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REQUIP XL 8MG PROLONGED RELEASED TABLETS

Active substance(s): ROPINIROLE

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Package Leaflet: Information for the User

REQUIP® XL 2mg PROLONGED RELEASE TABLETS
REQUIP® XL 4mg PROLONGED RELEASE TABLETS
REQUIP® XL 8mg PROLONGED RELEASE TABLETS
(ropinirole hydrochloride)
This medicine is available as one of the above names but will be referred to as Requip XL
throughout the following leaflet.
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, nurse specialist or pharmacist.
This medicine has been prescribed for you only. Don’t 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, nurse or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Requip XL is and what it is used for
2. What you need to know before you take Requip XL
3. How to take Requip XL
4. Possible side effects
5. How to store Requip XL
6. Contents of the pack and other information
1. What Requip XL is and what it is used for
Requip XL is used to treat Parkinson’s disease.
The active ingredient in Requip XL is ropinirole, which belongs to a group of medicines
called dopamine agonists. Dopamine agonists affect the brain in a similar way to a
natural substance called dopamine.
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.
You can take Requip XL (like Requip) either on its own or along with L-dopa (see
section 4 of this leaflet for more details). Requip XL should be prescribed and your
progress monitored by a doctor with experience in the treatment of Parkinson’s
disease.
2. What you need to know before you take Requip XL
Do not take Requip XL:
if you are allergic to ropinirole or any of the other ingredients of this medicine (listed
in section 6)
if you have serious kidney disease
if you have liver disease
→ Tell your doctor or nurse if you think any of these may apply to you.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Requip XL:
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 history of or currently have a serious mental health problem
if you have a history of or have experienced any unusual urges and/or
behaviours (such as excessive gambling or excessive sexual behaviour, see
section 4)
if you have an intolerance to some sugars (such as lactose).

Requip XL with food and drink
You can take Requip XL with or without food, as you prefer. Because high fat foods might
increase the amount of ropinirole absorbed by your body, it is recommended that you do
not take Requip XL at the same time as a high fat meal.
Pregnancy and breast-feeding
Requip XL is not recommended if you are pregnant, unless your doctor advises
that the benefit of you taking Requip XL is greater than the risk to your unborn baby.
Requip XL 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 advice before taking this medicine.
Driving and using machines
Requip XL can make you feel drowsy or dizzy.
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 sure
you’re not affected.
→ Talk to your doctor or nurse if this causes problems for you.
Requip XL contains lactose monohydrate and sunset yellow
Requip XL tablets contain a sugar called lactose monohydrate.
If you have been told that you have an intolerance to some sugars, contact your doctor or
nurse before taking Requip XL.
The 4 mg tablets contain a colouring called sunset yellow (E110), which may cause
allergic reactions.
Smoking and Requip XL
Tell your doctor or nurse if you start smoking, or give up smoking, while you’re
taking Requip XL. Your doctor or nurse may need to adjust your dose.
3. How to take Requip XL
Always take this medicine exactly as your doctor or nurse or pharmacist has
told you. Check with your doctor, nurse or pharmacist if you are not sure.
Do not give Requip XL to children. Requip XL is not normally prescribed for people
under 18.
You may be given Requip XL on its own to treat the symptoms of your Parkinson’s
disease. Or you may be given Requip XL as well as another medicine called L-dopa
(also called levodopa).
Requip XL should be prescribed and your progress monitored by a doctor with
experience in the treatment of Parkinson’s disease.
If you are taking L-dopa you may experience some uncontrollable movements
(dyskinesias) when you first start taking Requip XL. Tell your doctor if this happens, as
your doctor may need to adjust the dose of the medicines you are taking.
Tell your doctor if you or your family notices that you are developing any unusual
behaviours (such as an unusual urge to gamble or increased sexual urges and/or
behaviours) while you are taking Requip XL. Your doctor may need to adjust your
dose.
If you are switching from Requip film-coated (immediate-release) tablets
Your doctor or nurse will base your dose of Requip XL on the dose of Requip you were
taking. You will take the same or similar daily dose of Requip XL to your previous dose
of Requip but you will only take Requip XL once a day.

