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REQUIP XL 2MG PROLONGED RELEASE TABLETS

Active substance(s): ROPINIROLE / ROPINIROLE HYDROCHLORIDE

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ASSESSED AGAINST UK PIL DATED MAY 2016
PACKAGE LEAFLET: INFORMATION FOR THE USER



REQUIP® XL 2mg prolonged-release Tablets
(ropinirole hydrochloride)

Your medicine is available using the name Requip XL 2mg
prolonged-release Tablets, but will be referred to as Requip
XL throughout this leaflet. Other strengths 4mg & 8mg are
also available.

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.
2.
3.
4.
5.
6.

What Requip XL is and what it is used for
What you need to know before you take Requip XL
How to take Requip XL
Possible side effects
How to store Requip XL
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 monohydrate).

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.

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By austino at 3:53 pm, Oct 05, 2016

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.

You also need to be careful with Requip XL if you drive or
operate machinery. Please read the warning in section 2
of this leaflet.

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.

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.
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.

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.

Requip XL with food and drink

How much Requip XL will you need to take?

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 breastfeeding, 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 contains 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 4mg 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, 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.

Page 1 of 2

It may take a while to find out the best dose of Requip XL for
you.
The recommended starting dose of Requip XL is 2mg once
daily for the first week. Your doctor may increase your dose
to 4mg of Requip XL 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 24mg of Requip XL each day.
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 is 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, depressed 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.

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).

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).

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 out of the sight and reach of children.
Don’t use Requip XL after the expiry date shown 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.
Protect from light.
If your tablets appear to be discoloured or show any
other signs of deterioration, please return to your
pharmacist who will advise you further.
If you have any unwanted Requip XL, take them back to
your pharmacist, who will dispose of them in a way that
won’t harm the environment.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use.

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 2mg of ropinirole
(as hydrochloride).
The other ingredients are:

tablet core: hypromellose, hydrogenated castor oil,
carmellose sodium, povidone K29/32, maltodextrin,
magnesium stearate, lactose monohydrate,
silica colloidal anhydrous, mannitol (E421),
ferric oxide yellow (E172) and glycerol dibehenate.

film coat: Opadry pink OY-S-24900 (hypromellose,
ferric oxide yellow (E172), titanium dioxide (E171),
macrogol 400, red ferric oxide (E172)).

What Requip XL looks like and contents of the pack

Requip XL 2mg are pink, capsule-shaped, film-coated tablets
marked ‘G S’ on one side and ‘3 V 2’ on the other.
Requip XL is available in blister packs containing 28 tablets.

Tell your doctor if you experience any of these
behaviours; they will discuss ways of managing or
reducing the symptoms.

Page 2 of 2

Manufacturer

Requip XL is manufactured by:
SmithKline Beecham Plc,
T/A SmithKline Beecham Pharmaceuticals, Manor Royal,
Crawley, West Sussex, RH10 9QJ, United Kingdom.
OR
GlaxoSmithKline Pharmaceuticals SA, UI. Grunwaldzka,
60-322, Poznan, Poland.
OR
Glaxo Wellcome GmbH & Co. KG, Industriestrasse 32-36,
23843 Bad Oldesloe, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX.
PL No: 21828/0347

POM

Other formats

To listen to or request a copy of this leaflet in Braille, large
print or audio please call: 01302 365000 and ask for the
Regulatory Department.
Please be ready to give the following information:
Product name:
Requip XL 2mg
prolonged-release Tablets
Reference number:
21828/0347
Leaflet revision date: 29.09.16
REQUIP® is a registered trademark of the GlaxoSmithKline
group of companies.

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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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