Requip

Package leaflet: Information for the user

Requip 0.25 mg film-coated tablets, 0.5 mg film-coated tablets, 1 mg film-coated tablets, 2 mg film-coated tablets, 5 mg film-coated tablets

Ropinirole (as hydrochloride)
Please read all of this leaflet carefully before taking this medicine because it contains important
information for you.
This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Requip is and what it is used for
2. What you need to know before taking Requip
3. How to take Requip
4. Possible side effects
5. How to store Requip
6. Contents of the pack and other information

1. What Requip is and what it is used for

The active substance of Requip is ropinirole, which belongs to a group of medicines called dopamine agonists.
Dopamine agonists act on the brain in a way similar to a natural substance called dopamine.
Requip is used to treat Parkinson's disease.
People with Parkinson's disease have low levels of dopamine in certain areas of the brain. Ropinirole has effects similar to those of natural dopamine, thereby helping to reduce the symptoms of Parkinson's disease.

2. What you should know before taking Requip

Do not take Requip

• if you are allergic to ropinirole or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney disease
• if you have a liver disease

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Requip:

• if you are pregnant or think you may be pregnant
• if you are breastfeeding
• if you are under 18 years of age
• if you have a serious heart condition
• 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 are intolerant to certain sugars (such as lactose)

Tell your doctor if you develop symptoms such as depression, apathy, anxiety, fatigue, sweating, or
pain after stopping or reducing treatment with Requip (dopamine agonist withdrawal syndrome,
DAWS). If these problems persist for more than a few weeks, your doctor may need to adjust your
treatment.
Tell your doctor if you, or your family/carer, notice that you are developing impulses or urges to behave in
a way that is unusual for you and that you cannot resist the impulse, urge, or temptation to carry out certain
activities that could be harmful to yourself or others. These are called impulse control disorders and may
include behaviours such as gambling addiction, binge eating or excessive spending, abnormally high sex
drive, or increased sexual thoughts or feelings. Your doctor may need to adjust your dose or stop your
treatment.
Tell your doctor if you, or your family/carer, notice that you are developing episodes of hyperactivity,
euphoria, or irritability (symptoms of mania). These may occur with or without symptoms of impulse control
disorders (see above). Your doctor may need to adjust your dose or stop your treatment.
Tell your doctor if you think any of these apply to you. Your doctor may decide that Requip is not suitable
for you, or that you need further monitoring while taking it.
During treatment with Requip
Tell your doctor if you or your family notice that you are developing any unusual behaviour (such as an
unusual urge to gamble or an increased urge and/or sexual behaviour) while taking Requip. Your doctor
may decide it is necessary to adjust your dose or stop treatment.
Driving and using machines
Requip can cause drowsiness. It may cause severe drowsiness and sometimes causes sudden sleep
without warning signs.
Requip may cause hallucinations (seeing, hearing, or feeling things that are not there). If you experience
these, do not drive and do not use machinery.
If you experience these symptoms: do not drive, do not operate machinery, and do not put yourself in
situations where feeling drowsy or falling asleep suddenly could place you (or others) at risk of serious injury
or death. Avoid such activities until these symptoms no longer occur.
Talk to your doctor if this causes you problems.
Smoking and Requip
Tell your doctor if you are starting to smoke or if you are stopping smoking while taking Requip.
Your doctor may need to adjust your dose.
Other medicines and Requip
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine,
including herbal products or over-the-counter medicines. Remember to inform your doctor or pharmacist if
you start taking a new medicine while on Requip.
Some medicines may affect how Requip works, or make side effects more likely. Requip may also affect how
other medicines work.
These medicines include:

• the antidepressant fluvoxamine
• medicines used to treat other mental health problems, for example sulpiride
• hormone replacement therapy (HRT)
• metoclopramide, used to treat nausea and heartburn
• the antibiotics ciprofloxacin or enoxacin
• any other medicine for the treatment of Parkinson’s disease

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

You may need additional blood tests if you are taking any of these medicines with Requip:

• vitamin K antagonists (used to reduce blood clotting) such as warfarin (Coumadin).

