ROPINIROLO 2 mg Extended-Release Tablet

Зміст інструкції

1. Ropinirolo Krka 2 mg prolonged-release tablets, 4 mg prolonged-release tablets, 8 mg prolonged-release tablets
   1. What is Ropinirolo Krka and what is it 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. Package Contents and Other Information

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

Ropinirolo

Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Ropinirolo Krka and what is it used for

The active substance of Ropinirolo Krka is ropinirole, which belongs to a group of medicines known
as dopamine agonists, which have similar effects to a natural substance
called dopamine in the brain.

Ropinirolo Krka prolonged-release tablets are used to treat Parkinson's disease.
People with Parkinson's disease have low levels of dopamine in some parts of the brain. Ropinirole has
effects similar to those of natural dopamine, and therefore helps to reduce the symptoms
of Parkinson's disease.

2. What you need to know before taking Ropinirolo Krka

DO NOT TAKE Ropinirolo Krka:

• if you are allergicto ropinirole or any of the other ingredients of this medicine (listed in section 6);
• if you have a severe kidney disease;
• if you have a liver disease.

Tell your doctor if you think any of these apply to you.

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

• if you are pregnantor think you may be;
• if you are breast-feeding;
• if you are under 18 years of age;
• if you have a serious heart condition;
• if you have a serious mental health problem;
• if you have experienced unusual impulses and/or behaviours(such as compulsive gambling or excessive sexual impulses);
• if you have an intolerance to certain sugars (such as lactose).

Tell your doctor if any of these conditions apply to you. Your doctor may decide
that Ropinirolo Krka is not suitable for you and that you need further checks during your treatment.
Tell your doctor if you or someone close to you notices that you are developing urges or desires to behave in ways that are unusual for
you and you cannot resist the urge or temptation to carry out certain activities that
could harm yourself or others. These are called impulse control disorders and can include behaviours such as compulsive gambling, excessive
eating or spending, an abnormal, exaggerated desire for sexual activity or an increase in
sexual thoughts or feelings. Your doctor may need 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 the symptoms persist for more than a few
weeks, your doctor may need to adjust your treatment.

Smoking and Ropinirolo Krka
Tell your doctorif you start or stop smoking while taking Ropinirolo Krka. Your doctor may
need to adjust your dose.

Other medicines and Ropinirolo Krka:
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
Ropinirolo Krka.
Some medicines can affect the way Ropinirolo Krka works, or make it more likely
that you have side effects. Ropinirolo Krka can also affect the way 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 further blood testsif you are taking these medicines with Ropinirolo Krka:

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

Taking Ropinirolo Krka with food, drinks and alcohol
You can take Ropinirolo Krka with or without food.
Drinking alcohol is not recommended while taking Ropinirolo Krka.

Pregnancy and breast-feeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breast-feeding,
ask your doctor or pharmacist for advice before taking this medicine.
Ropinirolo Krka is not recommended during pregnancy, unless your doctor has considered
that the benefit of taking Ropinirolo Krka is greater than the risk to the unborn baby. Ropinirolo Krka is not recommended for mothers who are breast-feeding, as it may affect
milk production.

Driving and using machines
Ropinirolo Krka may cause dizziness. It can cause extreme drowsinesswith episodes of sudden
sleep onset without warning.Ropinirole can cause hallucinations (seeing, hearing or
sensing things that are not there). If you experience these symptoms, do not drive or use machines.
If there is a possibility that this may affect you: do not drive, do not use machinesand do notput yourself in a situation
where drowsiness or sleep attacks could put you (or other people) at risk of serious injury or
death. Do not engage in these activities until these effects have worn off.
Tell your doctor if this causes you problems.

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

3. How to take Ropinirolo Krka

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.

Use in children and adolescents
Do not give Ropinirolo Krka to children. Ropinirolo Krka is not normally prescribed to patients
under the age of 18.
Ropinirolo Krka may be prescribed to 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 begin to
take Ropinirolo Krka (dyskinesia). Tell your doctor if this happens, as your doctor may
need to adjust the dose of the medicine you are taking.
Ropinirolo Krka tablet(s) is designed to release medicine over a period of 24 hours. If you are
in a condition where the medicine passes through your body too quickly, for example in case of
diarrhoea, the tablet(s) may not dissolve completely and may not work
correctly. You may observe the tablet(s) in your stools. If this happens, tell your doctor as
soon as possible.

How much Ropinirolo Krka do you need to take?
It may take some time to find the best dose of Ropinirolo Krka for you.
The recommended starting doseof Ropinirolo Krka prolonged-release tablets is 2 mg once
daily for the first week. Your doctor may increase the dose to 4 mg of Ropinirolo Krka
prolonged-release tablets once daily, from the second week of treatment. If you are very
elderly, your doctor may increase your dose more slowly. After that, your doctor may adjust
your dose until you take the dose that is best for you. Some people take up to 24 mg
of Ropinirolo Krka prolonged-release tablets per day.
If you experience side effects at the beginning of treatment that you find difficult to tolerate, talk
to your doctor. Your doctor may advise you to switch to a lower dose of ropinirole immediate-release tablets to be taken three times a day.

Do not take more Ropinirolo Krka than you have been recommended by your doctor.
It may take several weeks for Ropinirolo Krka to work for you.

How to take your dose of Ropinirolo Krka
Take Ropinirolo Krka once a day, at the same time each day.

Swallow your Ropinirolo Krka prolonged-release tablet(s)
whole, with a glass of water.
DO NOT break, crush or chew the prolonged-release tablets. If you do,
there is a risk of overdose because the medicine will be released into your
body too quickly.

Switching from ropinirole immediate-release tablets
Your doctor will base your dose of Ropinirolo Krka prolonged-release tablets on the dose of
ropinirole immediate-release tablets you are taking.
Take your ropinirole immediate-release tablets as usual the day before
switching. Then take Ropinirolo Krka prolonged-release tablets the next morning and do not
take any more ropinirole immediate-release tablets.

If you take more Ropinirolo Krka than you should
Contact your doctor or pharmacist immediately.If possible, show them the pack of
Ropinirolo Krka.
Someone who has taken an overdose of Ropinirolo Krka may experience some of these symptoms:
feeling nauseous, vomiting, dizziness (feeling faint), feeling sleepy,
physical or mental fatigue, fainting, hallucinations.

If you forget to take Ropinirolo Krka
Do not take a double dose to make up for a missed dose.
If you have forgotten to take Ropinirolo Krka for one or more days, ask your doctor for advice on
how to resume taking it.

If you stop taking Ropinirolo Krka
Do not stop taking Ropinirolo Krka without talking to your doctor.
Take Ropinirolo Krka for the entire period indicated by your doctor. If you stop taking Ropinirolo
Krka suddenly, the symptoms of Parkinson's disease may worsen rapidly.
Sudden discontinuation could also induce the development of 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, decreased level of consciousness
(coma).
If you need to stop therapy with Ropinirolo Krka, your doctor will gradually reduce your dose.
If you have any further 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.
Side effects of Ropinirolo Krka are more likely to occur when you start taking it
or with increases in dose. They are usually mild and may become less troublesome after you have taken
the dose 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 feeling sleepy beforehand (sudden sleep attacks);
• hallucinations (“seeing” things that are not real);
• feeling sick (vomiting);
• dizziness (feeling like you are spinning);
• heartburn;
• stomach pain;
• 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 getting up quickly (this is caused by a drop in blood pressure);
• feeling sleepy during the day (excessive sleepiness);
• mental problems such as delirium (severe confusion), illusions (false beliefs) or paranoia (unfounded suspicion).

Some patients may experience the following side effects

• allergic reactions such as itchyred rashes on the skin (urticaria), swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing, rashand intense itching (see section 2);
• changes in liver function, evident in blood tests;
• aggressive behaviour;
• excessive use of Ropinirolo Krka (a desire for large doses of dopaminergic drugs in excess of what is needed to control motor symptoms, known as dopamine agonist withdrawal syndrome);
• after stopping or reducing treatment with Ropinirolo Krka: depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS);
• an inability to resist the urge to perform actions that could be harmful, which may include:
• a strong urge to gamble excessively, despite serious personal or family consequences;
• altered or increased sexual interest and behaviour that is distressing to you or others, for example, an increased sexual drive;
• compulsive 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 you need to satisfy your hunger).

Tell your doctor if you experience any of these behaviours, so they can decide how
to intervene to manage or reduce the symptoms.
If you are taking Ropinirolo Krka with L-dopa:
Patients taking Ropinirolo Krka with L-dopa may develop other side effects over time:

• involuntary jerky movements (dyskinesia) is a very common side effect. If you are taking L-dopa, you may experience some uncontrollable movements (dyskinesia) when you start taking Ropinirolo Krka. If this happens, tell your doctor, as they

may need to adjust the dose of the medicines you are taking.

• feeling confused is a common side effect.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the blister and the carton after
EXP/Scad. The expiry date refers to the last day of that month.
Do not store at a temperature above 30˚C.
Store in the original packaging to protect from moisture.
Do not dispose of any medicine in waste water 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 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, lactose monohydrate, anhydrous colloidal silicon dioxide, 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 paragraph 2). Ropinirolo Krka 4 mg and 8 mg prolonged-release tablets:hypromellose type 2208, lactose monohydrate, anhydrous colloidal silicon dioxide, 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 paragraph 2).

Description of the appearance of Ropinirolo Krka and package contents

Ropinirolo Krka 2 mg prolonged-release tablets:Pink, biconvex and oval tablets.

Ropinirolo Krka 4 mg prolonged-release tablets:Light brown, biconvex and
oval tablets.

Ropinirolo Krka 8 mg prolonged-release tablets:Red-brown, biconvex and oval tablets.
The tablets are available in boxes 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 Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations: