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
ropinirolum
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 them even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Contents of the leaflet:

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 in Aparxon PR is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists act in the brain similarly to a 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, there is a low level of dopamine in certain areas of the brain. Ropinirole acts like 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. You should inform the doctor if this applies to the patient.

Warnings and precautions
Before starting 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 breastfeeding,
• 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 unusual urges and (or) behaviours (such as uncontrollable gambling or increased sexual activity) (see section 4),
• if the patient has sugar intolerance (e.g. lactose intolerance).

You should inform the doctor if any of the above apply to the patient. The doctor may decide that Aparxon PR
is not suitable for the patient or may recommend additional monitoring tests during treatment.
While taking Aparxon PR
If, after stopping or reducing the dose of ropinirole, the patient experiences symptoms such as depression, apathy, anxiety, fatigue, sweating or pain (known as dopamine agonist withdrawal syndrome or DAWS), inform the doctor. If symptoms persist
for more than a few weeks, the doctor may decide to adjust the dose of the medicine.
Inform the doctor if the patient or their caregivers notice an increased tendency or desire to engage in unusual behaviours, or if the patient cannot stop themselves from performing certain actions that could harm themselves or others. These behaviours,
called impulse control disorders, may include: gambling, excessive appetite, compulsive spending, abnormally high sex drive and increased sexual thoughts and activities. The doctor may change the dose or stop the treatment.
Inform the doctor if the patient or their family/caregivers notice episodes of hyperactivity, euphoria or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorders (see above). Dose adjustment or reduction by the doctor may be necessary.
Smoking and use of Aparxon PR
Inform the doctor if the patient starts or stops smoking while taking Aparxon PR. The doctor may need to adjust the dose of the medicine.
Aparxon PR and other medicines
Tell your 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 if the patient starts taking any other medicine while using 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 indigestion
• antibiotics: ciprofloxacin and enoxacin
• other medicines used in Parkinson’s disease. Inform the doctor if the patient is taking or has 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.
Drinking alcohol while taking Aparxon PR is not recommended.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 breastfeeding, as it may affect milk production in the patient.
The doctor will advise if the patient is breastfeeding or planning to breastfeed. The doctor may recommend discontinuing Aparxon PR.
Driving and operating machinery
Aparxon PR may cause drowsiness. Sudden and irresistible drowsiness may occur, and sometimes also sudden and unexpected sleep attacks without prior warning of sleepiness.
If there is suspicion that such symptoms may occur: do not drive, operate machinery, or perform activities where drowsiness or falling asleep could put the patient (or others) at risk of serious injury or death. Do not perform such activities until symptoms resolve.
Talk to your doctor if this applies to the patient.
Hallucinations (seeing, hearing or feeling things that are not actually 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 contact their doctor before taking this medicine.
Aparxon PR contains castor oil
The medicine may cause indigestion and diarrhoea.

3. How to use Aparxon PR

This medicine should always be taken exactly as instructed by your doctor or pharmacist.
If you have any doubts, you should contact 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). If the 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 seen in the faeces. 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. The doctor may then 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 the form of coated tablets (immediate-release) 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.

How to take Aparxon PR tablets
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 split, chew or crush the extended-release tablet(s) – doing so may result in overdose due to too rapid release of the medicine into the body.

Switching treatment in patients currently 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
Contact your doctor or pharmacist immediately. If possible, show the Aparxon PR packaging.
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 you miss a dose of Aparxon PR
Do not take a larger number of extended-release tablets or a double dose to make up for a missed dose.
If you miss a dose of Aparxon PR 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 stop treatment unless instructed by your doctor.
If Aparxon PR is stopped abruptly, symptoms of Parkinson's disease 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 it becomes necessary to discontinue Aparxon PR, your doctor will gradually reduce the dose.

If you have any further questions about the use of this medicine, contact your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects of Aparxon PR may occur most often when starting treatment
or shortly after increasing the dose. Adverse effects are usually mild and become less
bothersome after a short period of taking the medicine. If you have any concerns about adverse
effects, consult your doctor.
You should stop taking Aparxon PR and immediately contact your doctor or go to the
emergency department of the 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 effects of unknown frequency. Urgent medical assistance or hospitalization may be required.

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

• fainting
• feeling drowsy
• nausea

Common adverse effects: 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 effects: 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 daytime sleepiness (irresistible sleepiness)
• psychiatric disorders such as delirium (severe disorientation), delusions (irrational thoughts) or paranoia (unjustified suspicion)
• hiccups

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

• changes in liver function, detected in blood tests
• spontaneous penile erection
• aggressive behaviour
• excessive use of Aparxon PR (craving for high doses of dopaminergic medication exceeding amounts required to control motor symptoms, known as dopamine dysregulation syndrome)
• inability to resist the impulse, drive or urge to perform actions 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 interest in sex and behaviour particularly disturbing to the patient or others, for example increased sexual drive.
  • Uncontrolled, excessive shopping or spending money.
  • 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.

You should tell your doctor if the patient experiences any of these behaviours so that
treatment or symptom relief can be arranged.
Taking Aparxon PR together with levodopa (L-dopa)
In patients taking Aparxon PR in combination with levodopa, other adverse effects may occur
over time:

• uncontrolled movements (dyskinesias) are a very common adverse effect. In patients taking L-dopa, 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 effect).

Reporting adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to collect 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 specified month.
Do not store above 30°C.
Keep the medicine in the original packaging to protect it 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 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, anhydrous colloidal 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, iron oxide red (E 172), iron oxide yellow (E 172) in the coating.
Aparxon PR 4 mg and 8 mg prolonged-release tablets
hypromellose, monohydrate lactose, anhydrous colloidal 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, 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
Pinkish-brown, biconvex, oval, film-coated tablets.
Packaging 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 box.
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 Member State | 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 |