Requip with food and drink
Taking Requip with food may reduce the likelihood of nausea or vomiting. Therefore, it is preferable to take
Requip with food, if possible.
Pregnancy and breastfeeding
Requip is not recommended if you are pregnant, unless your doctor considers that the benefit of taking
Requip outweighs the risk to the unborn child. Requip is not recommended if you are breastfeeding, as it
may affect milk production.
Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy.
Your doctor will advise you if you are breastfeeding or intend to breastfeed. Your doctor may advise you to
stop taking Requip.
Important information about some of the excipients in Requip
Requip tablets contain a small amount of a sugar called lactose. If your doctor has diagnosed you with an
intolerance to certain sugars, contact your doctor before taking Requip.
Requip film-coated tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Requip

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
To treat the symptoms of Parkinson's disease, you may be prescribed Requip alone. You may also be
prescribed it together with another medicine called L-dopa (also known as levodopa).
Do not administer Requip to children. Requip is not normally prescribed for people under 18
years of age.
How much Requip should you take?
It may take some time to find the optimal dose of Requip for you.
The usual starting dose is 0.25 mg of ropinirole three times a day for the first week. Your doctor will then
increase the dose each week for the following three weeks. After this, your doctor will gradually increase the
dose until the optimal dose for you is reached. The usual dose is 1 to 3 mg three times a day (i.e. a total daily
dose of 3 to 9 mg). If the symptoms of Parkinson's disease do not improve sufficiently, your doctor may decide
to increase the dose slightly and gradually.
Some patients take up to 8 mg of Requip three times a day (a total of 24 mg per day).
If you are also taking other medicines for the treatment of Parkinson's disease, your doctor may advise you to
gradually reduce the dosage of the other medicines. If you are taking L-dopa, you may experience some
involuntary movements (dyskinesia) when you start taking Requip. If this occurs, inform your doctor, as your
doctor may need to adjust the doses of the medicines you are taking.
Do not take more Requip than recommended by your doctor.
It may take several weeks for Requip to take effect.
How to take Requip
Take Requip three times a day.
Swallow the Requip tablet whole with a glass of water. It is preferable to take Requip with food, as this
reduces the likelihood of nausea.
If you take more Requip than you should
Contact your doctor or pharmacist immediately. If possible, show them the Requip packaging.
Taking more Requip than recommended may cause: nausea, vomiting, dizziness, drowsiness, mental or physical
fatigue, fainting, hallucinations.
If you forget to take Requip
Do not take extra tablets or double the dose to make up for the missed dose. Take only the next dose at
your usual time.
If you have forgotten to take Requip for one or more days, consult your doctor on how to restart treatment.
If you stop taking Requip
Do not stop taking Requip without consulting your doctor.
Continue taking Requip for as long as your doctor recommends. Do not stop unless your doctor tells you to.
If you stop taking Requip abruptly, the symptoms of Parkinson's disease may worsen rapidly. An abrupt
discontinuation may cause the development of a medical condition called neuroleptic malignant syndrome,
which can be life-threatening. Symptoms include: akinesia (loss of automatic movements), muscle rigidity,
fever, unstable blood pressure, tachycardia (increased heart rate), confusion, depression of consciousness
(e.g. coma).
If you need to stop taking Requip, your doctor will gradually reduce the dosage.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The side effects of Requip may be more likely at the beginning of treatment or when the dose is increased. Side effects are generally mild and may decrease after you have taken the medicine for a short time. If you are concerned about side effects, talk to your doctor.

