ROPINIROLO 2 мг Таблетки с пролонгированным высвобождением

Содержание инструкции

1. ROPINIROLO DOC Generici 2 mg prolonged-release tablets, 4 mg prolonged-release tablets, 8 mg prolonged-release tablets
   1. What is ROPINIROLO DOC Generici and what is it used for
   2. What you need to know before taking ROPINIROLO DOC Generici
   3. How to take ROPINIROLO DOC Generici
   4. Possible side effects
   5. How to store ROPINIROLO DOC Generici
   6. Package Contents and Other Information

ROPINIROLO DOC Generici 2 mg prolonged-release tablets, 4 mg prolonged-release tablets, 8 mg prolonged-release tablets

generic medicine

Read this leaflet carefully before you start 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 they have the same symptoms as you, as it may 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 DOC Generici is and what it is used for
• 2. What you need to know before you take ROPINIROLO DOC Generici
• 3. How to take ROPINIROLO DOC Generici
• 4. Possible side effects
• 5. How to store ROPINIROLO DOC Generici
• 6. Contents of the pack and other information

1. What is ROPINIROLO DOC Generici and what is it used for

The active ingredient of ROPINIROLO DOC Generici is ropinirole, which belongs to a group of medicines known
as dopamine agonists. Dopamine agonists stimulate the brain in a similar way to the natural substance
called dopamine.

ROPINIROLO DOC Generici is used for the treatment of Parkinson's disease.
People affected by Parkinson's disease have low levels of dopamine in some parts of the brain.
Ropinirole has effects similar to those of natural dopamine and helps to reduce the symptoms of Parkinson's
disease.

2. What you need to know before taking ROPINIROLO DOC Generici

Do not take ROPINIROLO DOC Generici

• 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.

Consult your doctor if you think any of these conditions apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking ROPINIROLO DOC Generici.
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain
after stopping or reducing treatment with ropinirole (dopaminergic agonist withdrawal syndrome or DAWS). If the problems persist for more than a few weeks, your doctor may need to
adjust your treatment.
Tell your doctor if you or someone caring for 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 disorders and can include behaviours such as gambling addiction, 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 your dose or
stop treatment.
Before taking ROPINIROLO DOC Generici your doctor must be informed:

• if you are pregnantor think you might be pregnant
• if you are breastfeeding
• if you are under 18 years of age
• if you have a serious heart condition
• if you have serious mental health problems
• if you have experienced unusual impulses and/or behaviours(e.g. excessive gambling or excessive sexual behaviour) (see section 4)
• 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 will assess whether
ROPINIROLO DOC Generici is not suitable for you or whether further investigations will be necessary while
you are taking ROPINIROLO DOC Generici.

Other medicines and ROPINIROLO DOC Generici
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 about any new medicines you are taking while you are taking
ROPINIROLO DOC Generici.
Some medicines can affect the action of ROPINIROLO DOC Generici or increase the likelihood
of side effects. ROPINIROLO DOC Generici can also affect the action of other medicines.
These medicines include:

• the antidepressant fluvoxamine
• medicines for the treatment of other mental health problems, e.g. sulpiride
• HRT(hormone replacement therapy)
• metoclopramide, used to treat nausea and heartburn
• 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.
Further blood tests may be necessary if you are taking the following medicines with
ROPINIROLO DOC Generici:

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

Smoking and ROPINIROLO DOC Generici
Tell your doctor if you start or stop smoking while taking ROPINIROLO DOC
Generici. Your doctor may need to adjust the dosage.

ROPINIROLO DOC Generici with food and drink
You can take ROPINIROLO DOC Generici with or without food, as you prefer.

Pregnancy, breastfeeding and fertility
If you are pregnant ROPINIROLO DOC Generici is not recommended, unless your doctor considers that the benefits
of ROPINIROLO DOC Generici for you are greater than the risk to the foetus.
ROPINIROLO DOC Generici is not recommended if you are breastfeeding as it may affect
milk production.
ROPINIROLO DOC Generici is not known to affect fertility in men.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor may also advise you if you are breastfeeding or planning to do so. Your doctor
may advise you to stop ROPINIROLO DOC Generici.

