REQUIP XL 2 MG PROLONGED RELEASE TABLETS

Active substance: ROPINIROLE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
Patient Information Leaflet

PHARMA CODE N° 4459

1
10000000111427
GSK-ESP-Aranda-ESARA
United Kingdom-GBR
ReQuip-XL

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

Information about your medication

2 Before you take ReQuip XL

K

268

Don’t take ReQuip XL:

This medicine has been prescribed for you
personally. Don’t pass it on to other people - it
may harm them, even if their symptoms seem to
be the same as yours.

2

Please read right through this leaflet before you
start taking these tablets.

• f you have serious kidney disease
i

• f you’re allergic (hypersensitive) to ropinirole
i
or any of the other ingredients of ReQuip XL
(see Section 6)
• f you have liver disease
i

If you have any more questions, ask your
Parkinson’s disease doctor, Parkinson’s disease
nurse specialist or pharmacist (chemist).
02-01-XX-273-11

Keep this leaflet. You may need to read it again.

➔ Tell your doctor or nurse if you think any of
these may apply to you.

If you have serious side effects, or if you notice
any side effects not listed in this leaflet, tell your
doctor, nurse or pharmacist.

Your doctor needs to know before you take
ReQuip XL:

Take special care with ReQuip XL

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

In this leaflet

• f you are breast-feeding
i

1 What ReQuip XL is and what it is for

• f you are under 18 years old
i

2 Before you take ReQuip XL

• f you have a serious heart complaint
i

3 While you’re taking ReQuip XL

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

4 How to take ReQuip XL

• f you have a history of or have experienced
i
any unusual urges and/or behaviours (such as
excessive gambling or excessive sexual behaviour)

5 Possible side effects
6 How to store ReQuip XL
7 Further information

• f you have an intolerance to some sugars
i
(such as lactose).

1 What ReQuip XL is and what it is for

TYPE SIZE: 9/11.5
HORIZONTAL SCALE: 100%

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.

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.

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.

10000000111427

Page 1 of 4
SIDE 1

1

Other medicines and ReQuip XL

4 How to take ReQuip XL

Tell your doctor, nurse or pharmacist if you’re
taking, or have recently taken, any other
medicines - including any herbal remedies or
medicines you bought without a prescription.

• ny other medicine for Parkinson’s disease.
a
➔ Tell your doctor or nurse if you’re taking, or
have recently taken, any of these.

10000000111427
GSK-ESP-Aranda-ESARA
United Kingdom-GBR

Always take ReQuip XL exactly as your Parkinson’s
disease doctor or nurse has told you to. Check with
your doctor, nurse or pharmacist if you’re not sure.
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

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 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.

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:
• he anti-depressant, fluvoxamine
t

ReQuip-XL

• RT (hormone replacement therapy)
H
2

• edication for other mental health problems,
m
for example sulpiride
• etoclopramide, which is used to treat nausea
m
and heartburn

K

268

02-01-XX-273-11

• imetidine, used in the treatment of
c
stomach ulcers
• he antibiotics, ciprofloxacin or enoxacin
t

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.
Tell your doctor or nurse immediately:
• f you’re pregnant, if you think you might be
i
pregnant, or if you’re planning to become
pregnant

How much ReQuip XL will you need to take?

• f you’re breast-feeding or planning to
i
breast-feed.
Your doctor or nurse may advise you to stop
taking ReQuip XL.

TYPE SIZE: 9/11.5
HORIZONTAL SCALE: 100%

Children
Do not give ReQuip XL to children. ReQuip XL is
not normally prescribed for people under 18.

3 While you’re taking ReQuip XL
If you drive or operate machinery
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.

It may take a while to find out the best dose of
ReQuip XL for you.
The usual 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

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.

Food and drink with ReQuip XL
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.

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.

Page 2 of 4
SIDE 2

10000000111427

1
10000000111427
GSK-ESP-Aranda-ESARA
United Kingdom-GBR
ReQuip-XL
2

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 someone takes too much ReQuip XL
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

K

268

Don’t take extra tablets or a double dose to make
up for a missed 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
02-01-XX-273-11

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 product, ask your doctor or pharmacist.

5 Possible side effects
Like all medicines, ReQuip XL 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

You may experience the following side effects:
• 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
• 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)
➔ Tell your doctor if you experience any of these
behaviours; they will discuss ways of managing
or reducing the symptoms

Very rare side effects
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.

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:
• ncontrollable movements (dyskinesias)
u
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.
• eeling confused is a common side effect.
f

If you get side effects
If you notice any unwanted effects (even ones
not mentioned in this leaflet) or if any of the side
effects becomes troublesome while you’re taking
ReQuip XL:

These may affect more than 1 in 10 people taking
ReQuip XL:
• ainting
f
• eeling drowsy
f
• eeling sick (nausea).
f

➔ Tell your doctor, nurse or pharmacist.

Common side effects

TYPE SIZE: 9/11.5
HORIZONTAL SCALE: 100%

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.

These may affect more than 1 in 100 people taking
ReQuip XL:
• allucinations (sensing things that are not real)
h
• eing sick (vomiting)
b
• eeling dizzy (a spinning sensation)
f
• eartburn
h
• tomach pain
s
• onstipation
c
• welling of the legs, feet or hands.
s

Uncommon side effects
These may affect more than 1 in 1,000 people
taking ReQuip XL:
• eeling dizzy or faint, especially when you stand
f
up suddenly (this is caused by a drop in blood
pressure)
• eeling very sleepy during the day
f
• alling asleep very suddenly without feeling
f
sleepy first (sudden sleep onset episodes)
• ental problems such as delirium (severe
m
confusion), delusions (unreasonable ideas) or
paranoia (unreasonable suspicions).

6 How to store ReQuip XL
Keep ReQuip XL out of the sight and reach of
children.

Do not store above 25°C. Store in the original
package.
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.

7 Further information
What ReQuip XL contains
The active substance in ReQuip XL is ropinirole.
Each prolonged-release tablet contains 2 mg, 4 mg
or 8 mg of ropinirole (as hydrochloride).
The other ingredients are:
• ablet cores: hypromellose 2208, hydrogenated
t
castor oil, carmellose sodium, povidone K29-32,
maltodextrin, magnesium stearate, lactose
monohydrate, anhydrous colloidal silica,
mannitol (E421), ferric oxide yellow (E172),
glycerol dibehenate
10000000111427

Page 3 of 4
SIDE 3

• ilm coats:
f
2 mg tablet: hypromellose 2910, ferric oxide
yellow (E172), titanium dioxide (E171),
macrogol 400, ferric oxide red (E172)

1
10000000111427

4 mg tablet: hypromellose 2910, titanium
dioxide (E171), macrogol 400, sunset yellow
(E110), indigo carmine (E132)

GSK-ESP-Aranda-ESARA

8 mg tablet: hypromellose 2910, ferric oxide
yellow (E172), titanium dioxide (E171), ferric
oxide black (E172), macrogol 400, ferric oxide
red (E172)

United Kingdom-GBR

What ReQuip XL looks like and contents
of the pack

ReQuip-XL
2

268

02-01-XX-273-11

PHARMA CODE N° 4459

K

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.
Marketing authorisation holder and manufacturer
Marketing Authorisation Holder: GlaxoSmithKline
UK, Stockley Park West, Uxbridge, Middlesex
UB11 1BT
Manufacturer: Glaxo Wellcome S.A., Avenida de
Extremadura 3, 09400 Aranda de Duero, Burgos,
Spain
A number of groups exist to provide further
information and support to Parkinson’s disease
patients and their carers. The main one is
Parkinson’s UK, who you can contact at the
address given below:
Parkinson’s UK
215 Vauxhall Bridge Road
London SW1V 1EJ
Other formats:
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:

TYPE SIZE: 9/11.5
HORIZONTAL SCALE: 100%

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
ReQuip XL 2 mg prolonged-release tablets
ReQuip XL 4 mg prolonged-release tablets
ReQuip XL 8 mg prolonged-release tablets
Reference number

10592/0293

This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: November 2012
ReQuip is a registered trademark of the
GlaxoSmithKline group of companies
© 2012 GlaxoSmithKline group of companies.
All rights reserved

10000000111427

Page 4 of 4
SIDE 4

Expand view ⇕

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.

Learn how medication, diet, and exercise are key to managing Multiple Sclerosis. Click Here

Close
Hide
(web1)