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PAGE 1: FRONT FACE (INSIDE OF REEL)

ROPINIROLE 0.25 mg FILM-COATED TABLETS ROPINIROLE 0.5 mg FILM-COATED TABLETS ROPINIROLE 1 mg FILM-COATED TABLETS ROPINIROLE 2 mg FILM-COATED TABLETS

PACKAGE LEAFLET INFORMATION FOR THE USER

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 further 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 this 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

OWHAT ROPINIROLE IS AND WHAT IT IS USED FOR

Ropinirole belongs to a group of medicines called dopamine agonists. This group of medicines mimics the effect of dopamine (a compound in the brain), which activates dopamine receptors.

Ropinirole is used to treat:

•    patients with Parkinson's disease (used alone or in combination with another medicine)

•    the symptoms of moderate to severe idiopathic Restless Legs Syndrome.

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.

OWHAT YOU NEED TO KNOW BEFORE YOU TAKE ROPINIROLE

Do not take Ropinirole

•    if you are allergic (hypersensitive) to ropinirole or any of the other ingredients of Ropinirole

•    if you are allergic (hypersensitive) to soya or peanut (for Ropinirole 0.5 mg, 1 mg and 2 mg film-coated tablets only)

•    if you have severe kidney problems

•    if you have liver problems.

Warnings and precautions

Talk to your doctor before taking Ropinirole

•    if you have neuroleptic akathisia (an inability to sit still or remain motionless caused by an antipsychotic medicine), tasikinesia (a compulsive tendency to walk caused by an antipsychotic medicine), or secondary Restless Legs Syndrome (caused by kidney problems, low iron anaemia or pregnancy)

•    if your Restless Legs Syndrome symptoms become worse earlier in the day or there is a reoccurrence of the symptoms in the early morning hours (your dosage may need to be adjusted or treatment stopped)

•    if you become sleepy or drowsy, or have episodes of sudden sleep onset (your dosage may need to be adjusted or treatment stopped)

•    if you have major psychiatric or psychotic disorders

•    if you have severe heart disease (blood pressure monitoring is recommended).

•    if you are taking any medicines used to treat high blood pressure and medicines used to suppress fast rhythms of the heart.

Tell your doctor 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 is not recommended for use in children and adolescents below 18 years.

Other medicines and Ropinirole

Talk to your doctor if you are taking any of the following:

•    high doses of oestrogens (hormone replacement therapy)

•    medicines known to inhibit the cytochrome P450 isoenzyme CYP1A2, such as ciprofloxacin (an antibiotic), enoxacin (an antibiotic) or fluvoxamine (used to treat depression)

•    stop or start smoking (your dose may need to be adjusted)

•    antipsychotic medicines and other medicines that block dopamine receptors in the brain, such as sulpiride (used to treat schizophrenia) or metoclopramide (used to treat nausea and vomiting).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Ropinirole with food and drink

Ropinirole should be taken with food to improve your ability to tolerate this medicine.

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.

Driving and using machines

Ropinirole may cause some people to become sleepy or drowsy and/or develop sudden sleep episodes. If this happens to you, do not drive or take on activities where impaired alertness may put you or others at risk of serious injury or death (e.g. operating machines) until the sleepiness or drowsiness and/or sudden sleep episodes have disappeared.

Important information about some of the ingredients of Ropinirole

This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Ropinirole.

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.

Restless Legs Syndrome

The dose should be taken just before bedtime, but can be taken up to 3 hours before retiring.

The initial dose is 0.25 mg once a day for 2 days. Afterwards, the dose can be increased in the following weeks to a maximum of 4 mg once a day.

For doses not possible with this medicinal product other strengths of this medicinal product are available.

Use in Children and Adolescents

Ropinirole is not recommended for use in children below 18 years.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Elderly

The dose should be increased in those over 65 years. This increase should be gradual.

Method of administration

The film-coated tablets should be swallowed whole with liquid and should be taken with food, to reduce the chance of feeling or being sick.

If you take more Ropinirole than you should

If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Ropinirole

If you forget to take a tablet, just carry on with the next one as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ropinirole

Contact your doctor if your symptoms get worse when you stop taking Ropinirole.

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.

The following side effects have been reported at the approximate frequencies shown:

Very common (affecting more than one person in 10):

•    Sleepiness

•    Fainting

•    Abnormal muscular movements

•    Feeling sick (nausea)

•    Being sick (vomiting).

Common (affecting fewer than one person in 10 but more than one person in 100):

•    Hallucinations (seeing things that are not really there)

•    Confusion

•    Dizziness (including vertigo)

•    Abdominal pain

•    Heartburn

•    Swollen legs

•    Nervousness

•    Fainting (in Restless Legs Syndrome)

•    Sleepiness

•    Fatigue (mental or physical tiredness).

Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):

•    Psychotic reactions (other than hallucinations) including delirium, delusions and paranoia

•    Excessive daytime sleepiness and sudden onset of sleep (in Parkinson's Disease)

•    Low blood pressure

•    A fall in blood pressure on standing up which causes dizziness, light-headedness or fainting.

Very rare (affecting fewer than one person in 10,000):

•    Liver reactions and increased liver enzymes.

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 0.5/1/2 mg film-coated tablets: lecithin (soya) may cause very rarely allergic reactions.

If any of the side effects get serious, or 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 that is stated on the blister foil and carton after EXP The expiry date refers to the last day of that month Ropinirole 0.25 mg: Do not store above 25°C. Store in the original container.

Ropinirole 0.5 mg: Do not store above 25°C. Store in the original container.

Ropinirole 1 mg: Do not store above 30°C. Store in the original container.

Ropinirole 2 mg: Do not store above 30°C. Store in the original container.

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.

©CONTENTS OF THE PACK AND OTHER INFORMATION

What Ropinirole contains

The active substance is ropinirole hydrochloride.

•    Each Ropinirole 0.25 mg film-coated tablet contains 0.285 mg ropinirole hydrochloride, equivalent to 0.25 mg ropinirole.

•    Each Ropinirole 0.5 mg film-coated tablet contains 0.57 mg ropinirole hydrochloride, equivalent to 0.5 mg ropinirole.

•    Each Ropinirole 1 mg film-coated tablet contains 1.14 mg ropinirole hydrochloride, equivalent to 1 mg ropinirole.

•    Each Ropinirole 2 mg film-coated tablet contains 2.28 mg ropinirole hydrochloride, equivalent to 2 mg ropinirole.

The other ingredients are: lactose monohydrate, microcrystalline cellulose,

hydroxypropylcellulose, croscarmellose sodium and magnesium stearate.

The tablet coating contains:

•    Ropinirole 0.25 mg (Opadry II 85F18422): poly(vinyl alcohol) - partially hydrolyzed, titanium dioxide (E171), macrogol 3350 and talc.

•    Ropinirole 0.5 mg (Opadry II 85G32558): poly(vinyl alcohol) - partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, lecithin (soya) (E322), iron oxide yellow (E172) and iron oxide black (E172).

•    Ropinirole 1 mg (Opadry II 85G11948): poly(vinyl alcohol) - partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, lecithin (soya) (E322), Fd&C Blue #2/ Indigo Carmine Aluminium (E132) and iron oxide yellow (E172).

•    Ropinirole 2 mg (Opadry II 85G34363): poly(vinyl alcohol) - partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, lecithin (soya) (E322), carmine (E120), iron oxide yellow (E172) and iron oxide black (E172).

What Ropinirole looks like and contents of the pack

Ropinirole 0.25 mg is a white, round slightly arched film-coated tablet, debossed "R 0.25" on one side and plain on the other.

Ropinirole 0.5 mg is a yellow, round slightly arched film-coated tablet, debossed "R 0.5" on one side and plain on the other.

Ropinirole 1 mg is a green, round slightly arched film-coated tablet, debossed "R 1" on one side and plain on the other.

Ropinirole 2 mg is a pink, round slightly arched film-coated tablet, debossed "R 2" on one side and plain on the other.

Ropinirole 0.25 mg comes in pack sizes of 12, 15, 21,24, 30, 60, 81,84, 90, 100, 126, 210 and 50 unit dose blisters (hospital presentation pack). Ropinirole 0.5 mg comes in pack sizes of 15, 21, 28, 30, 60, 84, 90, 100 and 126.

Ropinirole 1 mg comes in pack sizes of 15, 21,30, 60, 84, 90 and 100.

