ROPINIROLO 2 мг Таблетки с пролонгированным высвобождением

Содержание инструкции

1. Ropinirolo Sandoz 2 mg prolonged-release tablets, 4 mg prolonged-release tablets, 8 mg prolonged-release tablets
   1. What is Ropinirolo Sandoz and what is it 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. Content of the pack and other information

Information for the patient

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

Ropinirolo

Generic medicine

Read this leaflet carefully before taking this medicine as 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 because 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 Sandoz is and what it is used for
• 2. What you need to know before you take 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 is Ropinirolo Sandoz and what is it used for

The active ingredient of Ropinirolo Sandoz is ropinirole, which belongs to a group of medicines known as
dopamine agonists, which have similar effects on the brain to that of 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 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 Sandoz

DO NOT TAKE Ropinirolo Sandoz

• if you are allergicto 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 apply to you.

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

• if you are pregnantor think you might 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 behaviour);
• if you have an intolerance to certain sugars (such as lactose).

Inform your doctor if any of these conditions apply to you. Your doctor may decide that
Ropinirolo Sandoz is not suitable for you and that you need further checks during your treatment.
Dose adjustment may be required on a case-by-case basis according to the clinical response to the medicine.

During the intake of Ropinirolo Sandoz
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 impulse or temptation to carry out certain activities that could harm yourself or others.
These are called impulse control disordersand can include behaviours such as

compulsive gambling, overeatingor excessive spending, an increased sexual driveor thoughtsor feelings. Your doctor may decide to
change or stop your dose.
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain
after stopping or reducing your treatment with ropinirole. If the problems persist for more than a few
weeks, your doctor may need to change your treatment.

Smoking and Ropinirolo Sandoz
Tell your doctorif you start or stop smoking while taking Ropinirolo Sandoz. Your doctor may
decide to change your dose.

Other medicines and Ropinirolo Sandoz
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 you are
taking Ropinirolo Sandoz.
Some medicines can affect the way Ropinirolo Sandoz works, or make it more likely that
you will have side effects. Ropinirolo Sandoz 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 extra blood tests if you take these medicines with Ropinirolo Sandoz:

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

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breast-feeding,
ask your doctor or pharmacist for advice before taking this medicine.

Ropinirolo Sandoz is not recommended during pregnancyunless your doctor has decided that the benefit
for you of taking Ropinirolo Sandoz is greater than the risk to the foetus. Ropinirolo
Sandoz is not recommended in breastfeeding mothersas it may affect milk production.

Tellyour doctorimmediately if you are pregnant, suspect you are 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 Ropinirolo Sandoz.

Driving and using machines
Ropinirolo Sandoz can cause drowsiness. It can cause extreme sleepiness,and sometimes can cause

sudden sleep attacks without warning.
If you experience these symptoms: do not drive, operate machineryand do notput yourself in a
situation where drowsiness or falling asleep could put you (or others) at risk of serious injury or
death. Do not engage in these activities until the effects have worn off.

Tellyour doctor if this causes you problems.
Ropinirole can cause hallucinations (seeing, hearing or feeling things that are not there). If you experience these, do not drive and
do not operate machinery.

Ropinirolo Sandoz contains lactose. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Ropinirolo Sandoz

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

Do not give Ropinirolo Sandoz to children. Ropinirolo Sandoz is normally not prescribed to patients under
the age of 18.
Ropinirolo Sandoz may be prescribed to you alone to treat the symptoms of Parkinson's disease. Or
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 uncontrolled jerky movements when
you start taking Ropinirolo Sandoz. Tell your doctor if this happens, as your doctor may need to
reduce the dose of the medicines you are taking.
Ropinirolo Sandoz has been designed to release the drug over a period of 24 hours. If you have a condition such
that the drug passes through your body too quickly, for example in the case of diarrhea, the
tablets may not dissolve completely and therefore may not work properly. You
may see the tablet(s) in your stool. If this happens, tell your doctor as soon as
possible.

How much Ropinirolo Sandoz do you need to take?
It may take some time to find the best dose of Ropinirolo Sandoz for you.
The recommended starting doseof Ropinirolo Sandoz extended-release tablets is 2 mg once a
day for the first week. Your doctor may increase the dose to 4 mg of Ropinirolo Sandoz extended-release
tablets once a day, 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 Sandoz
extended-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 that you will need to take three times a day.

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

Take Ropinirolo Sandoz once a day, at the same time each day.
Swallow your Ropinirolo Sandoz extended-release tablet whole, with
a glass of water.
DO NOT break, crush or chew the extended-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 Sandoz extended-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 Sandoz extended-release tablets the next morning and stop taking the
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.
Someone who has taken an overdose of Ropinirolo Sandoz may experience some of these symptoms: feeling
unwell (nausea), feeling sick (vomiting), dizziness (a sensation of spinning), feeling
sleepy, physical or mental fatigue, fainting, hallucinations.

If you forget to take Ropinirolo Sandoz
Do not take extra extended-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 taking it.

If you stop taking Ropinirolo Sandoz
Do not stop taking Ropinirolo Sandoz without your doctor's advice.

Take Ropinirolo Sandoz for as long as your doctor tells you to.Do not stop unless your doctor
tells you to.
If you stop taking Ropinirolo Sandoz suddenly, the symptoms of Parkinson's disease may
worsen rapidly.
If you need to stop therapy with Ropinirolo Sandoz, your doctor will reduce your dose gradually.
If you suffer from Parkinson's disease, you should not abruptly stop treatment with Ropinirolo
Sandoz. A sudden interruption could cause the development of a condition called neuroleptic malignant
syndrome (NMS), which can be a serious health risk. The symptoms include:

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

If you have any 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 of Ropinirolo Sandoz 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 been taking the dose
for a while. If you are concerned about any side effects, speak with your doctor.

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

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

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

• “seeing” things that are not real (hallucinations)
• dizziness (feeling of spinning)
• falling asleep suddenly without any warning (sudden sleep attacks)
• feeling unwell (vomiting)
• abdominal pain
• 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 (hypotension)
• sudden drop in blood pressure when changing posture (postural hypotension)
• feeling sleepy during the day (excessive somnolence)
• mental problems such as serious confusion (delirium), unreasonable ideas (illusions) or unjustified suspicions (paranoia).

Side effects with frequency not known:

• 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 can cause difficulty swallowing or breathing (angioedema), skin rash and intense itching
• taking increasing amounts of medicine against medical advice and well beyond the doses needed to treat movement disorders (Dopamine Dysregulation Syndrome (DDS))
• inability to resist impulses, urges or temptations to perform actions that may be harmful, which may include:
• strong urge to gamble excessively despite serious personal or family consequences.
• altered or increased sexual interest and behaviour which is distressing to you or others, for example, increased sexual desire
• compulsive shopping or spending excessively
• 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)
• aggression (has been associated with psychotic reactions as well as compulsive symptoms)
• After stopping or reducing the treatment with Ropinirolo Sandoz: depression, apathy, anxiety, fatigue, sweating or pain (called dopamine agonist withdrawal syndrome) may occur.

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 the carton after the wording
EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 30˚C.
Store in the original package to protect from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Ropinirolo Sandoz contains
The active ingredient 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 ingredients are:

Ropinirolo Sandoz 2 mg prolonged-release tablets:
hypromellose type 2208, lactose monohydrate, anhydrous colloidal silicon dioxide, carbomers 4.000-11.000cP, 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, lactose monohydrate, anhydrous colloidal silicon dioxide, carbomers 4.000-11.000cP, 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 content of the pack

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

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

Ropinirolo Sandoz 8 mg prolonged-release tablets:
Red-brown, biconvex and oval tablets.
The tablets are available in boxes 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 Authorisation Holder and Manufacturers
Marketing Authorisation Holder
Sandoz SpA, Largo U. Boccioni, 1 – 21040 Origgio (VA)

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 authorised in the Member States of the European Economic Area with the following
denominations: