Ropinirole Sandoz

Package Leaflet:

Information for the patient
Ropinirolo Sandoz 2 mg prolonged-release tablets
Ropinirolo Sandoz 4 mg prolonged-release tablets
Ropinirolo Sandoz 8 mg prolonged-release tablets
Ropinirole
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important
information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ropinirolo Sandoz is and what it is used for

The active substance in Ropinirolo Sandoz is ropinirole, which belongs to a group of medicines known as
dopamine agonists, which have effects on the brain similar to a natural substance called
dopamine.
Ropinirolo Sandoz prolonged-release tablets are used to treat Parkinson's disease.
People with Parkinson's disease have low levels of dopamine in certain parts of the brain. Ropinirole has effects similar to natural dopamine and thus helps reduce the symptoms of Parkinson's disease.

2. What you need to know before taking Ropinirolo Sandoz

DO NOT TAKE Ropinirolo Sandoz

• if you are allergic to ropinirole or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney disease
• if you have liver disease. Inform your doctor if you think any of these conditions apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ropinirolo Sandoz:

• if you are pregnant or think you might be pregnant;
• if you are breastfeeding;
• if you are under 18 years of age;
• if you have severe heart disease;
• if you have severe mental health problems;
• if you have experienced unusual impulses and/or behaviours (such as excessive gambling or excessive sexual behaviour);
• if you have an intolerance to certain sugars (e.g. lactose).

Inform your doctor if you think any of these conditions apply to you. Your doctor may decide that
Ropinirolo Sandoz is not suitable for you and that you need further monitoring while taking it.
Dosage adjustments may be required on an individual basis depending on your clinical response to the medicine.

While taking Ropinirolo Sandoz
Inform your doctor if you or a family member or caregiver notice that you are developing urges or desires to behave in ways that are unusual for you and that you cannot resist the impulse or temptation to carry out certain activities which could harm yourself or others.
These are called impulse control disorders and may include behaviours such as gambling addiction, excessive eating, or excessive spending, abnormal, increased sexual desire, or increased sexual thoughts or feelings. Your doctor may decide to adjust or stop your dose.
Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing treatment with ropinirole. If problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Smoking and Ropinirolo Sandoz
Inform your doctor if you start or stop smoking while taking Ropinirolo Sandoz. Your doctor may decide to adjust your dose.

Other medicines and Ropinirolo Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Remember to inform your doctor or pharmacist if you start taking a new medicine while taking Ropinirolo Sandoz.
Some medicines may affect how Ropinirolo Sandoz works, or make it more likely that you will experience side effects. Ropinirolo Sandoz may also affect how other medicines work.
These include:

• the antidepressant fluvoxamine;
• medicines used for other mental health problems, e.g. sulpiride;
• HRT (hormone replacement therapy);
• metoclopramide, used to treat nausea and heartburn;
• the antibiotics ciprofloxacin or enoxacin;
• other medicines for Parkinson’s disease. Inform your doctor if you are taking, or have recently taken, any of these medicines.

You will need additional blood tests if you take any of these medicines together with Ropinirolo Sandoz:

• vitamin K antagonists (used to reduce blood clots), such as warfarin (Coumadin).

Ropinirolo Sandoz with food and drink and alcohol
You may take Ropinirolo Sandoz with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Ropinirolo Sandoz is not recommended during pregnancy, unless your doctor has determined that the benefit to you of taking Ropinirolo Sandoz outweighs the risk to the fetus. Ropinirolo Sandoz is not recommended for breastfeeding mothers, as it may affect milk production.
Inform your doctor immediately if you are pregnant, think you might be pregnant, or are planning a pregnancy. Your doctor will also advise you if you are breastfeeding or planning to breastfeed. Your doctor will advise you to stop taking Ropinirolo Sandoz.

Driving and using machines
Ropinirolo Sandoz may cause drowsiness. It may cause severe drowsiness, and sometimes may cause sudden sleep attacks without warning.
If you experience these symptoms: do not drive, do not operate machinery, and do not put yourself in any situation where drowsiness or falling asleep could place you (or others) at risk of serious injury or death. Do not engage in such activities until these effects have subsided.
Inform your doctor if this causes you problems.
Ropinirole may cause hallucinations (seeing, hearing, or sensing things that are not there). If you experience hallucinations, do not drive and do not use machinery.

