Prospect: 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 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 should not be given to others, 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

The active ingredient of Ropinirol Prolib Sandoz is ropinirol, which belongs to a group of medicines called dopamine agonists. Dopamine agonists act 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. Ropinirol has a similar effect to natural dopamine and, in this way, reduces the symptoms of Parkinson's disease.

Do not take Ropinirol Prolib Sandoz if:

• You are allergic to ropinirol or any of the other components of this medication (listed in section 6),
• You have anyserious kidney disease,
• 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 takeRopinirol Prolib Sandoz:

• If you arepregnantor think you may be,
• If you are in abreastfeedingperiod,
• 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 unusual behavior(such as an excessive need to gamble or excessive sexual behavior),
• If you have anyintolerance to some sugars(e.g., lactose).

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

Your doctor may need to adjust your dose according to your clinical response.

While taking Ropinirol Prolib Sandoz

Inform your doctor if you or your family members/caregivers notice that you are developing any unusual behavioror cannot resist the urge, behavior, or temptation to do certain activities that may harm you or others. This is calledimpulse control disordersand may include behaviors such as anirrational need to gamble, eat, or spend compulsively or an increase in sexual desires and/or behaviors.Your doctor may need to adjust or stop your treatment.

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

Smoking and Ropinirol Prolib Sandoz

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

Taking Ropinirol Prolib Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Some medications may affect the effect of ropinirol, or make it more likely to have side effects. Ropinirol may also alter the way other medications work.

These medications include:

• The antidepressantfluvoxamine,
• Medications formental disorders, such as sulpiride,
• Hormone replacement therapy(also known as HRT),
• Metoclopramide, which is used to treatnauseaandheartburn,
• The antibioticsciprofloxacinorenoxacin,
• Anyother medication for Parkinson's disease.

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

You will need to have additional blood tests if you are taking these medications with ropinirol:

• Anticoagulants (used to reduce blood clotting) such as warfarin (Coumadin).

Taking Ropinirol Prolib Sandoz with food, drinks, and alcohol

You can 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 medication.

Ropinirol is not recommended during pregnancy, unless your doctor tells you that the benefits for you outweigh any possible risks to the fetus.Ropinirol should not be taken during breastfeeding, as milk production may be affected.

Inform your doctorimmediately if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will recommend what you should do if you are breastfeeding or plan to start. Your doctor may recommend that you stop treatment with ropinirol.

Driving and operating machinery

Ropinirol may make you feel drowsy.You may feel extremely drowsyand experience sudden episodes of sleep.

Ifyou are affected,do not drive vehicles, operate machines, or perform activitieswhere a lack of attention may pose a risk or put you (or others) in danger of death or serious harm, until these episodes and/or drowsiness have disappeared.

Consult your doctorif this causes you any problems.

Ropinirol may cause hallucinations (seeing, hearing, or feeling things that are not there). If you are affected, do not drive or operate machines.

Ropinirol Prolib Sandoz contains lactose and ricin oil

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

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

Do not give this medication to children.Ropinirolis normally not prescribed to minors under 18 years old.

You may have been prescribed onlyropinirolfor the treatment of your Parkinson's disease symptoms, or you may also have been prescribed another medication called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience some uncontrolled sudden movements when you start takingropinirol. Consult your doctor if this occurs, as you may need to reduce the dose of the medications you are taking.

Ropinirol Prolib Sandoz is designed to release the medication over a period of 24 hours. If you have a condition in which your medication passes through your body too quickly, for example, diarrhea, the tablet may not dissolve completely and may not work properly. You may see tablets in your stool. If this occurs, inform your doctor as soon as possible.

What dose of Ropinirol Prolib Sandoz should you take?

You may need some time to determine what dose ofropinirolis best for you.

The recommended initial doseofropinirolextended-release tablets is 2 mg once a day for the first week. From there, your doctor may increase the dose to 4 mg ofropinirolextended-release tablets once a day, during the second week of treatment. In elderly people, your doctor may increase the dose more slowly. Then, your doctor may adjust the dose to reach the most suitable dose for you. Some people may take up to 24 mg ofropinirolextended-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 ofropinirolcapsules coated with film (immediate-release) that you will take three times a day.

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

You may need several weeks forropinirolto take effect.

