Ropinirole Teva Italia

Patient Information Leaflet: Information for the User

ROPINIROLO TEVA ITALIA 2 mg prolonged-release tablets, 4 mg prolonged-release tablets, 8 mg prolonged-release tablets

Generic 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ROPINIROLO TEVA ITALIA prolonged-release tablets are and what they are used for
2. What you need to know before taking ROPINIROLO TEVA ITALIA prolonged-release tablets
3. How to take ROPINIROLO TEVA ITALIA prolonged-release tablets
4. Possible side effects
5. How to store ROPINIROLO TEVA ITALIA prolonged-release tablets
6. Contents of the pack and other information

1. What ROPINIROLO TEVA ITALIA prolonged-release tablets are and what they are used for

The active substance of ROPINIROLO TEVA ITALIA prolonged-release tablets is ropinirole,
which belongs to a group of medicines called dopamine agonists. Dopamine agonists
act on the brain in the same way as a natural substance called dopamine.
ROPINIROLO TEVA ITALIA prolonged-release tablets are used for the treatment of
Parkinson's disease.
People affected by Parkinson's disease have low levels of dopamine in certain areas 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 should know before taking ROPINIRILO TEVA ITALIA prolonged-release tablets

DO NOT TAKE ROPINIROLO TEVA ITALIA prolonged-release tablets if:

• you are allergic to ropinirole or to any of the excipients of this medicine (listed in section 6).
• you suffer from severe kidney disease
• you suffer from liver disease. Please inform your doctor if you think any of the conditions listed above apply to you.

Warnings and precautions

Talk to your doctor before taking ROPINIROLO TEVA ITALIA prolonged-release tablets:

• 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 a serious mental health disorder
• if you have experienced strong urges and/or unusual behaviours (such as excessive gambling or hypersexuality) (see section 4 “Possible side effects”)
• if you have an intolerance to certain sugars (such as lactose). Inform your doctor if you think any of the above conditions apply to you. Your doctor may decide that ROPINIROLO TEVA ITALIA prolonged-release tablets are not suitable for you, or that you require additional monitoring while taking the tablets.

During treatment with ROPINIROLO TEVA ITALIA prolonged-release tablets, inform your doctor if you, a family member, or someone caring for you notices that you are developing impulses or urges 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 known as impulse control disorders and may include behaviours such as gambling addiction, binge eating or excessive spending, abnormally increased sexual desire, or an increase in sexual thoughts or sensations. Your doctor may consider it necessary to adjust or discontinue your treatment.

Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing treatment with ropinirole. If these problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Smoking and ROPINIROLO TEVA ITALIA prolonged-release tablets
Inform your doctor if you start or stop smoking while taking ROPINIROLO TEVA ITALIA prolonged-release tablets. Your doctor may need to adjust your dose or discontinue treatment.

Other medicines and ROPINIROLO TEVA ITALIA

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 if you start taking a new medicine while taking ROPINIROLO TEVA ITALIA prolonged-release tablets.
Some medicines may affect how ROPINIROLO TEVA ITALIA prolonged-release tablets work, or may increase the likelihood of other side effects. ROPINIROLO TEVA ITALIA prolonged-release tablets may also affect how other medicines work.
These include:

• the antidepressant fluvoxamine;
• medicines for other mental health conditions, for example sulpiride;
• HRT (hormone replacement therapy);
• metoclopramide, used to treat nausea and heartburn;
• the 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.

You will need additional blood tests if you are taking any of the following medicines together with ROPINIROLO TEVA ITALIA:

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

ROPINIROLO TEVA ITALIA prolonged-release tablets with food, drinks and alcohol

You may take ROPINIROLO TEVA ITALIA prolonged-release tablets with or without food.
It is not recommended to drink alcohol while taking ROPINIROLO TEVA ITALIA prolonged-release tablets.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
ROPINIROLO TEVA ITALIA prolonged-release tablets are not recommended during pregnancy unless your doctor determines that the benefit of taking ROPINIROLO TEVA ITALIA prolonged-release tablets outweighs the risk to the unborn baby.
ROPINIROLO TEVA ITALIA prolonged-release tablets are not recommended during breastfeeding, as they may affect milk production.
Your doctor will advise you if you are breastfeeding or planning to breastfeed. Your doctor may advise you to discontinue treatment with ROPINIROLO TEVA ITALIA prolonged-release tablets.

