Ropinirole Krka

Patient Information Leaflet

Ropinirolo Krka 2 mg prolonged-release tablets, 4 mg prolonged-release tablets, 8 mg prolonged-release tablets

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

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

The active substance of Ropinirolo Krka is ropinirole, which belongs to a group of medicines known
as dopamine agonists, having effects on the brain similar to those of a natural substance
called dopamine.
Ropinirolo Krka 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 those of natural dopamine, thus helping to reduce the symptoms of Parkinson's disease.

2. What you need to know before taking Ropinirole Krka

DO NOT TAKE Ropinirole Krka:

• 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.

Tell your doctor if you think any of these situations apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ropinirole Krka:

• if you are pregnant or think you might be;
• 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 impulses);
• if you have an intolerance to certain sugars (e.g. lactose).

Tell your doctor if you think any of these conditions apply to you. Your doctor may decide that Ropinirole Krka is not suitable for you and that you need further monitoring during treatment.
Tell 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 that could harm yourself or others. These are called impulse control disorders and may include behaviours such as gambling addiction, excessive eating or spending, abnormally increased sexual desire, or increased sexual thoughts or feelings. Your doctor may consider it necessary to adjust or stop your dose.
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing treatment with ropinirole. If symptoms persist for more than a few weeks, your doctor may need to adjust your treatment.
Smoking and Ropinirole Krka
Tell your doctor if you start or stop smoking while taking Ropinirole Krka. Your doctor may need to adjust your dose.
Other medicines and Ropinirole Krka:
Tell 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 Ropinirole Krka.
Some medicines can affect how Ropinirole Krka works, or make it more likely that you will experience side effects. Ropinirole Krka can also affect how other medicines work.
These include:

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

You will need additional blood tests if you are taking these medicines together with Ropinirole Krka:

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

Taking Ropinirole Krka with food, drinks and alcohol
You may take Ropinirole Krka with or without food.
During treatment with Ropinirole Krka, drinking alcohol is not recommended.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Ropinirole Krka is not recommended during pregnancy unless your doctor considers that the benefit to you from taking Ropinirole Krka outweighs the risk to the unborn baby. Ropinirole Krka is not recommended for breastfeeding mothers, as it may affect milk production.
Driving and using machines
Ropinirole Krka may cause dizziness. It may cause excessive sleepiness with episodes of sudden sleep attacks without warning. Ropinirole may cause hallucinations (seeing, hearing or feeling things that are not there). If you experience such symptoms, do not drive or operate machinery.
If you might be affected: do not drive, do not operate machinery, and do not put yourself in a situation where sleepiness or sudden sleep episodes could place you (or others) at risk of serious injury or death. Do not engage in these activities until these effects have disappeared.
Tell your doctor if this causes you problems.
Ropinirole Krka 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 Ropinirole Krka

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Use in children and adolescents
Do not give Ropinirole Krka to children. Ropinirole Krka is normally not prescribed for patients
under 18 years of age.
Ropinirole Krka may be prescribed for you alone to treat the symptoms of Parkinson’s disease, or it
may be prescribed together with another medicine called L-dopa (also known as levodopa). If you are
taking L-dopa, you may experience some involuntary, jerky movements when you start taking Ropinirole
Krka (dyskinesia). Inform your doctor if this occurs, as your doctor may need to adjust the dose of
your medicine.
Ropinirole Krka tablet(s) is 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, such as diarrhoea, the tablet(s)
may not dissolve completely and may not work properly. You may notice the tablet(s) in your faeces. If
this happens, inform your doctor as soon as possible.
How much Ropinirole Krka do you need to take?
It may take some time to find the best dose of Ropinirole Krka for you.
The recommended starting dose of Ropinirole Krka prolonged-release tablets is 2 mg once daily for
the first week. Your doctor may increase the dose to 4 mg of Ropinirole Krka prolonged-release tablets
once daily, starting 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 Ropinirole Krka prolonged-release tablets daily.
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 immediate-release
ropinirole tablets taken three times daily.
Do not take more Ropinirole Krka than your doctor has recommended.
It may take several weeks before Ropinirole Krka starts working for you.
How to take your dose of Ropinirole Krka
Take Ropinirole Krka once daily, at the same time each day.

Swallow your prolonged-release Ropinirole Krka tablet
whole, with a glass of water.
DO NOT break, chew or crush the prolonged-release tablets. Doing so may
cause overdose, as the medicine would be released into your body too
quickly.
Switching from immediate-release ropinirole tablets
Your doctor will base your dose of Ropinirole Krka prolonged-release tablets on the dose of
immediate-release ropinirole tablets you are currently taking.
Continue taking your immediate-release ropinirole tablets as usual the day before switching. Then take
Ropinirole Krka prolonged-release tablets the following morning and do not take any more
immediate-release ropinirole tablets.
If you take more Ropinirole Krka than you should
Contact your doctor or pharmacist immediately. If possible, show them the Ropinirole Krka
packaging.
People who have taken an overdose of Ropinirole Krka may experience some of these symptoms:
feeling nauseous, vomiting, dizziness (spinning sensation), drowsiness, physical or mental fatigue,
fainting, hallucinations.
If you forget to take Ropinirole Krka
Do not take a double dose to make up for the missed dose.
If you have forgotten to take Ropinirole Krka for one or more days, consult your doctor for advice on
how to resume treatment.
If you stop taking Ropinirole Krka
Do not stop taking Ropinirole Krka without first discussing it with your doctor.
Take Ropinirole Krka for the entire duration prescribed by your doctor. If you stop taking Ropinirole
Krka suddenly, symptoms of Parkinson’s disease may worsen rapidly.
Sudden discontinuation may also lead to a medical condition called neuroleptic malignant syndrome,
which can pose a serious health risk. Symptoms include: akinesia (loss of muscle movement), muscle
rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, and decreased
level of consciousness (coma).
If you need to stop treatment with Ropinirole Krka, your doctor will gradually reduce your dose.
If you have any further questions about using 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.
Side effects with Ropinirole Krka are more likely when you first start taking it or when your dose is increased. They are usually mild and may become less bothersome after taking the medicine for a while. 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;
• feeling nauseous.

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

• falling asleep suddenly without warning (episodes of sudden sleep attacks);
• hallucinations (“seeing” things that are not real);
• feeling unwell (vomiting);
• dizziness (spinning sensation);
• 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 quickly (caused by a drop in blood pressure);
• feeling sleepy during the day (extreme sleepiness);
• mental problems such as delirium (severe confusion), illusions (unreasonable beliefs) or paranoia (unfounded suspicions).

Some patients may experience the following side effects:

• allergic reactions such as itchy, red swellings on the skin (hives), swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing, rash and severe itching (see section 2);
• changes in liver function, noticeable in blood tests;
• aggressive behaviour;
• excessive use of Ropinirole Krka (craving for high doses of dopaminergic medicines beyond what is needed to control motor symptoms, known as dopamine agonist withdrawal syndrome);
• after stopping or reducing treatment with Ropinirole Krka: depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS);
• inability to resist the impulse to carry out behaviours that could be harmful, which may include:
  • strong urge to gamble excessively, despite serious personal or family consequences;
  • altered or increased sexual interest and behaviour causing considerable concern to you or others, for example, increased libido;
  • uncontrollable shopping or excessive spending;
  • compulsive eating (eating large amounts of food in a short period of time) or bulimia (eating more food than normal and more than needed to satisfy hunger).

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 Krka with L-dopa:
Patients taking Ropinirole Krka with L-dopa may develop additional side effects over time:

• involuntary jerky movements (dyskinesia), which is a very common side effect. If you are taking L-dopa, you may experience some uncontrollable movements (dyskinesia) when you start taking Ropinirole Krka. If this happens, inform your doctor, as the doctor may need to adjust the dose of the medicines you are taking.

• confusion is a common side effect.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ropinirolo Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP/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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ropinirolo Krka contains

• The active substance is ropinirole. Ropinirolo Krka 2 mg prolonged-release tablets: Each prolonged-release tablet contains 2 mg of ropinirole (as hydrochloride). Ropinirolo Krka 4 mg prolonged-release tablets: Each prolonged-release tablet contains 4 mg of ropinirole (as hydrochloride). Ropinirolo Krka 8 mg prolonged-release tablets: Each prolonged-release tablet contains 8 mg of ropinirole (as hydrochloride).
• The excipients are: Ropinirolo Krka 2 mg prolonged-release tablets: hypromellose type 2208, monohydrate lactose, anhydrous colloidal silica, carbomers 4,000-11,000 mPa.s, 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 (see section 2). Ropinirolo Krka 4 mg and 8 mg prolonged-release tablets: hypromellose type 2208, monohydrate lactose, anhydrous colloidal silica, carbomers 4,000-11,000 mPa.s, 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 (see section 2).

Description of the appearance of Ropinirolo Krka and contents of the pack
Ropinirolo Krka 2 mg prolonged-release tablets: Pink, biconvex, oval tablets.
Ropinirolo Krka 4 mg prolonged-release tablets: Light brown, biconvex, oval tablets.
Ropinirolo Krka 8 mg prolonged-release tablets: Red-brown, biconvex, oval tablets.
The tablets are available in packs of 10, 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
KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, Slovenia

Local representative for Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany

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