REQUIP XL 4MG PROLONGED RELEASED TABLETS

Active substance: 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 s
start of you treatment you expe
ur
t,
erience side effects that you find difficult to tolerate, sp
e
peak to you doctor.
ur
Your doc may ad
ctor
dvise you to switch to a lower dos of Requip film-coat (immed
o
se
ted
diate-release) tablets w
which you
will take t
three times a day.
s
ke
equip XL th your d
han
doctor or n
nurse has r
recommen
nded.
Don’t tak more Re
ke
eeks for Re
equip XL to work for yo
ou.
It may tak a few we
your dose o Requip X
of
XL
Taking y
Take Req
quip XL on a day, at the sam time eac day. 
nce
me
ch
uip
lets whole, with a gla of wate
ass
er.
Swallow your Requ XL tabl
eak, chew or crush the tablets - if you d there’s a danger y
w
do,
you could
Don’t bre
overdose because the medicin will be re
e,
ne
eleased into your body too quickl
o
y
ly.
XL
are
ed
se
body over a 24 hour
Requip X tablets a designe to releas the drug into your b
period. If the tablets pass thro
f
s
ough your body in les than 24 hours the medicine
ss
may not b completely release You may see tablets in your s
be
ed.
y
stool. If this happens,
let your d
doctor know
w.
ke
equip XL than you sh
hould
If you tak more Re
Contact a doctor, n
nurse or ph
harmacist immediate If possi
ely.
ible, show t
them the R
Requip XL pack.
e
taken an ov
verdose of Requip XL may have any of thes symptom feeling sick (nause being
se
ms:
ea),
Someone who has t
sick (vom
miting), dizziness (a spin
nning sensa
ation), feelin drowsy, mental or p
ng
physical tired
dness, faint
ting, hallucinations.
rget to take Requip X
XL
If you for
Do not ta a doub dose to make up for a forgo
ake
ble
o
otten dose.
If you ha missed taking Re
ave
d
equip XL f one day or more, ask your d
for
y
,
doctor or nurse for ad
dvice on how to start
taking it a
again.
op
Requip XL without ad
dvice
Don’t sto taking R
Take Requip XL fo as long as your d
or
g
doctor or nurse recommends. Don’t stop unless your doctor or nurse
y
advises y to.
you
ddenly stop taking Req
p
quip XL, yo Parkinso
our
on’s diseas symptom may quic get mu worse.
se
ms
ckly
uch
If you sud
ed
taking Requ XL, your doctor or nurse will r
uip
reduce your dose grad
dually.
If you nee to stop t
If you hav any furth questions on the u of this m
ve
her
use
medicine, ask your doc
ctor, nurse or pharmac
cist.
4. POSSI
IBLE SIDE EFFECTS
S
Like all m
medicines, this medicin can have side effec but not everyone g
ne
e
cts,
gets them.
e
s
p
o
when you first start tak
king it, or w
when your
The more common side effects of Requip XL are more likely to happen w
dose has just been increased. They are usually mild, and ma become less troub
s
ay
e
blesome aft you’ve t
ter
taken the
dose for a while. If y
you’re worri about side effects, talk to you doctor or nurse.
ied
ur
Very com
mmon side effects:
e
may affec more tha 1 in 10 people
ct
an
• faintin
ng
• feeling drowsy
g
• feeling sick (naus
g
sea).
n
cts:
Common side effec
may affec up to 1 in 10 people
ct
n
e
• halluc
cinations (se
ensing thing that are not real)
gs
• being sick (vomit
ting)
• feeling dizzy (a s
g
spinning sensation)
• heartb
burn
• stoma pain
ach
• constipation
• swellin of the le
ng
egs, feet or hands.
mon side ef
ffects:
Uncomm
may affec up to 1 in 100 people
ct
n
• feeling dizzy or fa
g
aint, especially when y stand u suddenly (this is ca
you
up
y
aused by a drop in bloo pressure
od
e)
• feeling very sleep during th day
g
py
he
• falling asleep ver suddenly without feeling sleep first (sudd sleep o
ry
y
py
den
onset episo
odes)
• menta problem such a delirium (severe confusion delusio
al
ms
as
m
n),
ons (unrea
asonable id
deas) or paranoia
(unrea
asonable su
uspicions).
You may experienc the follo
y
ce
owing side effects:
e
• inability to resist the impuls drive or temptation to perform an action that could be harmf to you o others,
se,
r
n
m
ful
or
which may includ
de:
• strong impuls to gamble excessive despite serious personal or fa
se
e
ely
amily conse
equences
• alte
ered or increased sex
xual interest and behaviour of sig
gnificant con
ncern to yo or to others, for exa
ou
ample, an
inc
creased sex
xual drive
• uncontrollable excessive shopping or spending
e
e
• bin
nge eating (eating larg amounts of food in a short ti
ge
s
n
ime period) or compu
)
ulsive eating (eating m
g
more food
tha normal a more th is need to satisf your hun
an
and
han
ded
fy
nger).
→ Tell y
your docto if you e
or
experience any of th
e
hese beha
aviours; th
hey will dis
scuss way of managing or
ys
reduc
cing the sy
ymptoms.
