160 mm

160 mm

PACKAGE LEAFLET: INFORMATION FORTHE USER

ROPINIROLE 0.25 mg FILM-COATED TABLETS ROPINIROLE 0.5 mg FILM-COATED TABLETS ROPINIROLE 1.0 mg FILM-COATED TABLETS ROPINIROLE 2.0 mg FILM-COATED TABLETS

(ropinirole)

Readall ofthis leaflet carefully beforeyou start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    Ifyou have any further questions, askyour doctor or pharmacist (chemist).

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs ofillness arethe same as yours.

Ifyou get any sideeffects talk toyour doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Ropiniroleis and what it is used for.

2.    Whatyouneedtoknowbeforeyou takeRopinirole.

3.    HowtotakeRopinirole.

4.    Possiblesideeffects.

5.    How to store Ropinirole.

6.    Contents ofthe pack and other information.

1. WHAT ROPINIROLE IS ANDWHATITIS USED FOR

The active ingredient in Ropinirole is ropinirole, which belongs to a group ofmedicines called dopamine agonists. Dopamine agonists affect the brain in a similar way to a natural substance called dopamine.

Ropinirole is used to treat Parkinson's disease. People with Parkinson's disease have low levels ofdopaminein some parts oftheir brains. Ropinirolehas effects similar to those ofnatural dopamine, so it helps to reduce the symptoms of Parkinson's disease.

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Ropinirole is also used to treat the symptoms of

Cioderate to severe idiopathic Restless egs Syndrome.

Moderate to severe Restless Legs Syndrome is typically represented by patients who have difficulty sleeping or severe discomfort in their legs or arms.

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Restless Legs Syndrome is a condition characterised by an irresistible urge to move the legs and occasionally the arms, usually accompanied by uncomfortable sensations such as tingling, burning or prickling.Thesefeelings occur during periods ofrest or inactivity such as sitting or lying down, especially in bed, and are worse in theevening or at night.

Usually theonly reliefis obtained by walking about or moving theaffected limbs, which often leads to problems sleeping.

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Ropinirole relieves the discomfort and reduces the urge to move the limbs that disrupts night time sleep.

2. WHATYOUNEEDTOKNOWBEFOREYOU TAKE ROPINIROLE

Do not take Ropinirole:

•    ifyou are allergic to ropinirole hydrochloride or any ofthe other ingredients ofthis medicine listed in Section 6

ifyou have a serious kidneydisease if you have liver disease.

Tell your doctor ifyou think anyofthese may apply to you.

Warningsand precautions

Talk to your doctor or pharmacist before taking Ropinirole. Medicines are not always suitable for everyone. Your doctor needs to know beforeyou take Ropinirole ifyou suffer from or have suffered in the past from any of the following conditions:

•    you are pregnant or think you may be pregnant

•    you are breast-feeding

•    you are under 18years old

•    you have a serious heart complaint

•    you have a serious mental health problem.

Your doctor will then decide if Ropinirole is suitable for you, or whether you need extra check-ups while you are taking it.

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Tell your doctor ifyou or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourselfor others. These are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings.

Your doctor may need to adjust or stop your dose.

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SW-iile you are taking Ropinirole

yourdoctorifyou oryour familynoticesthatyou are developing any unusual behaviours (such as an unusual urgeto gambleorincreased sexual urges and/orbehaviours) whileyou aretaking Ropinirole. Your doctor may need to adjust or stop your dose.

Other medicines and Ropinirole

Tell yourdoctororpharmacist ifyouaretaking

or have recently taken any other medicines,

including any herbal medicines or other medicines you obtained without a prescription. Remember to tell your doctor or pharmacist ifyou begin taking newmedicine whileyou aretaking Ropinirole.

Some medicines can affect the way Ropinirole works, or make it more likely that you will have side effects. Ropinirole can also affect the way some other medicines work.

These include:

•    theanti-depressantfluvoxamine

•    medication for other mental health problems, for example sulpiride

•    HRT(hormonereplacementtherapy)

•    metoclopramide, which is used to treat nausea and heartburn

•    the antibiotics ciprofloxacin or enoxacin

•    any other medicine for Parkinson's disease or Restless Legs Syndrome.

Tell your doctor ifyou are taking, or have recently taken, anyofthese.

Smoking and Ropinirole

Tell your doctor ifyou start smoking, or give up smoking, while you are taking Ropinirole. Your doctor may need to adjust your dose.

Ropinirole with food and drink

Ifyou take Ropinirolewith food,you maybeless likely to feel sick (nauseous) or be sick (vomit). So it's best to take it with food ifyou can.

Pregnancyandbreast-feeding

Ropinirole is not recommended ifyou are pregnant, unless your doctor advises that the benefit to you oftaking Ropiniroleis greater than the risk to your unborn baby. Ropinirole is not recommended ifyou are breast-feeding, as it can affect your milk production.

Tell your doctor immediately ifyou are pregnant, if you think you might be pregnant, orifyou are planning to become pregnant. Your doctor will also adviseyou ifyou arebreast-feeding or planning to do so. Your doctor may advise you to stop taking Ropinirole.

Driving and using machines

Ropinirole can make you feel drowsy. It can make people feel extremely sleepy, and it sometimes makes people fall asleep very suddenly without warning.

Ifyou could beaffected: donot drive, do not operatemachines and do not putyourselfin any situation where feeling sleepy or falling asleep could put you (or other people) at risk of serious injury or death. Do not take part in these activities until you are no longer affected.

Talk to your doctor if this causes problems for you.

Important information about some of the ingredients of Ropinirole

This medicinal product contains lactose.

Ifyou havebeen told by your doctor thatyou have an intolerance to some sugars, contact your doctor before taking Ropinirole.

3. HOWTOTAKEROPINIROLE

Always take Ropinirole exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist ifyou are not sure.

You may be given Ropinirole on its own to treat the symptoms ofyour Parkinson's disease Restless Legs Syndrome. You may be given Ropinirole as well as another medicine called L-dopa (also called levodopa).

Do not give Ropinirole to children. Ropinirole is not normally prescribed for people under 18.

How much Ropinirole will you need to take?

Always take Ropinirole exactly as your doctor has told you. You should check with your doctor and pharmacist ifyou are not sure.

Swallow the Ropinirole tablet(s) whole with water. Do not chew the tablet(s).

Theexact dose ofRopinirole people takecan be different. Your doctor will decide on the dose you need to take each day and you should follow the doctors instructions. When you first start taking Ropinirole, the doseyou takewill be increased gradually.

Parkinson's disease

Itmay take a while to find out the best dose of Ropiniroleforyou.

The recommended starting dose is 0.25 mg of ropinirole three times each day for the first week. Then your doctor will increaseyour dose each week, for the next three weeks. After that, your doctor will gradually increase the dose until you are taking the dose that is best for you. The recommended dose is 1 mg to 3 mg three times each day (making a total daily dose of3 mg to 9 mg). Ifyour Parkinson's disease symptoms have not improved enough, your doctor may decide to gradually increase your dose some more. Some peopletakeup to8mg ofRopinirolethreetimes a day (24 mg daily altogether).

Ifyou are also taking other medicines for Parkinson's disease, your doctor may advise you to gradually reduce the dose of the other medicine.

Restless Legs Syndrome

Take Ropinirole once a day by mouth, everyday at the same time each day. Ropinirole is usually taken just before bedtime, but can be taken up to 3 hours before going to bed.

The starting dose is 0.25 mg once daily. After two daysyour doctor will probably increaseyour dose to 0.5 mg once daily for the remainder ofyour first week oftreatment.Thenyour doctor may gradually increaseyour doseover the next three weeks to a dose of2 mg per day. Ifyour symptoms have not improved, the dose may be increased gradually up to a maximumof4mg daily. After three months oftreatment with Ropinirole,your doctor may adjustyour doseor discontinueyour treatment depending on your symptoms and how you feel.

o not take any more Ropinirole than your doctor has recommended.

It may take a few weeks for Ropiniroleto workfor you.

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Ifyoursymptomsgetworse

Occasionally, people taking Ropinirole find that their Restless Legs Syndrome symptoms get worse. For example, symptoms may start earlier in the day, or after a shorter time at rest. Or the symptoms may affect other parts ofthe body, such as thearms.

See your doctor if this happens to you.

Taking your dose of Ropinirole

Swallowyour Ropinirolewhole, with a glass of water. It is best to take Ropinirole with food, because that makes it less likely that you will feel sick (nauseous).

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Ifyou takemore Ropinirolethanyou should

Contact a doctor or pharmacist immediately. If possible, show them the Ropinirole pack.

Someone who has taken an overdoseofRopinirole may have any of these symptoms: feeling sick (nausea), being sick (vomiting), dizziness (a spinning sensation), feeling drowsy, mental or physical tiredness, fainting, seeing, feeling or hearing things that are not there (hallucinations).

Ifyou forget to take Ropinirole

Do not take extra or a double dose to make up for a missed dose. Just take your next dose at the usual time.

Ifyou have missed taking Ropinirole for one day or more, askyour doctor for adviceon howto start taking it again.

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Do not stop taking Ropinirole without advice

Take Ropinirole for as long as your doctor recommends. Do not stop unless your doctor advises you to.

Ifyou suddenly stop taking Ropinirole,your symptoms may quickly get much worse.

Ifyou need to stop taking Ropinirole,your doctor will reduce your dose gradually.

If you have any further questions on theuseofthis product, ask your doctor or pharmacist.

4. POSSIBLESIDEEFFECTS

Like all medicines, Ropinirole can cause side effects, although not everybody gets them.

Theside effects ofRopinirole are more likely to happen when you first start taking it, or when your dose has just been increased.They areusually mild, and may become less troublesome after you have taken the dose for a while. Ifyou're worried about side effects, talk to your doctor.

Ifyou notice any of the following serious side effects, stop taking ropiniroleandcontact a doctorimmediately:

• swelling ofthe face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (frequency not known).

Tell your doctor ifyou experience anyofthese behaviors; they will discuss ways ofmanaging or reducing your symptoms.

Not known (cannot be estimated from the availabledata):

•    changes in the liver function, which have shown up in blood tests

•    allergic reactions such as red, itchy swellings on the skin (hives), rash or intense itching.

Ifyou'retaking Ropinirole with L-dopa

People who are taking Ropinirole with L-dopa may develop other side effects over time:

•    uncontrolled jerky movements are a very common side effect

•    feeling confused is a common side effect.

If you get side effects

Ifyou get any side effects talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.

5. HOWTOSTOREROPINIROLE

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 label and outer carton after 'EXP'.Theexpiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect theenvironment.

6. CONTENTSOFTHEPACKANDOTHER INFORMATION

What Ropinirolecontains

The active substance in Ropinirole is ropinirole.

Each film-coated tablet contains 0.25 mg,

0.5 mg, 1 mg or 2 mg ropinirole (as hydrochloride).

The other ingredients are: Cellulose, Microcrystalline, LactoseMonohydrate, Croscarmellose Sodium, Hypromellose, Magnesium stearate.

The Coating includes:

0.25 mg:

Hypromellose,Titanium Dioxide(E 171),

Macrogol 400, Polysorbate 80.

0.5 mg:

Hypromellose,Titanium Dioxide(E 171), Macrogol400, Ferric OxideYellow(E 172).

1    mg:

Hypromellose, Macrogol 400, FerricOxide(E172),TitaniumDioxide(E171), Indigo CarmineAluminium (E 132).

2    mg:

Hypromellose,Titanium Dioxide (E 171),

Macrogol 400, Ferric Oxide Red (E 172), FerricOxideYellow(E 172)

What Ropinirolelookslikeandcontentsofthepack

Your medicine comes as a film-coated tablet.

450 mm

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Other side effects

Verycommon sideeffects

Thesemay affect morethan 1 in 10people taking Ropinirole:

•    fainting (syncope)

•    feeling drowsy

•    feeling sick or being sick

•    uncontrollable movements (dyskinesia).

Common side effects

Thesemay affect upto1 in 10people taking Ropinirole:

•    hallucinations ('seeing' things that aren't really there)

•    feeling dizzy (a spinning sensation)

•    heartburn

•    abdominal pain

•    swelling ofthe legs

•    fatigue (mental or physical tiredness)

•    nervousness

•    worsening of RLS (symptoms may start earlier I than usual or be more intense, or affect other

I previously unaffected limbs, such as the arms or return in the early morning).

Ropinirole 0.25 mg: White to off-white colour, capsule shaped biconvex, film-coated tablets with break-lineon both sides.

Ropinirole 0.5 mg: Yellow coloured, capsule shaped biconvex, film-coated tablets with break-line on both sides.

Ropinirole 1 mg: Green coloured, capsule shaped biconvex, film-coated tablets with break-line on both sides.

Ropinirole 2 mg: Light pink, capsule shaped biconvex, film-coated tablets with break-line on both sides.

The tablet can be divided into equal halves.

Ropinirole is available in HDPE multidose container with child resistant closure (PP) of 21, 28, 84and 126 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN61TL,

United Kingdom.

Manufacturer

Generics [UK] Ltd., Potters Bar, Herts, EN6 1TL, United Kingdom.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft, H-2900 Komarom,

Mylan utca 1,Hungary.

Ropinirole can makeyou feel drowsy. It can make people feel extremely sleepy, and it sometimes makes people fall asleep very suddenly without warning. This can occur most commonly with people with Parkinson's. Ifyou experience this, then do not drive or operate machinery.

Uncommon sideeffects

Thesemay affect upto1 in 100peopletaking

Ropinirole:

•    lowblood pressure

•    feeling dizzy or faint, especially when you stand up suddenly (this is caused by a drop in blood pressure)

•    feeling very sleepy during the day (extreme somnolence)

falling asleep very suddenly without feeling sleepy first (sudden sleep onset episodes)

•    mental problems such as delirium (severe confusion), delusions (unreasonable ideas) or paranoia (unreasonable suspicions)

*    inability to resist the impulse, drive or temptation, to perform an action that could be harmful to you or others, which may include: strong impulse to gamble excessively despite serious personal or family consequences

*    altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive

*    uncontrollable excessive shopping or spending

*    binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).

This leaflet was last approved in: 03/2013

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