Prospect: Information for the user

Ropinirol Kern Pharma 4 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 must not give it 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.

1. Contents of the package and additional information

The active ingredient ofRopinirol Kern Pharmais 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 Kern Pharma 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 Kern Pharma

• If you are allergic to ropinirol or any of the other components of Ropinirol Kern Pharma,
• If you have any severe kidney disease,
• If you have any liver disease.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ropinirol Kern Pharma:

• If you are pregnant or think you may be pregnant,
• If you are breastfeeding,
• If you are under 18 years old,
• If you have any severe heart disease,
• If you have any severe mental disorder,
• If you have any impulsive behavior and/or abnormal behavior (such as excessive need to gamble or excessive sexual behavior),
• If you have intolerance to some sugars (e.g. lactose).

Inform your doctor if you think you are in any of these situations. Your doctor will decide if your treatment with Ropinirol Kern Pharma is suitable for you, or if you need any additional monitoring while taking it.

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 SAAD). If the problems persist after a few weeks, your doctor may need to adjust your treatment.

While taking Ropinirol Kern Pharma

Inform your doctor if you or your family/caregiver notice that you are developing impulses or desires to behave in a way that is not usual for you and that you cannot resist the impulse, desire or temptation to carry out certain activities that could harm you or others. These are called impulse control disorders and may include behaviors such as compulsive gambling, excessive eating or spending, abnormally high sexual desire or an increase in sexual thoughts or feelings. Your doctor may need to adjust or discontinue your treatment.

Smoking and Ropinirol Kern Pharma

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

Use of Ropinirol Kern Pharma with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

Some medications may affect the effect of ropinirol, or make it more likely that you will have adverse effects. Ropinirol may also alter the way other medications work.

These medications include:

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

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

Use of Ropinirol Kern Pharma with food, drink and alcohol

You can take Ropinirol Kern Pharma with or without food.

It is not recommended to take alcoholic beverages while taking ropinirol.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Ropinirol is not recommended during pregnancy, unless your doctor tells you that the benefits for you are greater than any possible risk to the fetus. Ropinirol should not be used during breastfeeding, as milk production may be affected.

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

Driving and operating machinery

Ropinirol may cause drowsiness and cause you to have sudden episodes of sleep. If this happens, do not drive vehicles or perform activities in which a lack of attention could pose a risk or put you or others in danger of death or serious harm (e.g. operating machinery), until these episodes and/or drowsiness have disappeared.

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

Ropinirol Kern Pharma contains lactose and hydrogenated ricin oil.

If your doctor has told you that you have 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 forRopinirolprescribed by your doctor. Consult your doctor or pharmacist if you have any doubts.

Use in children

Do not give Ropinirol Kern Pharma to children.Ropinirol is usually not prescribed to minors under 18 years old.

You may have beenprescribedonlyropinirol for 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 taking ropinirol. Consult your doctorif this occurs, as you may need to reduce your L-dopa dose.

What dose of Ropinirol Kern Pharma should you take?

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

Normal initial doseofropinirol prolonged-release tablets is 2mg once a day for the first week. From there, your doctor may increase the dose to 4mg of ropinirol prolonged-release tablets once a day, during the second week of treatment. In older people, the doctor may increase the dose more slowly. Then, your doctor may adjust the dose to reach the most suitable dose for you. Some peoplemay takeup to 24mg of ropinirol prolonged-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 switch to a lower dose of ropinirol film-coated tablets (immediate-release) that you will take three times a day.

Do not take more Ropinirol Kern Pharma tablets than your doctor hasprescribed.

You may need several weeks for ropinirol to take effect.

How to take your Ropinirol Kern Pharma dose

TakeRopinirol Kern Pharmaonce a day, at the same time of day.

Swallow the Ropinirol Kern Pharma 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 receiving an excessive dose, as the medication will be released in your body too quickly.

If you switch from ropinirol film-coated tablets (immediate-release)

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

Take your ropinirol film-coated tablets (immediate-release) as usual the day before the switch. Then, take your ropinirol prolonged-release tablets in the morning, and do not take any more ropinirol film-coated tablets (immediate-release).

If you take more Ropinirol Kern Pharma than you should

If you have taken more ropinirol than you should, consult your doctor or go to the nearest hospital immediately, or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested. If possible, show them the packaging.

Someone who hassuffereda ropinirol overdose may experience some of the following symptoms: nausea,vomiting, dizziness, drowsiness, fatigue (mental or physical exhaustion), feeling of fainting, hallucinations.

If you forget to take Ropinirol Kern Pharma

Do not take a double dose to compensate for the missed doses.

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

If you interrupt the treatment with Ropinirol Kern Pharma

Do not interrupt the treatment withRopinirol Kern Pharmawithout having consulted your doctor first.

TakeRopinirol Kern Pharmafor the time your doctor indicates. Do not suspend the treatment unless your doctor tells you to.

If you suddenly stop takingRopinirol Kern Pharma, your Parkinson's disease symptoms may worsen rapidly.

If you need to stop your ropinirol treatment, your doctor will gradually reduce the dose.

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

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

The side effectsofRopinirol Kern Pharmaare more likely to 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 patients):

• dizziness,
• drowsiness,
• nausea.

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

• hallucinations (seeing things that are not really there),
• vomiting,
• dizziness,
• heartburn,
• stomach pain,
• constipation,
• swelling of the legs, feet, or hands.

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

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

Side effects of unknown frequency:

• after stopping or reducing treatment with Ropinirol Kern Pharma: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or SAAD) may occur,
• spontaneous penile erection.

Some patients may experience the following side effects

• allergic reactions such as redness, skin inflammation with itching (urticaria), swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing, intense itching, or hives,
• changes in liver function, which may be detected by blood tests.
• 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 impulse to gamble excessively despite severe personal or family consequences.
  • altered or increased sexual interest and significant concern behavior towards yourself or others, for example, an increase in sexual desire.
  • uncontrollable excessive spending.
  • eating disorders (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).

Inform your doctor if you have experienced any of these behaviors; they will discuss how to manage or reduce the symptoms

If you are takingropinirolwith L-dopa

People takingropinirolwith L-dopa may develop other side effects over time:

• very common side effects are involuntary movements,
• a common side effect is confusion.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a 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, website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep 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 after CAD. The expiration date is the last day of the month indicated.

Do not storeat a temperature above30 °C.

Store in the original packaging to protect it from moisture.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGREpoint of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Composition of Ropinirol Kern Pharma 4 mg prolonged-release tablets

• The active ingredient isRopinirol.Each prolonged-release tablet contains 4 mg of Ropinirol (as hydrochloride).
• The other components are:

Tablet core: hypromellose 2208, lactose monohydrate, anhydrous colloidal silica, carbomer 4.000-11.000 mPa.s, hydrogenated ricin oil, magnesium stearate.

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

Appearance of the product and contents of the packaging

Ropinirol Kern Pharma 4 mgare prolonged-release tablets of light brown color, biconvex and oval.

The tablets are available in packaging of21, 28, 42 and 84prolonged-release tablets in blister (OPA/Al/PVC//Al).

Only some packaging sizes may be commercially marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

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

Last review date of this leaflet: May 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/