ROPINIROL 2 mg Modified-Release Tablets

2. What you need to know before you take Ropinirol Prolib Sandoz

Do not take Ropinirol Prolib Sandoz if:

• you are allergic to ropinirol or any of the other ingredients of this medicine (listed in section 6),
• you have any severe kidney disease,
• you have any 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 Ropinirol Prolib Sandoz:

• if you are pregnantor think you may be pregnant,
• if you are breast-feeding,
• if you are under 18 years old,
• if you have any serious heart disease,
• if you have any serious mental health problem,
• if you have any impulsive or compulsive behaviour(such as an excessive desire to gamble or an increased sexual desire),
• if you have intolerance to some sugars(e.g. lactose).

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

A dose adjustment may be necessary depending on the case, according to the clinical response.

While taking Ropinirol Prolib Sandoz

Tell your doctor if you or your family/caregivers notice that you are developing any unusual behaviour or cannot resist the impulse, drive or temptation to perform certain activities that could harm yourself or others. This is called impulse control disordersand can include behaviours such as an excessive desire to gamble, eat or spend money compulsively or an increase in sexual desires and/or behaviour.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 (called dopamine agonist withdrawal syndrome or DAWS). If the problems persist after a few weeks, your doctor may need to adjust your treatment.

Smoking and Ropinirol Prolib Sandoz

Tell your doctorif you start or stop smoking while taking Ropinirol Prolib Sandoz. Your doctor may need to adjust your dose.

Taking Ropinirol Prolib Sandoz with other medicines

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

Remember to tell your doctor or pharmacist if you start taking a new medicine while taking Ropinirol Prolib Sandoz.

Some medicines may affect the effect of ropinirol, 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 disorders, such as sulpiride,
• hormone replacement therapy(also called HRT),
• metoclopramide, which is used to treat nauseaand heartburn,
• the antibiotics ciprofloxacinor enoxacin,
• any other medicine for Parkinson's disease.

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

You may need to have extra blood tests if you are taking these medicines with ropinirol:

• vitamin K antagonists (used to prevent blood clotting) such as warfarin (Coumadin).

Taking Ropinirol Prolib Sandoz with food, drinks and alcohol

You can take Ropinirol Prolib Sandoz with or without food.

Pregnancy, breast-feeding and fertility

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.

Ropinirol is not recommended during pregnancy, unless your doctor considers that the benefit to you is greater than the risk to your baby. Ropinirol should not be taken during breast-feeding, as milk production may be affected.

Tell your doctor immediatelyif you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will advise you on what to do if you are breast-feeding or plan to breast-feed. Your doctor may recommend that you stop taking ropinirol.

Driving and using machines

Ropinirol may make you feel drowsy. It may make you feel extremely drowsyand cause you to suddenly fall asleep.

If you are affected, do not drive or operate machineryor perform any other tasks where lack of attention may put you or others at risk of serious injury or death, until such episodes and/or drowsiness have stopped.

Consult your doctorif this causes you any problems.

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

Ropinirol Prolib Sandoz contains lactose and hydrogenated castor oil

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

This medicine may cause stomach upset and diarrhoea because it contains hydrogenated castor oil.

3. How to take Ropinirol Prolib Sandoz

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

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

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

Ropinirol Prolib Sandoz is designed to release the active substance over a 24-hour period. If you have a condition where your medicine passes through your body too quickly, for example, diarrhoea, the tablet may not dissolve completely and may not work properly. You may see tablets in your stool. If this happens, tell your doctor as soon as possible.

What dose of Ropinirol Prolib Sandoz should you take?

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

The recommended starting doseof ropinirol prolonged-release tablets is 2 mg once daily for the first week. From then on, your doctor may increase your dose to 4 mg of ropinirol prolonged-release tablets once daily, during the second week of treatment. In elderly people, your doctor may increase the dose more slowly. After that, your doctor may adjust the dose until you reach the dose that is best for you. Some people may take up to 24 mg of ropinirol 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 immediate-release film-coated tablets that you would take three times a day.

Do not take more Ropinirol Prolib Sandoz tablets than your doctor has prescribed.

It may take several weeks for ropinirol to start working.

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

Swallow Ropinirol Prolib Sandoz tablets whole with a glass of water.

Do not break, chew or crushthe prolonged-release tablets. If you do, you may be at risk of getting too much medicine at once, because the medicine will be released into your body too quickly.

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

Your doctor will adjust your dose of ropinirol prolonged-release tablets based on the dose of ropinirol immediate-release film-coated tablets you were taking.

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

If you take more Ropinirol Prolib Sandoz than you should

If you or someone else has taken too much Ropinirol Prolib Sandoz, talk to a doctor or pharmacist or go to the nearest hospital casualty department immediately. Take this leaflet and any remaining tablets with you. Someone who has taken an overdose of ropinirol may have some of the following symptoms: nausea, vomiting, dizziness, drowsiness, fainting, hallucinations.

If you forget to take Ropinirol Prolib Sandoz

Do not take more tablets or a double dose to make up for a forgotten dose.

If you have missed taking Ropinirol Prolib Sandoz for one or more days, talk to your doctor before you start taking it again.

If you stop taking Ropinirol Prolib Sandoz

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

Take Ropinirol Prolib Sandoz for as long as your doctor recommends.Do not stop taking Ropinirol Prolib Sandoz unless your doctor tells you to.

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

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

If you have Parkinson's disease, you should not stop taking Ropinirol Prolib Sandoz suddenly. Stopping suddenly may cause you to develop a condition called Neuroleptic Malignant Syndrome (NMS), which can be life-threatening. The symptoms include:

• loss of muscle movement (akinesia),
• stiff muscles,
• fever,
• unstable blood pressure,
• fast heart rate (tachycardia),
• confusion,
• reduced consciousness (e.g. coma).

If you have any other questions about 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.

The side effects of Ropinirol Prolib Sandoz are usually mild and may become less troublesome after a few days. If you are worried about side effects, talk to your doctor.

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

• fainting,
• feeling drowsy (somnolence),
• feeling sick (nausea).

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

• seeing things that are not really there (hallucinations),
• dizziness (vertigo),
• suddenly falling asleep without warning (sudden onset of sleep),
• being sick (vomiting),
• abdominal pain,
• heartburn,
• stomach pain,
• constipation,
• swelling of the legs, feet or hands.

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

• feeling dizzy or fainting, especially when standing up quickly, due to low blood pressure (hypotension),
• low blood pressure when standing up (postural hypotension),
• feeling extremely drowsy during the day (excessive daytime somnolence),
• mental problems such as severe confusion (delirium), irrational ideas (delusional thoughts) or irrational suspicions (paranoia),
• hypo.

Side effects with frequency not known(frequency cannot be estimated from the available data)

• changes in liver function, detected in blood tests (increased liver enzymes),
• allergic reactions such as swelling, skin rash (hives), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), skin rash or intense itching,
• taking more than the prescribed dose of medicines and more than the required dose for the treatment of motor disabilities (dopamine dysregulation syndrome (DDS)),
• inability to resist the impulse, drive or temptation to perform 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 behaviour towards you or others, for example, an increased sexual desire,
• excessive or uncontrolled shopping or spending,
• binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more than normal and more than needed to satisfy your hunger),
  • aggression (has been associated with psychotic reactions, as well as compulsive symptoms),
  • after stopping or reducing treatment with ropinirol: depression, apathy, anxiety, fatigue, sweating or pain (called dopamine agonist withdrawal syndrome or DAWS),
  • spontaneous penile erection.

Tell your doctor if you experience any of the above behaviours; your doctor will find a way to manage or reduce these symptoms.

If you are taking ropinirol with L-dopa

People taking ropinirol with L-dopa may develop other side effects after some time:

• uncontrollable movements (dyskinesia), which is a common side effect. If you are taking L-dopa, you may experience uncontrollable movements (dyskinesia) when you first start taking ropinirol. Tell your doctor if this happens, as your doctor may need to adjust the dose of the medicines you are taking,
• feeling confused is a common side effect,
• nausea and drowsiness have been commonly reported in clinical trials of prolonged-release adjunct therapy.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Prolib Sandoz

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 packaging and on the blister after CAD/EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

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 your pharmacy. If you are unsure, 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 of Ropinirol Prolib Sandoz

The active substance is ropinirol.

Ropinirol Prolib Sandoz 2 mg prolonged-release tablets:

Each prolonged-release tablet contains 2 mg of ropinirol (as hydrochloride).

Ropinirol Prolib Sandoz 4 mg prolonged-release tablets:

Each prolonged-release tablet contains 4 mg of ropinirol (as hydrochloride)

Ropinirol Prolib Sandoz 8 mg prolonged-release tablets:

Each prolonged-release tablet contains 8 mg of ropinirol (as hydrochloride)

The other ingredients are:

Ropinirol Prolib Sandoz 2 mg prolonged-release tablets:

Tablet core: hypromellose 2208, lactose monohydrate, colloidal anhydrous silica, carbomer 4,000-11,000 cP, hydrogenated ricin oil and magnesium stearate.

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

Ropinirol Prolib Sandoz 4 mg and 8 mg prolonged-release tablets:

Tablet core: hypromellose 2208, lactose monohydrate, colloidal anhydrous silica, carbomer 4,000-11,000 cP, hydrogenated ricin oil and magnesium stearate.

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

Appearance and Package Contents

Ropinirol Prolib Sandoz 2 mg are pink, biconvex, oval prolonged-release tablets.

Ropinirol Prolib Sandoz 4 mg are light brown, biconvex, oval prolonged-release tablets.

Ropinirol Prolib Sandoz 8 mg are reddish-brown, biconvex, oval prolonged-release tablets.

The tablets are available in packs of 7, 10, 14, 21, 28, 30, 42, 60, 84 and 90 prolonged-release tablets in blisters (OPA/Al/PVC//Al).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

Novo mesto,

Slovenia

or

TAD Pharma GmbH,

Heinz-Lohmann-Str. 5,

27472 Cuxhaven,

Germany

or

Salutas Pharma GmbH,

Otto-von-Guericke Allee 1,

39179 Barleben,

Germany

or

Lek, d.d.,

Verovškova 57,

1526 Ljubljana, Slovenia

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

Date of last revision of thisleaflet:July 2023

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