Ropodrin

Package leaflet: Information for the patient

Ropodrin, 2 mg, prolonged-release tablets
Ropodrin, 4 mg, prolonged-release tablets
Ropodrin, 8 mg, prolonged-release tablets
Ropinirolum
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, 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Ropodrin is and what it is used for

The active substance in Ropodrin 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.
Ropodrin prolonged-release tablets are 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 in the brain and thus helps to relieve the symptoms of Parkinson's disease.

2. Important information before using Ropodrin

When not to use Ropodrin
if the patient is allergic to ropinirole or any of the other ingredients of this medicine
(listed in section 6),
if the patient has severe kidney disease without regular hemodialysis,
if the patient has liver disease.
You should inform the doctor if this applies to the patient.

Warnings and precautions
Before starting treatment with Ropodrin, discuss this with the doctor or pharmacist.
Before starting treatment with Ropodrin, consult a doctor:

• 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 serious psychiatric disorders,
• if the patient has particular urges and (or) behaviors (such as uncontrollable gambling or excessive sexual activity),
• if the patient has intolerance to certain 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 the doctor. If symptoms persist for more than a few weeks, the doctor may decide to modify the dose of the medicine.

If the patient, a relative, or caregiver notices that the patient begins to experience an overwhelming, irresistible urge to behave in a way completely different from their previous behavior and is unable to resist such impulses, even though the behaviors may harm the patient or others, inform the doctor immediately. Such irresistible urges and unusual behaviors may result from so-called impulse control disorders. Manifestations may include compulsive gambling, binge eating, compulsive shopping, excessive sexual drive, or obsessive thoughts about sex. The doctor will decide whether the dose of the medicine should be reduced or the medicine discontinued completely.

Inform the doctor if the patient or their family or caregiver notice episodes of excessive physical activity, excitement, or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorders (see above). The doctor may decide to adjust the dose or discontinue the medicine.

You should inform the doctor if this applies to the patient. The doctor may decide that Ropodrin is not an appropriate medicine for the patient or may recommend additional monitoring tests during treatment.

While taking Ropodrin
Inform the doctor if the patient or their family notice any unusual behaviors (such as an unusual urge to gamble or increased sexual drive and/or sexual behaviors) while taking Ropodrin. The doctor will decide whether the dose should be reduced or the medicine discontinued.

Smoking and Ropodrin
You should inform the doctor about starting or stopping smoking while taking Ropodrin. The doctor may find it necessary to adjust the dose of the medicine.

Other medicines and Ropodrin
Tell the 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.

Remember to inform the doctor or pharmacist about starting any other medicine while taking Ropodrin.

Some medicines may affect the action of Ropodrin or increase the risk of adverse effects. Ropodrin may also affect the action of other medicines. These include:

• fluvoxamine (an antidepressant),
• medicines used for other psychiatric disorders, for example sulpiride,
• hormone replacement therapy (HRT),
• metoclopramide, a medicine used to treat nausea and heartburn,
• antibiotics: ciprofloxacin and enoxacin,
• other medicines used in Parkinson's disease.

Inform the doctor if the patient is taking or has recently taken any of these medicines.

The patient may require additional blood tests if taking Ropodrin together with the following medicines:

• vitamin K antagonists (used to reduce blood clot formation), such as warfarin (coumarin), acenocoumarol.

Ropodrin and food
Ropodrin may be taken with or without food.

Pregnancy and breastfeeding
Ropodrin is not recommended during pregnancy, unless the doctor determines that the benefit to the patient outweighs the risk to the unborn child. Ropodrin is not recommended during breastfeeding, as it may affect milk production in the patient.

If the patient is pregnant, 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 will also provide advice if the patient is breastfeeding or planning to breastfeed. The doctor may recommend discontinuing Ropodrin.

Driving and operating machinery
Ropodrin may cause drowsiness. Uncontrollable drowsiness may occur, and sometimes sudden and unexpected episodes of falling asleep without prior warning may happen.

