Ropinirole ProLib Sandoz 4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Ropinirol Prolib Sandoz 2 mg prolonged-release tablets EFG

Ropinirol Prolib Sandoz 4 mg prolonged-release tablets EFG

Ropinirol Prolib Sandoz 8 mg prolonged-release tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ropinirol Prolib Sandoz is and what it is used for

The active substance in Ropinirol Prolib Sandoz is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists work in the same way as a natural substance found in the brain, called dopamine.

Ropinirol Prolib Sandoz 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. Ropinirole has an effect similar to natural dopamine and thus reduces the symptoms of Parkinson's disease.

2. What you need to know before you start taking Ropinirol Prolib Sandoz

Do not take Ropinirol Prolib Sandoz if:

• you are allergic to ropinirol or to any of the other ingredients of this medicine (listed in section 6),
• you have severe kidney disease,
• you have liver disease.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ropinirol Prolib Sandoz:

• if you are pregnant or think you might be pregnant,
• if you are breastfeeding,
• if you are under 18 years of age,
• if you have a serious heart condition,
• if you have a serious mental disorder,
• if you experience impulsive behaviors and/or unusual behavior (such as an overwhelming urge to gamble or excessive sexual behavior),
• if you have an intolerance to certain sugars (e.g., lactose).

Inform your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with ropinirol (called dopamine agonist withdrawal syndrome or DAWS). If problems persist after a few weeks, your doctor may need to adjust your treatment.

While taking Ropinirol Prolib Sandoz

Inform your doctor if you or your family members/caregivers notice that you are developing any unusual behavior or are unable to resist the impulse, behavior, or temptation to carry out certain activities that could harm you or others. This is called impulse control disorders and may include behaviors such as an uncontrollable urge to gamble, eat, or spend money compulsively, or an increase in sexual urges and/or behaviors. Your doctor may need to adjust or stop your treatment.

Inform your doctor if you or your family/caregiver notice 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 doctor if you think you are in any of these situations. Your doctor will decide whether ropinirol treatment is suitable for you or whether you need additional monitoring while taking it. Depending on the individual case, dose adjustment may be necessary according to clinical response.

Smoking and Ropinirol Prolib Sandoz

Inform your doctor if you have started or stopped smoking while taking Ropinirol Prolib Sandoz. Your doctor may need to adjust your dose.

Other medicines and Ropinirol Prolib Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines or those obtained without a prescription.

Remember to inform your doctor or pharmacist if you start taking a new medicine while on Ropinirol Prolib Sandoz.

Some medicines may affect the action of ropinirol or make adverse effects more likely. Ropinirol may also alter the way other medicines work.

These medicines include:

• the antidepressant fluvoxamine,
• medicines for mental disorders, such as sulpiride,
• hormone replacement therapy (also called HRT),
• metoclopramide, used to treat nausea and stomach acid,
• the antibiotics ciprofloxacin or enoxacin,
• any other medicine for Parkinson's disease.

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

You will need additional blood tests if you are taking these medicines with ropinirol:

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

Taking Ropinirol Prolib Sandoz with food and drinks

You may take Ropinirol Prolib Sandoz with or without food.

Pregnancy, breastfeeding, and fertility

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.

Ropinirol is not recommended during pregnancy, unless your doctor determines that the benefit to you outweighs any possible risk to the fetus. Ropinirol should not be taken during breastfeeding, as milk production may be affected.

Inform your doctor immediately if you are pregnant, think you are pregnant, or plan to become pregnant. Your doctor will advise you on what to do if you are breastfeeding or plan to start. Your doctor may recommend that you discontinue ropinirol treatment.

Driving and using machines

Ropinirol may make you feel drowsy. It may cause extreme drowsiness and sudden episodes of falling asleep.

If you are affected, you must not drive, operate machinery, or perform activities where lapses in attention could pose a risk or place you (or others) in danger of death or serious injury, until these episodes and/or drowsiness have resolved.

Consult your doctor if this causes you any problems.

Ropinirol may cause hallucinations (seeing, hearing, or feeling things that are not present). If affected, do not drive or use machinery.

Ropinirol Prolib Sandoz contains lactose and castor oil

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine. This medicine may cause stomach discomfort and diarrhea because it contains hydrogenated castor oil.

3. How to take Ropinirol Prolib Sandoz

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not give this medicine to children. Ropinirole is not normally prescribed for patients under 18 years of age.

You may have been prescribed ropinirole alone for the treatment of your Parkinson's disease symptoms, or you may also have been prescribed another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience some involuntary movements (dyskinesias) when you start taking ropinirole. Consult your doctor if this occurs, as you may need an adjustment in the dose of your medicines.

Ropinirol Prolib Sandoz is designed to release the medicine over a 24-hour period. If you have a condition causing your medicine to pass through your body too quickly, for example, diarrhoea, the tablet may not dissolve completely and may not work properly. You may see tablets in your stools. If this happens, inform your doctor as soon as possible.

