Prospect: Information for the User

Ropinirol Stada 2 mg prolonged-release tablets EFG

Ropinirol Stada 4 mg prolonged-release tablets EFG

Ropinirol Stada 8 mg prolonged-release tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What Ropinirol Stada is and for what it is used

2. What you need to know before starting to take Ropinirol Stada

3. How to take Ropinirol Stada

4. Possible adverse effects

5. Storage of Ropinirol Stada

6. Contents of the package and additional information

The active ingredient of Ropinirol Stada is ropinirol, which belongs to a group of medications called dopamine agonists. Dopamine agonists act in the same way as a natural substance found in the brain, called dopamine.

Ropinirol prolonged-release tablets are used for the treatment of Parkinson's disease.

People with Parkinson's disease have low levels of dopamine in certain parts of the brain. Ropinirol has a similar effect to natural dopamine and, in this way, reduces the symptoms of Parkinson's disease.

Do not take Ropinirol Stada:

• if you areallergicto ropinirol or any of the other components (see section 6).
• if you have anyserious kidney disease.
• if you have anyliver disease.

Inform your doctor if you think you may be in any of these situations.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ropinirol.

• if you arepregnantor think you may be pregnant.
• if you are inbreastfeeding.
• if you areunder 18 years old.
• if you have anyserious heart disease.
• if you have anyserious mental disorder.
• if you experience anyimpulsive behavior and/or abnormal behavior.

Inform your doctorif you experience symptoms such asdepression, apathy, anxiety, fatigue, sweating, or painafter stopping or reducing treatment with ropinirol (known as dopamine agonist withdrawal syndrome or SAAD).If these symptoms persist for more than a few weeks, your doctor may need to adjust your treatment.

Inform your doctorif you or your family/caregiver notice that you are developing impulses or desires to behave in an unusual way for you and that you cannot resist the impulse, desire, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as pathological gambling, excessive eating or spending, abnormally elevated sexual desire, or an increase in sexual thoughts or feelings.Your doctor may need to adjust or stop your treatment..

Inform your doctorif you or your family/caregiver notice that you are developing episodes of hyperactivity, euphoria, or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorder (see above). Your doctor may need to adjust or stop your treatment.

Inform your doctorif you think you may be in any of these situations. Your doctor will decide if your treatment with ropinirol is suitable for you, or if you need additional monitoring while taking it.

Other medicines and Ropinirol Stada

Inform your doctor or pharmacist if you are taking, have taken recentlyor may need to takeany other medicine.

Remember to inform your doctoror pharmacist if you start taking a new medicine while takingropinirol.

Some medicines may affect the wayropinirolworks, or make it more likely that you will have side effects. Ropinirol may also alter the way other medicines work.

These medicines include:

• theantidepressant fluvoxamine.
• medicines formental disorders, such assulpiride.
• THS(hormone replacement therapy).
• metoclopramide, which is used to treatnauseaandheartburn.
• theantibiotics ciprofloxacin or enoxacin.
• any othermedicine for Parkinson's disease.

Inform your doctorif you are taking, or have taken recently, any of these medicines.

If you are taking the following medicines with ropinirol,you may need additional blood tests:

• Anticoagulant vitamin K antagonists (used to reduce blood clotting) such as Warfarin (coumarin).

Taking Ropinirol Stada with food and drink

You can take ropinirol with or without food, as you prefer.

Pregnancy, breastfeeding, and fertility

Ropinirol Stada is not recommended during pregnancy, unless your doctor tells you that the benefits of takingropinirolare greater than any possible risk to the fetus.

Ropinirol Stada should not be used during breastfeeding,as milk production may be affected.

The effect of ropinirol on fertility is unknown.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.Your doctor will recommend what you should do if you are breastfeeding or plan to breastfeed. Your doctor may recommend that you stop takingropinirol.

Driving and operating machinery

Ropinirol may make you feel drowsy.Some people may feel extremely drowsy, or fall asleep suddenly without warning..

Ropinirol may causehallucinations(seeing, hearing, or feeling things that are not real).

If you experience this:do not drive, do not use machinery, anddo notput yourself in situations where feeling drowsy or falling asleep may put you, or others, at risk of serious harm or death. Do not do these activities until you are no longer affected.

Consult your doctorif this may affect you.

Ropinirol Stada contains sodium

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

Ropinirol Stada 2 mg contains lactose

This medicine containslactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Ropinirol Stada 4 mg contains yellow orange (E110)

This medicine may cause allergic reactions because it contains yellow orange (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions of this medication as indicated by your doctoror pharmacist. In case of doubt, consult your doctor or pharmacist again.