Driving and operating machinery
ROPINIROLO DOC Generici may make you feel tired. In some people it can cause extreme
sleepiness,and, in some cases, sudden sleep onset, without warning.
If you experience this: do not drive, do not operate machineryand do not engagein any activity in which
sleepiness or sudden sleep attacks could put you (or others) at risk of serious accidents or of
death. Do not engage in these activities until such episodes have resolved.
Talk to your doctor if this happens.
Ropinirole can cause hallucinations (seeing, hearing or feeling things that are not there). If you experience this, do not drive and
do not operate machinery.
ROPINIROLO DOC Generici 2 mg:
The prolonged-release tablets of ROPINIROLO DOC Generici contain a sugar called

lactose. If your doctor has told you that you have an intolerance to certain sugars, contact them before taking
this medicine.
ROPINIROLO DOC Generici 4 mg:
The prolonged-release tablets of ROPINIROLO DOC Generici contain a colouring agent called

sunset yellow (E110)which may cause allergic reactions.

3. How to take ROPINIROLO DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
ROPINIROLO DOC Generici can be prescribed alone for the treatment of the symptoms of Parkinson's disease. ROPINIROLO DOC Generici can also be prescribed in combination with another medicine
called L-dopa (also called levodopa). If you are already taking L-dopa, it is possible that when you start
taking ROPINIROLO DOC Generici, you may experience uncontrollable movements (dyskinesia). Tell your
doctor if this happens, the doctor may need to adjust the dosage of the medicines you are taking.
The tablets of ROPINIROLO DOC Generici are designed to release the drug over a period
longer than 24 hours. If you suffer from a condition where the medicine passes too quickly through the body, for
example diarrhea, the tablets may not dissolve completely and not work correctly. You may
see the tablets in your stools. If this happens, tell your doctor as soon as possible.

How much ROPINIROLO DOC Generici do you need to take?
Determining what the best dosage of ROPINIROLO DOC Generici for you may require some
time.

The initialrecommendeddose is 2 mg once a day for the first week. From the second week
of treatment, your doctor may increase the dose of ROPINIROLO DOC Generici extended-release
tablets to 4 mg once a day. In very elderly patients, the doctor may increase the dose
very slowly. Subsequently, the doctor may adjust the dosage to establish the most
suitable dose for you. Some patients require up to 24 mg of ROPINIROLO DOC Generici extended-release
tablets per day.
If, at the beginning of treatment, you experience any undesirable effects that you find difficult to tolerate, talk to your
doctor. The doctor may advise you to switch to a lower dose of ropinirole film-coated tablets
(extended release) that must be taken three times a day.

Use in children and adolescents
Do not give ROPINIROLO DOC Generici to children.ROPINIROLO DOC Generici is not normally
prescribed to people under 18 years of age.

Do not take more tablets of ROPINIROLO DOC Generici than your doctor has recommended.
It takes several weeks for ROPINIROLO DOC Generici to work.

How to take ROPINIROLO DOC Generici
Take ROPINIROLO DOC Generici once a day, every day at about the same time.
Swallow the extended-release tablets of ROPINIROLO DOC Generici whole with a glass
of water.
Do not split, chew or crush the extended-release tablets; if you do, you run the risk of
overdose, because the medicine will be released too quickly into your body.

If you were taking ropinirole film-coated tablets (extended release)
The doctor will determine the dosage of ROPINIROLO DOC Generici extended-release tablets based
on the dose of ropinirole film-coated tablets (extended release) you were taking. The day
before switching to extended-release tablets, take ropinirole film-coated tablets (extended
release) as usual. The next morning, take ROPINIROLO DOC Generici extended-release
tablets and do not take any more ropinirole film-coated tablets (extended release).

If you take more ROPINIROLO DOC Generici than you should
Contact your doctor or pharmacist immediately.If possible, show them the package of ROPINIROLO
DOC Generici.
Anyone who takes a higher dose than they should of ROPINIROLO DOC Generici may experience any of
these symptoms: feeling unwell (nausea), vomiting, dizziness (vertigo), drowsiness, mental or physical
fatigue, fainting, hallucinations.

If you forget to take ROPINIROLO DOC Generici
Do not take an extra dose of extended-release tablets or a double dose to make up for the
missed dose.
If you have forgotten to take ROPINIROLO DOC Generici for one or more days, ask your doctor for advice.
The doctor will tell you how to restart taking the medicine.

If you stop taking ROPINIROLO DOC Generici
Do not suddenly stop taking ROPINIROLO DOC Generici without first
consulting your doctor.A sudden interruption of treatment can lead to the development of a condition
called neuroleptic malignant syndrome, which represents a serious health risk. Symptoms include:
akinesia (loss of muscle movement), stiff muscles, fever, unstable blood pressure, tachycardia
(increased heart rate), confusion, low level of consciousness (e.g. coma).