Hallucinations (seeing, hearing, or feeling things that are not actually present) may occur during treatment with ropinirole. 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 where drowsiness or falling asleep could expose the patient (or others) to the risk of serious injury or death. Do not perform such activities until symptoms have resolved.

Talk to the doctor if this situation applies to the patient.

Ropodrin 2 mg prolonged-release tablets contain a sugar called lactose. If the doctor has previously informed the patient about intolerance to certain sugars, the patient should contact the doctor before taking this medicinal product.

Ropodrin 4 mg prolonged-release tablets contain a colouring agent called sunset yellow (E110), which may cause allergic reactions.

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

3. How to use Ropodrin

This medicine should always be used as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Ropodrin may be used in the treatment of Parkinson's disease symptoms, either as a single medicine or
in combination with another medicine called L-dopa (or levodopa). If the patient is taking L-dopa,
involuntary movements (dyskinesias) may occur when starting treatment with Ropodrin. If such
symptoms occur, the doctor should be informed, as they may adjust the doses of medicines the patient
is taking.
Ropodrin tablets are designed to release the medicine over 24 hours. If the patient has a condition
causing the medicine to pass through the body too quickly (e.g. diarrhoea), the tablet(s) may not
dissolve completely and may not work properly. The patient may notice the tablet(s) in the stool. If
this occurs, the doctor should be informed as soon as possible.
What dose of Ropodrin should be used
Determining the appropriate dose of Ropodrin for the patient may take time.
The recommended starting dose of Ropodrin extended-release tablets is 2 mg once daily for the
first week. The doctor may increase the dose of Ropodrin extended-release tablets to 4 mg once daily
starting 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 daily of Ropodrin in the form of extended-release tablets.
If intolerable side effects occur at the beginning of treatment, the doctor should be informed. The
doctor may recommend changing the therapy to a lower dose of ropinirole in immediate-release
tablets, which the patient would take three times a day.
Use in children and adolescents
Ropodrin must not be given to children. Ropodrin is not prescribed to patients under 18 years of age.
Do not take a higher dose of Ropodrin than recommended by your doctor.
It may take several weeks before the beneficial effect of the medicine becomes apparent.
How to take Ropodrin
Ropodrin should be taken once daily, at the same time each day.
The extended-release Ropodrin tablet(s) should be swallowed whole with a glass of water.
Do not break, chew or crush the extended-release tablet(s). If this happens, there is a risk of overdose
due to the medicine being released too quickly into the body.
Switching treatment in patients previously taking ropinirole immediate-release coated tablets
The doctor will determine the dose of Ropodrin extended-release tablets based on the previously
used dose of ropinirole immediate-release coated tablets. The patient should take their usual dose of
ropinirole immediate-release coated tablets on the day before switching treatment. The next morning,
the patient should take Ropodrin extended-release tablets and must not take any further ropinirole
immediate-release coated tablets.
Taking more Ropodrin than recommended
Seek immediate advice from your doctor or pharmacist. If possible, show the Ropodrin packaging.
In a person who has taken more than the recommended dose of Ropodrin, symptoms such as nausea,
vomiting, dizziness, drowsiness, mental or physical fatigue, fainting, or hallucinations may occur.
Missing a dose of Ropodrin
Do not take a double dose to make up for a missed dose.
If a dose of Ropodrin has been missed for one day or longer, consult your doctor about restarting
treatment with Ropodrin.
Stopping treatment with Ropodrin
Do not stop taking Ropodrin suddenly without consulting your doctor. If Ropodrin is stopped
abruptly, Parkinson's disease symptoms may rapidly worsen.
Sudden discontinuation of the medicine may lead to a very serious condition known as neuroleptic
malignant syndrome (NMS). Symptoms of NMS include, among others: akinesia (loss of ability to
move), muscle rigidity, fever, fluctuations in blood pressure, tachycardia, confusion, and disturbances
of consciousness (up to coma).
Ropodrin should be taken for as long as directed by your doctor.
Do not stop taking it unless instructed by your doctor.
If it becomes necessary to discontinue Ropodrin, the 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects of Ropodrin may most commonly occur when starting treatment or
shortly after increasing the dose.
Adverse effects are usually mild and tend to become less bothersome after a short period
of using the medicine. If you have any concerns about adverse effects, consult your
doctor.
Very common adverse effects (may occur in at least 1 out of 10 patients)

