ROPINIROLE STADA 8 mg PROLONGED-RELEASE TABLETS

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

Do not take Ropinirol Stada:

• if you are allergicto ropinirole 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

Consult your doctor or pharmacist before taking ropinirole.

• if you are pregnantor think you may be pregnant.
• if you are breast-feeding.
• if you are under 18 years old.
• if you have a serious heart condition.
• if you have a serious mental health condition.
• if you have impulsive or abnormal behaviour.

Tell your doctorif you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or painafter stopping or reducing treatment with ropinirole (called dopamine agonist withdrawal syndrome or DAWS). If these symptoms persist for more than a few weeks, your doctor may need to adjust your treatment.

Tell your doctorif you or your family/carer notice that you are developing impulses or desires to behave in ways that are unusual for you and you cannot resist the impulse, desire or temptation to carry out certain activities that could harm yourself or others. This is called impulse control disorders and can include behaviours such as pathological gambling, excessive eating or spending, abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your treatment.

Tell your doctorif you or your family/carer notice that you are developing episodes of overactivity, euphoria or irritability (symptoms of mania). These can occur with or without symptoms of impulse control disorders (see above). Your doctor may need to adjust or stop your treatment.

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

Other medicines and Ropinirol Stada

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Remember to tell your doctoror pharmacist if you start taking a new medicine while taking ropinirole.

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

These medicines include:

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

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

If you are taking the following medicines with ropinirole, you may need to have extra blood tests:

• Vitamin K antagonists (used to prevent blood clotting) such as Warfarin (coumarin).

Taking Ropinirol Stada with food and drink

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

Pregnancy, breast-feeding and fertility

Ropinirole is not recommended during pregnancy, unless your doctor advises you that the benefit for you of taking ropinirole is greater than the risk to your unborn baby.

Ropinirole must not be used during breast-feeding, as it may affect milk production.

The effect of ropinirole on fertility has not been studied.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will recommend what you should do if you are breast-feeding or think you may be pregnant. Your doctor may recommend that you stop taking ropinirol.

Driving and using machines

Ropinirole may make you feel drowsy. Some people may experienceextreme drowsinessor suddenly fall asleep without warning.

Ropinirole may cause hallucinations(seeing, hearing or feeling things that are not real).

If you experience this: do not drive, do not use machines, and do notput yourself in situations where feeling drowsy 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 doctorif this is a concern for you.

Ropinirol Stada contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet; this is essentially “sodium-free”.

Ropinirol Stada 2 mg contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Ropinirol Stada 4 mg contains orange yellow S (E110)

This medicine may cause allergic reactions because it contains orange yellow S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Ropinirol Stada

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist.If you are unsure, consult your doctor or pharmacist again.

You may have been prescribed ropinirole on its own to treat the symptoms of your Parkinson's disease, or you may have been prescribed ropinirole in addition to another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience some uncontrollable movements (dyskinesias) when you start taking ropinirole. Tell your doctor if this happens, as they may need to adjust the dose of the medicines you are taking.

Ropinirole prolonged-release tablets are designed to release the active substance over a 24-hour period. If you are in a state where medicines pass through your body very quickly, for example with diarrhoea, the tablet may not dissolve completely and may not work properly. You may see tablets in your stools. If this happens, tell your doctor as soon as possible.

What dose of Ropinirol Stada should you take?

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

The recommended starting doseis 2 mg once daily for the first week. From then on, your doctor may increase your dose to 4 mg of ropinirole prolonged-release tablets once daily, during the second week of treatment. In elderly people, the doctor may increase the dose more slowly. After that, your doctor may adjust your dose to the best dose for you. Some people take up to 24 mg of ropinirole prolonged-release tablets each day.

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

Use in children and adolescents

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

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

It may take several weeks for ropinirole to start working.

How to take your dose of Ropinirol Stada

Takeropiniroleonce a day, at the same time each day.

Swallowthe ropinirole prolonged-release tabletswholewith a glass of water.

Do not break, chew or crushthe ropinirole prolonged-release tablets- if you do, you may be at risk of receiving a dose that is too high, because the medicine will be released into your body too quickly.

If you are switching fromropiniroleimmediate-release tablets

Your doctor will adjust your dose of ropinirole prolonged-release tablets based on the dose of ropinirole immediate-release tablets you are taking.

Take your ropinirole immediate-release tablets as normal on the day before you switch. Then take your ropinirole prolonged-release tablets the next morning and do not take any more ropinirole immediate-release tablets.

If you take more Ropinirol Stada than you should

If you have taken too many ropinirole tablets, or if a child has taken some, contact your doctor or pharmacist immediately, or call the national Poison Information Centre on 91 562 04 20, quoting the medicine and the amount taken. It is recommended that you take the medicine pack and this leaflet with you to the doctor or pharmacist.

Someone who has taken an overdose of ropinirole may experience some of the following symptoms: feeling sick (nausea), being sick (vomiting), dizziness (a spinning sensation), drowsiness, physical or mental tiredness, fainting or hallucinations.

If you forget to take Ropinirol Stada

Do not takeextra tablets or a double doseto make up for a forgotten dose.

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

If you stop taking Ropinirol Stada

Do not stop takingropinirolewithout talking to your doctor first.

Takeropinirolefor as long as your doctor recommends.

Do not stop treatment unless your doctor tells you to. If you suddenly stop taking ropinirole, your Parkinson's disease symptoms may quickly get much worse. Stopping treatment suddenly may cause you to develop a condition called neuroleptic malignant syndrome, which can be life-threatening. The symptoms include: akinesia (loss of muscle movement), muscle stiffness, fever, unstable blood pressure, rapid heart rate, confusion or decreased level of consciousness (such as coma).

If you need to stop taking ropinirole, your doctor will reduce your dose gradually. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Ropinirole side effects are more likely to happen when you first start taking the medicine or when your dose is increased. Side effects 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 peopletaking ropinirole:

• fainting
• drowsiness
• feeling sick (nausea)

Common side effects

May affect up to 1 in 10 peopletaking ropinirole:

• suddenly falling asleep (sleep attacks)
• hallucinations (seeing, hearing or feeling things that are not real)
• being sick (vomiting)
• feeling dizzy (a spinning sensation)
• heartburn
• stomach pain
• constipation
• swelling of the legs, feet or hands

Uncommon side effects

May affect up to 1 in 100 peopletaking ropinirole:

• dizziness or fainting, especially when standing up quickly (this is due to low blood pressure)
• low blood pressure (hypotension)
• feeling extremely drowsy during the day (excessive daytime somnolence)
• mental problems such as delirium (severe confusion), delusions (irrational thoughts) or paranoia (irrational suspicions)
• hiccups

Some patients may have the following side effects (frequency not known: cannot be estimated from the available data):

• allergic reactions such as redness, skin inflammation with itching (urticaria), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, rash or intense itching (see section 2)
• changes in liver function, which can be detected by blood tests
• acting aggressively
• overuse of ropinirole (craving for more doses of dopaminergic medicines than required to control motor symptoms, known as dopamine dysregulation syndrome)
• inability to resist the impulse, desire or temptation to perform certain actions that could be harmful to you or others, which may include:
• • strong impulse to gamble excessively, despite significant personal or family problems
  • altered or increased sexual interest or behaviour, and disturbing behaviour, for example, an excessive interest in sex
  • uncontrollable shopping or spending
  • binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than you need to satisfy your hunger)
• episodes of overactivity, euphoria or irritability
• after stopping or reducing treatment with ropinirole: depression, apathy, anxiety, fatigue, sweating or pain (called dopamine agonist withdrawal syndrome or DAWS)

spontaneous erections

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

If you are takingRopinirol Stadawith L-dopa

People taking ropinirole with L-dopa may develop other effects:

• a very common side effect is uncontrollable movements (dyskinesias). If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you start taking ropinirole. Tell your doctor if this happens, as they may need to adjust the dose of the medicines you are taking.
• a common side effect is confusion.

Reporting of side effects:

If you get 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ropinirol Stada

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 blister, bottle, and carton, after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

HDPE bottle: The shelf life after first opening is 60 days.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofRopinirol Stada

• The active substance of Ropinirol Stada is ropinirol.

Each prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirol (as hydrochloride).

• The other ingredients are:

Prolonged-release tablet core:ammonio methacrylate copolymer type B, hypromellose (E464), sodium lauryl sulfate, copovidone, and magnesium stearate (E572).

Coating film:

• 2 mg: hypromellose (E464), red iron oxide (E172), lactose monohydrate, titanium dioxide (E171), and triacetin.
• 4 mg: macrogol 400, hypromellose (E464), yellow-orange aluminum lake (E110), titanium dioxide (E171), and indigo carmine aluminum lake (E132).
• 8 mg: hypromellose (E464), red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172), macrogol 400, and titanium dioxide (E171).

Appearance and Package Contents of the Product

Ropinirol Stada 2 mg are pink, round, biconvex, prolonged-release tablets, 6.8 ± 0.1 mm in diameter and 5.5 ± 0.2 mm in thickness.

Ropinirol Stada 4 mg are light brown, oval, biconvex, prolonged-release tablets, 12.6 x 6.6 ± 0.1 mm in diameter and 5.3 ± 0.2 mm in thickness.

Ropinirol Stada 8 mg are red, oval, biconvex, prolonged-release tablets, 19.2 x 10.2 ± 0.2 mm in diameter and 5.2 ± 0.2 mm in thickness.

Ropinirol Stadais available in white opaque PVC/PCTFE-aluminum blisters and white opaque HDPE bottles with a white polypropylene cylindrical cap with three points of opening in the security ring and the desiccant inserted.

Package sizes of:

Blister: 21, 28, 84 prolonged-release tablets

Bottle: 21, 28, 84 prolonged-release tablets

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Pharmathen, S.A.

6, Dervenakion str.,

15351 Pallini, Athens

Greece

or

Pharmathen International S.A.

Sapes Industrial Park, Block 5

(Rodopi) 69300

Greece

or

STADA Arzneimittel AG

Stadastrasse, 2-18

61118 Bad Vilbel

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Ropinirol 2 mg Retardtabletten

Ropinirol 4 mg Retardtabletten

Ropinirol 8 mg Retardtabletten

Spain: Ropinirol Stada 2 mg prolonged-release tablets EFG

Ropinirol Stada 4 mg prolonged-release tablets EFG

Ropinirol Stada 8 mg prolonged-release tablets EFG

France: ROPINIROL EG 2 mg prolonged-release tablet

ROPINIROL EG 4 mg prolonged-release tablet

ROPINIROL EG 8 mg prolonged-release tablet

Italy: Ropinirolo EG STADA 2 mg prolonged-release tablets

Ropinirolo EG STADA 4 mg prolonged-release tablets

Ropinirolo EG STADA 8 mg prolonged-release tablets

Netherlands: Ropinirol retard CF 2 mg tablets with prolonged release

Ropinirol retard CF 4 mg tablets with prolonged release

Ropinirol retard CF 8 mg tablets with prolonged release

Date of the last revision of this leaflet:August 2023.

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