Driving and using machines

ROPINIROLO TEVA ITALIA prolonged-release tablets may make you feel sleepy. It may make people feel very drowsy, and sometimes cause sudden sleep without warning signs.
If you experience these symptoms: avoid driving, operating machinery, or placing yourself in situations where feeling sleepy or falling asleep could put you (or others) at risk of serious injury or death.
Do not engage in such activities until these episodes have resolved.
Inform your doctor if these symptoms cause you problems.
Ropinirole may cause hallucinations (seeing, hearing, or feeling things that are not there). If you experience hallucinations, do not drive or use machinery.

ROPINIROLO TEVA ITALIA prolonged-release tablets contain lactose.
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take ROPINIROLO TEVA ITALIA prolonged-release tablets

Always take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Do not administer ROPINIROLO TEVA ITALIA prolonged-release tablets to children.
ROPINIROLO TEVA ITALIA prolonged-release tablets are normally prescribed for individuals over 18 years of age.
ROPINIROLO TEVA ITALIA prolonged-release tablets may be prescribed alone for the treatment of Parkinson’s disease symptoms, or they may be prescribed in addition to another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience uncontrollable movements (dyskinesia) when starting treatment with ROPINIROLO TEVA ITALIA prolonged-release tablets. If this occurs, inform your doctor, who may need to adjust the doses of the medicines you are taking.
ROPINIROLO TEVA ITALIA modified-release tablets are formulated to release the medicine gradually over a 24-hour period. If a condition occurs in which the medicine passes through the body too quickly (for example, in case of diarrhoea), the tablets may not dissolve completely and may not work properly. You may find the tablets in your stools.
If this happens, inform your doctor as soon as possible.

How many ROPINIROLO TEVA ITALIA prolonged-release tablets should you take?
It takes time to find the right dose of ROPINIROLO TEVA ITALIA prolonged-release tablets suitable for you.
The recommended starting dose of ROPINIROLO TEVA ITALIA prolonged-release tablets is 2 mg once daily during the first week. Your doctor may increase the dose to 4 mg of ROPINIROLO TEVA ITALIA prolonged-release tablets once daily, starting from the second week of treatment. If you are elderly, your doctor may increase the dose more slowly. Afterwards, your doctor may adjust the dose until reaching the most appropriate one for you. Some people take up to 24 mg of ROPINIROLO TEVA ITALIA prolonged-release tablets daily.
If, at the beginning of treatment, you experience side effects that are difficult to tolerate, speak with your doctor. Your doctor may advise you to switch to a lower dose of immediate-release ropinirole tablets, to be taken three times daily.
Do not take more ROPINIROLO TEVA ITALIA prolonged-release tablets than prescribed by your doctor.
It may take several weeks before ROPINIROLO TEVA ITALIA prolonged-release tablets start to take effect.

Taking ROPINIROLO TEVA ITALIA prolonged-release tablets
Take ROPINIROLO TEVA ITALIA prolonged-release tablets once daily, at the same time each day.
Take ROPINIROLO TEVA ITALIA prolonged-release tablets with a glass of water, without crushing them.
DO NOT break, chew, or crush the prolonged-release tablet(s). Doing so may result in overdose, as the medicine would be released into the body too quickly.

Switching from immediate-release ropinirole tablets
Your doctor will determine your dose of ROPINIROLO TEVA ITALIA prolonged-release tablets based on the dose of immediate-release ropinirole tablets you are currently taking.
On the day before switching, take your usual dose of immediate-release ropinirole tablets. Then, take ROPINIROLO TEVA ITALIA prolonged-release tablets the following morning and stop taking immediate-release ropinirole tablets.

If you take more ROPINIROLO TEVA ITALIA prolonged-release tablets than you should
Contact a doctor or pharmacist immediately. If possible, show the ROPINIROLO TEVA ITALIA prolonged-release tablets packaging.
Symptoms of overdose with ROPINIROLO TEVA ITALIA prolonged-release tablets may include: feeling unwell (nausea), vomiting, dizziness (a spinning sensation), drowsiness, mental or physical fatigue, fainting, hallucinations.

If you forget to take ROPINIROLO TEVA ITALIA prolonged-release tablets
Do not take a double dose to make up for a missed dose.
If you have missed taking ROPINIROLO TEVA ITALIA prolonged-release tablets for one or more days, consult your doctor for advice on how to resume treatment.

If you stop taking ROPINIROLO TEVA ITALIA prolonged-release tablets
Do not stop treatment with ROPINIROLO TEVA ITALIA prolonged-release tablets suddenly without first talking to your doctor. Sudden discontinuation may 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 reduced level of consciousness (e.g. coma).
Take ROPINIROLO TEVA ITALIA prolonged-release tablets for the duration recommended by your doctor. Do not stop treatment unless advised by your doctor.
If you stop taking ROPINIROLO TEVA ITALIA prolonged-release tablets suddenly, symptoms of Parkinson’s disease may worsen rapidly.
If you need to stop treatment with ROPINIROLO TEVA ITALIA prolonged-release tablets, your doctor will gradually reduce the 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 everybody gets them.
Side effects with ROPINIROLO TEVA ITALIA prolonged-release tablets may occur more frequently at the beginning of treatment, or when the dose has recently been increased. They are usually mild and may become less troublesome after taking the medicine for some time. If any of the side effects worry you, tell your doctor.

