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REQUIP XL 4MG 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 (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, 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.
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 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
s
of you
ur treatmentt, you expe
erience side
e effects that you find difficult to tolerate, sp
peak to you
ur doctor.
Your docctor may ad
dvise you to
o switch to a lower dosse of Requip film-coatted (immed
diate-release) tablets w
which you
will take three
t
timess a day.
ke more Re
equip XL th
han your doctor
d
or nurse
n
has recommen
r
nded.
Don’t tak
eeks for Re
equip XL to work for yo
ou.
It may takke a few we
y
dose of
o Requip XL
X
Taking your
Take Req
quip XL on
nce a day, at the sam
me time eac
ch day. 
uip XL tabllets whole, with a gla
ass of wate
er.
Swallow your Requ
eak, chew
w or crush the tablets - if you do,
d there’s a danger yyou could
Don’t bre
overdose
e, because the medicin
ne will be re
eleased into
o your bodyy too quicklly.
X tablets are
a designe
ed to releasse the drug into your body
b
over a 24 hour
Requip XL
period. Iff the tabletss pass thro
ough your body in lesss than 24 hours the medicine
may not be
b completely release
ed. You mayy see tablets in your stool.
s
If this happens,
let your doctor
d
know
w.
ke more Re
equip XL than you sh
hould
If you tak
Contact a doctor, nurse
n
or ph
harmacist immediate
ely. If possiible, show tthem the Requip
R
XL pack.
e who has taken
t
an ovverdose of Requip XL may have any of thesse symptom
ms: feeling sick (nause
ea), being
Someone
sick (vom
miting), dizziness (a spin
nning sensa
ation), feelin
ng drowsy, mental or p
physical tired
dness, faintting, hallucinations.
X
If you forrget to take Requip XL
Do not ta
ake a doub
ble dose to
o make up for a forgo
otten dose.
If you ha
ave missed
d taking Re
equip XL for
f one day
y or more,, ask your d
doctor or nurse for ad
dvice on how to start
taking it again.
a
op taking Requip
R
XL without ad
dvice
Don’t sto
Take Requip XL fo
or as long
g as your doctor
d
or nurse recommends. Don’t stop unless your
y
doctor or nurse
advises you
y to.
ddenly stop
p taking Req
quip XL, yo
our Parkinso
on’s diseasse symptom
ms may quicckly get mu
uch worse.
If you sud
ed to stop taking
t
Requ
uip XL, your doctor or nurse will reduce
r
your dose grad
dually.
If you nee
If you havve any furth
her questions on the use
u of this medicine,
m
ask your docctor, nurse or pharmac
cist.
4. POSSIIBLE SIDE EFFECTS
S
Like all medicines,
m
this medicin
ne can have
e side effeccts, but not everyone g
gets them.
e common side effectss of Requip
p XL are more likely to
o happen w
when you first start tak
king it, or w
when your
The more
dose hass just been increased. They are usually mild, and ma
ay become
e less troub
blesome aftter you’ve ttaken the
dose for a while. If you’re
y
worriied about side effects, talk to you
ur doctor or nurse.
Very com
mmon side
e effects:
may affecct more tha
an 1 in 10 people
• faintin
ng
• feeling
g drowsy
• feeling
g sick (naussea).
n side effec
cts:
Common
may affecct up to 1 in
n 10 people
e
• halluccinations (se
ensing thing
gs that are not real)
• being sick (vomitting)
• feeling
g dizzy (a spinning
s
sensation)
• heartb
burn
• stoma
ach pain
• constipation
• swellin
ng of the le
egs, feet or hands.
mon side efffects:
Uncomm
may affecct up to 1 in
n 100 people
• feeling
g dizzy or fa
aint, especially when you
y stand up
u suddenlyy (this is ca
aused by a drop in bloo
od pressure
e)
• feeling
g very sleep
py during th
he day
• falling asleep verry suddenlyy without feeling sleep
py first (sudd
den sleep o
onset episo
odes)
• menta
al problem
ms such as
a delirium
m (severe confusion
n), delusio
ons (unrea
asonable id
deas) or paranoia
(unrea
asonable su
uspicions).
You may
y experienc
ce the follo
owing side
e effects:
• inability to resist the impulsse, drive orr temptation
n to perform
m an action that could be harmfful to you o
or others,
which may includ
de:
• strong impulsse to gamble
e excessive
ely despite serious personal or fa
amily conse
equences
• alte
ered or increased sexxual interest and behaviour of sig
gnificant con
ncern to yo
ou or to others, for exa
ample, an
inccreased sexxual drive
• uncontrollable
e excessive
e shopping or spending
• bin
nge eating (eating larg
ge amountss of food in
n a short tiime period)) or compu
ulsive eating
g (eating m
more food
tha
an normal and
a more th
han is need
ded to satisffy your hun
nger).
→ Tell your
y
docto
or if you experience
e
e any of th
hese beha
aviours; th
hey will dis
scuss way
ys of managing or
reduc
cing the sy
ymptoms.