What dose of Ropinirol Prolib Sandoz should you take?

It may take some time to determine the best ropinirole dose for you.

The recommended starting dose of ropinirole prolonged-release tablets is 2 mg once daily during the first week. From here, your doctor may increase the dose to 4 mg of ropinirole prolonged-release tablets once daily during the second week of treatment. In elderly patients, your doctor may increase the dose more slowly. Afterwards, your doctor may adjust the dose until reaching the most appropriate dose for you. Some patients may take up to 24 mg of ropinirole prolonged-release tablets daily.

If you experience adverse effects at the beginning of your treatment that you cannot tolerate, consult your doctor. Your doctor may advise you to switch to a lower dose of ropinirole film-coated tablets (immediate-release) taken three times daily.

Do not take more Ropinirol Prolib Sandoz tablets than your doctor has prescribed.

Several weeks may be needed before ropinirole starts to take effect.

Take Ropinirol Prolib Sandoz once daily, at the same time each day.

Swallow the Ropinirol Prolib Sandoz tablets whole, with a glass of water.

DO NOT break, chew or crush the prolonged-release tablets. Doing so may result in the risk of receiving too high a dose, as the medicine would be released into your body too quickly.

If switching from ropinirole film-coated tablets (immediate-release)

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

Take your usual dose of ropinirole film-coated tablets (immediate-release) the day before the switch. Then, take your first dose of ropinirole prolonged-release tablets the following morning, and do not take any further ropinirole film-coated tablets (immediate-release).

If you take more Ropinirol Prolib Sandoz than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

Someone who has taken an overdose of ropinirole may experience symptoms such as nausea, vomiting, dizziness, somnolence, fatigue (mental or physical tiredness), feeling faint, hallucinations.

If you forget to take Ropinirol Prolib Sandoz

Do not take extra tablets or a double dose to make up for missed doses.

If you have forgotten to take Ropinirol Prolib Sandoz for one or more days, consult your doctor for advice on how to restart treatment.

If you stop taking Ropinirol Prolib Sandoz

Do not stop treatment with Ropinirol Prolib Sandoz without first consulting your doctor.

Take Ropinirol Prolib Sandoz for as long as your doctor tells you to. Do not stop taking Ropinirol Prolib Sandoz unless your doctor tells you to.

If you stop treatment with Ropinirol Prolib Sandoz abruptly, your Parkinson's disease symptoms may worsen rapidly.

If you need to discontinue treatment with Ropinirol Prolib Sandoz, your doctor will gradually reduce the dose.

If you have Parkinson's disease, you should not stop treatment with Ropinirol Prolib Sandoz suddenly. An abrupt discontinuation may lead to a condition called Neuroleptic Malignant Syndrome (NMS), which may be life-threatening. Symptoms include:

• akinesia (loss of muscular movement),
• muscle rigidity,
• fever,
• unstable blood pressure,
• tachycardia (increased heart rate),
• confusion,
• decreased level of consciousness (e.g., coma).

If you have any further questions about the use of this medicine, ask 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 Ropinirol Prolib Sandoz usually occur at the beginning of treatment or when the dose is increased. These are generally mild and may become less bothersome over time. Inform your doctor if you are concerned about any adverse effects.

Very common (may affect more than 1 in 10 people)

• fainting,
• drowsiness,
• feeling sick (nausea).

Common (may affect up to 1 in 10 people)

• hallucinations (seeing, hearing, or feeling things that are not really there),
• dizziness (spinning sensation),
• sudden sleep without warning (sudden onset of sleep),
• being sick (vomiting),
• abdominal pain,
• heartburn,
• stomach pain,
• constipation,
• swelling of the legs, feet, or hands.

Uncommon (may affect up to 1 in 100 people)

• feeling dizzy or fainting, especially when standing up suddenly, due to a drop in blood pressure (hypotension),
• low blood pressure (hypotension),
• feeling very sleepy during the day (excessive somnolence),
• mental problems such as severe confusion (delirium), irrational thoughts (delusions), or irrational suspicions (paranoia),
• hiccups.

Not known (frequency cannot be estimated from available data)

• changes in liver function, detected in blood tests (increased liver enzymes),

• allergic reactions such as swelling, skin hives (urticaria), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema), rash or intense itching (see section 2),

• taking higher doses of medication than recommended by your doctor and exceeding the doses required for the treatment of motor disabilities (dopamine dysregulation syndrome, DDS),

• inability to resist the impulse, desire, or temptation to carry out an action that could be harmful to you or others, which may include:

• strong urge to gamble excessively despite serious personal or family consequences,

• altered or increased interest in sexual activity and obsessive behavior towards yourself or others, for example, increased libido,

• excessive or uncontrolled shopping or spending,

• binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more than normal and more than needed to satisfy hunger),

  • aggression (has been associated with psychotic reactions as well as compulsive symptoms),
  • after stopping or reducing ropinirol treatment: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome, DAWS),
  • spontaneous penile erection,
  • episodes of overactivity, euphoria, or irritability.

