Aropilo

Package leaflet: Information for the patient

Aropilo, 0.25 mg, film-coated tablets
Aropilo, 0.5 mg, film-coated tablets
Aropilo, 1 mg, film-coated tablets
Aropilo, 2 mg, film-coated tablets
Ropinirole
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Contents of the leaflet

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 a naturally occurring substance called dopamine.
Aropilo is used in the treatment of Parkinson's disease.
In patients with Parkinson's disease, there is a low level of dopamine in certain parts of the brain. Ropinirole acts like naturally occurring dopamine and thus helps to relieve the symptoms of Parkinson's disease.
Aropilo is also used to treat moderate to severe restless legs syndrome (RLS).
Restless legs syndrome is also known as Ekbom's syndrome. People with restless legs syndrome have an irresistible urge to move their legs, and sometimes their arms or other parts of the body. This is usually accompanied by unpleasant sensations in the limbs – sometimes described as "pins and needles" or "tingling" – which typically begin when the patient sits down or lies down and are relieved only by movement. Patients often therefore have difficulty sitting still, and especially with sleeping.
Aropilo helps to relieve these unpleasant sensations and reduces the urge to move the limbs.

2. Important information before taking Aropilo

When not to take Aropilo

• if the patient has a hypersensitivity to ropinirole 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.

Tell your doctor if any of these situations apply to the patient.
Warnings and precautions
Before starting treatment with Aropilo, discuss this with your doctor or pharmacist if:

• the patient is pregnant or suspects she may be pregnant;
• the patient is breastfeeding;
• the patient is under 18 years of age;
• the patient has severe heart disease;
• the patient has severe psychiatric disorders;
• the patient has particular urges and/or behaviors (uncontrolled gambling or excessive sexual activity);
• the patient has sugar intolerances (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 longer than a few weeks, the doctor may decide to adjust the dose of the medication.

Inform the doctor if the patient or their family/caregiver notice unusual behaviors resulting from irresistible impulses, compulsions, or obsessive performance of certain actions that are harmful to the patient or others. These behaviors are called impulse control disorders and may include gambling addiction, compulsive eating or spending, increased sexual drive, or intensified sexual thoughts and feelings. The doctor may decide to adjust the dose or discontinue the medication.

Tell your doctor if any of the conditions listed above apply to the patient. The doctor may decide that Aropilo is not the appropriate medicine 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, as well as any medicines the patient plans to take, including herbal preparations or other over-the-counter medicines. 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 adverse 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;
• cimetidine, used in the treatment of stomach ulcers;
• any other medicines used for Parkinson’s disease.

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).

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

Pregnancy, breastfeeding and fertility
Aropilo is not recommended during pregnancy unless the doctor determines that the benefit outweighs the potential risk to the fetus.
Aropilo is not recommended for breastfeeding women, as it may affect lactation.
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.
The doctor may recommend discontinuing Aropilo.

Driving and operating machinery
Aropilo may cause drowsiness. In very rare cases, sudden and uncontrollable sleepiness may occur, sometimes accompanied by sudden and unexpected sleep attacks, even without prior warning of drowsiness.

Hallucinations (seeing, hearing, or feeling things that are not actually present) may occur during treatment with ropinirole. If the patient experiences hallucinations, he or she should not drive or operate machinery.

If such symptoms occur, the patient should not drive or perform tasks where reduced alertness could place the patient or others at risk of serious injury or death (e.g. operating machinery) until these symptoms have resolved.

Discuss with the treating doctor if this situation poses a problem 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.

Worsening of symptoms
During treatment with ropinirole, worsening of restless legs syndrome symptoms may occur, including earlier onset of symptoms during the day, increased intensity of symptoms, or the appearance of symptoms in previously unaffected limbs (e.g. arms), as well as a shift in the timing of symptoms to early morning hours. If any of these symptoms occur, consult your doctor.

Aropilo contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient 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, this medicine is considered "sodium-free".

3. How to use Aropilo

Aropilo should always be used as directed by the doctor or pharmacist. If in doubt, contact the treating doctor or pharmacist again.
Aropilo 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). You should inform the doctor if the patient or their family notice any unusual behaviour (such as a strong urge to gamble or increased sexual desire and/or sexual behaviour) while taking Aropilo.
The doctor may change the dose of the 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:
In the treatment of Parkinson's disease:
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.
The doctor will then increase the dose weekly over the next three weeks.
Subsequently, the doctor will gradually increase the dose to the best dose for the patient.
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, the 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 the patient is taking other medicines for Parkinson's disease, the doctor may recommend gradually reducing the doses of those medicines.
If the patient is taking L-dopa, involuntary movements (dyskinesias) may occur when starting Aropilo treatment.
Do not take more Aropilo than prescribed by the doctor.
It may take several weeks before Aropilo starts to work.

How to take Aropilo tablets
Take Aropilo three times daily. Swallow the tablets with a glass of water. Aropilo is best taken with food, as this reduces the likelihood of nausea (feeling sick).

In the treatment of restless legs syndrome:
Finding the optimal dose of Aropilo may take time.
The initial dose of ropinirole is 0.25 mg once daily. After two days, the doctor will likely increase the dose to 0.5 mg once daily for the remainder of the week. The doctor may then gradually increase the dose to 2 mg once daily over a period of three weeks.
If there is insufficient improvement in symptoms of restless legs syndrome, the dose may be gradually increased to a maximum dose of 4 mg once daily for optimal effect. After three months of treatment with Aropilo, depending on the patient's symptoms and well-being, the treating doctor may adjust the dose or consider discontinuing treatment.
If you feel the effect of the medicine is too strong or too weak, contact your doctor or pharmacist. Do not take more tablets than prescribed by your treating doctor.
Continue treatment even if there is no immediate improvement, as the therapeutic effect may only become apparent after several weeks.