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

• fainting
• drowsiness
• feeling unwell (nausea)

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

• hallucinations (‘seeing’ things that are not really there)
• feeling unwell (vomiting)
• dizziness (a spinning sensation)
• stomach burning
• stomach pain
• constipation
• swelling of the legs, feet or hands

Uncommon side effects (may affect up to 1 in 100 people)

• feeling dizzy or faint, especially when standing up suddenly (this is caused by a drop in blood pressure)
• feeling sleepy during the daytime (excessive sleepiness)
• falling asleep suddenly without first feeling sleepy (episodes of sudden sleep attacks)
• mental problems such as delirium (severe confusion), mania (irrational thoughts) or paranoia (irrational suspiciousness)

Some patients experience the following side effects

• allergic reactions such as flushing, itchy swellings on the skin (urticaria), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, rash or severe itching
• changes in liver function, as shown by blood tests
• acting in an aggressive manner
• excessive use of ROPINIROLO TEVA ITALIA (desire to take doses of dopaminergic medicines higher than needed to control motor symptoms, known as dopamine dysregulation syndrome)
• after stopping or reducing treatment with ROPINIROLO TEVA ITALIA: depression, apathy, anxiety, fatigue, sweating or pain (called dopamine agonist withdrawal syndrome or DAWS) may occur
• inability to resist the impulse to carry out actions 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 sexual desire
  • uncontrolled shopping or excessive spending
  • uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal, more than needed to satisfy your hunger)

If you experience any of these behaviours, inform your doctor, so that he/she can decide how to intervene to manage or reduce the symptoms.

If you are taking ROPINIROLO TEVA ITALIA prolonged-release tablets with L-dopa
Patients taking ROPINIROLO TEVA ITALIA prolonged-release tablets in combination with L-dopa may develop additional side effects over time:

• uncontrolled movements (dyskinesia) are a very common side effect. If you are taking L-dopa, you may develop some involuntary movements (dyskinesia) when you start taking ROPINIROLO TEVA ITALIA. If this happens, tell your doctor, as your doctor may need to adjust the dose of your medicines.
• feeling confused is a common side effect.

Reporting of side effects
If you get 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.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 ROPINIRIDE TEVA ITALIA prolonged-release tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or packaging following EXP. The expiry date refers to the last day of the month.
Do not store above 30 °C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What ROPINIROLO TEVA ITALIA Prolonged-Release Tablets Contain

• The active substance is ropinirole.
  ROPINIROLO TEVA ITALIA prolonged-release 2 mg tablets: Each prolonged-release tablet contains 2 mg of ropinirole (as hydrochloride).

ROPINIROLO TEVA ITALIA prolonged-release 4 mg tablets:
Each prolonged-release tablet contains 4 mg of ropinirole (as hydrochloride).
ROPINIROLO TEVA ITALIA prolonged-release 8 mg tablets:
Each prolonged-release tablet contains 8 mg of ropinirole (as hydrochloride).

• Other excipients are:
  ROPINIROLO TEVA ITALIA prolonged-release 2 mg 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 film coating.

ROPINIROLO TEVA ITALIA prolonged-release 4 mg and 8 mg 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 film coating.

Description of the Appearance of ROPINIROLO TEVA ITALIA Prolonged-Release Tablets and Pack Contents

ROPINIROLO TEVA ITALIA prolonged-release 2 mg tablets:
The tablets are pink, biconvex and oval in shape.

ROPINIROLO TEVA ITALIA prolonged-release 4 mg tablets:
The tablets are opaque light brown, biconvex and oval in shape.

ROPINIROLO TEVA ITALIA prolonged-release 8 mg tablets:
The tablets are reddish-brown, biconvex and oval in shape.

The tablets are available in packs of 7, 21, 28, 30, 42, 84, 90 and 100 prolonged-release tablets in blisters (OPA/Al/PVC//Al).
Not all pack sizes may be marketed.

Marketing Authorization Holder
TEVA Italia S.r.l.
Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturer Responsible for Batch Release
Krka d.d., Novo mesto Šmarješka cesta 6, Slovenia
TAD Pharma GmbH Heinz-Lohmann-Str. 5, D-27472 Cuxhaven, Germany
Merckle GmbH Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany

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