If you experience any of the above behaviors, inform your doctor; he or she will determine how to manage or reduce these symptoms.

If you are taking ropinirol with L-dopa

People who take ropinirol with L-dopa may develop additional adverse effects after some time:

• uncontrolled movements (dyskinesia), which are a common adverse effect. If you are taking L-dopa, you may experience uncontrolled movements (dyskinesias) when first starting ropinirol. Inform your doctor if this occurs, as your doctor may adjust the dose of your medications,
• feeling confused is a common adverse effect,
• nausea and drowsiness have been frequently reported in clinical trials of extended-release combination therapy.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ropinirole Prolib Sandoz

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

Do not use this medicine after the expiry date which is stated on the outer packaging and on the blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ropinirol Prolib Sandoz

The active substance is ropinirole.

Ropinirol Prolib Sandoz 2 mg prolonged-release tablets:

Each prolonged-release tablet contains 2 mg of ropinirole (as hydrochloride).

Ropinirol Prolib Sandoz 4 mg prolonged-release tablets:

Each prolonged-release tablet contains 4 mg of ropinirole (as hydrochloride).

Ropinirol Prolib Sandoz 8 mg prolonged-release tablets:

Each prolonged-release tablet contains 8 mg of ropinirole (as hydrochloride).

The other components are:

Ropinirol Prolib Sandoz 2 mg prolonged-release tablets:

Tablet core: hypromellose 2208, lactose monohydrate, colloidal anhydrous silica, carbomer 4,000–11,000 cP, hydrogenated castor oil and magnesium stearate.

Coating: hypromellose 2910, titanium dioxide (E171), macrogol 400, iron oxide red (E172) and iron oxide yellow (E172).

Ropinirol Prolib Sandoz 4 mg and 8 mg prolonged-release tablets:

Tablet core: hypromellose 2208, lactose monohydrate, colloidal anhydrous silica, carbomer 4,000–11,000 cP, hydrogenated castor oil and magnesium stearate.

Coating: hypromellose 2910, titanium dioxide (E171), macrogol 400, iron oxide red (E172), iron oxide yellow (E172) and iron oxide black (E172).

Appearance of the product and contents of the pack

Ropinirol Prolib Sandoz 2 mg are pink, biconvex, oval-shaped prolonged-release tablets.

Ropinirol Prolib Sandoz 4 mg are light brown, biconvex, oval-shaped prolonged-release tablets.

Ropinirol Prolib Sandoz 8 mg are reddish-brown, biconvex, oval-shaped prolonged-release tablets.

The tablets are available in packs of 7, 10, 14, 21, 28, 30, 42, 60, 84 and 90 prolonged-release tablets in blisters (OPA/Al/PVC//Al).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturing Responsible Party:

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

Novo mesto,

Slovenia

or

TAD Pharma GmbH,

Heinz-Lohmann-Str. 5,

27472 Cuxhaven,

Germany

or

Salutas Pharma GmbH,

Otto-von-Guericke Allee 1,

39179 Barleben,

Germany

or

Lek, d.d.,

Verovškova 57,

1526 Ljubljana, Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria	Ropinirol Sandoz 2 mg – Extended release tablets Ropinirol Sandoz 4 mg – Extended release tablets Ropinirol Sandoz 8 mg - Extended release tablets
Belgium	Ropinirol Sandoz 2 mg tablets with prolonged release Ropinirol Sandoz 4 mg tablets with prolonged release Ropinirol Sandoz 8 mg tablets with prolonged release
Germany	Ropinirol HEXAL 2 mg Extended release tablets Ropinirol HEXAL 4 mg Extended release tablets Ropinirol HEXAL 8 mg Extended release tablets
Italy	ROPINIROLO SANDOZ 2 mg prolonged release tablets ROPINIROLO SANDOZ 4 mg prolonged release tablets ROPINIROLO SANDOZ 8 mg prolonged release tablets
Luxembourg	Ropinirol Sandoz 2 mg prolonged release tablets Ropinirol Sandoz 4 mg prolonged release tablets Ropinirol Sandoz 8 mg prolonged release tablets
Netherlands	Ropinirol Sandoz retard 2 mg, tablets with prolonged release Ropinirol Sandoz retard 4 mg, tablets with prolonged release Ropinirol Sandoz retard 8 mg, tablets with prolonged release
Sweden	Ropinirol Sandoz 2 mg prolonged release tablets Ropinirol Sandoz 4 mg prolonged release tablets Ropinirol Sandoz 4 mg prolonged release tablets

Date of the last revision of this leaflet: November 2025

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