Very rare
e side effec
cts:
may affecct up to 1 in
n 10,000 pe
eople
A very sm
mall numb
ber of people taking Re
equip XL (le
ess than 1 in 10,000) have experrienced:
• chang
ges in liver function,
f
wh
hich have shown
s
up in
n blood testts
• allergiic reactionss such as red,
r
itchy swellings
s
on
n the skin (hives), sw
welling of th
he face, lips, mouth, ttongue or
throat which mayy cause diffficulty in sw
wallowing orr breathing,, rash or inttense itchin
ng.
atients may
y have the following side effects (frequen
ncy not known)
Some pa
• act in an aggresssive manne
er.
quip XL wiith L-dopa
If you’re taking Req
w are taking Requip XL with L-d
dopa may develop
d
oth
her side effe
ects over tim
me:
People who
• uncon
ntrollable movements
m
(dyskinesias) are a very comm
mon side e
effect. If yo
ou are takin
ng L-dopa you may
experience some uncontro
ollable movvements (dyskinesias)) when you
u first starrt taking Re
equip XL. Tell your
doctorr if this happens, as yo
our doctor may
m need to
t adjust the
e dose of th
he medicine
es you are taking.
• feeling
g confused is a common side effe
ect.
ng of side effects
e
Reportin
If you ge
et any side effects, talk to your doctor, pha
armacist orr nurse. Th
his includess any possible side effects not
listed in
n this lea
aflet. You can also
o report side
s
effeccts directlyy via the
e Yellow Card Sch
heme at:
www.mhrra.gov.uk/yellowcard
By reportting side efffects you ca
an help pro
ovide more information
n on the saffety of this medicine.
5. HOW TO
T STORE
E REQUIP XL
X
• Keep Requip XL out of the sight
s
and re
each of chilldren.
• Don’t use Requip
p XL after th
he expiry date shown on the cartton.
• Do no
ot store abo
ove 25°C. Store
S
in the original pacckage to prrotect from light.
• If you have any unwanted Requip XL
L, don’t disp
pose of the
em in waste
e water or household rubbish. Take them
back to
t your pha
armacist, wh
ho will dispose of them
m in a way that
t
won’t h
harm the en
nvironment.
• If you notice thatt your table
ets have be
ecome disco
oloured or show any o
other signs of deteriorration, spea
ak to your
pharm
macist.
6. CONTENTS OF THE
T
PACK
K AND OTH
HER INFOR
RMATION
What Requip XL co
ontains
The activ
ve substan
nce in Req
quip XL is ropinirole
e. Each pro
olonged-re
elease tabllet contain
ns 2 mg, 4 mg or 8
mg of ropinirole (a
as hydroch
hloride).
er ingredients are:
The othe
• tablett cores:
stearate,
hypromelllose, hydro
ogenated castor
c
oil, carmellose
c
sodium, po
ovidone K2
29-39, malttodextrin, magnesium
m
lactose monohydrat
m
e, anhydrous colloidal silica, man
nnitol E421, ferric oxid
de yellow (E
E172), glyce
erol dibehe
enate
• film coats:
c
2 mg tablet: hyprom
mellose, ferrric oxide ye
ellow (E172), titanium dioxide
d
(E171), macro
ogol 400, re
ed iron oxide (E172)
4 mg tablet: hyprom
mellose, titanium dioxid
de (E171), macrogol
m
4
400,
sunset yellow (E110), indigo carmine (E
E132)
8 mg tab
blet: hyprom
mellose, ferrric oxide yellow
y
(E17
72), titanium
m dioxide (E
E171), blacck iron oxid
de (E172), macrogol
400, red iron oxide (E172)
(
ooks like an
nd contentts of the pa
ack
What Requip XL lo
®
haped, film-ccoated table
ets marked ‘GS’ on one side and ‘3V2’ on the
e other.
Requip XL 2mg tablets: pink capsule-sh
®
Requip XL 4mg ta
ablets: light brown capsule-shap
ped, film-coated tablets marked ‘G
GS’ on one
e side and ‘‘WXG’ on
the other.
®
Requip XL 8mg ta
ablets: red
d-brown cap
psule-shaped, film-coated tablets marked ‘GS’ on one
e side and ‘5CC’ on
the other.
er packs of 28 tablets.
All strengths: bliste
cturer
Manufac
Manufacttured by Sm
mithKline Beecham
B
Ph
harmaceuticals, Mano
or Royal, Crrawley, We
est Sussex, RH10 9QJJ, UK and
procured from within
n the EU an
nd repackaged by the Product Licence Hold
der: OPD Laboratories
s Ltd, Watfo
ord, Herts
WD24 4PR.
P
®
R
Ta
ablets
5814/0924
POM
Requip XL 2mg Prolonged Release
PL No: 15
®
Requip XL 4mg Prolonged Release
R
Ta
ablets
PL No: 15
5814/0925
®
Requip XL 8mg Prolonged Release
R
Ta
ablets
PL No: 15
5814/0926
ed tradema
ark of the GlaxoSmithK
G
Kline group of compan
nies.
Requip iss a registere
Leaflet re
evision and issue date (Ref.): 10.04.2014.
To request a copy of
o this leafle
et in Braille, large printt or audio please call 0
01923 332 796.
7

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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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