Ropinirolo Sandoz contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Ropinirolo Sandoz

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Do not give Ropinirolo Sandoz to children. Ropinirolo Sandoz is normally not prescribed for patients under 18 years of age.
Ropinirolo Sandoz may be prescribed alone to treat the symptoms of Parkinson's disease. Alternatively, Ropinirolo Sandoz may be prescribed together with another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience some sudden, uncontrolled movements when you start taking Ropinirolo Sandoz. Inform your doctor if this occurs, as your doctor may need to reduce the dose of your medicines.
Ropinirolo Sandoz has been designed to release the medicine over a 24-hour period. If you have a condition causing the medicine to pass through your body too quickly, for example diarrhoea, the tablets may not dissolve completely and therefore may not work properly. You may see the tablet(s) in your faeces. If this happens, inform your doctor as soon as possible.
How much Ropinirolo Sandoz should you take?
It may take some time to find the best dose of Ropinirolo Sandoz for you.
The recommended starting dose of Ropinirolo Sandoz prolonged-release tablets is 2 mg once daily for the first week. Your doctor may increase the dose to 4 mg of Ropinirolo Sandoz prolonged-release tablets once daily from the second week of treatment. If you are elderly, your doctor may increase your dose more slowly. Afterwards, your doctor may adjust your dose until you are taking the dose best suited for you. Some people take up to 24 mg of Ropinirolo Sandoz prolonged-release tablets per day.
If you experience side effects at the beginning of treatment that you find difficult to tolerate, discuss this with your doctor. Your doctor may advise you to switch to a lower dose of ropinirole immediate-release tablets, which you will need to take three times a day.
Do not take more Ropinirolo Sandoz than your doctor has recommended.
It may take several weeks before Ropinirolo Sandoz starts to work for you.
Take Ropinirolo Sandoz once daily, at the same time each day.

Swallow your Ropinirolo Sandoz prolonged-release tablet whole with a glass of water.
DO NOT break, chew or crush the prolonged-release tablets. Doing so may lead to overdose, as the medicine will be released into your body too quickly.
Switching from ropinirole immediate-release tablets
Your doctor will base your dose of Ropinirolo Sandoz prolonged-release tablets on the dose of ropinirole immediate-release tablets you are currently taking.
Continue taking your ropinirole immediate-release tablets as usual the day before switching. Then take Ropinirolo Sandoz prolonged-release tablets the following morning and do not take any more ropinirole immediate-release tablets.
If you take more Ropinirolo Sandoz than you should
Contact your doctor or pharmacist immediately. If possible, show them the Ropinirolo Sandoz packaging.
People who have taken an overdose of Ropinirolo Sandoz may experience some of the following symptoms: feeling unwell (nausea), illness (vomiting), dizziness (spinning sensation), drowsiness, physical or mental fatigue, fainting, hallucinations.
If you forget to take Ropinirolo Sandoz
Do not take extra prolonged-release tablets or a double dose to make up for a missed dose.
If you have forgotten to take Ropinirolo Sandoz for one or more days, ask your doctor for advice on how to resume treatment.
If you stop taking Ropinirolo Sandoz
Do not stop taking Ropinirolo Sandoz without medical advice.
Take Ropinirolo Sandoz for as long as your doctor tells you to. Do not stop unless your doctor advises you to do so.
If you stop taking Ropinirolo Sandoz suddenly, the symptoms of Parkinson's disease may worsen rapidly.
If you need to stop treatment with Ropinirolo Sandoz, your doctor will gradually reduce your dose.
If you have Parkinson's disease, you must not stop treatment with Ropinirolo Sandoz abruptly. Sudden discontinuation may cause the development of a condition called neuroleptic malignant syndrome (NMS), which may pose a serious health risk. Symptoms include:

• akinesia (loss of muscle movement),
• muscle rigidity,
• fever,
• unstable blood pressure,
• tachycardia (increased heart rate),
• confusion,
• reduced level of consciousness (e.g. coma).

