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PACKAGE LEAFLET: INFORMATION FOR THE USER_

Ropinirole 0.25mg Film-coated Tablets Ropinirole 0.5mg Film-coated Tablets Ropinirole 1mg Film-coated Tablets Ropinirole 2mg Film-coated Tablets

Ropinirole

Read all of this leaflet carefully before you start 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet.

What is in this leaflet:

1.    What Ropinirole is and what it is used for

2.    What you need to know before you take Ropinirole

3.    How to take Ropinirole

4.    Possible side effects

5.    How to store Ropinirole

6.    Contents of the pack and other information

Q What Ropinirole is and what it is used for

Ropinirolebelongstoagroupofmedicinescalleddopamine agonists. Dopamine agonists act like a naturally occurring chemical in your brain called dopamine.

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Ropinirole is used to treat

•    Parkinson's disease. Ropinirole works by acting in a similar way to natural dopamine and helps to reduce the symptoms of Parkinson's disease. Parkinson's disease is caused by dopamine dropping to low levels in the brain.

•    Restless Legs Syndrome. Ropinirole is used to treat the symptoms of moderate to severe idiopathic. Restless legs syndrome which often presents as difficulty sleeping or severe discomfort in the legs or arms.

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.These feelings occur during periods of rest or inactivity such as sitting or lying down, especially in bed, and are worse in the evening or at night. Usually the only relief is obtained by walking about or moving the affected limbs, which often leads to problems sleeping. Ropinirole relieves the discomfort and reduces the urge to move the limbs that disrupts night time sleep.

Q What you need to know before you take Ropinirole

Do NOT take Ropinirole 1mg Film-coated Tablets if you

•    Are allergic (hypersensitive) to ropinirole hydrochloride, allura red AC or any of the other ingredients of Ropinirole.

Do NOT take Ropinirole 0.25mg/0.5mg/1mg/2mg Film-coated Tablets if you

•    Are allergic (hypersensitive) to ropinirole hydrochloride or any oftheother ingredients of Ropinirole

•    Haveliverdisease

•    Haveseriouskidneydisease.

Warnings and precautions

Tell your doctor before you start to take this medicine if any

of the following apply to you. Your doctor may want to

carefully supervise your treatment or may want to reduce

your dose or stop your treatment:

•    Youhaveaseriousheartcomplaint

•    You have, or have ever had, serious mental health problems

•    If you or your family/carer notices that you are developing

urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive 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 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.

Children and adolescents

Ropinirole should not be given to children and adolescents under the age of 18 years.

Other medicines and Ropinirole

Tell your doctor if you:

•    Are already receiving any other medicines for restless legs syndrome

•    Are taking other medicines for Parkinson's disease

•    Give up or start smoking whilst taking Ropinirole.

Your doctor may need to adjust your dose.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effect of Ropinirole may be increased or decreased by other medicines and vice versa. These medicines include:

•    Ciprofloxacin or enoxacin (types of antibiotics used to treat infections)

•    Cimetidine (used to treat stomach ulcers)

•    Fluvoxamine (used to treat depression)

•    Theophylline (used to treat asthma)

•    Hormone replacement therapy (also called HRT, used to treat symptoms of the menopause)

•    Drugs used to treat psychiatric conditions and other drugs that block dopamine in the brain (e.g. sulpiride or metoclopramide)

•    Drugs used to lower the blood pressure or to treat

•    heart problems.

Ropinirole with food and drink

Ropinirole should be taken with food as this may reduce the likelihood ofyou feeling or being sick. You should not drink alcohol whilst taking Ropinirole.

Pregnancy, breast-feeding and fertility

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

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Ropinirole can cause dizziness, extreme sleepiness (somnolence) and sudden sleep onset episodes (suddenly falling asleep without apparently feeling sleepy). If you suffer from these effects you must not drive or put yourself in a situation where sleepiness or falling asleep may put you at risk of serious injury or death (for example using machinery) until these episodes have been resolved.

Important information about some of the ingredients of Ropinirole.

Ropinirole contains lactose monohydrate, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Ropinirole img Film-coated Tablets also contain allura red AC, a type of dye. This may cause allergic reactions (See section 4 possible side effects).

Q How to take Ropinirole

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

How to take Ropinirole for Parkinson's disease

You may be given Ropinirole on its own to treat the

symptoms of your Parkinson's disease. Or you may be given Ropinirole as well as another medicine called L-dopa (also called levodopa).

Ropinirole should be taken three times a day.

The usual starting dose is o.25mg ropinirole three times a day for the first week. Your doctor will then increase your dose gradually each week for the next three weeks. After that, your doctor will gradually increase the dose until you are taking the best dose for you. The usual dose is img to 3mg three times a day (a total daily dose of 3mg to gmg). Some people take upto 8mg three times a day (a total daily dose of 24mg).

How to take Ropinirole for Restless Legs Syndrome

Take Ropinirole once a day, every day at about 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 usual starting dose is o.25mg once daily. After two days your doctor will probably increase your dose to o.smg once daily for the remainder of your first week of treatment. Then your doctor may increase your dose by o.smg per week over three weeks to a dose of2mg per day. In some patients with insufficient improvement, the dose may be increased gradually uptoa maximum of 4mg daily.

Use in Children and Adolescents

Ropinirole should not be given to children and adolescents under the age of 18 years.

Taking your dose of Ropinirole

You should swallow the film-coated tablet(s) whole with water and preferably with food.Taking Ropinirole with food may decrease the occurrence of nausea (feeling sick) which is a possible side effect of Ropinirole.

Do not chew the film-coated tablet(s).

After three months of treatment with Ropinirole, your doctor may adjust your dose or discontinue your treatment dependingonyour symptoms and howyou feel.

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You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to work for you. If you have the impression that the effect of Ropinirole is too strong or too weak, talk to your doctor or pharmacist. Do not take more tablets than your doctor has recommended.

If you take more Ropinirole than you should

You should never take more tablets than your doctor recommends. If you take moreRopinirolethanyoushould,or if someone else has taken your medicine, tell a doctor or pharmacist immediately. Showthem the package.

If you forget to take Ropinirole

Do not take a double dose to make upfora forgotten dose. If you find you have forgotten to take a dose of your Ropinirole, leave out that dose completely and take your next dose at the normal time.lfyou havemissed taking Ropiniroleformore than a few days consult your doctor for advice on restarting Ropinirole.

If you stop taking Ropinirole

You should not stop treatment with Ropinirole unless your doctor has told you to. If you are being treated for Parkinson's disease, treatment should be stopped gradually by reducing the number of daily doses over a period of one week. If your symptoms worsen after you stop treatment with Ropinirole, you should contact your doctor.

If you have any further questions on the use ofthis product, ask your doctor or pharmacist.

Q Possible side effects

Like all medicines, Ropinirole can cause side effects, although not everybody gets them. Tell your doctor if you notice any side effects and they worry you.The more common side effects of Ropinirole are usually mild and usually occur when patients first start their therapy and/or when the dose is increased.

Tell your doctor if you experience:

Unusual worsening of symptoms (e.g. symptoms become worse, start earlier in the day or after less time at rest, or

affect other parts of your body such as yours arms) during

treatment for restless legs syndrome. Your doctor may adjust

the dose of Ropinirole that you are taking.

Very common side effects (affecting more than linio people)

•    Fainting

•    Unwanted jerky movements [particularly if you are also taking levodopa(L-Dopa)]

•    Feelingdrowsyorsleepy

•    Feeling or being sick. Taking Ropinirole with food may reduce the chance of this effect.

Common side effects (affecting less than 1 in 10 people)

•    Feeling confused [particularly if you are also taking levodopa (L-Dopa)]

• Hallucinations (seeing or hearing things)

• Dizziness (or spinning sensation)

•    Stomach ache (abdominal pain) or upset stomach (with indigestion or bloating). Taking Ropinirole with food may reduce the chance of these effects

•    Swelling of the legs (oedema)

•    Nervousness

•    Fatigue (mental or physical tiredness).

Uncommon side effects (affecting less than 1 in 100 people)

•    Psychotic reactions such as irrational ideas (delusion), irrational suspiciousness (paranoia) and severe confusion (delirium)

•    Excessive daytime drowsiness (extreme somnolence)

•    Sudden sleep onset episodes (suddenly falling asleep without feeling sleepy)

•    Reduced blood pressure, which may make you feel dizzy or faint especially when standing up from a sitting or lying position.

Very rare side effects (affecting less than 1 in 10,000 people)

•    Changes in your liver function (abnormal blood tests). Your doctor may want to monitor you.

Some patients may have the following side effects:

•    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).

Ropinirole img Film-coated Tablets contain allura red AC, a type of dye. Allura red AC may cause allergic reactions.

If any of the side effects gets serious, if you notice any side effects not listed in this leaflet, or if you experience any of these behaviours, please tell your doctor or pharmacist; they will discuss ways of managing or reducing the symptoms.

@ How to store Ropinirole

Keep out of the sight and reach of children.

Do not use Ropinirole after the expiry date which is stated on the blister and the carton after EXP: The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicinesyounolongeruse.Thesemeasureswillhelpto protect the environment.

Q Contents of the pack and other information What Ropinirole contains

The active substance is ropinirole. Each film-coated tablet contains o.25mg, o.smg, img, 2mg of ropinirole (as hydrochloride).

The other ingredients of the tablet core are lactose monohydrate, cellulose, microcrystalline, maize starch, silica

colloidal anhydrous, magnesium stearate. The film coating contains:

0.25mg film-coated tablets: hypromellose 6 cp (E464), lactose monohydrate, titanium dioxide (E171), macrogol 3350, triacetin iron oxide yellow (E172), iron oxide black (E172) quinoline yellow aluminium lake (E104)

0.5mg film-coated tablets: hypromellose 6 cp (E464), lactose monohydrate, titanium dioxide (E171), macrogol 3350, triacetin indigo carmine aluminium lake (E132), quinoline yellow aluminium lake (E104).

1mg film-coated tablets: hypromellose 15 cp (E464), lactose monohydrate, titanium dioxide (E171), macrogol 4000, iron oxide red (E172), allura red AC aluminium lake (E129), indigo carmine aluminium lake (E132).

2mg film-coated tablets: hypromellose 15 cp (E464), lactose monohydrate, titanium dioxide (E171), macrogol 4000, iron oxide red (E172), sodium citrate dehydrate (E331C).

What Ropinirole looks like and contents of the pack

Ropinirole is supplied as film-coated tablets.

Ropinirole o.25mg Film-coated Tablets are blue, round, biconvextablets embossed with ‘RO’ on one side and '025' on the other side. They are available in blister packs of 2,12, 21, 84,126 and 210 tablets.

Ropinirole o.smg Film-coated Tablets are green, round, biconvextablets embossed with ‘RO’ on one side and '05' on the other side. They are available in blister packs of 21, 28 and 84, tablets.

Ropinirole img Film-coated Tablets are pink, round, biconvex tablets embossed with ‘RO’ on one side and 'i' on the other side. They are available in blister packs of 21, 28 and 84, tablets.

Ropinirole 2mg Film-coated Tablets are white, round, biconvextablets embossed with ‘RO’ on one side and '2' on the other side. They are available in blister packs of 21, 28 and

84, tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Pliva Pharma Ltd.,

Ridings Point, Whistler Drive,

Castleford, West Yorkshire,

WF10 5HX, UK.

Manufacturer

Teva Operations Poland Sp. z.0.0. ul. Mogilska 80 31-456 Krakow Poland.

This leaflet was last revised in November 2012

PL 10622/0319 PL 10622/0320 PL 10622/0321 PL 10622/0322

01015-C

® PLIVA

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