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PACKAGE LEAFLET: INFORMATION FOR THE USER_

Ropinirole 5mg 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 yourdoctor 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

0 What Ropinirole is and what it is used for

Ropinirole belongs to a group of medicines called dopamine agonists. Dopamine agonists act like a naturally occurring chemical in your brain called dopamine.

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.

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(PANTONE® is a registered trademark of Pantone, Inc.)

Parkinson's disease is caused by dopamine dropping to low levels in the brain.

Q What you need to know before you take Ropinirole

Do NOT take Ropinirole if you

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

•    Haveliverdisease

•    Have serious kidney disease.

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:

•    You have a serious heart complaint

•    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 ofi8 years.

Other medicines and Ropinirole

Tell your doctor ifyou:

•    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 ofthe 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 of you feeling or being sick. You should not drink alcohol whilst taking Ropinirole.

Pregnancy, breast-feeding and fertility

Ropinirole is not recommended ifyou 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 ifyou are breast-feeding, as it can affect your milk production.

Tell yourdoctor immediately ifyou are pregnant, ifyou thinkyou might be pregnant, or ifyou 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). Ifyou sufferfrom 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.

0 How to take Ropinirole

Always take Ropinirole exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are notsure.

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 up to 8mg three times a day (a total daily dose of 24mg).

Use in Children and Adolescents

Ropinirole should not be given to children and adolescents under the age ofi8 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 depending on your symptoms and how you feel.

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. Ifyou take more Ropinirole than you should, or if someone else has taken your medicine, tell a doctor or pharmacist immediately. Show them the package.

If you forget to take Ropinirole

Do not take a double dose to make up for a 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. If you have missed taking Ropinirole for more than a few days consult your doctor for advice on restarting Ropinirole.

BLACK

Colours:

(PANTONE® is a registered trademark of Pantone, Inc.)

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 ofone week. Ifyoursymptoms worsen after you stop treatment with Ropinirole, you should contact your doctor.

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

© 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.

Very common side effects (affecting more than i in to 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 i in to people)

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

•    Hallucinations (seeing or hearing things)

•    Dizziness(orspinningsensation)

•    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 i in too 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 i 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:

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.

0 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 medicines you no longer use. These measures will help to protect the environment.

Q Contents of the pack and other information

What Ropinirole looks like and contents of the pack

Ropinirole is supplied as film-coated tablets.

Ropinirole smg Film-coated Tablets are yellow, round, biconvex tablets embossed with 'RO' on one side and '5' on the other side. They are available in blister packs of 21, 28 and 84 film-coated 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.

Lithuania: Ropinirole PLIVA smg pl_vele dengtos tablet_s

Romania: ROPINIROL PLIVA smg comprimate filmate Poland: LIRONA

This leaflet was last revised in November 2012.

PL 10622/0323

• 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).

What Ropinirole contains

The active substance is ropinirole. Each film-coated tablet contains s.omg of ropinirole (as hydrochloride).

The other ingredients ofthe tablet core are lactose monohydrate, cellulose, microcrystalline, maize starch, silica colloidal anhydrous, magnesium stearate. The film coating contains hypromellose 15 cp (E464), lactose monohydrate, macrogol 4000, titanium dioxide (E171), iron oxide yellow (E172) indigo carmine aluminium lake (E132), quinoline yellow aluminium lake (E104).

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom: Ropinirole smg Film-coated Tablets

Germany: Ropinirol AWD smg Filmtabletten

Slovak Republic: LIRONA smg

Czech Republic: LIRONA smg potahovane tablety

Hungary: Ropinirol Pliva smgtabletta

Ireland: Lirona smg Film-coated Tablets

Italy: Ropinirolo GERMED PLIVA

Spain: Ropinirol UR 5,omg comprimidos recubiertos

con pelfcula EFG

Estonia: Ropinirole PLIVA

Latvia: Ropinirole PLIVA smg apvalkotas tablets

01014-C

® PLIVA

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