Very rare side effec
e
cts:
may affec up to 1 in 10,000 pe
ct
n
eople
A very sm numb of people taking Re
mall
ber
equip XL (le than 1 in 10,000) have exper
ess
rienced:
• chang in liver f
ges
function, wh
hich have s
shown up in blood test
n
ts
• allergi reactions such as r
ic
s
red, itchy s
swellings on the skin (hives), sw
n
welling of th face, lips, mouth, t
he
tongue or
throat which may cause diff
y
ficulty in sw
wallowing or breathing, rash or int
r
,
tense itchin
ng.
atients may have the following side effects (frequen not known)
y
ncy
Some pa
• act in an aggress
sive manne
er.
quip XL wi L-dopa
ith
If you’re taking Req
who
dopa may d
develop oth side effe
her
ects over tim
me:
People w are taking Requip XL with L-d
• uncon
ntrollable m
movements (dyskinesias) are a very comm
mon side e
effect. If yo are takin L-dopa you may
ou
ng
experience some uncontro
ollable mov
vements (dyskinesias) when you first star taking Re
)
u
rt
equip XL. Tell your
doctor if this happens, as yo doctor m need t adjust the dose of th medicine you are taking.
r
our
may
to
e
he
es
• feeling confused is a common side effe
g
ect.
ng
effects
Reportin of side e
If you ge any side effects, talk to your doctor, pha
et
armacist or nurse. Th includes any possible side effects not
r
his
s
listed in this lea
n
aflet. You can also report s
o
side effec
cts directly via the Yellow Card Sch
y
e
heme at:
www.mhr
ra.gov.uk/yellowcard
By report
ting side eff
fects you ca help pro
an
ovide more information on the saf
n
fety of this medicine.
5. HOW T STORE REQUIP X
TO
E
XL
• Keep Requip XL out of the s
sight and re
each of chil
ldren.
• Don’t use Requip XL after th expiry date shown on the cart
p
he
ton.
• Do no store abo 25°C. S
ot
ove
Store in the original pac
ckage to pr
rotect from light.
• If you have any unwanted Requip XL don’t disp
L,
pose of the in waste water or household rubbish. Take them
em
e
back t your pha
to
armacist, wh will dispose of them in a way t
ho
m
that won’t h
harm the en
nvironment.
• If you notice that your table have be
t
ets
ecome disco
oloured or show any o
other signs of deterior
ration, spea to your
ak
pharm
macist.
6. CONTENTS OF T
THE PACK AND OTH
K
HER INFOR
RMATION
What Requip XL co
ontains
The activ substan in Req
ve
nce
quip XL is ropinirole Each pro
e.
olonged-re
elease tabl contain 2 mg, 4 mg or 8
let
ns
mg of ropinirole (a hydroch
as
hloride).
er
The othe ingredients are:
• tablet cores:
t
hypromel
llose, hydro
ogenated c
castor oil, c
carmellose sodium, po
ovidone K2
29-39, malt
todextrin, magnesium stearate,
m
lactose m
monohydrate, anhydrous colloidal silica, man
nnitol E421, ferric oxid yellow (E
de
E172), glyce dibehe
erol
enate
• film c
coats:
2 mg tablet: hyprom
mellose, ferr oxide ye
ric
ellow (E172), titanium d
dioxide (E171), macro
ogol 400, re iron oxide (E172)
ed
4 mg tablet: hyprom
mellose, titanium dioxid (E171), m
de
macrogol 4
400, sunset yellow (E110), indigo carmine (E
E132)
8 mg tab
blet: hyprom
mellose, fer oxide y
rric
yellow (E17
72), titanium dioxide (E
m
E171), blac iron oxid (E172), macrogol
ck
de
400, red iron oxide (
(E172)
ooks like an content of the pa
nd
ts
ack
What Requip XL lo
®
haped, film-c
coated table marked ‘GS’ on one side and ‘3V2’ on the other.
ets
e
Requip XL 2mg tablets: pink capsule-sh
®
Requip XL 4mg ta
ablets: light brown capsule-shap
ped, film-coated tablets marked ‘G on one side and ‘
GS’
e
‘WXG’ on
the other.
®
Requip XL 8mg ta
ablets: red
d-brown cap
psule-shaped, film-coated tablets marked ‘GS’ on one side and ‘5CC’ on
e
the other.
er
All strengths: bliste packs of 28 tablets.
cturer
Manufac
Manufact
tured by Sm
mithKline B
Beecham Ph
harmaceuticals, Mano Royal, Cr
or
rawley, We Sussex, RH10 9QJ UK and
est
J,
procured from within the EU an repackaged by the Product Licence Hold OPD Laboratories Ltd, Watfo Herts
n
nd
der:
s
ord,
WD24 4P
PR.
®
Release Ta
ablets
5814/0924
POM
Requip XL 2mg Prolonged R
PL No: 15
®
Requip XL 4mg Prolonged R
Release Ta
ablets
PL No: 15
5814/0925
®
Requip XL 8mg Prolonged R
Release Ta
ablets
PL No: 15
5814/0926
s
ed
ark
GlaxoSmithK
Kline group of compan
nies.
Requip is a registere tradema of the G
Leaflet re
evision and issue date (Ref.): 10.04.2014.
To request a copy o this leafle in Braille, large print or audio please call 0
of
et
t
01923 332 7
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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