Very common side effects
May affect more than 1 in 10 people taking Requip:

• fainting
• drowsiness
• nausea

Common side effects
May affect up to 1 in 10 people taking Requip:

• hallucinations (“seeing” things that are not really there)
• vomiting
• dizziness
• heartburn
• stomach ache
• swelling of the legs, feet or hands

Uncommon side effects
May affect up to 1 in 100 people taking Requip:

• dizziness or fainting, especially when standing up from a sitting or lying position (caused by a drop in blood pressure)
• low blood pressure (hypotension)
• excessive daytime sleepiness
• falling asleep suddenly without first feeling sleepy (sudden sleep episodes)
• mental problems such as severe confusion, delirium (irrational thoughts), and paranoia (irrational suspiciousness)

Some patients may experience the following side effects (frequency not known: cannot be estimated
based on available data)

• allergic reactions such as swollen, red, itchy skin (urticaria), swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing, skin rash or severe itching (see section 2)
• aggression
• excessive use of Requip (irresistible urge to take dopaminergic drugs at doses higher than needed to control motor symptoms, known as dopamine dysregulation syndrome)
• after stopping or reducing treatment with Requip: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS)
• changes in liver function, as observed in blood tests.

You may experience the following side effects:

• inability to resist the impulse, desire, or temptation to carry out actions that could be harmful to yourself or others, which may include: strong urge to gamble excessively despite serious personal or family consequences; altered or increased sexual interest and behaviour causing significant concern to you or others, for example increased sexual desire; uncontrolled excessive spending or shopping; binge eating (consuming large amounts of food in a short period of time); or compulsive eating (eating more food than needed to satisfy hunger)
• episodes of hyperactivity, euphoria, or irritability

Tell your doctor if you experience any of these behaviours; ways to manage or reduce symptoms will be discussed.

If you are taking Requip together with L-dopa
People taking Requip together with L-dopa may experience additional side effects over time:

• involuntary movements (dyskinesia) are a very common side effect. If you are taking L-dopa, you may develop some involuntary movements (dyskinesia) when you start taking Requip. If this happens, inform your doctor, as your doctor may need to adjust the dose of the medicines you are taking
• feeling confused is a very common side effect.

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Requip

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister and packaging.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Requip contains
The active substance in Requip is ropinirole.
One film-coated tablet contains 0.25; 0.5; 1; 2 or 5 mg of ropinirole (as hydrochloride).
The other components are:

• Tablet core: monohydrate lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
• Film coating:
  0.25 mg tablets: hypromellose, macrogol 400, titanium dioxide (E 171), polysorbate 80 (E 433)
  0.5 mg tablets: hypromellose, macrogol 400, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), indigo carmine lake (E 132)
  1 mg tablets: hypromellose, macrogol 400, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine lake (E 132)
  2 mg tablets: hypromellose, macrogol 400, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172)
  5 mg tablets: hypromellose, macrogol 400, titanium dioxide (E 171), indigo carmine lake (E 132), polysorbate 80 (E 433)

Description of the appearance of Requip and package contents
Requip is supplied as film-coated tablets, pentagonal in shape, with "SB" imprinted on one side.
Requip 0.25 mg: white tablets with "4890" imprinted on the other side.
Requip 0.5 mg: yellow tablets with "4891" imprinted on the other side.
Requip 1 mg: green tablets with "4892" imprinted on the other side.
Requip 2 mg: pink tablets with "4893" imprinted on the other side.
Requip 5 mg: blue tablets with "4894" imprinted on the other side.
The 0.25 mg tablets are supplied in blisters of 21, 84 or 210 tablets.
The 0.5 mg tablets are supplied in blisters of 21 tablets.
The 1 mg, 2 mg and 5 mg tablets are supplied in blisters of 21 or 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder is
Laboratoire GlaxoSmithKline
23, Rue François Jacob
92500 Rueil-Malmaison
France
Local representative:
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 - 37135 Verona (Italy)

The manufacturer is
Glaxo Wellcome S.A., Avenida de Extremadura, 3, Aranda de Duero (Burgos), Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria, Belgium, France, Germany, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Spain and Sweden:
Requip.

