REQUIP XL 8 MG PROLONGED-RELEASE TABLETS

Active substance: ROPINIROLE HYDROCHLORIDE

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Package Leaflet: Information for the User

PHARMA CODE N° 4745

4
10000000119615
GSK-ESP-Aranda-ESARA
United Kingdom-GBR
ReQuip-XL
2

2 mg, 4 mg, 8 mg, prolonged-release tablets
ropinirole (as hydrochloride)

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.

2 What you need to know before you take
ReQuip XL

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor,
nurse specialist or pharmacist.
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Do not take ReQuip XL:
• f you are allergic (hypersensitive) to ropinirole
i
or any of the other ingredients of this medicine
(listed in section 6)

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.

• f you have serious kidney disease
i
• f you have liver disease
i
➔ 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:

What is in this leaflet
1 What ReQuip XL is and what it is used for

• f you are pregnant or think you may be
i
pregnant

2 What you need to know before you take
ReQuip XL

• f you are breast-feeding
i

3 How to take ReQuip XL

• f you are under 18 years old
i

4 Possible side effects

• f you have a serious heart complaint
i

5 How to store ReQuip XL

• f you have a history of or currently have a
i
serious mental health problem

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.

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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.

• f you have a history of or have experienced
i
any unusual urges and/or behaviours (such
as excessive gambling or excessive sexual
behaviour, see section 4)
• f you have an intolerance to some sugars (such
i
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, 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.

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These include:

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.

• the anti-depressant, fluvoxamine

• HRT (hormone replacement therapy)


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• 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.


ReQuip-XL
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➔ 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
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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.

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.

ReQuip XL is not recommended if you are breastfeeding, as it can affect your milk production.

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.

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

How much ReQuip XL will you need to take?

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.

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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.

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.

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.

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.

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.

The 4 mg tablets contain a colouring called sunset
yellow (E110), which may cause allergic reactions.

Don’t take more ReQuip XL than your doctor or
nurse has recommended.

Smoking and ReQuip XL

It may take a few weeks for ReQuip XL to work for
you.

ReQuip XL contains lactose and sunset yellow

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.

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.
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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.

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If you take more ReQuip XL than you should

United Kingdom-GBR

Contact a doctor, nurse or pharmacist
immediately. If possible, show them the ReQuip XL
pack.

ReQuip-XL
2

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
268

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.

• nability to resist the impulse, drive or
i
temptation to perform an action that could be
harmful to you or others, which may include:
• trong impulse to gamble excessively despite
s
serious personal or family consequences
• ltered or increased sexual interest and
a
behaviour of significant concern to you or
to others, for example, an increased sexual
drive
• ncontrollable excessive shopping or spending
u

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

Don’t stop taking ReQuip XL without advice
02-01-XX-273-11

You may experience the following side effects
(frequency not known):

• inge eating (eating large amounts of food
b
in a short time period) or compulsive eating
(eating more food than normal and more
than is needed to satisfy your hunger).

Do not take a double dose to make up for a
forgotten dose.
K

• ental problems such as delirium (severe
m
confusion), delusions (unreasonable ideas) or
paranoia (unreasonable suspicions).

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

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:
• hanges in liver function, which have shown up
c
in blood tests
• llergic reactions such as red, itchy swellings
a
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)

Like all medicines, this medicine can have side
effects, but not everyone gets them.

• ct in an aggressive manner.
a

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.

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:

• fainting

• feeling drowsy


• eeling confused is a common side effect.
f

• feeling sick (nausea).


Reporting of side effects

Common side effects:

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• ncontrollable movements (dyskinesias) are
u
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.

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

Very common side effects:
may affect more than 1 in 10 people

may affect up to 1 in 10 people
• hallucinations (sensing things that are not real)

• being sick (vomiting)

• feeling dizzy (a spinning sensation)


By reporting side effects you can help provide
more information on the safety of this medicine.

• heartburn

• stomach pain


5 How to store ReQuip XL

• constipation


Keep this medicine out of the sight and reach of
children.

• 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)

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.
Do not throw away any medicines via wastewater
or household waste Ask your pharmacist how to
throw away medicines you no longer use.
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6 Contents of the pack and other
information

4

What ReQuip XL contains

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The active substance in ReQuip XL is ropinirole.
Each prolonged-release tablet contains 2 mg, 4 mg
or 8 mg of ropinirole (as hydrochloride).

GSK-ESP-Aranda-ESARA

The other ingredients are:
United Kingdom-GBR
ReQuip-XL
2

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PHARMA CODE N° 4745

K

• tablet cores:

hypromellose 2208, hydrogenated castor
oil, carmellose sodium, povidone K29-32,
maltodextrin, magnesium stearate, lactose
monohydrate, anhydrous colloidal silica,
mannitol (E421), ferric oxide yellow (E172),
glycerol dibehenate
• film coats:

2 mg tablet: hypromellose 2910, ferric oxide
yellow (E172), titanium dioxide (E171),
macrogol 400, ferric oxide red (E172)
4 mg tablet: hypromellose 2910, titanium
dioxide (E171), macrogol 400, sunset yellow
(E110), indigo carmine (E132)
8 mg tablet: hypromellose 2910, ferric oxide
yellow (E172), titanium dioxide (E171), ferric
oxide black (E172), macrogol 400, ferric oxide
red (E172)

What ReQuip XL looks like and contents of the
pack
ReQuip XL (all strengths) prolonged-release tablets
are provided as capsule-shaped, film-coated
tablets, marked ‘GS’ on one side.
ReQuip XL 2 mg: pink tablets marked ‘3V2’ on
reverse side.
ReQuip XL 4 mg: light brown tablets marked
‘WXG’ on reverse side.
ReQuip XL 8 mg: red tablets marked ‘5CC’ on
reverse side.
All strengths: blister packs of 28 tablets.

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Marketing authorisation holder and manufacturer
Marketing Authorisation Holder: SmithKline
Beecham Limited, Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer: Glaxo Wellcome S.A., Avenida de
Extremadura 3, 09400 Aranda de Duero, Burgos,
Spain
Other formats
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
ReQuip XL 2 mg prolongedrelease tablets
ReQuip XL 4 mg prolongedrelease tablets
ReQuip XL 8 mg prolongedrelease tablets
Reference number 10592/0293
This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: February 2014
ReQuip is a registered trademark of the
GlaxoSmithKline group of companies
© 2014 GlaxoSmithKline group of companies.
All rights reserved

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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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