Take Ropinirol Prolib Sandoz once a day, at the same time of day.

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

DO NOT break, chew, or crush the extended-release tablets. If you do, there may be a risk of receiving an excessive dose, as the medication will be released into your body too quickly.

If you change from ropinirol immediate-release tablets

Your doctor will adjust your dose ofropinirolextended-release tablets based on thedose of ropinirol immediate-release tablets you were taking.

Take your ropinirol immediate-release tablets as usual the day before the change. Then, take your ropinirol extended-release tablets in the morning, and do not take any more ropinirol immediate-release tablets.

If you take more Ropinirol Prolib Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

Someone who has suffered an overdose ofropinirolmay experience some of the following symptoms: nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical exhaustion), feeling of fainting, hallucinations.

If you forgot to take Ropinirol Prolib Sandoz

Do not takemore tablets ora double dose to compensate for the missed doses.

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

If you interrupt treatment with Ropinirol Prolib Sandoz

Do not interrupt treatment withRopinirol Prolib Sandozwithout having consulted your doctor first.

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

If you suddenly stop treatment withRopinirol Prolib Sandoz, your Parkinson's disease symptoms may worsen rapidly.

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

If you have Parkinson's disease, do not suddenly stop treatment with Ropinirol Prolib Sandoz. Sudden interruption may cause the appearance of a condition called Malignant Neuroleptic Syndrome (MNS) that may pose a risk to your health. 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 other doubts about the use of this medication, ask your doctor or pharmacist.

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

The side effects of Ropinirol Prolib Sandoz usually occur at the beginning of treatment, or when the dose is increased. These 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 affect more than 1 in 10 people)

• dizziness,
• feeling sleepy (somnolence),
• feeling sick (nausea).

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

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

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

• feeling dizzy or dizziness, especially when standing up suddenly, this is due to a drop in blood pressure (hypotension),
• drop in blood pressure when changing position (postural hypotension),
• feeling extremely sleepy during the day (extreme somnolence),
• mental problems such as severe confusion (delirium), irrational ideas (delusional ideas) or irrational suspicions (paranoia),
• hypotension.

Side effects of unknown frequency (frequency cannot be estimated from available data)

• changes in liver function, detected in blood tests (increase in liver enzymes),
• allergic reactions such as swelling, hives on the skin (urticaria), swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema), skin rash or intense itching,
• taking excessive amounts of medication above those recommended by your doctor and above the required doses for motor disabilities treatment,(dopamine dysregulation syndrome (DDS)),
• inability to resist the impulse, desire, or temptation to perform an action that could be harmful to you or others, which may include:

-strong impulse to gamble excessively despite severe personal or family consequences,

-alteration or increase in sexual interest and obsessive behavior towards yourself or others, for example, an increase in sexual desire,

-uncontrolled excessive 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 (associated with psychotic reactions, as well as compulsive symptoms),
• depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS) after interrupting or reducing ropinirol treatment,
• spontaneous penile erection.

Inform your doctor if you experience any of the above behaviors; he will find a way to manage or reduce these symptoms.

When taking ropinirol with L-dopa

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish 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 packaging and in the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

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

Composition of Ropinirol Prolib Sandoz

The active ingredient is ropinirol.

Ropinirol Prolib Sandoz 2 mg prolonged-release tablets:

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

Ropinirol Prolib Sandoz 4 mg prolonged-release tablets:

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

Ropinirol Prolib Sandoz 8 mg prolonged-release tablets:

Each prolonged-release tablet contains 8 mg of ropinirol (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 ricin oil, and magnesium stearate.

Capsule coating:hypromellose 2910, titanium dioxide (E171), macrogol 400, red iron oxide (E172), and yellow iron oxide (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 ricin oil, and magnesium stearate.

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

Appearance of the product and contents of the package

Ropinirol Prolib Sandoz 2 mg are prolonged-release tablets of pink color, biconvex, and oval shape.

Ropinirol Prolib Sandoz 4 mg are prolonged-release tablets of light brown color, biconvex, and oval shape.

Ropinirol Prolib Sandoz 8 mg are prolonged-release tablets of reddish-brown color, biconvex, and oval shape.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

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 medicine is authorized in the member states of the European Economic Area with the following names:

Date of the last review of thisleaflet:July 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/