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 or nurse if you think any of these may apply to you. Your doctor
or nurse may decide that Requip XL isn’t suitable for you, or that you need extra
check-ups while you’re taking it.

Take your Requip as normal the day before you switch. Then take your Requip XL on
the next day and don’t take any more Requip.

You also need to be careful with Requip XL if you drive or operate machinery. Please
read the warning in section 3 of this leaflet.

The recommended starting dose of Requip XL tablets is 2 mg once daily for the first
week.
Your doctor may increase your dose to 4 mg of Requip XL tablets once daily, from the
second week of treatment. If you are very elderly your doctor may increase your dose
more slowly. After that, the doctor may adjust your dose until you are taking the dose
that is best for you. Some people take up to 24 mg of Requip XL tablets each day.

Other medicines and Requip XL
Tell your doctor, nurse or pharmacist if you are taking, have recently taken, or
might take any other medicines - including any herbal remedies or medicines you
bought without a prescription.
Some medicines can affect the way Requip XL works, or make it more likely that you’ll
have side effects. Requip XL can also affect the way some other medicines work.
These include:
the anti-depressant, fluvoxamine
HRT (hormone replacement therapy)
medication for other mental health problems, for example sulpiride
metoclopramide, which is used to treat nausea and heartburn
cimetidine, used in the treatment of stomach ulcers
the antibiotics, ciprofloxacin or enoxacin
any other medicine for Parkinson’s disease.
→ Tell your doctor or nurse if you’re taking, or have recently taken, any of these.
Remember to tell your doctor or nurse if you start taking any other medicine while
you’re taking Requip XL.

Your doctor or nurse will be monitoring your progress closely after switching to Requip
XL.
If there is any change in the control of your symptoms before your next appointment,
talk to your doctor or nurse as soon as possible in case dose adjustment is needed.
How much Requip XL will you need to take?
It may take a while to find out the best dose of Requip XL for you.

If at the start of your treatment, you experience side effects that you find difficult to
tolerate, speak to your doctor. Your doctor may advise you to switch to a lower dose of
Requip film-coated (immediate-release) tablets which you will take three times a day.
Don’t take more Requip XL than your doctor or nurse has recommended.
It may take a few weeks for Requip XL to work for you.
Taking your dose of Requip XL
Take Requip XL once a day, at the same time each day.
Swallow your Requip XL tablets whole, with a glass of
water.
Don’t break, chew or crush the tablets - if you do, there’s
a danger you could overdose, because the medicine will be
released into your body too quickly.

Requip XL tablets are designed to release the drug into your body over a 24 hour
period. If the tablets pass through your body in less than 24 hours the medicine may
not be completely released. You may see tablets in your stool. If this happens, let your
doctor know.
If you take more Requip XL than you should
Contact a doctor, nurse or pharmacist immediately. If possible, show them the
Requip XL pack.
Someone who has taken an overdose of Requip XL 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 Requip XL
Do not take a double dose to make up for a forgotten dose.
If you have missed taking Requip XL for one day or more, ask your doctor or
nurse for advice on how to start taking it again.
If you stop taking Requip XL
Don’t stop taking Requip XL without advice.
Take Requip XL for as long as your doctor or nurse recommends. Don’t stop
unless your doctor or nurse advises you to.
If you suddenly stop taking Requip XL, your Parkinson’s disease symptoms may
quickly get much worse. A sudden stop could cause you to develop a medical
condition called neuroleptic malignant syndrome which may represent a major health
risk. The symptoms include: akinesia (loss of muscle movement), rigid muscles, fever,
unstable blood pressure, tachycardia (increased heart rate), confusion, drepressed
level of consciousness (e.g. coma).
If you need to stop taking Requip XL, your doctor or nurse will reduce your dose
gradually.
If you have any further questions on the use of this medicine, ask your doctor, nurse or
pharmacist.

