Ropinirole Doc Generici

Package leaflet: Information for the user

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

Equivalent medicine
Please read this leaflet carefully before 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 effect, including those not listed in this leaflet, contact 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 taking 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 ROPINIROLO DOC Generici is and what it is used for

The active substance of ROPINIROLO DOC Generici is ropinirole, which belongs to a group of medicines known as dopamine agonists. Dopamine agonists stimulate the brain in a manner similar 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 certain parts of the brain. Ropinirole has effects similar to those of natural dopamine and helps 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 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.

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.
Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing treatment with ropinirole (dopamine agonist withdrawal syndrome or DAWS). If these problems persist for more than a few weeks, your doctor may need to adjust your treatment.
Inform your doctor if you or someone in your family or someone caring for you notices 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 the dose or discontinue therapy.
Before taking ROPINIROLO DOC Generici, you must inform your doctor:

• 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 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).

Inform your doctor if you think any of these conditions apply to you. Your doctor will assess whether ROPINIROLO DOC Generici is unsuitable for you or whether further investigations are needed while you are taking ROPINIROLO DOC Generici.
Other medicines and ROPINIROLO DOC Generici
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 about any new medicines you start taking while on ROPINIROLO DOC Generici.
Some medicines may affect the action of ROPINIROLO DOC Generici or increase the likelihood of side effects. ROPINIROLO DOC Generici may also affect the action of other medicines.
These medicines include:

• the antidepressant fluvoxamine
• medicines used to treat other mental health conditions, e.g. sulpiride
• HRT (hormone replacement therapy)
• metoclopramide, used to treat nausea and heartburn
• antibiotics ciprofloxacin or enoxacin
• any other medicine for Parkinson's disease.

Inform your doctor if you are taking or have recently taken any of these medicines.
Additional blood tests may be required 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
Inform your doctor if you start or stop smoking while taking ROPINIROLO DOC Generici. Your doctor may need to adjust your dose.
ROPINIROLO DOC Generici with food and drink
You may take ROPINIROLO DOC Generici with or without food, as you prefer.
Pregnancy, breastfeeding and fertility
ROPINIROLO DOC Generici is not recommended if you are pregnant, unless your doctor considers that the benefits of ROPINIROLO DOC Generici for you outweigh the risk to the fetus.
ROPINIROLO DOC Generici is not recommended if you are breastfeeding, as it may affect milk production.
It is not known whether ROPINIROLO DOC Generici affects fertility in men.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor may also advise you if you are breastfeeding or planning to breastfeed. Your doctor may recommend that you discontinue ROPINIROLO DOC Generici.
Driving and using machines
ROPINIROLO DOC Generici may make you feel tired. In some people it may cause excessive sleepiness, and in some cases, sudden onset of sleep without warning.
If you are affected in this way: do not drive, do not use machinery, and do not engage in any activity where drowsiness or sudden sleep attacks could put you (or others) at risk of serious injury or death. Do not engage in such activities until these episodes have resolved.
Discuss this with your doctor if this occurs.
Ropinirole may cause hallucinations (seeing, hearing, or feeling things that are not there). If you experience hallucinations, do not drive and do not use machinery.
ROPINIROLO DOC Generici 2 mg:
The prolonged-release tablets of ROPINIROLO DOC Generici contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her 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 exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
ROPINIROLO DOC Generici may be prescribed alone for the treatment of Parkinson’s disease symptoms. ROPINIROLO DOC Generici may also be prescribed in combination with another medicine called L-dopa (also known as levodopa). If you are already taking L-dopa, you may experience uncontrollable movements (dyskinesia) when you start taking ROPINIROLO DOC Generici. Inform your doctor if this occurs; your doctor may need to adjust the dosage of your medicines.
The ROPINIROLO DOC Generici tablets are designed to release the drug over a period exceeding 24 hours. If you have a condition causing the medicine to pass through your body too quickly (e.g. diarrhoea), the tablets may not dissolve completely and may not work properly. You may see the tablets in your stools. If this happens, inform your doctor as soon as possible.

How much ROPINIROLO DOC Generici should you take?
Determining the optimal dose of ROPINIROLO DOC Generici for you may take some time.
The recommended starting dose is 2 mg once daily for the first week. From the second week of treatment, your doctor may increase the dose of ROPINIROLO DOC Generici prolonged-release tablets to 4 mg once daily. In very elderly patients, your doctor may increase the dose more slowly. Afterwards, your doctor may adjust the dose until the most suitable dose for you is established. Some patients may require up to 24 mg of ROPINIROLO DOC Generici prolonged-release tablets per day.
If you experience side effects at the beginning of treatment that are difficult to tolerate, discuss this with your doctor. Your doctor may advise you to switch to a lower dose of ropinirole film-coated tablets (immediate-release), which must be taken three times daily.

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

Do not take more ROPINIROLO DOC Generici tablets than your doctor has recommended.
It may take several weeks for ROPINIROLO DOC Generici to take effect.

How to take ROPINIROLO DOC Generici
Take ROPINIROLO DOC Generici once daily, at approximately the same time each day.
Swallow the prolonged-release tablets whole with a glass of water.
Do not divide, chew or crush the prolonged-release tablets; doing so may result in overdose, as the medicine would be released too quickly into your body.

