ROPINIROLE TEVA 4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Ropinirol Teva 4 mg prolonged-release tablets EFG

Ropinirol hydrochloride

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 others. It may harm them, even if their signs of illness are the same as yours.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

The active substance of Ropinirol Teva prolonged-release tablets is ropinirol, which belongs to a group of medicines called dopamine agonists. Dopamine agonists work in a similar way to a natural substance called dopamine that is found in the brain.

Ropinirol Teva prolonged-release tablets are used to treat Parkinson's disease.

People with Parkinson's disease have low levels of dopamine in some parts of their brain. Ropinirol has a similar effect to natural dopamine and helps to reduce the symptoms of Parkinson's disease.

2. What you need to know before you take Ropinirol Teva

Do not take Ropinirol Teva:

• if you are allergic (hypersensitive) to ropinirol or any of the other ingredients of this medicine (listed in section 6).

if you have severe kidney disease.

• if you have liver disease.

Tell your doctor if you think you may have any of these conditions.

Warnings and precautions

Before taking Ropinirol Teva, tell your doctor or pharmacist if:

• you are pregnantor think you may be pregnant.
• you are breast-feeding.
• you are under 18 years.

• you have a serious heart condition.
• you have a serious mental health problem.
• if you have impulsive or abnormal behaviour(see section 4).
• if you have an intolerance to some 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 (called 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 cravings to behave in ways that are unusual for you and you cannot resist the impulse, urge or temptation to carry out certain activities that could be harmful to you or others. These are called impulse control disorders and can include behaviours such as binge eating, compulsive shopping, or an increased sex drive. Your doctor may need to adjust or stop your dose.

Tell your doctorif you think you may have any of these conditions. Your doctor will decide if your treatment with Ropinirol Teva is suitable for you, or if you need any additional monitoring while taking it.

While taking Ropinirol Teva

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

Your doctor may need to adjust or stop your treatment.

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

Smoking and Ropinirol Teva

Tell your doctorif you start or stop 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 take any other medicines, including herbal medicines or medicines bought without a prescription.

Remember to tell 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 affect the way other medicines work.

These medicines include:

• the antidepressant fluvoxamine.
• medicines for mental health problems, 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.

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 to have extra blood tests:

• Vitamin K antagonists (used to prevent 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 breast-feeding

Ropinirol Teva should not be used during pregnancy, unless your doctor advises you that the benefit to you is greater than the risk to your baby. Ropinirol Teva should not be used during breast-feeding, as it may affect milk production.

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

Driving and using machines

Ropinirol Teva may make you feel dizzy or somnolent. Some people may experience extreme somnolenceor sudden sleep onsetwithout warning.

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

Consult your doctor if this is a problem for you.

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

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 some sugars, contact your doctor before taking this medicine.

3. How to take Ropinirol Teva

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Do not give Ropinirol Teva to children. Ropinirol Teva is not normally prescribed for people under 18 years.

You may have been prescribed Ropinirol Teva on its own to treat your Parkinson's disease symptoms, or you may have been prescribed Ropinirol Teva as well as another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience some uncontrolled movements (dyskinesia) when you first start taking Ropinirol Teva. Tell your doctor if this happens, as they may need to adjust the doses of the medicines you are taking.

Ropinirol Teva tablets are designed to release the medicine over a 24-hour period. If you have a condition where your medicines pass through your body too quickly, for example diarrhoea, the tablets may not dissolve properly and may not work correctly. You may see the tablets in your stool. If this happens, tell your doctor as soon as possible.

What dose of Ropinirol Teva should you take?

It may take some time to find the best dose of Ropinirol Teva for you.

The recommended starting dose of Ropinirol Teva is 2 mg once daily for the first week. After this, your doctor may increase your dose to 4 mg of Ropinirol Teva prolonged-release tablets once daily, during the second week of treatment. In elderly people, the doctor may increase the dose more slowly. After this, your doctor may adjust your dose to the best level for you. Some people take up to 24 mg of Ropinirol Teva prolonged-release tablets each day.

If you experience side effects that you cannot tolerate when you first start treatment, talk to your doctor. Your doctor may advise you to switch to a lower dose of ropinirol film-coated tablets (immediate release) that you take three times a day.

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

It may take several weeks for Ropinirol Teva to start working.

How to take your dose of Ropinirol Teva

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

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

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

Take your ropinirol film-coated tablets (immediate release) as usual the day before you switch. Then, take your Ropinirol Teva prolonged-release tablets the next 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 pack.

Someone who has taken too much Ropinirol Teva may experience some of the following symptoms: nausea, vomiting, dizziness, somnolence, fatigue (mental or physical tiredness), feeling faint, hallucinations.

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

If you forget to take Ropinirol Teva

Do not take extra prolonged-release tablets or a double dose to make up for a forgotten dose.

If you have forgotten to take Ropinirol Teva for one or more days, consult your doctor for advice on how to start taking it again.

If you stop taking Ropinirol Teva

Do not stop taking Ropinirol Teva without talking to your doctor first.

Take Ropinirol Teva for as long as your doctor has told you. Do not stop treatment unless your doctor tells you to.

If you suddenly stop taking Ropinirol Teva, your Parkinson's disease symptoms may quickly get worse.

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

Do not stop taking Ropinirol Teva suddenly without talking to your doctor. Stopping Ropinirol Teva suddenly may cause you to develop a medical condition called neuroleptic malignant syndrome, which can be life-threatening. Symptoms include: akinesia (loss of muscle movement), muscle rigidity, fever, unstable blood pressure, rapid heart rate, confusion, decreased level of consciousness (e.g. coma).

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Ropinirol Teva side effects are most likely to happen when you first start taking the medicine, or when your dose is increased. These are usually mild and may become less troublesome after a while. Tell your doctor if you are worried about side effects.

Very common side effects: may affect more than 1 in 10 people

• dizziness

• feeling faint
• sleepiness
• 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 when standing up quickly (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 sleepy during the day (excessive daytime somnolence).
• suddenly falling asleep without warning (sudden sleep onset).
• mental problems such as severe confusion (delirium), irrational ideas (delusions) or paranoia (irrational suspicions).

Rare side effects: may affect up to 1 in 1,000 people

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

o Strong impulse to gamble excessively despite severe personal or family consequences.

o Altered or increased sexual interest or behaviour that is very distressing for you or others, for example, an increased sexual drive.

o Uncontrolled or excessive shopping or spending

o Eating large amounts of food in a short period of time (binge eating) or eating compulsively (eating more food than needed to satisfy hunger)

• excessive use of Ropinirol Teva (excessive desire for high doses of dopaminergic medicines 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 (called dopamine agonist withdrawal syndrome or DAWS) may occur.

Tell your doctor if you experience any of these behaviours, they will discuss ways to control or reduce the symptoms.

If you are taking Ropinirol Teva with L-dopa

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

• uncontrolled movements are a very common side effect. If you are taking L-dopa, you may experience uncontrolled movements (dyskinesia) when you first start taking Ropinirol Teva.

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

• confusion is a common side effect.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ropinirol Teva

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 carton and blister after EXP.

The expiry date is the last day of the month stated.

Do not store above 30°C.

Store in the original package to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Ropinirol Teva

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

Core of the prolonged-release tablet: hypromellose, lactose monohydrate, colloidal anhydrous silica, carbomer 4,000-11,000 mPa.s, hydrogenated ricin 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 Container Content

Ropinirol Teva 4 mg prolonged-release tablets EFG:

The tablets are light brown, biconvex, and oval.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U

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 Member States of the European Economic Area under the following names:

This leaflet was last revised in May 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74669/P_74669.html

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