If you’re taking Requip XL with L-dopa
People who are taking Requip XL with L-dopa may develop other side effects over
time:
uncontrollable movements (dyskinesias) are a very common side effect. If you are
taking L-dopa you may experience some uncontrollable movements (dyskinesias)
when you first start taking Requip XL. Tell your doctor if this happens, as your
doctor may need to adjust the dose of the medicines you are taking.
feeling confused is a common side effect.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5. How to store Requip XL
Keep Requip XL out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the
carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use.
If you notice that your tablets have become discoloured or show any other signs of
deterioration, speak to your pharmacist.
6. Contents of the pack and other information
What Requip XL contains
The active substance in Requip XL is ropinirole. Each prolonged-release tablet
contains 2 mg, 4 mg or 8 mg of ropinirole (as hydrochloride).
The other ingredients are:
tablet cores:
hypromellose, hydrogenated castor oil, carmellose sodium, povidone K29-32,
maltodextrin, magnesium stearate, lactose monohydrate, anhydrous colloidal silica,
mannitol E421, ferric oxide yellow (E172), glycerol dibehenate

4. Possible side effects
Like all medicines, this medicine can have side effects, but not everyone gets them.
The more common side effects of Requip XL 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’ve taken the dose for a while. If you’re
worried about side effects, talk to your doctor or nurse.
Very common side effects:
may affect more than 1 in 10 people
fainting
feeling drowsy
feeling sick (nausea).
Common side effects:
may affect up to 1 in 10 people
falling asleep very suddenly without feeling sleepy first (sudden sleep onset
episodes)
hallucinations (sensing things that are not real)
being sick (vomiting)
feeling dizzy (a spinning sensation)
heartburn
stomach pain
constipation
swelling of the legs, feet or hands.
Uncommon side effects:
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
mental problems such as delirium (severe confusion), delusions (unreasonable
ideas) or paranoia (unreasonable suspicions).
You may experience the following side effects (frequency not known):
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).
→ Tell your doctor if you experience any of these behaviours; they will discuss
ways of managing or reducing the symptoms.
Very rare side effects:
may affect up to 1 in 10,000 people
A very small number of people taking Requip XL (less than 1 in 10,000) have
experienced:
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.
Some patients may have the following side effects (frequency not known:
cannot be estimated from the available data)
act in an aggressive manner
excessive use of Requip XL (craving for large doses of dopaminergic drugs in
excess of that required to control motor symptoms, known as dopamine
dysregulation syndrome)

film coats:
2 mg tablet: hypromellose, ferric oxide yellow (E172), titanium dioxide (E171),
macrogol 400, red iron oxide (E172)
4 mg tablet: hypromellose, titanium dioxide (E171), macrogol 400, sunset yellow
(E110), indigo carmine (E132)
8 mg tablet: hypromellose, ferric oxide yellow (E172), titanium dioxide (E171), black
iron oxide (E172), macrogol 400, red iron oxide (E172)
What Requip XL looks like and contents of the pack
Requip® XL 2mg tablets: pink capsule-shaped, film-coated tablets marked ‘GS’ on one
side and ‘3V2’ on the other.
Requip® XL 4mg tablets: light brown capsule-shaped, film-coated tablets marked
‘GS’ on one side and ‘WXG’ on the other.
Requip® XL 8mg tablets: red-brown capsule-shaped, film-coated tablets marked ‘GS’
on one side and ‘5CC’ on the other.
All strengths: blister packs of 28 tablets.
Manufacturer
Manufactured by SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, West
Sussex, RH10 9QJ, UK and procured from within the EU and repackaged by the
Product Licence Holder: O.P.D. Laboratories Ltd., Watford, Herts WD24 4PR.
Requip® XL 2mg Prolonged Release Tablets
Requip® XL 4mg Prolonged Release Tablets
Requip® XL 8mg Prolonged Release Tablets

PL: 15814/0924
PL: 15814/0925
PL: 15814/0926

POM

Requip is a registered trademark of the GlaxoSmithKline group of companies.
Leaflet revision and issue date (Ref.): 21.10.2016.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332
796.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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