Package leaflet: Information for the user

REQUIP 2 mg prolonged-release tablets, 4 mg prolonged-release tablets, 8 mg prolonged-release tablets

Ropinirole
Please read this leaflet carefully before taking this medicine because it contains important information for you.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Requip is and what it is used for
2. What you need to know before taking Requip
3. How to take Requip
4. Possible side effects
5. How to store Requip
6. Contents of the pack and other information

1. What is Requip and what is it used for

The active substance of Requip is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists act on the brain in a way similar to a natural substance called dopamine.
Requip prolonged-release tablets are used to treat Parkinson's disease.
People with Parkinson's disease have low levels of dopamine in certain areas of the brain. Ropinirole has effects similar to those of natural dopamine, thus helping to reduce the symptoms of Parkinson's disease.

2. What you should know before taking Requip

Do not take Requip:

• if you are allergic to ropinirole or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney disease
• if you have liver disease. Inform your doctor if you think any of these apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before starting to take Requip:

• if you are pregnant or think you might be pregnant
• if you are breastfeeding
• if you are under 18 years of age
• if you have a serious heart condition
• if you have a severe mental health disorder
• if you have experienced any unusual impulse and/or behaviour (see section 4)
• if you are intolerant to certain sugars (such as lactose).

Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue,
sweating, or pain after stopping or reducing treatment with Requip (dopaminergic agonist
withdrawal syndrome or DAWS). If these problems persist for more than a few weeks, your doctor may need to adjust your treatment.
Inform your doctor if you, or your family/carer, notice that you are developing impulses or urges to behave in an unusual way and cannot resist the impulse, urge, or temptation to carry out certain activities that could be harmful to yourself or others.
These are called impulse control disorders and may include behaviours such as gambling addiction, excessive eating or spending, abnormally high sex drive, or increased sexual thoughts or feelings. Your doctor may need to adjust your dose or stop treatment.
Inform your doctor if you, or your family/carer, notice that you are developing episodes of hyperactivity, euphoria, or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorders (see above). Your doctor may need to adjust your dose or stop treatment.
Inform your doctor if you think any of these apply to you. Your doctor may decide that Requip is not suitable for you, or that you require additional monitoring while taking it.

During treatment with Requip
Inform your doctor if you or your family notice that you are developing any unusual behaviour
(such as an unusual urge to gamble or an increased urge and/or sexual behaviour ) while taking Requip. Your doctor may consider it necessary to adjust the dose or stop treatment.

Smoking and Requip
Inform your doctor if you start smoking or stop smoking while taking Requip. Your doctor may consider it necessary to adjust your dose.

Other medicines and Requip
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including herbal products or over-the-counter medicines.
Remember to inform your doctor or pharmacist if you start taking a new medicine while on Requip.
Some medicines may affect the action of Requip or make side effects more likely. Requip may also affect the action of other medicines.
These medicines include:

• the antidepressant fluvoxamine
• medicines used to treat other mental health disorders, such as sulpiride
• hormone replacement therapy (HRT)
• metoclopramide, used to treat nausea and heartburn
• the antibiotics ciprofloxacin or enoxacin
• any other medicine for the treatment of Parkinson’s disease.
  Inform your doctor if you are taking or have recently taken any of these medicines.

You may need additional blood tests if you are taking any of these medicines with Requip:

• vitamin K antagonists (used to reduce blood clotting) such as warfarin (Coumadin).

Requip with food and drink
You may take Requip with or without food, as you prefer.

Pregnancy and breastfeeding
Requip is not recommended if you are pregnant, unless your doctor considers that the benefit of taking Requip outweighs the risk to the unborn child. Requip is not recommended if you are breastfeeding, as it may affect milk production.
Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy. Your doctor will advise you if you are breastfeeding or intend to breastfeed. Your doctor may advise you to stop taking Requip.

Driving and using machines
Requip can cause drowsiness. It may cause severe drowsiness and sometimes cause sudden sleep without warning signs.
Requip may cause hallucinations (seeing, hearing, or feeling things that are not there). If you experience this, do not drive and do not operate machinery.
If you experience these symptoms: do not drive, do not operate machinery, and avoid situations where feeling drowsy or falling asleep could put you (or others) at risk of serious injury or death. Do not engage in such activities until these symptoms have resolved.
Talk to your doctor if this causes you problems.