Method of administration
Take Aropilo once daily.
Swallow Aropilo with a glass of water. Aropilo may be taken with or without food. Taking Aropilo with food may reduce the likelihood of nausea.
Aropilo is usually taken just before going to bed, but the dose may be taken up to 3 hours before bedtime.

Taking more Aropilo than prescribed
If you take more Aropilo than prescribed, contact your doctor or pharmacist immediately. Show them the medicine packaging.
In a person who has taken more than the prescribed dose of Aropilo, the following may occur: nausea, vomiting, dizziness, drowsiness, feeling of fatigue (mental or physical), fainting, hallucinations.

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

Stopping Aropilo treatment
Do not stop taking Aropilo unless instructed by your doctor. Aropilo should be taken for as long as your doctor recommends.
If Aropilo is stopped abruptly, symptoms of Parkinson's disease may worsen significantly. Sudden 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 discontinuation of Aropilo is necessary, your treating doctor will gradually reduce the dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects with Aropilo occur when some patients start treatment for the first time and/or when the dose is increased. Side effects are usually mild and may decrease after a short period of taking the medicine.
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist.

Parkinson's disease

Very common side effects (occur in more than 1 in 10 people):

• fainting
• feeling sleepy
• nausea

Common side effects (may occur in up to 1 in 10 people):

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

Uncommon side effects (may occur in up to 1 in 100 people):

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

The following side effects 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 large doses of dopaminergic medication, larger than necessary to control motor symptoms, known as dopamine dysregulation syndrome)
• depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing the dose of Aropilo (known as dopamine agonist withdrawal syndrome or DAWS)
• changes in liver function, detected in blood tests
• spontaneous erection

The following side effects may occur:

• inability to resist impulses, urges or compulsions to perform actions that could be harmful to the patient or others, including:
• 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 food than normal and more than needed to satisfy hunger)

Tell your doctor if the patient shows any of these behaviours so that ways of managing or reducing these symptoms can be discussed.

Taking Aropilo with levodopa (L-dopa)
In patients taking Aropilo with levodopa, the following side effects may occur over time:

• involuntary movements (dyskinesias) are a very common side effect. If the patient is taking L-dopa, involuntary movements (dyskinesias) may occur when starting treatment with Aropilo. If these symptoms occur, inform your doctor, who may adjust the doses of medicines being taken.
• feeling confused is a common side effect.

Restless Legs Syndrome (RLS)

Very common side effects (occur in more than 1 in 10 people):

• nausea
• vomiting

Common side effects (may occur in up to 1 in 10 people):

• nervousness
• fainting
• sleepiness
• feeling of fatigue (mental or physical)
• dizziness (feeling of spinning)
• abdominal pain
• worsening of RLS symptoms (symptoms may appear earlier than usual, be more intense, or affect other limbs previously unaffected, such as arms, or symptoms may appear early in the morning)

Uncommon side effects (may occur in up to 1 in 100 people):

• feeling confused
• hallucinations (seeing things that are not there)
• dizziness or fainting, especially when suddenly standing up (related to low blood pressure)
• hiccups

Very rare side effects (may occur in 1 in 10,000 people):

• excessive daytime sleepiness (irresistible sleepiness)
• sudden sleep attacks without prior warning of sleepiness (sudden onset of sleep)

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

• inability to resist impulses, urges or compulsions to perform actions that could be harmful to the patient or others, including:
• 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 food than normal and more than needed to satisfy hunger)
• spontaneous erection

Tell your doctor if the patient shows any of these behaviours so that ways of managing or reducing these symptoms can be discussed.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Aropilo

Keep the medicine out of the sight and reach of children.
Do not use after the expiry date stated on the packaging (blister or container) and carton.
The expiry date refers to the last day of the specified month.
Do not store above 25ºC.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste bins. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Aropilo contains
The active substance is ropinirole (Ropinirolum).
One 0.25 mg Aropilo coated tablet contains 0.25 mg of ropinirole as ropinirole hydrochloride.
One 0.5 mg Aropilo coated tablet contains 0.5 mg of ropinirole as ropinirole hydrochloride.
One 1 mg Aropilo coated tablet contains 1 mg of ropinirole as ropinirole hydrochloride.
One 2 mg Aropilo coated tablet contains 2 mg of ropinirole as ropinirole hydrochloride.

Other ingredients:
Tablet core:
Microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate.

Coating:
Aropilo 0.25 mg coated tablets (white)
Opadry 03B28796 white: hypromellose, polyethylene glycol 400, titanium dioxide (E171).

Aropilo 0.5 mg coated tablets (yellow)
Opadry 03B32439 yellow: indigo carmine (E132), lacquer, hypromellose, iron oxide red (E172), polyethylene glycol 400, titanium dioxide (E171), iron oxide yellow (E172).

Aropilo 1 mg coated tablets (green)
Opadry 03B21634 green: indigo carmine (E132), lacquer, hypromellose, polyethylene glycol 400, titanium dioxide (E171), iron oxide yellow (E172).

Aropilo 2 mg coated tablets (pink)
Opadry 03B34666 pink: hypromellose, iron oxide red (E172), polyethylene glycol 400, titanium dioxide (E171), iron oxide yellow (E172).

What Aropilo looks like and contents of the pack
Aropilo 0.25 mg coated tablets are round, white or off-white in colour.
Aropilo 0.5 mg coated tablets are round, yellow in colour.
Aropilo 1 mg coated tablets are round, green in colour.
Aropilo 2 mg coated tablets are round, pink in colour.

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

50 ml polyethylene bottle with polyethylene cap:
84 coated tablets.

50 ml polyethylene bottle 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 countries under the following names:
Poland: Aropilo