Ropinirole Teva 8 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ropinirol Teva 8 mg prolonged-release tablets EFG

Ropinirol hydrochloride

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

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

Contents of the leaflet

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. How to store Ropinirol Teva
6. Contents of the pack and other information

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

The active substance in Ropinirol Teva prolonged-release tablets 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 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. Ropinirole has an effect similar to natural dopamine and thus reduces the symptoms of Parkinson's disease.

2. What you need to know before taking Ropinirol Teva

Do not take Ropinirol Teva:

• if you are allergic (hypersensitive) to ropinirol or to any of the other components of this
  medicine (listed in section 6).
• if you have severe kidney disease.
• if 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 Ropinirol Teva:

• if you are pregnant or think you may 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 severe mental disorder.

  • if you experience impulsive behaviour and/or abnormal behaviour (see section 4).
  • if you have an intolerance to certain sugars (e.g.: lactose).

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

Tell your doctor if you or your family/carer notice that you are developing impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could be harmful to you or others. These are known as impulse control disorders and may include behaviours such as pathological gambling, binge eating, compulsive spending, abnormally increased libido, or increased sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

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

While taking Ropinirol Teva

Tell your doctor if you or your family notice that you are developing abnormal behaviours (such as an uncontrollable need to gamble or increased sexual desires and/or behaviours) while taking Ropinirol Teva.

Your doctor may need to adjust or stop your dosage.

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

Smoking and Ropinirol Teva

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

Other medicines and Ropinirol Teva

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

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

Some medicines may affect the action of Ropinirol Teva, or make it more likely that you experience side effects. Ropinirol Teva 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 known as HRT).
• metoclopramide, used to treat nausea and stomach acid.
• the antibiotics ciprofloxacin or enoxacin.
• any other medicine for Parkinson’s disease.

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

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

• Vitamin K antagonists (used to reduce blood clotting), such as warfarin.

Ropinirol Teva with food and drink

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

Pregnancy and breastfeeding

Use of Ropinirol Teva is not recommended during pregnancy unless your doctor considers that the benefit to you outweighs any possible risk to your baby. Ropinirol Teva should not be used during breastfeeding, as milk production may be affected.

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

Driving and using machines

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

If this happens: do not drive, do not use machines, and avoid situations where feeling sleepy or falling asleep could put you or others at serious risk of injury or death. Do not engage in these activities until you are no longer affected.

Consult your doctor if this affects you.

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

Ropinirol Teva contains lactose.

Ropinirol Teva prolonged-release tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Ropinirol Teva

Follow exactly the instructions for taking this medicine as given 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 normally not prescribed for individuals under 18 years of age.

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 medicine called L-dopa (also known as levodopa). If you are taking L-dopa, you might experience some uncontrolled movements (dyskinesia) when you start taking Ropinirol Teva. Inform your doctor if this occurs, as you may need adjustments in the doses of your medicines.

Ropinirol Teva tablets are designed to release the medicine over a period of approximately 24 hours. If you have a condition causing medicines to 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 stools. If this happens, inform your doctor as soon as possible.

What dose of Ropinirol Teva should you take?

It may take some time to determine which dose of Ropinirol Teva is best for you.

The recommended starting dose of Ropinirol Teva is 2 mg once daily during the first week. From there, your doctor may increase the dose to 4 mg of Ropinirol Teva prolonged-release tablets once daily during the second week of treatment. In very elderly patients, the doctor may increase the dose more slowly. Afterwards, your doctor may adjust the dose until reaching the most appropriate dose for you. Some people take up to 24 mg of Ropinirol Teva 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 ropinirol film-coated tablets (immediate-release) which you would take three times daily.

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

It may take several weeks for Ropinirol Teva to take effect.

How to take your dose of Ropinirol Teva

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

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

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

Take your usual dose of ropinirole film-coated tablets (immediate-release) the day before the switch. Then, take your first dose of Ropinirol Teva prolonged-release tablets the following morning, and do not take any further doses of ropinirole 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 overdosed on Ropinirol Teva may experience symptoms such as nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical tiredness), feeling faint, hallucinations.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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 double the dose to make up for missed doses.

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

If you stop taking Ropinirol Teva

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

Take Ropinirol Teva for as long as your doctor has prescribed. Do not discontinue treatment unless instructed by your doctor.

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

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

Do not stop using Ropinirol Teva suddenly without speaking to your doctor. Abrupt discontinuation could cause you to develop a serious medical condition called neuroleptic malignant syndrome, which may be life-threatening. Symptoms include: akinesia (loss of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, and 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 experiences them.

Adverse reactions with Ropinirol Teva are most likely to 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 adverse effects: may affect more than 1 in 10 people

• dizziness
• feeling faint
• somnolence
• nausea
  • uncontrolled movements (dyskinesia)

Common adverse 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 adverse effects: may affect up to 1 in 100 people

• feeling very sleepy during the day (excessive somnolence)
• falling asleep suddenly without initially feeling sleepy (sudden sleep episodes)
• mental problems such as delirium (severe confusion), delusional thoughts (irrational ideas), or paranoia (irrational suspicions)
• hiccups

Not known: frequency cannot be estimated from available data

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

• changes in liver function, which may be detected by blood tests.

• spontaneous penile erection

• acting in an aggressive manner

• inability to resist the impulse, instinct, or temptation to perform an action that could harm you or others, which may include:

  o Strong urge to gamble excessively despite serious personal or family consequences.
  o Disturbance or increase in sexual interest and behavior causing significant impact to you or others, for example, increased sexual drive.
  o Uncontrolled excessive spending or shopping
  o Binge eating (consuming 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 high doses of dopaminergic medications required to control motor symptoms, known as dopamine agonist withdrawal syndrome).

• After stopping or reducing ropinirol treatment: depression, apathy, anxiety, fatigue, sweating, or pain may occur (this is known as dopamine agonist withdrawal syndrome or DAWDS).

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

If you are taking Ropinirol Teva with L-dopa

People who take Ropinirol Teva with L-dopa may develop other adverse effects after some time:

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

Tell your doctor if this occurs, as they may need to adjust the dose of the medicines you are taking.

• a common adverse effect is confusion.

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through 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 Teva

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after 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.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ropinirol Teva

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

Core of the prolonged-release tablet: hypromellose, monohydrate lactose, anhydrous colloidal silica, carbomer 4,000-11,000 mPa.s, hydrogenated castor oil, magnesium stearate.

Coating film: hypromellose, 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 container

Ropinirol Teva 8 mg prolonged-release tablets EFG:

The tablets are brownish-red, biconvex and oval-shaped.

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

Only certain pack 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)

Manufacturer

KRKA, d.d.,

Novo mesto, Šmarješka cesta 6,

Novo mesto,

Slovenia

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

This patient information leaflet was last reviewed in May 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. 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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