Aropilo

Package leaflet: Information for the patient

Aropilo, 5 mg, coated tablets
Ropinirole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask 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 reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Aropilo is and what it is used for
2. Important information before taking Aropilo
3. How to take Aropilo
4. Possible side effects
5. How to store Aropilo
6. Contents of the pack and other information

1. What Aropilo is and what it is used for

The active substance in Aropilo 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.
Aropilo 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 acts like naturally occurring dopamine and thereby helps to relieve the symptoms of Parkinson's disease.

2. Important information before using Aropilo

When not to use Aropilo

• if the patient has a known hypersensitivity to ropinirole 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 situations may apply to the patient.
Warnings and precautions
Before starting treatment with Aropilo, 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 unusual urges and/or behaviours (such as uncontrollable gambling or increased sexual drive);
• if the patient has carbohydrate intolerance (e.g. lactose intolerance).

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 or their family/carer notice any unusual behaviours caused by an irresistible impulse, compulsion, or an obsessive need to perform certain actions, which may be harmful to the patient or others. These behaviours are known as impulse control disorders and may include gambling addiction, binge eating or compulsive spending, increased sexual drive, or intense sexual thoughts and feelings. The doctor may decide to adjust the dose or discontinue the medicine.
Please inform the doctor if any of the above conditions apply to the patient. The doctor may decide that Aropilo is not suitable for the patient or may recommend additional monitoring during treatment.

Aropilo with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including any herbal preparations or other medicines purchased without a prescription. Inform your doctor or pharmacist if the patient starts taking any new medicines during treatment with Aropilo.
Some medicines may affect the action of Aropilo or increase the risk of side effects. Aropilo may also affect the action of other medicines.
These include:

• the antidepressant fluvoxamine
• HRT (hormone replacement therapy)
• antibiotics: ciprofloxacin and enoxacin
• medicines used for other psychiatric disorders, such as sulpiride
• metoclopramide, a medicine used to treat nausea and heartburn
• 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 Aropilo:

• Vitamin K antagonists (used to reduce blood clotting), such as warfarin (Coumadin).

Aropilo with food and drink
Taking Aropilo with food may reduce the likelihood of vomiting and nausea. It is recommended, whenever possible, to take the medicine with food.

Pregnancy and breastfeeding
Aropilo is not recommended during pregnancy unless the doctor decides that the benefit of treatment outweighs the potential risk to the fetus.
Aropilo is not recommended for breastfeeding women, as it may affect lactation.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The doctor may decide to discontinue Aropilo.

Driving and operating machinery
Aropilo may cause drowsiness. In very rare cases, sudden and uncontrollable sleepiness or even sudden, unexpected sleep attacks (without prior warning of drowsiness) may occur.
Hallucinations (seeing, hearing, or feeling things that are not actually present) may also occur during treatment with Aropilo. If the patient experiences hallucinations, they should not drive or operate machinery.
If such symptoms occur, the patient should not drive or perform any activities where reduced alertness could put themselves or others at risk of serious injury or death (e.g. operating machinery) until these symptoms have resolved.
Please consult your treating doctor if this situation is problematic for the patient.

Smoking and use of Aropilo
Inform your doctor if the patient starts or stops smoking during treatment with Aropilo. The doctor may need to adjust the dose.

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

Aropilo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered "sodium-free".

3. How to take Aropilo

Aropilo must always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should contact your doctor or pharmacist.
Aropilo may be used in the treatment of Parkinson's disease symptoms either as monotherapy or
in combination with another medicine called L-dopa (also known as levodopa).
You should inform your doctor if you or a member of your family notice any unusual behaviour
(such as a strong urge to gamble or increased desire and/or sexual behaviour) while taking Aropilo.
Your doctor may change the dose of your medicine or discontinue treatment.
Aropilo must not be given to children. Aropilo is not usually prescribed for individuals under
18 years of age.

Recommended dose
Finding the optimal dose of Aropilo may take time.
The usual starting dose is 0.25 mg three times a day for the first week.
Your doctor will then increase the dose weekly over the next three weeks.
After that, your doctor will gradually increase the dose until reaching the best dose for you.
The usual dose is 1 mg to 3 mg three times a day (total daily dose: 3 mg to 9 mg). If sufficient
relief of Parkinson's disease symptoms has not been achieved, your doctor may decide to
gradually increase the dose.
Some patients receive a dose of up to 8 mg of Aropilo three times a day (total 24 mg per day).
If you are taking other medicines for Parkinson's disease, your doctor may recommend gradually
reducing the doses of those medicines.
If you are taking L-dopa, involuntary movements (dyskinesias) may occur when starting Aropilo.
If these symptoms occur, inform your doctor, who may adjust the doses of your medicines.

Do not take more Aropilo than prescribed by your doctor.
It may take several weeks before Aropilo starts to work.

Method of administration
Aropilo should be taken three times daily.
Tablets should be swallowed with a glass of water. It is best to take Aropilo with food, as this
reduces the likelihood of nausea (feeling sick).

Taking more than the recommended dose of Aropilo
Contact your doctor or pharmacist immediately. Show them the Aropilo packaging.
A person who has taken an excessive dose may experience: nausea, vomiting, dizziness, drowsiness,
feeling tired (mentally or physically), fainting, hallucinations.

If you miss a dose of Aropilo
Do not take a double dose to make up for a missed dose.
If you remember the missed dose, take the next dose at the usual time.
If you have missed taking Aropilo for one or more days, consult your doctor about restarting treatment.

Stopping Aropilo
Do not stop taking Aropilo unless your doctor advises you to do so. Continue taking Aropilo for as
long as your doctor recommends.
If Aropilo is stopped suddenly, Parkinson's disease symptoms may worsen significantly.
Abrupt discontinuation may lead to a condition called neuroleptic malignant syndrome, which can
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, your doctor will gradually reduce the dose.
If you have any doubts about how to take 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.
The most commonly reported adverse reactions with Aropilo occur when some patients
begin treatment for the first time and/or when the dose is increased. Adverse reactions are
usually mild and may decrease after a short period of taking the medicine.
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.

Very common adverse reactions (occur in more than 1 in 10 people):

• fainting
• feeling sleepy
• nausea.

Common adverse reactions (may occur in up to 1 in 10 people):

• hallucinations (seeing things that are not real)
• vomiting
• dizziness (sensation of spinning)
• heartburn
• abdominal pain
• swelling of the legs, feet or hands.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• dizziness or fainting, particularly when suddenly standing up (related to low blood pressure)
• excessive daytime sleepiness (irresistible sleepiness)
• sudden onset of sleep without warning (sudden sleep attacks)
• psychiatric disorders such as delirium (severe confusion), delusions (irrational thoughts) or paranoia (unfounded suspicion)
• hiccups.

The following adverse reactions may occur in some patients (frequency unknown:
cannot be estimated from 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)
• aggression
• compulsive use of Aropilo (irresistible urge to take high doses of dopaminergic medicines, higher than necessary to control motor symptoms, known as dopamine dysregulation syndrome)
• upon stopping or reducing the dose of Aropilo, depression, apathy, anxiety, fatigue, sweating or pain may occur (referred to as dopamine agonist withdrawal syndrome or DAWS)
• changes in liver function detected in blood tests
• spontaneous erection.

The following adverse reactions may occur:

• inability to resist impulses, urges or compulsions to perform actions that could be harmful to the patient or others; this includes:
  • strong impulse to gamble uncontrollably, despite serious personal or family consequences
  • altered or increased sexual interests and behaviours of significance to the patient or others, e.g. activities related to increased sexual drive
  • compulsive, uncontrolled spending or shopping
  • binge eating (consuming large amounts of food in a short time) or compulsive eating (eating more than normal and more than needed to satisfy hunger).

If the patient exhibits any of these behaviours, inform the doctor so that ways of managing or reducing these symptoms can be discussed.

Use of Aropilo in combination with levodopa (L-dopa)
In patients taking Aropilo with levodopa, the following adverse reactions may occur over time:

• involuntary movements (dyskinesias) are a very common adverse reaction. In patients taking levodopa, involuntary movements (dyskinesias) may occur when starting treatment with Aropilo. If these symptoms occur, inform the doctor, who may adjust the doses of medicines being taken.
• feeling confused is a common side effect.

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 for Monitoring Adverse Reactions to 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

Keep this medicine out of sight and reach of children.
Do not use after the expiry date stated on the packaging (blister or container) and
the cardboard box. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
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 contains
The active substance is ropinirole (Ropinirolum).
One Aropilo 5 mg coated tablet contains 5 mg of ropinirole as ropinirole hydrochloride.
Other ingredients:
Tablet core: Microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate.
Coating:
Opadry 03B20462 blue: indigo carmine (E132), lac, hypromellose, polyethylene glycol 400, titanium dioxide (E171).

What Aropilo looks like and contents of the pack
Aropilo 5 mg coated tablets are round, light blue in colour.

PVC/Polychlorotrifluoroethylene (PCTFE)/PVC/Aluminium blisters:
Pack sizes: 2, 12, 21, 28, 84, 126, 210 coated tablets.

50 ml container with polyethylene cap:
84 coated tablets.

50 ml container with polyethylene cap containing a moisture absorber in the cap:
84 coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
VIPHARM S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Tel. (+4822) 679 51 35
Fax: (+4822) 678 92 87
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area member states under the following names:
Poland: Aropilo