Important information about some of the excipients in Requip
Requip prolonged-release tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking Requip.
The 4 mg prolonged-release tablets contain a colouring agent called sunset yellow FCF (E110) which may cause allergic reactions.
Requip prolonged-release tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Requip

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your
doctor or pharmacist.
Do not give Requip to children. Requip is not normally prescribed for people under 18 years of age.
To treat the symptoms of Parkinson’s disease, your doctor may prescribe Requip alone or in combination
with another medicine called L-dopa ( also known as levodopa ). If you are taking L-dopa, you may experience
some involuntary movements (dyskinesia) when you start taking Requip. If this occurs, inform your doctor,
as your doctor may need to adjust the doses of the medicines you are taking.
Requip prolonged-release tablets are formulated to release the medicine over a 24-hour period. If you have
a condition in which medicines pass through your body too quickly, for example diarrhoea, the tablets may
not dissolve completely and may not work properly. You may find tablet residues in your stools. If this
happens, inform your doctor as soon as possible.
How much Requip should you take?
It may take some time to find the optimal Requip dose for you.
The recommended starting dose of Requip prolonged-release tablets is 2 mg once daily for the first week.
From the second week of treatment, your doctor may increase the dose of Requip prolonged-release tablets
to 4 mg once daily. If you are elderly, your doctor may increase the dose more slowly. After this, your doctor
will adjust the dose until the optimal dose for you is reached. Some patients take up to 24 mg of Requip
prolonged-release tablets per day.
If you experience side effects at the beginning of treatment that are difficult to tolerate, discuss this with your
doctor. Your doctor may advise you to switch to a lower dose of ropinirole film-coated tablets (immediate-release) to be taken three times daily.
Do not take more Requip than your doctor has prescribed.
It may take several weeks for Requip to take effect.
How to take your dose of Requip
Take Requip once daily, at the same time every day.
The Requip prolonged-release tablet must be swallowed whole with a glass of water.
Do not break, chew or crush the prolonged-release tablet – doing so is dangerous, as you may ingest too
high a dose, since the medicine would be released into your body too quickly.

If you are switching from treatment with ropinirole film-coated tablets (immediate-release)
Your doctor will determine your starting dose of Requip prolonged-release tablets based on the dose of
ropinirole film-coated tablets (immediate-release) you are currently taking.
On the day before switching, take your usual dose of ropinirole film-coated tablets (immediate-release).
Then, on the following morning, take Requip prolonged-release tablets and stop taking ropinirole film-coated
tablets (immediate-release).
If you take more Requip than you should
Contact your doctor or pharmacist immediately. If possible, show them the Requip packaging.
Taking more Requip than prescribed may cause any of the following symptoms: nausea, vomiting,
dizziness, drowsiness, mental or physical fatigue, fainting, hallucinations.
If you forget to take Requip
Do not take extra prolonged-release tablets or a double dose to make up for a missed dose.
If you have missed taking Requip for one or more days, consult your doctor for advice on how to restart
treatment.
If you stop taking Requip
Do not stop taking Requip without consulting your doctor.
Continue taking Requip for as long as your doctor recommends. Do not stop unless your doctor tells you
to.
If you stop taking Requip abruptly, your Parkinson’s disease symptoms may worsen rapidly. Sudden
discontinuation may lead to a medical condition called neuroleptic malignant syndrome, which can be
life-threatening. Symptoms include: akinesia (loss of automatic movements), muscle rigidity, fever, unstable
blood pressure, tachycardia (increased heart rate), confusion, and reduced level of consciousness (e.g. coma).
If you need to stop taking Requip, your doctor will gradually reduce the dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects with Requip are more likely to occur at the beginning of treatment or when the dose is increased. Side effects are usually mild and may become less troublesome after you have taken the medicine for a short time. If you are concerned about side effects, talk to your doctor.