You may have been prescribed only ropinirol for the treatment of your Parkinson's disease symptoms, or you may have also been prescribed another medication called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience some uncontrollable movements (dyskinesias) when you start taking ropinirol. Inform your doctor if this occurs, as you may need to adjust the doses of the medications you are taking.

The prolonged-release ropinirol tablets have been designed to release the active ingredient over a period of 24 hours. If you are in a state where medications pass through your body very quickly, for example with diarrhea, the tablet may not dissolve completely and may not work properly. You may see tablets in your stools. If this occurs, inform your doctor as soon as possible.

What dose of Ropinirol Stada should you take?

You may need some time to determine what dose of ropinirol is best for you.

The recommended initial doseis 2 mg once a day for the first week. From here, your doctor may increase the dose to 4 mg of ropinirolprolonged-release tablets once a day, during the second week of treatment. In very elderly people, the doctor may increase the dose more slowly. Your doctor may then adjust the dose to reach the most suitable dose for you. Some people take up to 24 mg of ropinirolprolonged-release tablets each day.

If you experience adverse effects at the start of your treatment that you cannot tolerate, consult your doctor. Your doctor may advise you to change to a lower dose of ropinirol film-coated tablets (immediate release) that you take three times a day.

Use in children and adolescents

Do not give ropinirol to children. Ropinirolis usually not prescribed to people under 18 years old.

Do not take more Ropinirol Stada tablets than your doctor has recommended.

You may need several weeks for ropinirolto take effect.

How to take your Ropinirol Stada dose

Takeropinirolonce a day, at the same time every day.

Swallow the prolonged-release ropinirol tablets whole,with a glass of water.

Do not break, chew, or crush the prolonged-release tablets- if you do, there may be a risk of you receiving an excessive dose, as the medication will be released into your body too quickly.

If you change fromropinirolfilm-coated tablets (immediate release)

Your doctor will adjust your dose of ropinirol prolonged-release tablets based on the dose of ropinirol film-coated tablets (immediate release) you are taking.

Take your ropinirol film-coated tablets (immediate release) as normal the day before changing. Then, take your ropinirolprolonged-release tablets the next morning, and do not take any more ropinirol film-coated tablets (immediate release).

If you take moreRopinirol Stadathan you should

If you have taken too many ropiniroltablets, or if you discover that a child has taken them,consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Someone who has experienced a ropinirol overdose may have some of the following symptoms: feeling unwell (nausea), feeling dizzy (vomiting), vertigo (a sensation of rotation), drowsiness, physical or mental fatigue, fainting, or hallucinations.

If you forget to takeRopinirol Stada

Do nottake extra tablets or a double doseto compensate for the missed doses.

If you have forgotten to takeropinirolfor one or several days, consult your doctor to have them recommend how to start taking it again.

If you interrupt the treatment withRopinirol Stada

Do not interrupt the treatment withropinirolwithout having consulted your doctor first.

Takeropinirolfor the time your doctor tells you to.

Do not suspend the treatment unless your doctor tells you to.

If you suspend the treatment withropinirol abruptly, the symptoms of your Parkinson's disease may worsen rapidly. A sudden interruption of treatment may cause the appearance of a condition known as neuroleptic malignant syndrome, which can represent a serious risk to your health. The symptoms include: akinesia (loss of muscular movement), muscular rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, or decreased level of consciousness (e.g. coma).

If you need to stop takingropinirol, your doctor will gradually reduce your dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

Ropinirol side effects usually appear more frequently at the beginning of treatment or when the dose is increased. Side effects are generally mild and may be less bothersome over time. Inform your doctor if you are concerned about side effects.

Very common side effects

May affectmore than 1 in 10 peoplewho take ropinirol:

• dizziness
• drowsiness
• feeling unwell (nausea)

Common side effects

May affectup to 1 in 10 peoplewho take ropinirol:

• falling asleep suddenly without feeling sleepy beforehand (sudden onset of sleep episodes)
• hallucinations (seeing, hearing, or feeling things that are not really there)
• feeling dizzy (vomiting)
• feeling dizzy (dizziness)
• heartburn
• stomach pain
• constipation
• swelling of the legs, feet, or hands

Uncommon side effects

May affectup to 1 in 100 peoplewho take ropinirol:

• dizziness or fainting, especially when standing up suddenly (this is due to a drop in blood pressure)
• low blood pressure (hypotension)
• excessive daytime sleepiness (excessive somnolence)
• mental problems such as delirium (severe confusion), delusional ideas (irrational ideas), or paranoia (irrational suspicions)
• hypothermia