Ropinirole 2 mg comes in pack sizes of 15, 21,28, 30, 60, 84, 90 and 100.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Teva UK Limited, Eastbourne, BN22 9AG This leaflet was last revised in October 2012

PL 00289/1192, 1193, 1194 & 1195

TEUZD

TEVA UK LIMITED    62401_-B

TFWTl	Ref:	231-30-87084-W LEA ROPINIROLE A/S F/C TAB TUK					06 March 2013
TEVA UK LIMITED	Version:	1		Trackwise Parent: 163970	Child:	188102
PL Number(s), MA Holder & Packer: Reason for revision:	PL 00289/1192-5. TEVA UK Limited Licence (Post Licence Regulatory Team), Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann. Leaflet PL correction.

231-10-06633/06643/06653 34 (00011)

TBC Univers 8 Pt

PANTONE® GREEN C

PAGE 1: FRONT FACE (INSIDE OF REEL)

Ropinirole is used to treat:

•    patients with Parkinson's disease (used alone or in combination with another medicine)

•    the symptoms of moderate to severe idiopathic Restless Legs Syndrome.

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.

©WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROPINIROLE

Do not take Ropinirole

• if you are allergic (hypersensitive) to ropinirole or any of the other ingredients of Ropinirole • if you are allergic (hypersensitive) to soya or peanut (for Ropinirole 0.5 mg, 1 mg and 2 mg film-coated tablets only)

• if you have severe kidney problems • if you have liver problems.

Warnings and precautions

Talk to your doctor before taking Ropinirole • if you have neuroleptic akathisia (an inability to sit still or remain motionless caused by an antipsychotic medicine), tasikinesia (a compulsive tendency to walk caused by an antipsychotic medicine), or secondary Restless Legs Syndrome (caused by kidney problems, low iron anaemia or pregnancy)

• if your Restless Legs Syndrome symptoms become worse earlier in the day or there is a reoccurrence of the symptoms in the early morning hours (your dosage may need to be adjusted or treatment stopped)

• if you become sleepy or drowsy, or have episodes of sudden sleep onset (your dosage may need to be adjusted or treatment stopped)

• if you have major psychiatric or psychotic disorders

• if you have severe heart disease (blood pressure monitoring is recommended)

• if you are taking any medicines used to treat high blood pressure and medicines used to suppress fast rhythms of the heart.

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.

Driving and using machines

Ropinirole may cause some people to become sleepy or drowsy and/or develop sudden sleep episodes. If this happens to you, do not drive or take on activities where impaired alertness may put you or others at risk of serious injury or death (e.g. operating machines) until the sleepiness or drowsiness and/or sudden sleep episodes have disappeared.

Important information about some of the ingredients of Ropinirole

This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Ropinirole.

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.

Parkinson's Disease

The initial dose is 0.25 mg three times a day for 1 week (0.75 mg/day). Afterwards, your doctor may increase the dose according to the following schedule:

Following this, your doctor may continue to gradually increase the dose, up to a maximum of 24 mg/day.

Restless Legs Syndrome

The dose should be taken just before bedtime, but can be taken up to 3 hours before retiring. The initial dose is 0.25 mg once a day for 2 days. Afterwards, the dose can be increased in the following weeks to a maximum of 4 mg once a day.

TPTvTI	Ref:	231-30-87084-W LEA ROPINIROLE A/S F/C TAB TUK					06 March 2013
TEVA UK LIMITED	Version:	1		Trackwise Parent: 163970	Child:	188102
PL Number(s), MA Holder & Packer: Reason for revision:	PL 00289/1192-5. TEVA UK Limited Licence (Post Licence Regulatory Team), Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann. Leaflet PL correction.

231-10-06633/06643/06653 34 (00011)

TBC Univers 8 Pt

PANTONE® GREEN C

PAGE 2: REAR FACE (OUTSIDE OF REEL)

For doses not possible with this medicinal product other strengths of this medicinal product are available.

Use in Children and Adolescents

Ropinirole is not recommended for use in children below 18 years.

Elderly

The dose should be increased in those over 65 years. This increase should be gradual.

Method of administration

The film-coated tablets should be swallowed whole with liquid and should be taken with food, to reduce the chance of feeling or being sick.

If you take more Ropinirole than you should

If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Ropinirole

If you forget to take a tablet, just carry on with the next one as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ropinirole

Contact your doctor if your symptoms get worse when you stop taking Ropinirole.

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

4 POSSIBLE SIDE EFFECTS

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

The following side effects have been reported at the approximate frequencies shown:

Very common (affecting more than one person in 10):

•    Sleepiness

•    Fainting

•    Abnormal muscular movements

•    Feeling sick (nausea)

•    Being sick (vomiting).

