teva UK Ref: 231-30-62401-D LEA ROPINIROLE A/S F/C TAB TUK <DEB Version: 1 07 July 2015

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 Ropinirole

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. See section 4.

planning to have a baby, ask your doctor or pharmacist for advise before taking this medicine.

Smoking and Ropinirole

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

Driving and using machines

Ropinirole can make you feel drowsy. In very rare cases, it can make people feel extremely sleepy

and it sometimes makes people fall asleep very suddenly without warning. If you could be affected: don't drive, don't operate machines and don't put yourself in any situation where feeling sleepy or falling asleep could put you (or other people) at risk of serious injury or death. Don't take part in these activities until you are no longer affected.

Talk to your doctor if this causes problems for you.

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

If your symptoms get worse

Some people taking Ropinirole find that their RLS symptoms get worse - for example, symptoms may start earlier than usual or be more intense, or affect other previously unaffected limbs, such as the arms or return in the early morning.

Tell your doctor as soon as possible if you get any of these symptoms.

3

What Ropinirole Teva is and what it is used for

Ropinirole contains Lactose

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.

Ropinirole belongs to a group of medicines called dopamine agonists. Dopamine agonists act in a similar way to a natural substance called dopamine, in the brain.

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.

3

How to take Ropinirole Teva

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

Position for pharmacode

People with Parkinson's disease have low levels of dopamine in some parts of their brains.

Ropinirole has effects similar to those of natural dopamine, so it helps to reduce the symptoms of Parkinson's disease.

Restless Legs (RLS) is also called Ekbom syndrome. People with restless legs syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of their bodies. Usually, they have unpleasant sensations in their limbs - sometimes described as 'crawling' or 'bubbling' - which can begin as soon as they sit or lie down, and are relieved only by movement. So they often have problems with sitting still, and especially with sleeping.

Ropinirole relieves the unpleasant sensations, and so reduces the urge to move the legs and other limbs.

You must talk to a doctor if you do not feel better or if you feel worse.

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).

If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking Ropinirole. Tell your doctor if this happens, as your doctor may need to adjust the dose of the medicines you are taking.

It may take a while to find out the best dose of Ropinirole for you. The usual starting dose is 0.25 mg of ropinirole three times each day for the first week. Then your doctor will increase your 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 usual is 1 mg to 3 mg three times each day (making a total daily dose of 3 mg to 9 mg). If your Parkinson's disease symptoms have not improved enough, your doctor may decide to gradually increase your dose some more.

3

What you need to know before you take Ropinirole Teva

Some people take up to 8 mg of Ropinirole three times a day (24 mg daily altogether).

Do not take Ropinirole

•    if you are allergic (hypersensitive) to ropinirole or any of the other ingredients of this medicine (listed in section 6)

•    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 disease.

Tell your doctor if you think any of these may

apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Ropinirole

•    if you are pregnant or think you may be pregnant

•    if you are breast-feeding

•    if you are under 18 years old

•    if you have a serious heart complaint

•    if you have a serious mental health problem

•    if you have experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour)

•    if you have intolerance to some sugars (such as lactose)

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

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.

Tell your doctor if you think any of these may apply to you.

Your doctor may need to adjust or stop your dose.

Children and adolescents

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

Other medicines and Ropinirole

Talk to your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines including any herbal remedies or other medicines you bought without a prescription. Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking 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:

•    the anti-depressant fluvoxamine

•    medication for other mental health problems,

for example sulpiride

•    any other medicine for Parkinson's disease

•    any other drug which blocks the action of dopamine in the brain

•    metoclopramide, which is used to treat nausea and heartburn

•    HRT (horm one replacement therapy)

•    the antibiotics ciprofloxacin or enoxacin

•    Tell your doctor if you are taking or have recently taken any of these.

Ropinirole with food and drink

If you take Ropinirole with food, you may be less likely to feel sick (nauseous) or be sick (vomit). So it may be best to take it with food if you can.

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. If you are pregnant or breast-feeding, think you may be pregnant or are

Don't take any more Ropinirole than your doctor has recommended.

It may take a few weeks for Ropinirole to work for you.

Method of administration

Take Ropinirole three times a day.

Swallow your Ropinirole tablets whole, with a glass of water. It's best to take Ropinirole with food, because that makes it less likely that you'll feel sick (nauseous).

Restless Legs Syndrome

It may take a while to find out the best dose of Ropinirole for you.

The usual starting dose is 0.25 mg once a day. After two days, your doctor will probably increase your dose to 0.5 mg daily for the rest of the week. Then your doctor may gradually increase your dose over the next three weeks, up to a daily dose of 2 mg.

If a 2 mg daily dose does not improve your RLS symptoms enough, your doctor may gradually increase your dose some more, up to a maximum of 4 mg daily. After you have been taking Ropinirole for three months, your doctor may adjust your dose or advise you to stop taking it.

If you feel that the effects of Ropinirole are too strong or too weak, talk to your doctor or your pharmacist. Do not take more Ropinirole than your doctor has recommended.

Carry on taking Ropinirole as your doctor advises, even if you do not feel better. Ropinirole may take a few weeks to work for you.

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

Method of administration

Take your Ropinirole tablet(s) once a day.

Swallow the tablet(s) whole, with a glass of water. Do not chew or crush the tablets.

You can take Ropinirole with or without food. If you take it with food, you may be less likely to feel sick (nauseous).

Ropinirole is usually taken just before bedtime, but you can take it up to 3 hours before you go to bed.).

Use in Children and Adolescents

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

Older people

Ropinirole dose should be individually titrated in patients over 65 years old, with careful monitoring of tolerability, to the optimal clinical response.

If you take more Ropinirole than you should

Contact a doctor or pharmacist immediately. If possible, show them the Ropinirole pack. Someone who has taken an overdose of Ropinirole may have any of these symptoms: feeling sick (nausea), being sick (vomiting), dizziness (a spinning sensation), feeling drowsy, mental or physical tiredness, fainting, hallucinations.

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

If you have missed taking Ropinirole for more than a few days, ask your doctor for advice on how to start taking it again.

If you stop taking Ropinirole

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

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you suddenly stop taking Ropinirole your Parkinson's disease symptoms may quickly get much worse.

If you need to stop taking Ropinirole your doctor will reduce your dose gradually.

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

Possible side effects

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

The side effects of Ropinirole are more likely to happen when you first start taking it, or when your dose has just been increased. They are usually mild, and may become less troublesome after you have taken the dose for a while.

If you're worried about side effects, talk to your doctor.

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

Possible side effects in treatment of Parkinson's disease

Very common: may affect more than 1 in 10 people

•    fainting

•    feeling drowsy

•    feeling sick (nausea)

Common: may affect up to 1 in 10 people

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

•    being sick (vomiting)

•    feeling dizzy (a spinning sensation)

•    heartburn

•    abdominal pain

•    swelling of the legs

Uncommon: may affect up to 1 in 100 people

•    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)

Not known: frequency cannot be estimated from the available data

•    a very small number of people have had changes in liver function, which have shown up in blood tests

•    allergic reactions such as red, itchy swellings on the skin (hives), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, rash or intense itching

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

•    Uncontrollable movements (dyskinesia) are a very common side effect. If you are taking L-dopa you may experience some uncontrollable movements (dyskinesia) when you first start taking Ropinirole. Tell your doctor if this happens, as your doctor may need to adjust the doses of the medicines you are taking

•    Feeling confused is a common side effect

Possible side effects in treatment of Restless Legs Syndrome:

Very common: may affect more than 1 in 10 people

•    feeling sick (nausea)

•    being sick (vomiting).

Common: may affect up to 1 in 10 people

•    nervousness

•    fainting

•    drowsiness

•    fatigue (mental or physical tiredness)

•    dizziness (a 'spinning' sensation)

•    stomach pain

•    worsening of RLS (symptoms may start earlier than usual or be more intense, or affect other previously unaffected limbs, such as the arms or return in the early morning)

Uncommon: may affect up to 1 in 100 people

•    confusion

•    hallucinations ('seeing' things that are not really there)

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

Very rare: may affect up to 1 in 10,000 people

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

•    feeling very sleepy during the day (extreme somnolence)

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

Some patients may have the following side effects

•    allergic reactions such as red, itchy swellings on the skin (hives), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, rash or intense itching (see Section 2)

•    other psychotic reactions in addition to hallucinations, such as severe confusion (delirium), irrational ideas (delusions) and irrational suspiciousness (paranoia)

Possible side effects in treatment of Restless Legs Syndrome and Parkinson's disease

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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Ropinirole Teva

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 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 March 2015

PL 00289/1192, 1193, 1194 & 1195

^tj~r^TWil

TEVA UK LIMITED

62401-D

PAGE 4: AFTER FOLDING REAR FACE (OUTSIDE OF REEL AFTER FOLDING AND TACKING)

FOLD

LINE. PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)

Pharma code: 34

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.

^6 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 March 2015

PL 00289/1192, 1193, 1194 & 1195

^tTr^rWn

TEVA UK LIMITED    320 x 323

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 Ropinirole

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. See section 4.

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

[1 What Ropinirole Teva is and what it is used for

Ropinirole belongs to a group of medicines called dopamine agonists. Dopamine agonists act in a similar way to a natural substance called dopamine, in the brain.

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.

People with Parkinson's disease have low levels of dopamine in some parts of their brains. Ropinirole has effects similar to those of natural dopamine, so it helps to reduce the symptoms of Parkinson's disease.

Restless Legs (RLS) is also called Ekbom syndrome. People with restless legs syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of their bodies. Usually, they have unpleasant sensations in their limbs -sometimes described as 'crawling' or 'bubbling' - which can begin as soon as they sit or lie down, and are relieved only by movement. So they often have problems with sitting still, and especially with sleeping.

Ropinirole relieves the unpleasant sensations, and so reduces the urge to move the legs and other limbs.

You must talk to a doctor if you do not feel better or if you feel worse.