Some patients may experience the following side effects (frequency not known: cannot be estimated from available data):

• allergic reactionssuch as redness,inflammationof the skin with itching (urticaria), swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing,hivesor intense itching (see section 2)
• changes in liver function, which can be detected by blood tests
• acting aggressively
• excessive use of ropinirol (anxiety about taking an excessive dose of dopaminergic medications compared to the necessary dose to control motor symptoms, known as dopamine dysregulation syndrome
• inability to resist the impulse, desire, or temptation to perform certain actions that may be harmful to you or others, which may include:
• • excessive urge to gamble, despite significant personal or family consequences
  • altered or increased sex drive, and very concerning behavior for you or others, for example, excessive sexual behavior
  • uncontrollable buying or spending
  • binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than necessary to satisfy hunger)
• episodesof hyperactivity, euphoria, or irritability
• afterstopping or reducing treatment with ropinirol: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS)

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Inform your doctor if you experience any of these behaviors; they will indicate ways to manage or reduce symptoms.

If you are takingRopinirol Stadawith L-dopa

People taking ropinirol with L-dopa may develop other side effects:

• a very common side effect are involuntary movements (dyskinesias). If you are taking L-dopa, you may experience some involuntary movements (dyskinesias) when you start taking ropinirol. Tell your doctor if this happens, your doctor may need to adjust the dose of the medications you are taking.
• a common side effect is confusion.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack, in the bottle, and in the case, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

HDPE bottle: The expiration date after the first opening is 60 days.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofRopinirol Stada

• The active ingredient ofRopinirol Stadais ropinirol.

Each prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirol (as hydrochloride).

• Theothercomponents are:

Prolonged-release tablet core:copolymer of amine methacrylate type B, hypromellose (E464), sodium lauryl sulfate, copovidone, and magnesium stearate (E572).

Coating:

• 2 mg: hypromellose (E464), iron oxide red (E172), lactose monohydrate, titanium dioxide (E171), and triacetin.
• 4 mg: macrogol 400, hypromellose (E464), yellow-orange aluminum lake (E110), titanium dioxide (E171), and red iron lake (E132).
• 8 mg: hypromellose (E464), iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172), macrogol 400, and titanium dioxide (E171).

Appearance of the product and contents of the package

Ropinirol Stada 2 mg are prolonged-release tablets of pink color, round, biconvex, 6.8 ± 0.1 mm in diameter, and 5.5 ± 0.2 mm in thickness.

Ropinirol Stada 4 mg are prolonged-release tablets of light brown color, oval, biconvex, 12.6 x 6.6 ± 0.1 mm in diameter, and 5.3 ± 0.2 mm in thickness.

Ropinirol Stada 8 mg are prolonged-release tablets of red color, oval, biconvex, 19.2 x 10.2 ± 0.2 mm in diameter, and 5.2 ± 0.2 mm in thickness.

Ropinirol Stadais presented in white opaque PVC/PCTFE-aluminum blisters and white opaque HDPE bottles, with a white polypropylene cap with three opening points in the safety ring and the desiccant inserted.

Package sizes are:

Blister: 21, 28, 84 prolonged-release tablets

Bottle: 21, 28, 84 prolonged-release tablets

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Pharmathen, S.A.

6, Dervenakion str.,

15351 Pallini, Athens

Greece

or

Pharmathen International S.A.

Sapes Industrial Park, Block 5

(Rodopi) 69300

Greece

or

STADA Arzneimittel AG

Stadastrasse, 2-18

61118 Bad Vilbel

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Ropinirol 2 mg Retardtabletten

Ropinirol 4 mg Retardtabletten

Ropinirol 8 mg Retardtabletten

Spain:Ropinirol Stada 2 mg prolonged-release tablets EFG

Ropinirol Stada 4 mg prolonged-release tablets EFG

Ropinirol Stada 8 mg prolonged-release tablets EFG

France:ROPINIROL EG 2 mg prolonged-release tablet

ROPINIROL EG 4 mg prolonged-release tablet

ROPINIROL EG 8 mg prolonged-release tablet

Italy:Ropinirolo EG STADA 2 mg prolonged-release tablets

Ropinirolo EG STADA 4 mg prolonged-release tablets

Ropinirolo EG STADA 8 mg prolonged-release tablets

Netherlands:Ropinirol retard CF 2 mg tablets with prolonged release

Ropinirol retard CF 4 mg tablets with prolonged release

Ropinirol retard CF 8 mg tablets with prolonged release

Last review date of this leaflet:August 2023.

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/