Common (affecting fewer than one person in 10 but more than one person in 100):

•    Hallucinations (seeing things that are not really there)

•    Confusion

•    Dizziness (including vertigo)

•    Abdominal pain

•    Heartburn

•    Swollen legs

•    Nervousness

•    Fainting (in Restless Legs Syndrome)

•    Sleepiness

•    Fatigue (mental or physical tiredness).

Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):

•    Psychotic reactions (other than hallucinations) including delirium, delusions and paranoia

•    Excessive daytime sleepiness and sudden onset of sleep (in Parkinson's Disease)

•    Low blood pressure

•    A fall in blood pressure on standing up which causes dizziness, light-headedness or fainting.

Very rare (affecting fewer than one person in 10,000):

•    Liver reactions and increased liver enzymes.

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 0.5/1/2 mg film-coated tablets: lecithin (soya) may cause very rarely allergic reactions.

If any of the side effects get serious, or 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 that is stated on the blister foil and carton after EXP The expiry date refers to the last day of that month Ropinirole 0.25 mg: Do not store above 25°C. Store in the original container.

Ropinirole 0.5 mg: Do not store above 25°C. Store in the original container.

Ropinirole 1 mg: Do not store above 30°C. Store in the original container.

Ropinirole 2 mg: Do not store above 30°C. Store in the original container.

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.

©CONTENTS OF THE PACK AND OTHER INFORMATION

What Ropinirole contains

The active substance is ropinirole hydrochloride.

•    Each Ropinirole 0.25 mg film-coated tablet contains 0.285 mg ropinirole hydrochloride, equivalent to 0.25 mg ropinirole.

•    Each Ropinirole 0.5 mg film-coated tablet contains 0.57 mg ropinirole hydrochloride, equivalent to 0.5 mg ropinirole.

•    Each Ropinirole 1 mg film-coated tablet contains 1.14 mg ropinirole hydrochloride, equivalent to

1    mg ropinirole.

•    Each Ropinirole 2 mg film-coated tablet contains 2.28 mg ropinirole hydrochloride, equivalent to

2    mg ropinirole.

The other ingredients are: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium and magnesium stearate.

The tablet coating contains:

•    Ropinirole 0.25 mg (Opadry II 85F18422): poly(vinyl alcohol) - partially hydrolyzed, titanium dioxide (E171), macrogol 3350 and talc.

•    Ropinirole 0.5 mg (Opadry II 85G32558): poly(vinyl alcohol) - partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, lecithin (soya) (E322), iron oxide yellow (E172) and iron oxide black (E172).

•    Ropinirole 1 mg (Opadry II 85G11948): poly(vinyl alcohol) - partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, lecithin (soya) (E322), FD&C Blue #2/ Indigo Carmine Aluminium (E132) and iron oxide yellow (E172).

•    Ropinirole 2 mg (Opadry II 85G34363): poly(vinyl alcohol) - partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, lecithin (soya) (E322), carmine (E120), iron oxide yellow (E172) and iron oxide black (E172).

What Ropinirole looks like and contents of the pack:

Ropinirole 0.25 mg is a white, round slightly arched film-coated tablet, debossed "R 0.25" on one side and plain on the other.

Ropinirole 0.5 mg is a yellow, round slightly arched film-coated tablet, debossed "R 0.5" on one side and plain on the other.

Ropinirole 1 mg is a green, round slightly arched film-coated tablet, debossed "R 1" on one side and plain on the other.

Ropinirole 2 mg is a pink, round slightly arched film-coated tablet, debossed "R 2" on one side and plain on the other.

Ropinirole 0.25 mg comes in pack sizes of 12, 15, 21, 24, 30, 60, 81, 84, 90, 100, 126, 210 and 50 unit dose blisters (hospital presentation pack).

Ropinirole 0.5 mg comes in pack sizes of 15, 21, 28, 30, 60, 84, 90, 100 and 126.

Ropinirole 1 mg comes in pack sizes of 15, 21, 30, 60, 84, 90 and 100.

Ropinirole 2 mg comes in pack sizes of 15, 21, 28, 30, 60, 84, 90 and 100.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Teva UK Limited, Eastbourne, BN22 9AG

This leaflet was last revised in October 2012 PL 00289/1192, 1193, 1194 & 1195

^ET7W71

TEVA UK LIMITED 87084-W