• fainting
• feeling sleepy
• nausea

Common adverse effects (may occur in less than 1 out of 0 patients)

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

Uncommon adverse effects (may occur in less than 1 out of 100 patients)

• dizziness or fainting, especially when standing up suddenly (related to low blood pressure)
• excessive daytime sleepiness (irresistible sleepiness)
• psychiatric disorders such as delirium (severe disorientation), delusions (irrational thoughts) or paranoia (unfounded suspicion or feeling persecuted)
• hiccups

Adverse effects with unknown frequency (frequency cannot be determined from
available data)

• allergic reactions such as red, itchy skin swellings (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 tests observed in blood tests.
• aggressive behaviour
• misuse of Ropodrin (craving for large amounts of dopaminergic medicines exceeding those required to control motor symptoms, known as dopamine dysregulation syndrome).
• inability to resist an impulse, urge or temptation to perform an action that may be harmful to the patient or others, including:
  • strong urge to gamble despite serious personal or family consequences.
  • change or increase in sexual interests and behaviours in a way that causes concern to the patient or others, e.g. increased libido.
  • uncontrolled compulsive shopping or spending excessive amounts of money.
  • binge eating (consuming large amounts of food in a very short time) or compulsive overeating (eating larger amounts of food than normal and more than needed to satisfy hunger).
• episodes of hyperactivity, excitement or irritability.
• after stopping or reducing the dose of Ropodrin, symptoms such as depression, apathy, anxiety, fatigue, sweating or pain may occur (known as dopamine agonist withdrawal syndrome or DAWS).
• spontaneous erection.

If any of these behaviours occur in the patient, inform the doctor:
ways of managing or reducing these symptoms will be discussed.
Taking Ropodrin together with levodopa (L-dopa)
In patients taking Ropodrin in combination with levodopa, other adverse effects may occur over time:

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your
doctor or pharmacist. Adverse 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,
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store the medicine Ropodrin

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the blister, bottle, and carton. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
HDPE bottles: the shelf life after opening is 60 days.
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 Ropodrin contains

• The active substance is ropinirole. One prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirole (as hydrochloride).
• Other ingredients are:
  • Core of the prolonged-release tablets: ammonium methacrylate copolymer (type B), hypromellose (E464), sodium lauryl sulfate, copovidone, magnesium stearate (E572).
  • Coating:

What Ropodrin looks like and contents of the pack
Ropodrin 2 mg prolonged-release tablets: pink, round, biconvex tablets with a diameter of
6.8±0.1 mm and thickness of 5.5±0.2 mm.
Ropodrin 4 mg prolonged-release tablets: light brown, oval, biconvex tablets with
dimensions of 12.6 x 6.6±0.1 mm and thickness of 5.3±0.2 mm.
Ropodrin 8 mg prolonged-release tablets: red, oval, biconvex tablets with
dimensions of 19.2 x 10.2±0.2 mm and thickness of 5.2±0.2 mm.
Ropodrin 2 mg, 4 mg and 8 mg are packaged in PVC/PCTFE/Aluminium blisters and HDPE bottles
with PP screw cap with tamper-evident seal and desiccant, contained in a cardboard box.
Pack sizes
Blisters: 28, 30, 56, 84 prolonged-release tablets
Bottle: 28, 30, 56, 84 prolonged-release tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Hungary
Manufacturer
Pharmathen S.A.
Hungary
This medicinal product is authorised for sale in the European Economic Area Member States under the following names: