Aropilo sr

Poland
Brand name Aropilo sr
Form tablets, prolonged release
Active substance / Dosage
ropinirole hydrochloride · 4.56 mg
Prescription type Prescription only
ATC code
N04BC04
Registration number 100283012
Manufacturer Actavis Ltd.
Aropilo sr tablets, prolonged release

Table of Contents

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
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

  • Keep this leaflet, as you may need to read it again.
  • Ask your doctor or pharmacist if you have any questions.
  • This medicine has been prescribed for you only. Do not pass it on to other people. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

  1. What AROPILO SR is and what it is used for
  2. What you need to know 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 AROPILO SR is and what it is used for

The active substance in AROPILO SR is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists act in the brain in a similar way to the naturally occurring substance called dopamine.
AROPILO SR, prolonged-release tablets, is 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 in a similar way to naturally occurring dopamine in the brain and thus helps to relieve the symptoms of Parkinson's disease.

2. Important information before using AROPILO SR

When not to take AROPILO SR:

  • if the patient has a known hypersensitivity to the active substance or to 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. Please inform your doctor if any of these conditions apply.

Warnings and precautions
Before starting treatment with AROPILO SR, 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 health disorders
if the patient has specific impulses and (or) behaviors (see section 4)
if the patient has sugar intolerance (e.g. lactose).
If after stopping or reducing the dose of ropinirole the patient experiences symptoms such as
depression, apathy, anxiety, lack of energy, sweating, or pain (known as dopamine agonist withdrawal syndrome (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, a family member, or caregiver notices the emergence of new
impulses or behaviors not previously observed in the patient, and if the patient feels unable to resist the urge, drive, or temptation to carry out certain actions that could harm themselves or others. This condition is known as impulse control disorders and may include behaviors such as compulsive gambling, excessive eating or spending, increased sexual drive, or intensified sexual thoughts or feelings. The doctor may consider it necessary to adjust the dose or discontinue the medicine.
Please inform your doctor if any of these conditions occur. The doctor may decide that AROPILO SR is not suitable for the patient or may recommend additional monitoring during treatment.
While taking AROPILO SR
Contact your doctor if the patient or a family member observes any unusual behaviors during treatment with AROPILO SR (such as uncontrollable urge to gamble or increased and (or) excessive sexual activity). The doctor may recommend adjusting the dose or discontinuing the medicine.
Smoking and use of AROPILO SR
Please inform your doctor if you start or stop smoking while taking AROPILO SR. The doctor may need to adjust the dose.
AROPILO SR and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal medicines and other medicines available without a prescription, as well as any medicines the patient plans to take.
Remember to inform your doctor or pharmacist if starting any new medicine while taking AROPILO SR.
Some medicines may affect the action of ropinirole or increase the risk of side effects. Ropinirole may also affect the action of other medicines.
These include:
fluvoxamine (an antidepressant)
medicines used for other mental health disorders, such as sulpiride
HRT (hormone replacement therapy)
metoclopramide, a medicine used to treat nausea and heartburn
antibiotics ciprofloxacin and enoxacin
any other medicines used for Parkinson’s disease.
Please inform your doctor if the patient is taking or has recently taken any of these medicines. Additional blood tests should be performed if the patient is taking the following medicines together with ropinirole:

  • Vitamin K antagonists (used to reduce blood clotting), such as warfarin (Coumadin).
    Taking AROPILO SR with food and drink
    AROPILO SR can be taken with or without food, according to the patient’s preference.
    Pregnancy and breastfeeding
    AROPILO SR is not recommended during pregnancy, unless the doctor determines that the benefit to the patient outweighs the risk to the unborn child. AROPILO SR is not recommended during breastfeeding, as it may affect milk production in the patient.
    Please inform your doctor immediately if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant. The doctor will also provide advice if the patient is breastfeeding or plans to breastfeed. The doctor may recommend discontinuing AROPILO SR.
    Driving and using machines
    AROPILO SR may cause drowsiness. Sudden, uncontrollable drowsiness may occur, and sometimes sudden and unexpected sleep attacks without prior warning of sleepiness.
    Hallucinations (seeing, hearing, or sensing things that are not present) may occur during treatment with AROPILO SR. If the patient experiences hallucinations, they should not drive or operate machinery.
    If there is suspicion that such symptoms may occur: do not drive, operate machinery, or perform any activities in which drowsiness or falling asleep could put the patient (or others) at risk of serious injury or death. Such activities should be avoided until symptoms resolve.
    Please talk to your doctor if this situation is problematic for the patient.
    AROPILO SR contains lactose
    If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
    AROPILO SR contains sodium
    The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use AROPILO SR

This medicine should always be taken exactly as your doctor has told you. If you are unsure,
you should contact your doctor or pharmacist.
AROPILO SR must not be used in children. AROPILO SR is not intended for use in patients under
18 years of age.
AROPILO SR may be used in the treatment of symptoms of Parkinson's disease either as a single
treatment 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 AROPILO SR.
If such symptoms occur, inform your doctor, who may adjust the doses of the medicines the patient
is taking.
AROPILO SR 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. The tablets may
be visible in the stool. In such a case, contact your doctor as soon as possible.

What dose of AROPILO SR should be taken?
Finding the right dose of AROPILO SR for the patient may take time.
The recommended starting dose of prolonged-release AROPILO SR is 2 mg once daily for the
first week. Your doctor may increase the dose to 4 mg of AROPILO SR once daily 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 may
take up to 24 mg of prolonged-release AROPILO SR tablets per day.
If the patient experiences severe side effects at the beginning of treatment, inform the doctor. The
doctor may recommend changing the treatment to a lower dose of ropinirole in coated tablets
(immediate-release), to be taken three times a day.
Do not take more AROPILO SR than prescribed by your doctor.
It may take several weeks before the beneficial effect of the medicine becomes apparent.

How to take AROPILO SR
AROPILO SR should be taken once daily, at the same time each day.
The prolonged-release AROPILO SR tablet(s) must be swallowed whole with a glass of water.
Do not break, chew or crush the prolonged-release tablet(s) – doing so may lead to overdose
due to too rapid release of the medicine in the body.

Two white tablets with the marking GS and a purple checkmark, and four broken tablets with the same marking and a purple X

Switching treatment in patients currently taking ropinirole immediate-release coated tablets
The doctor will determine the dose of prolonged-release AROPILO SR tablets based on the previous
dose of immediate-release ropinirole coated tablets.
Take the previously prescribed dose of immediate-release ropinirole coated tablets on the day
before switching treatment. The next morning, take AROPILO SR prolonged-release tablets and do
not take any further doses of immediate-release ropinirole coated tablets.

Taking more AROPILO SR than prescribed
Contact your doctor or pharmacist immediately. If possible, show the AROPILO SR packaging.
In a person who has taken more than the prescribed dose of AROPILO SR, symptoms such as nausea,
vomiting, dizziness, drowsiness, mental or physical fatigue, fainting, or hallucinations may occur.

If you miss a dose of AROPILO SR
Do not take a larger number of prolonged-release tablets or a double dose to make up for a missed dose.
If you have not taken AROPILO SR for a day or longer, consult your doctor about resuming treatment.

Stopping AROPILO SR treatment
Do not stop taking AROPILO SR unless your doctor tells you to.
AROPILO SR should be taken for as long as your doctor recommends. Do not stop unless instructed
by your doctor.
If AROPILO SR is stopped suddenly, symptoms of Parkinson's disease may worsen rapidly. Sudden
discontinuation may lead to a condition known as neuroleptic malignant syndrome, which can be a
serious health risk. Symptoms include: akinesia (loss of muscle movement), muscle rigidity, fever,
unstable blood pressure, tachycardia (rapid heartbeat), confusion, and reduced level of consciousness
(e.g. coma).
If it becomes necessary to stop taking AROPILO SR, 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 ropinirole may most commonly occur 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,
you should consult your doctor.

Very common adverse effects
May occur in more than 1 in 10 patients taking ropinirole:

  • dizziness or fainting
  • feeling sleepy
  • nausea

Common adverse effects
May occur in up to 1 in 10 patients taking ropinirole:

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

Uncommon adverse effects
May occur in up to 1 in 100 patients taking ropinirole:

  • dizziness or fainting, particularly when changing suddenly to an upright position (related to low blood pressure)
  • very strong feeling of sleepiness during the day (excessive daytime sleepiness)
  • psychiatric disorders such as delirium, hallucinations (irrational thoughts) or paranoia (unfounded suspicion)
  • hiccups

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

  • allergic reactions such as red, itchy swellings on the skin (urticaria), swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing, rash or intense itching (see section 2)
  • changes in liver function, which have been observed in blood tests
  • aggressive behaviour
  • excessive intake of ropinirole (uncontrolled urge to take high doses of dopaminergic medicines, higher than necessary to control motor symptoms, known as dopamine dysregulation syndrome)
  • inability to resist the impulse, drive or temptation to carry out behaviours 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 that is particularly troubling to the patient or others, for example increased sexual drive.
    • Uncontrolled, excessive shopping or spending money.
    • Sudden binge eating (consuming large amounts of food in a short time), compulsive eating (eating more food than needed to satisfy hunger).
  • depression, apathy, anxiety, lack of energy, sweating or pain after stopping or reducing the dose of ropinirole (referred to as dopamine agonist withdrawal syndrome or DAWS)
  • spontaneous erections

You should tell your doctor if any of these behaviours occur in the patient, so that appropriate treatment or symptom relief can be arranged.

Taking AROPILO SR with L-dopa
In patients taking AROPILO SR with L-dopa, other adverse effects may occur:

  • Involuntary movements (dyskinesias) are a very common adverse effect. In patients taking L-dopa, involuntary movements (dyskinesias) may occur when starting treatment with AROPILO SR. If these symptoms occur, inform your doctor, who may adjust the doses of medicines being taken by the patient.
  • Feeling of disorientation is a common adverse effect.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the 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 "Expiry date" or "EXP". The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Medicines must 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 is ropinirole. Each prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirole (as ropinirole hydrochloride).
  • Other ingredients are: hypromellose, sodium croscarmellose, maltodextrin, lactose monohydrate, hydrogenated castor oil, colloidal anhydrous silica, magnesium stearate; colouring 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, mottled, oval tablets, 16 mm x 8.2 mm, with engraved marking "2x" on one side.
AROPILO SR, 4 mg, prolonged-release tablets:
Brown, mottled, oval tablets, 16 mm x 8.2 mm, with engraved marking "4x" on one side.
AROPILO SR, 8 mg, prolonged-release tablets:
Dark pink, mottled, oval tablets, 16 mm x 8.2 mm, with engraved marking "8x" on one side.
Pack sizes:
AROPILO SR prolonged-release tablets are available in blister packs containing 21, 28, 30, 42, 56, 84, or 90 prolonged-release tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland

Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark Aropilo SR
Czech Republic Aropilos
Poland AROPILO SR
Slovakia Aropilos