What you need to know before you take Ropinirole Teva

Do not take Ropinirole

•    if you are allergic (hypersensitive) to ropinirole or any of the other ingredients of this medicine (listed in section 6)

•    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 disease.

Tell your doctor if you think any of these may apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ropinirole

•    if you are pregnant or think you may be pregnant

•    if you are breast-feeding

•    if you are under 18 years old

•    if you have a serious heart complaint

•    if you have a serious mental health problem

•    if you have experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour)

•    if you have intolerance to some sugars

(such as lactose)

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.

Tell your doctor if you think any of these may apply to you.

Your doctor may need to adjust or stop your dose.

Children and adolescents

Do not give Ropinirole to children.

Ropinirole is not normally prescribed for people under 18.

Other medicines and Ropinirole

Talk to your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines including any herbal remedies or other medicines you bought without a prescription. Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking 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:

•    the anti-depressant fluvoxamine

•    medication for other mental health problems, for example sulpiride

•    any other medicine for Parkinson's disease

•    any other drug which blocks the action of dopamine in the brain

•    metoclopramide, which is used to treat nausea and heartburn

•    HRT (hormone replacement therapy)

•    the antibiotics ciprofloxacin or enoxacin

•    Tell your doctor if you are taking or have recently taken any of these.

Ropinirole with food and drink

If you take Ropinirole with food, you may be less likely to feel sick (nauseous) or be sick (vomit). So it may be best to take it with food if you can.

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. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advise before taking this medicine.

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Smoking and Ropinirole

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

Driving and using machines

Ropinirole can make you feel drowsy. In very rare cases, it can make people feel extremely sleepy and it sometimes makes people fall asleep very suddenly without warning. If you could be affected: don't drive, don't operate machines and don't put yourself in any situation where feeling sleepy or falling asleep could put you (or other people) at risk of serious injury or death. Don't take part in these activities until you are no longer affected.

Talk to your doctor if this causes problems for you.

If your symptoms get worse

Some people taking Ropinirole find that their RLS symptoms get worse - for example, symptoms may start earlier than usual or be more intense, or affect other previously unaffected limbs, such as the arms or return in the early morning.

Tell your doctor as soon as possible if you get any of these symptoms.

Ropinirole contains Lactose 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 Teva

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

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).

If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking Ropinirole. Tell your doctor if this happens, as your doctor may need to adjust the dose of the medicines you are taking.

It may take a while to find out the best dose of Ropinirole for you. The usual starting dose is 0.25 mg of ropinirole three times each day for the first week. Then your doctor will increase your 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 usual is 1 mg to 3 mg three times each day (making a total daily dose of 3 mg to 9 mg). If your Parkinson's disease symptoms have not improved enough, your doctor may decide to gradually increase your dose some more.

Restless Legs Syndrome

It may take a while to find out the best dose

of Ropinirole for you.

The usual starting dose is 0.25 mg once a day. After two days, your doctor will probably increase your dose to 0.5 mg daily for the rest of the week. Then your doctor may gradually increase your dose over the next three weeks, up to a daily dose of 2 mg. If a 2 mg daily dose does not improve your RLS symptoms enough, your doctor may gradually increase your dose some more, up to a maximum of 4 mg daily. After you have been taking Ropinirole for three months, your doctor may adjust your dose or advise you to stop taking it.

If you feel that the effects of Ropinirole are too strong or too weak, talk to your doctor or your pharmacist. Do not take more Ropinirole than your doctor has recommended.

Carry on taking Ropinirole as your doctor advises, even if you do not feel better. Ropinirole may take a few weeks to work for you.

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

Method of administration

Take your Ropinirole tablet(s) once a day. Swallow the tablet(s) whole, with a glass of water. Do not chew or crush the tablets.

You can take Ropinirole with or without food. If you take it with food, you may be less likely to feel sick (nauseous).

Ropinirole is usually taken just before bedtime, but you can take it up to 3 hours before you go to bed.).

Use in Children and Adolescents

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

Older people

Ropinirole dose should be individually titrated in patients over 65 years old, with careful monitoring of tolerability, to the optimal clinical response.

If you take more Ropinirole than you should

Contact a doctor or pharmacist immediately. If possible, show them the Ropinirole pack. Someone who has taken an overdose of Ropinirole may have any of these symptoms: feeling sick (nausea), being sick (vomiting), dizziness (a spinning sensation), feeling drowsy, mental or physical tiredness, fainting, hallucinations.

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

Some people take up to 8 mg of Ropinirole three times a day (24 mg daily altogether).

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

Don't take any more Ropinirole than your doctor has recommended.

It may take a few weeks for Ropinirole to work for you.

Method of administration

Take Ropinirole three times a day.

Swallow your Ropinirole tablets whole, with a glass of water. It's best to take Ropinirole with food, because that makes it less likely that you'll feel sick (nauseous).

If you have missed taking Ropinirole for more than a few days, ask your doctor for advice on how to start taking it again.

If you stop taking Ropinirole

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

If you suddenly stop taking Ropinirole your Parkinson's disease symptoms may quickly get much worse.

If you need to stop taking Ropinirole your doctor will reduce your dose gradually.

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