Very common side effects
May affect more than 1 in 10 people taking Requip:

• fainting
• drowsiness
• nausea

Common side effects
May affect up to 1 in 10 people taking Requip:

• falling asleep suddenly without prior warning of feeling sleepy (sudden onset sleep episodes)
• hallucinations (“seeing” things that are not really there)
• feeling unwell (vomiting)
• dizziness
• heartburn
• stomach ache
• constipation
• swelling in legs, feet or hands

Uncommon side effects
May affect up to 1 in 100 people taking Requip:

• dizziness or fainting, especially when standing up from a sitting or lying position (caused by a drop in blood pressure)
• low blood pressure (hypotension)
• excessive daytime sleepiness
• mental problems such as delirium (severe confusion), delusions (irrational beliefs) or paranoia (irrationally suspicious attitude)

Some patients may experience the following side effects (frequency not known: cannot be estimated from the available data)

• allergic reactions, such as flushing, itchy skin swelling (urticaria), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing and breathing, rash or severe itching (see section 2)
• changes in liver function, observed in blood tests
• acting aggressively
• excessive use of Requip (irresistible urge to take dopaminergic medication at doses higher than needed to control motor symptoms, known as dopamine dysregulation syndrome)
• inability to resist the impulse, desire or temptation to carry out actions that could be harmful to you or others, which may include:
  • strong urge to gamble excessively despite serious personal or family consequences
  • altered or increased sexual interest and behaviour causing significant concern to you or others, for example increased sexual desire
  • uncontrolled excessive spending or shopping
  • binge eating (consuming large amounts of food in a short period of time)
  • compulsive eating (eating more food than needed to satisfy hunger)
• episodes of hyperactivity, euphoria or irritability
• After stopping or reducing treatment with Requip: depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviours; ways to manage or reduce the symptoms will be discussed.

If you are taking Requip together with L-dopa
People who take Requip together with L-dopa may experience additional side effects over time:

• uncontrolled movements (dyskinesia) are a very common side effect. If you are taking L-dopa, you may develop some involuntary movements (dyskinesia) when you start taking Requip. If this happens, tell your doctor, as your doctor may need to adjust the dose of your medicines.
• confusion is a very common side effect.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Requip

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Requip contains
The active substance in Requip is ropinirole.
One prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirole (as hydrochloride).
The other components are:

• Core of the prolonged-release tablet: hypromellose, hydrogenated castor oil, sodium carmellose, povidone (K29-32), maltodextrin, magnesium stearate, lactose monohydrate, anhydrous colloidal silica, mannitol (E421), yellow iron oxide (E172), glycerol dibehenate
• Film coating:
  2 mg prolonged-release tablet: OPADRY pink OY-S-24900 (hypromellose, yellow iron oxide (E172), titanium dioxide (E171), macrogol 400, red iron oxide (E172))
  4 mg prolonged-release tablet: OPADRY light brown OY-27207 (hypromellose, titanium dioxide (E171), macrogol 400, sunset yellow FCF lake (E110), indigo carmine lake (E132))
  8 mg prolonged-release tablet: OPADRY red 03B25227 (hypromellose, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), macrogol 400, red iron oxide (E172))

Description of the appearance of Requip and package contents
Requip (all strengths) is supplied as prolonged-release, capsule-shaped tablets, imprinted with “GS” on one side.
Requip 2 mg: pink prolonged-release tablets, imprinted with “3V2” on the other side.
Requip 4 mg: light brown prolonged-release tablets, imprinted with “WXG” on the other side.
Requip 8 mg: red prolonged-release tablets, imprinted with “5CC” on the other side.
All strengths: packages containing blisters of 28 or 84 prolonged-release tablets. The 2 mg prolonged-release tablets are also available in a package containing 42 prolonged-release tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder is:
Laboratoire GlaxoSmithKline
23, Rue François Jacob
92500 Rueil-Malmaison
France
Local representative:
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 - 37135 Verona (Italy)

Manufacturer
Glaxo Wellcome S.A., Avenida de Extremadura, 3, Aranda de Duero (Burgos), Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria, Belgium, Germany, Ireland, Luxembourg, Netherlands: Requip modutab
Finland and Sweden: Requip Depot
France and Portugal: Requip LP
Greece: Requip XL
Italy: Requip
Spain: Requip Prolib