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects with Ropinirole Sandoz are more likely when you first start taking it or when your dose is increased. They are usually mild and may become less troublesome after taking the dose for some time. If you are concerned about side effects, talk to your doctor.

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

• fainting
• feeling sleepy (somnolence)
• feeling unwell (nausea)

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

• “seeing” things that are not real (hallucinations)
• dizziness (spinning sensation)
• falling asleep suddenly without warning (episodes of sudden sleep attacks)
• feeling unwell (vomiting)
• abdominal pain
• heartburn
• stomach ache
• constipation
• swelling of the legs, feet and hands

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

• feeling faint or dizzy, especially when standing up suddenly; this is caused by a drop in blood pressure (hypotension)
• sudden drop in blood pressure after changing posture (postural hypotension)
• feeling sleepy during the day (excessive daytime sleepiness)
• mental problems such as severe confusion (delirium), irrational beliefs (illusions) or unfounded suspicions (paranoia)

Side effects where frequency is unknown:

• changes in liver function, evident in blood tests (increased liver enzymes)
• allergic reactions such as itchy, red swellings on the skin (urticaria), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), skin rash and severe itching
• taking increasing amounts of the medicine against medical advice and far beyond the doses needed to treat motor disabilities (Dopamine Dysregulation Syndrome, DDS)
• inability to resist the impulse, action or temptation to carry out behaviours that could be harmful, which may include:
  • strong impulse to gamble excessively despite serious personal or family consequences
  • altered or increased sexual interest and behaviour causing significant concern to you or others, for example, increased sexual desire
  • uncontrolled shopping or excessive spending
  • compulsive eating (eating large amounts of food in a short period of time) or binge eating (eating more food 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 Ropinirole Sandoz: depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome).

Tell your doctor if you experience any of these behaviours, so that he or she can decide how to manage or reduce the symptoms.

If you are taking Ropinirole Sandoz with L-dopa
Patients taking Ropinirole Sandoz with L-dopa may develop additional side effects over time:

• involuntary movements (dyskinesia) are a very common side effect. If you are taking L-dopa, you may experience some uncontrolled movements (dyskinesia) when you start taking Ropinirole Sandoz. Inform your doctor if this occurs, as your doctor may adjust the doses of the medicines you are taking.
• feeling confused is a common side effect.
• Drowsiness and nausea are commonly reported in clinical studies with the prolonged-release formulation used as add-on therapy.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ropinirolo 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 blister and carton after the word
EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ropinirolo Sandoz contains
The active substance is ropinirole.
Ropinirolo Sandoz 2 mg prolonged-release tablets:
Each prolonged-release tablet contains 2 mg of ropinirole (as hydrochloride).
Ropinirolo Sandoz 4 mg prolonged-release tablets:
Each prolonged-release tablet contains 4 mg of ropinirole (as hydrochloride).
Ropinirolo Sandoz 8 mg prolonged-release tablets:
Each prolonged-release tablet contains 8 mg of ropinirole (as hydrochloride).

The other components are:
Ropinirolo Sandoz 2 mg prolonged-release tablets:
hypromellose type 2208, monohydrate lactose, anhydrous colloidal silicon dioxide, carbomers 4,000-11,000 cP, hydrogenated castor oil, magnesium stearate in the tablet core and hypromellose type 2910, titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow iron oxide (E172) in the coating.
Ropinirolo Sandoz 4 mg and 8 mg prolonged-release tablets:
hypromellose type 2208, monohydrate lactose, anhydrous colloidal silicon dioxide, carbomers 4,000-11,000 cP, hydrogenated castor oil, magnesium stearate in the tablet core and hypromellose type 2910, titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) in the coating.

Description of the appearance of Ropinirolo Sandoz and contents of the pack
Ropinirolo Sandoz 2 mg prolonged-release tablets:
Pink, biconvex, oval tablets.
Ropinirolo Sandoz 4 mg prolonged-release tablets:
Light brown, biconvex, oval tablets.
Ropinirolo Sandoz 8 mg prolonged-release tablets:
Red-brown, biconvex, oval 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).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder
Sandoz SpA, Largo U. Boccioni, 1 – 21040 Origgio (VA), Italy

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

This medicinal product is authorized in the European Economic Area countries with the following names: