Leaflet: Information for the user

Ropinirol Teva 8 mg prolonged-release tablets EFG

Ropinirol hydrochloride

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist. This includes any side effect not listed in this leaflet. See section 4

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

2. What you need to know before taking Ropinirol Teva

3. How to take Ropinirol Teva

4. Possible side effects

5. Storage of Ropinirol Teva

6. Contents of the pack and additional information

The active ingredient of Ropinirol Teva prolonged-release tablets 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 Teva 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 Teva:

- if you areallergic(hypersensitive) to ropinirol or to any of the other components of this

medication (listed in 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 Teva:

• if you arepregnantor think you may be pregnant.
• if you are inbreastfeeding.
• if you areunder 18 years.

- if you have anyserious heart disease.

- if you have anyserious mental disorder.

• if you exhibit anyimpulsive behavior and/or abnormal behavior(see section 4).
• if you have intolerance to some 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 the symptoms persist after a few weeks, your doctor may need to adjust your treatment

Inform your doctor if you or your family/caregiver notice that you are developing impulses or urges to behave in ways that are unusual for you and you cannot resist the impulse, instinct or temptation to carry out certain activities that may be harmful to you or others. These are called impulse control disorders and may include behaviors such as compulsive gambling, excessive eating or spending, an abnormally elevated sex drive or an increase in sexual thoughts or feelings.Your doctor may need to adjust or stop your dose.

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

While taking Ropinirol Teva

Inform your doctor if you or your family members notice that you are developing abnormal behaviors (such as an abnormal need to gamble or an increase in desires and/or sexual behaviors) while taking Ropinirol Teva.

Your doctor may need to adjust or stop your treatment.

Inform your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating or pain when stopping or reducing treatment with Ropinirol. If the problems persist after a few weeks, your doctor may need to adjust your treatment.

Smoking and Ropinirol Teva

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

Other medicines and Ropinirol Teva

Inform your doctor or pharmacist if you are taking, have taken recently or may need to use any other medicine,including herbal remedies or over-the-counter medicines.

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

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

These medicines include:

- the antidepressant fluvoxamine.

- medication 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 medicine for Parkinson's disease.

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

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

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

Ropinirol Teva with food and drink

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

Pregnancy and breastfeeding

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

If you are pregnant, or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor may recommend that you stop taking Ropinirol Teva.

Driving and operating machinery

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

If you experience this:do not drive, do not operate 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 doctor if this may affect you.

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

Ropinirol Teva contains lactose.

Ropinirol Tevaprolonged-release tablets contain a sugar called lactose.If your doctor has told you that you haveintolerance to some sugars, contact him before taking this medicine.

Follow the exact administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Do not give Ropinirol Teva to children. Ropinirol Teva is not usually prescribed for individuals under 18 years old.

You may have been prescribed Ropinirol Teva alone 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 involuntary movements (dyskinesia) when you start taking Ropinirol Teva. Inform your doctor if this occurs, as you may need to adjust the doses of the medications you are taking.

Ropinirol Teva tablets are designed to release the medication over a period of around 24 hours. If you have any condition where your medications pass through your body too quickly, for example diarrhea, the tablets may not dissolve completely and may not work properly. You may see the tablets in your stool. If this occurs, inform your doctor as soon as possible.

What dose of Ropinirol Teva should you take?

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

The recommended initial dose of Ropinirol Teva is 2 mg once a day for the first week. From there, your doctor may increase the dose to 4 mg of Ropinirol Teva prolonged-release tablets once a day, during the second week of treatment. In very elderly individuals, your doctor may increase the dose more slowly. After that, your doctor may adjust the dose to reach the most suitable dose for you. Some people take up to 24 mg of Ropinirol Teva 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 Teva tablets than your doctor has recommended.

You may need several weeks for Ropinirol Teva to take effect.

How to take your Ropinirol Teva dose

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

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

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

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

If you take more Ropinirol Teva than you should

Contact your doctor or pharmacist immediately.If possible, show them the Ropinirol Teva packaging.

Someone who has experienced an overdose of Ropinirol Teva may have some of the following symptoms: nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical exhaustion), feeling of fainting, hallucinations.

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 ingested.

If you forget to take Ropinirol Teva

Do not take extra prolonged-release tablets or a double dose to compensate for the missed doses.

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

If you interrupt treatment with Ropinirol Teva

Do not interrupt treatment with Ropinirol Teva without having consulted your doctor first.

Take Ropinirol Teva for the time your doctor indicates. Do not suspend treatment unless your doctor tells you to.

If you suddenly stop taking Ropinirol Teva, your Parkinson's disease symptoms may worsen rapidly.

If you need to stop taking Ropinirol Teva, your doctor will gradually reduce the dose.

Do not stop using Ropinirol Teva suddenly without talking to your doctor. A sudden interruption could cause you to develop a serious medical condition called neuroleptic malignant syndrome, which can pose a significant risk to your health. Symptoms include: akinesia (loss of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, depression of consciousness (e.g., coma).

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

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

Ropinirol Teva side effects are 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 people

• dizziness

- feeling of fainting

- drowsiness

- nausea

• uncontrolled movements (dyskinesia)

Common side effects: may affect up to 1 in 10 people

- hallucinations (seeing things that are not really there)

- vomiting

- dizziness

- heartburn

• low blood pressure (hypotension)
• dizziness or fainting, especially when standing up suddenly (this is due to a drop in blood pressure).

- stomach pain

• confusion

- constipation

- swelling of the legs, feet, or hands

Uncommon side effects: may affect up to 1 in 100 people

- feeling extremely drowsy during the day (excessive somnolence).

- falling asleep suddenly without feeling tiredinitially(episodes of sudden sleep).

- mental problems such as delirium (severe confusion), delusional ideas (irrational ideas) or paranoia (irrational suspicions).

• hypophagia

Not known: the frequency cannot be estimated from available data

• allergic reactions such as redness,inflammationof the skin with itching (urticaria), swelling of theface, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing,hivesorintense itching (see section 2).
• changes in liver function, which can be detected by blood tests.
• spontaneous erections of the penis
• acting aggressively
• inability to resist that impulse, instinct, or temptation to perform an action that could harm you or others, which may include:

orStrong impulse to gamble excessively despite severe personal or family consequences.

orAlteration or increase in sexual interest and behavior affecting you or others, for example, increased sexual desire.

orExcessive or uncontrolled spending

orBinge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than needed to satisfy hunger)

• excessive use of Ropinirol Teva (excessive desire for large doses of dopaminergic medications that require control of motor symptoms, known as dopamine dysregulation syndrome).
• After stopping or reducing treatment with ropinirol: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviors, they will discuss ways to control or reduce symptoms.

If you are taking Ropinirol Teva with L-dopa

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

• uncontrolled movements are a very common side effect. If you are taking L-dopa, you mayexperience uncontrolled movements (dyskinesias) the first time you take Ropinirol Teva.

Inform your doctor if this occurs, they may need to adjust the dose of the medications you are taking.

• 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 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 on 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.

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.

Do not dispose of the medication through the drains or trash. Ask your pharmacist how to dispose of the medication that you do not need. This will help protect the environment.

Ropinirol Teva Composition

• The active ingredient is ropinirol. Each prolonged-release tablet contains 8 mg of ropinirol (as hydrochloride).
• The other components are:

Prolonged-release tablet core: hypromellose, lactose monohydrate, anhydrous colloidal silica, carbomer 4,000-11,000 mPa.s, hydrogenated ricin oil, magnesium stearate.

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

Product appearance and packaging contents

Ropinirol Teva 8 mg prolonged-release tablets EFG:

The tablets are reddish-brown, biconvex, and oval-shaped.

The tablets are available in blister packs (OPA/Al/PVC/Al) of 21, 28, 42, and 84 prolonged-release tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder

Teva Pharma, S.L.U

C/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas. Madrid (Spain)

Responsible manufacturer

KRKA, d.d.,

Novo mesto, Šmarješka cesta 6,

Novo mesto,

Slovenia

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

This leaflet was revised in May 2023

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/

You can access detailed and updated information on this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/74668/P_74668.html

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