REQUIP XL 8MG PROLONGED RELEASE TABLET

Active substance: ROPINIROLE

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Package Leaflet: Information for the User

ReQuip®

XL 8 mg Prolonged
Release Tablets
(ropinirole hydrochloride)
The name of this medicine is ReQuip XL 8 mg
Prolonged-Release Tablets but will be referred to as
ReQuip XL throughout this leaflet. Other strengths are
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.

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.
ReQuip XL with food and drink

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.

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.

What is in this leaflet

Pregnancy and breast-feeding

1
2

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.

3
4
5
6

What ReQuip XL is and what it is 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 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’re allergic (hypersensitive) 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).
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.
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.
Other medicines and ReQuip XL
Tell your doctor, nurse or pharmacist if you are
taking, or 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.

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 and sunset yellow
ReQuip XL tablets contain a sugar called lactose.
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.
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.
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.
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.
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.
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.
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
 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
 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).

You may experience 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)
➔ 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)
 act in an aggressive manner.
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 you have any unwanted ReQuip XL tablets,
don’t dispose of them in waste water or household
rubbish. Take them back to your pharmacist, who
will dispose of them in a way that won’t harm the
environment.
If your tablets show signs of discolouration or
deterioration, please contact your doctor or
pharmacist who will tell you what to do
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 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, colloidal
anhydrous silica, mannitol (E421), yellow iron oxide
(E172), glycerol dibehenate
 film coat:
‘Opadry red 03B25227’ (hypromellose, yellow iron
oxide (E172), titanium dioxide (E171), black iron
oxide (E172), macrogol 400, red iron oxide (E172).
What ReQuip XL 8 mg looks like and contents
of the pack
ReQuip XL are red capsule-shaped, film-coated
tablets, marked with ‘GS’ on one side and ‘5CC’ on the
other.
Each pack contains 28 tablets.
Manufacturer
SmithKline Beecham Pharmaceuticals, Manor Royal,
Crawley, West Sussex, RH10 9QJ
GlaxoSmithKline Pharmaceuticals S.A., Ul.
Grunwaldzka 61-322, Poznan, Poland.
Glaxo Wellcome GmbH & Co. KG, Industriestrasse
32-36, 23843 Bad Oldesloe, Germany.
Glaxo Wellcome SA, Avenida de Extremadura, 3,
Aranda de Duero (Burgos), Spain
PL 39467/0090 ReQuip XL 8 mg Prolonged Release
Tablets
Procured from within the EU by PL Holder PilsCo Ltd,
10-16 Colvilles Place, East Kilbride, G75 0SN.
Leaflet date: 11/06/2014
ReQuip® is a registered trademark of the
GlaxoSmithKline group of companies

POM

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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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