E 172), yellow iron oxide (E 172) in the coating.
Aparxon PR 4 mg and 8 mg prolonged-release tablets
hypromellose, monohydrate lactose, colloidal anhydrous silica, carbomers 4,000 – 11,000 mPa.s, hydrogenated castor oil, magnesium stearate in the tablet core and hypromellose, titanium dioxide (E 171), macrogol 400, red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (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
Pinkish-brown, biconvex, oval, film-coated tablets.
Pack sizes containing 21, 28, 42 or 84 prolonged-release tablets in blisters OPA/Aluminium/PVC/Aluminium or in blisters OPA/Aluminium/PVC/Aluminium, which may be divided into single doses, in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation 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
Poland

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

| Country | 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 |