Aropilo sr
Poland
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 this leaflet carefully before taking this medicine, because it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any 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 other people, even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet
- What AROPILO SR is and what it is used for
- Important information before taking AROPILO SR
- How to take AROPILO SR
- Possible side effects
- How to store AROPILO SR
- 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 work in the brain in a similar way to the 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 acts 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 components 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 specific impulses and (or) behaviors (see section 4)
if the patient has sugar intolerance (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 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 new-onset urges or behaviors that the patient has not previously experienced and an inability to resist the impulse, 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 other 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 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 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 of treatment 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 is planning to become pregnant. The doctor will also provide advice if the patient is breastfeeding or planning to breastfeed. The doctor may recommend discontinuing AROPILO SR.
Driving and operating machinery
AROPILO SR may cause drowsiness. Sudden and irresistible drowsiness may occur, and sometimes sudden and unexpected episodes of falling asleep without prior warning of sleepiness.
Hallucinations (seeing, hearing, or feeling things that are not actually 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 activity in which excessive sleepiness 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.
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, 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 as directed by your doctor. If you have any doubts,
you should 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 a
single medicine 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 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 possibly be seen in the stool. In such a case, contact your doctor as soon as
possible.
What dose of AROPILO SR should be used?
Finding the right 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 changing the therapy to treatment with a lower dose of ropinirole in
the form of coated tablets (immediate-release), which the patient would take three times a day.
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.
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 result in overdose
due to too rapid release of the medicine in the body.
Switching treatment in patients currently taking ropinirole in the form of coated tablets
(immediate-release)
Your doctor will determine the dose of prolonged-release AROPILO SR tablets based on the
previously used dose of ropinirole in the form of coated tablets (immediate-release).
Take your usual dose of ropinirole in the form of coated tablets (immediate-release) on the day
before switching treatment. The next morning, take AROPILO SR prolonged-release tablets and
do not take any more ropinirole in the form of coated tablets (immediate-release).
Taking more than the recommended dose of AROPILO SR
Seek immediate medical advice from your doctor or pharmacist. If possible, show the
packaging of AROPILO SR.
In a person who has taken more than the recommended 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 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 restarting
treatment with AROPILO SR.
Stopping treatment with AROPILO SR
Do not stop taking AROPILO SR unless your doctor advises you to do so.
AROPILO SR should be taken for as long as your doctor recommends. Do not stop taking it
unless your doctor tells you to.
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 treatment with 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 any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions of ropinirole may occur most frequently 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 occur in more than 1 in 10 patients taking ropinirole:
- fainting
- drowsiness
- nausea
Common adverse reactions
May occur in up to 1 in 10 patients taking ropinirole:
- sudden sleep attacks without prior warning of sleepiness (sudden sleep attacks)
- hallucinations (seeing things that are not real)
- vomiting
- dizziness
- heartburn
- abdominal pain
- constipation
- swelling of the legs, feet or hands
Uncommon adverse reactions
May occur in 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 sleepiness)
- psychiatric disorders such as delirium (confusion), hallucinations (irrational thoughts) or paranoia (unfounded suspicion)
The following adverse reactions 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)
- liver function abnormalities detected in blood tests
- aggressive behaviour
- compulsive use of ropinirole (uncontrolled urge to take large doses of dopaminergic medicines, larger than necessary to control motor symptoms, known as dopamine dysregulation syndrome)
- inability to resist the impulse, urge or temptation to perform activities that may 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 sexual drive.
- 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, the following may occur: depression, apathy, anxiety, lack of energy, sweating or pain (referred to as dopamine agonist withdrawal syndrome or DAWS)
If any of these behaviours occur, you should inform your doctor 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 (dyskinesias) are a very common adverse reaction. 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.
- Feeling of disorientation is a common adverse reaction.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 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 words
"Expiry date" or "EXP". The expiry date refers to the last day of the stated 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 speckled, oval tablets, 16 mm x 8.2 mm, with the engraved mark "2x" on one side.
AROPILO SR, 4 mg, prolonged-release tablets:
Brown speckled, oval tablets, 16 mm x 8.2 mm, with the engraved mark "4x" on one side.
AROPILO SR, 8 mg, prolonged-release tablets:
Dark pink speckled, oval tablets, 16 mm x 8.2 mm, with the engraved mark "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 European Economic Area countries under the following names:
Denmark Aropilo SR
Czech Republic Aropilos
Poland AROPILO SR
Slovakia Aropilos