If you were previously taking ropinirole film-coated tablets (immediate-release)
Your doctor will determine the dose of ROPINIROLO DOC Generici prolonged-release tablets based on the dose of ropinirole film-coated tablets (immediate-release) you were previously taking. On the day before switching to the prolonged-release tablets, take your usual dose of ropinirole film-coated tablets (immediate-release). The following morning, take ROPINIROLO DOC Generici prolonged-release tablets and discontinue taking ropinirole film-coated tablets (immediate-release).

If you take more ROPINIROLO DOC Generici than you should
Contact your doctor or pharmacist immediately. If possible, show them the ROPINIROLO DOC Generici packaging.
Taking more than the prescribed dose of ROPINIROLO DOC Generici may cause any of the following symptoms: feeling unwell (nausea), vomiting, dizziness, somnolence, mental or physical fatigue, fainting, hallucinations.

If you forget to take ROPINIROLO DOC Generici
Do not take a double dose or an extra dose of prolonged-release tablets to make up for a missed dose.
If you have forgotten to take ROPINIROLO DOC Generici for one or more days, consult your doctor. Your doctor will advise you on how to resume treatment.

If you stop taking ROPINIROLO DOC Generici
Do not stop taking ROPINIROLO DOC Generici suddenly without first consulting your doctor. Abrupt discontinuation of treatment may lead to a serious condition called neuroleptic malignant syndrome, which poses a significant health risk. Symptoms include: akinesia (loss of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, and reduced level of consciousness (e.g. coma).
Take ROPINIROLO DOC Generici for the entire duration recommended by your doctor.
Do not stop treatment unless advised by your doctor.
If you stop taking ROPINIROLO DOC Generici suddenly, your Parkinson’s disease symptoms may rapidly worsen.
If treatment with ROPINIROLO DOC Generici needs to be discontinued, your doctor will gradually reduce your dose.

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 ROPINIRIROLE DOC Generici are more likely when you first start taking it or when the dose is increased.
Side effects are usually mild and may become less bothersome after you have been taking the medicine for a short period.
Consult your doctor if you are concerned about any side effects.

Very common side effects
May affect more than 1 in 10 people treated with ROPINIRIROLE DOC Generici

• fainting
• drowsiness
• feeling unwell (nausea)

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

• hallucinations (“seeing” things that are not real)
• vomiting
• dizziness (spinning sensation)
• heartburn
• stomach ache
• constipation
• swelling in the legs, feet or hands

Uncommon side effects
May affect 1 to 10 people in 1,000 treated with ROPINIRIROLE DOC Generici

• dizziness or fainting, especially when standing up suddenly (caused by a drop in blood pressure)
• excessive daytime sleepiness (extreme drowsiness)
• sudden sleep attacks without prior warning of sleepiness (sudden onset sleep episodes)
• mental problems, for example delirium (severe confusion), mania (irrational thoughts) or paranoia (unreasonable suspicions)
• hiccups

Side effects with unknown frequency
Frequency cannot be estimated from the available data

• excessive consumption of ROPINIRIROLE DOC Generici (craving for high doses of dopaminergic drugs exceeding those required to control motor symptoms, a condition known as dopamine dysregulation syndrome)
• after stopping or reducing treatment with ROPINIRIROLE DOC Generici: depression, apathy, anxiety, fatigue, sweating or pain may occur (known as dopamine agonist withdrawal syndrome or DAWS)
• spontaneous penile erection

Some patients may experience the following side effects

• allergic reactions such as, for example, red, itchy swelling of the skin (urticaria), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, skin rash or severe itching (see section 2)
• changes in liver function as shown by blood tests
• aggressive behaviour

You may experience the following side effects:

• inability to resist the impulse to carry out actions that could be harmful to yourself or others, which may include:
  • strong urge 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 libido;
  • uncontrolled 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).

Inform your doctor if any of these behaviours occur, so that appropriate action can be taken to manage or reduce the symptoms.

If you are taking ROPINIRIROLE DOC Generici with L-dopa
Patients taking ROPINIRIROLE DOC Generici with L-dopa may experience additional side effects over time:

• uncontrolled movements (dyskinesia) are a very common side effect. If you are taking L-dopa, uncontrolled movements (dyskinesia) may occur when you start taking ROPINIRIROLE DOC Generici. Inform your doctor if this happens, as your doctor may need to adjust the dosage of your medicines
• confusion is a common side effect.

Reporting of side effects
If you experience 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 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 ROPINIRONE DOC Generici

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 the carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
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. Pack contents and other information

What ROPINIROLO DOC Generici contains
The active substance in ROPINIROLO DOC Generici is ropinirole.
One prolonged-release tablet contains 2 mg, 4 mg or 8 mg of ropinirole (as hydrochloride).
The other components 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 contents of the pack
ROPINIROLO DOC Generici 2 mg: prolonged-release tablet, pink in colour, round, biconvex, 6.8
± 0.1 mm in diameter and 5.5 ± 0.2 mm in thickness.
ROPINIROLO DOC Generici 4 mg: prolonged-release tablet, light brown in colour, oval, biconvex,
12.6 x 6.6 ± 0.1 mm in size and 5.3 ± 0.2 mm in thickness.
ROPINIROLO DOC Generici 8 mg: prolonged-release tablet, red in colour, oval, biconvex,
19.2 x 10.2 ± 0.2 mm in size and 5.2 ± 0.2 mm in thickness.
All formulations are available in PVC/PCTFE-Aluminium opaque white blisters in packs of 28 or 84 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan (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).