Take ROPINIROLO DOC Generici for the entire period recommended by your doctor.
Do not stop treatment unless your doctor advises you to do so.
If you suddenly stop treatment with ROPINIROLO DOC Generici, you may experience a rapid
worsening of the symptoms of Parkinson's disease.
If you need to stop treatment with ROPINIROLO DOC Generici, your doctor will gradually reduce the dose.
If you have any doubts 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 DOC Generici are more likely to occur when you first start taking it or when your
dose is increased.
Side effects are usually mild and may become less troublesome after you have been taking the
medicine for a short time.
Tell your doctor if side effects worry you.

Very common side effects
may affect more than 1 in 10people treated with ROPINIROLO DOC Generici

• fainting
• feeling sleepy
• feeling sick (nausea).

Common side effects
May affect 1 to 10 people in 100treated with ROPINIROLO DOC Generici

• hallucinations (“seeing” things that are not real)
• vomiting
• dizziness (feeling like you are spinning)
• heartburn
• stomach pain
• constipation
• swelling of the legs, feet or hands.

Uncommon side effects
May affect 1 to 100 people in 1,000treated with ROPINIROLO DOC Generici

• feeling dizzy or faint, especially when getting up quickly (this is caused by a drop in blood pressure)
• feeling very sleepy during the day (excessive sleepiness)
• falling asleep suddenly without warning (sudden onset of sleep)
• mental problems, for example delirium (severe confusion), mania (unreasonable ideas) or paranoia (unreasonable suspicions)
• hiccups.

Side effects of unknown frequency
The frequency cannot be estimated based on available data

• excessive use of ROPINIROLO DOC Generici (an urge to take high doses of dopaminergic drugs excessive to those required for motor symptom control, a condition known as dopamine dysregulation syndrome)
• after stopping or reducing treatment with ROPINIROLO DOC Generici: depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS)
• spontaneous erection of the penis.

Some patients may experience the following side effects

• allergic reactions such as e.g. red and itchy skin rash (urticaria), swelling of the face, lips, mouth, tongue or throat which can cause difficulty in swallowing or breathing, skin rash or intense itching (see section 2)
• changes in liver function which are detected by blood tests
• aggressive behaviour.

You may experience the following side effects:

• an inability to resist the impulse to perform actions that could be harmful to yourself or others, which may include:
• a strong urge to gamble excessively, despite serious personal or family consequences;
• altered or increased sexual interest and behaviour that causes significant distress to you or others; for example an increased sexual drive;
• compulsive shopping or spending;
• binge eating (eating large amounts of food in a short period of time) or bulimia (eating more food than normal and more than is needed to satisfy your hunger).

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

• uncontrollable movements (dyskinesia) is a very common side effect. If you are taking L-dopa, uncontrollable movements (dyskinesia) may occur when you start taking ROPINIROLO DOC Generici. Tell your doctor if this happens, as they 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, 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 DOC Generici

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 packaging. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
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 DOC Generici contains
The active ingredient of ROPINIROLO DOC Generici is ropinirole.
A prolonged-release tablet contains 2 mg, 4 mg or 8 mg of ropinirole (as hydrochloride).
The other ingredients are:

• Prolonged-release tablet core:ammonium methacrylate copolymer type B, hypromellose (E464), sodium lauryl sulfate, copovidone, magnesium stearate (E572).
• Tablet coating:

Description of the appearance of ROPINIROLO DOC Generici and package contents
ROPINIROLO DOC Generici 2 mg: prolonged-release tablet of pink colour, round, biconvex with a diameter of 6.8
± 0.1 mm and a thickness of 5.5  0.2 mm.
ROPINIROLO DOC Generici 4 mg: prolonged-release tablet of light brown colour, oval,
biconvex with dimensions 12.6 x 6.6 ± 0.1 mm in diameter and a thickness of 5.3  0.2 mm.
ROPINIROLO DOC Generici 8 mg: prolonged-release tablet of red colour, oval, biconvex with
dimensions 19.2 x 10.2 ± 0.2 mm in diameter and a thickness of 5.2  0.2 mm.
All formulations are available in PVC/PCTFE- Aluminium white opaque blisters in packs of 28 or 84 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano (Italy).

Manufacturer
Pharmathen S.A. - 6, Dervenakion str. - 153 51 Pallini, Attiki (Greece).
Pharmathen International S.A. - Industrial Park Sapes, Rodopi Prefecture, Block No 5 - Rodopi
69300 (Greece).