Aropilo sr

Patient Information Leaflet

AROPILO SR, 2 mg, prolonged-release tablets
AROPILO SR, 4 mg, prolonged-release tablets
AROPILO SR, 8 mg, prolonged-release tablets
Ropinirole
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. 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.

Table of contents

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 a naturally occurring substance called dopamine.
AROPILO SR 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 like naturally occurring dopamine in the brain and thereby 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 psychiatric disorders
if the patient has particular impulses and (or) behaviours (see section 4)
if the patient has intolerance to sugars (e.g. lactose).
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 [DAWS]), inform your doctor. If symptoms persist for more than a few weeks, your doctor may decide to adjust the dose of the medicine.
Inform your doctor if the patient, a family member, or caregiver notices new impulses or behaviours not previously observed in the patient, and if the patient cannot resist the urge, drive, or compulsion to carry out certain actions that could harm themselves or others. This condition is known as impulse control disorders and may include behaviours such as compulsive gambling, excessive eating or spending, increased sexual drive, or intensified sexual thoughts or feelings. Your doctor may consider it necessary to adjust the dose or discontinue the medicine.
Please inform your doctor if any of these conditions occur. Your 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 behaviours during treatment with AROPILO SR (such as uncontrollable urge to gamble or increased and (or) excessive sexual activity). Your doctor may recommend adjusting the dose or discontinuing the medicine.

Smoking and use of AROPILO SR
Please inform your doctor if the patient starts or stops smoking during treatment with AROPILO SR. Your 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 obtained without a prescription, as well as any medicines the patient plans to take.
Remember to inform your doctor or pharmacist if the patient starts taking any other medicine during treatment with 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 psychiatric 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 may 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. Your doctor will also provide advice if the patient is breastfeeding or plans to breastfeed. The doctor may recommend discontinuing AROPILO SR.

Driving and operating machinery
AROPILO SR may cause drowsiness. Sudden and uncontrollable drowsiness may occur, and sometimes sudden unexpected sleep attacks without prior warning of sleepiness.
Hallucinations (seeing, hearing, or sensing things that are not actually present) may occur during treatment with AROPILO SR. If the patient experiences hallucinations, he or she should not drive or operate machinery.
If there is any suspicion that such symptoms may occur: do not drive, operate machinery, or perform any activity 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 been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

AROPILO SR contains sodium
This 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 used exactly as your doctor has instructed. If in doubt, consult 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 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 AROPILO SR treatment.
If such symptoms occur, inform your doctor, who may adjust the doses of medicines the patient is
taking.
AROPILO SR tablets are designed to release the medicine gradually over a period exceeding 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
tablets may be observed in the stool. In such a case, contact your doctor as soon as possible.

What dose of AROPILO SR should be used?
Determining the appropriate dose of AROPILO SR for the patient may take some 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 take up to 24 mg
of prolonged-release AROPILO SR tablets per day.
If the patient experiences intolerable side effects at the beginning of treatment, inform the 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 AROPILO SR than that 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.
Prolonged-release AROPILO SR tablet(s) must be swallowed whole,
with a glass of water.
Do not break, chew or crush prolonged-release tablets – doing so may result in overdose due to
rapid release of the medicine into the body.

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

Taking more AROPILO SR than prescribed
Seek immediate medical advice from a doctor or pharmacist. 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 a dose of AROPILO SR is missed
Do not take a double dose or extra tablets to make up for a missed dose.
If AROPILO SR has not been taken for one day or longer, consult your doctor before restarting
treatment with AROPILO SR.

Stopping AROPILO SR treatment
Do not stop taking AROPILO SR unless instructed by your doctor.
AROPILO SR should be taken for as long as your doctor recommends. Do not stop treatment unless
your doctor advises it.
If AROPILO SR is stopped suddenly, symptoms of Parkinson's disease may rapidly worsen. Abrupt
discontinuation may lead to a condition known as neuroleptic malignant syndrome, which may be
life-threatening. 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 discontinue AROPILO SR, 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 everybody will experience them.
Adverse reactions of ropinirole may occur most often 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,
you should consult your doctor.

Very common adverse reactions
May affect more than 1 in 10 patients taking ropinirole:

• fainting
• drowsiness
• nausea

Common adverse reactions
May affect up to 1 in 10 patients taking ropinirole:

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

Uncommon adverse reactions
May affect up to 1 in 100 patients taking ropinirole:

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

In some patients the following adverse reactions may occur (frequency unknown: cannot be estimated from available data):

• allergic reactions such as red, itchy swellings on the skin (urticaria), facial swelling, swelling of the lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing, rash or intense itching (see section 2).
• liver function abnormalities detected in blood tests.
• aggressive behaviour.
• compulsive use 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 sexual interest and behaviour 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 (eating more food than needed to satisfy hunger).
• after stopping or reducing the dose of ropinirole, symptoms such as depression, apathy, anxiety, lack of energy, sweating or pain may occur (known as dopamine agonist withdrawal syndrome or DAWS).
• spontaneous erection.

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 reactions may occur:

• Involuntary movements (dyskinesia) are a very common adverse reaction. In patients taking L-dopa, involuntary movements (dyskinesia) 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 reaction.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this 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 following the terms
"Expiry date" or "EXP". The expiry date refers to the last day of the indicated 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. Such measures 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] red iron oxide (E 172), yellow iron oxide (E 172), lactose monohydrate; [4 mg and 8 mg prolonged-release tablets] red iron oxide (E 172), yellow iron oxide (E 172), lactose monohydrate, black iron oxide (E 172).

What AROPILO SR looks like and contents of the pack
AROPILO SR, 2 mg, prolonged-release tablets:
Pink speckled, oval tablets, 16 mm x 8.2 mm, with engraved marking "2x" on one side.
AROPILO SR, 4 mg, prolonged-release tablets:
Brown speckled, oval tablets, 16 mm x 8.2 mm, with engraved marking "4x" on one side.
AROPILO SR, 8 mg, prolonged-release tablets:
Dark pink speckled, 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 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