Skip to Content

UK Edition. Click here for US version.

REQUIP 2MG

Active substance(s): ROPINIROLE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
2
62000000002041
GSK-ESP-Aranda-ESARA

Package Leaflet: Information for the User

United Kingdom-GBR
Requip

0.25 mg, 1 mg, 2 mg, 5 mg
film-coated tablets

N/A

ropinirole (as the hydrochloride)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.

N/A

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your
doctor or pharmacist.

N/A
1
K

This medicine has been prescribed for you only.
Do not 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
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

0

What is in this leaflet
1 What ReQuip is and what it is used for
2 What you need to know before
you take ReQuip

0

3 How to take ReQuip
4 Possible side effects
5 How to store ReQuip
6 Contents of the pack and other information

1 What ReQuip is and what it is used for

2 What you need to know before you
take ReQuip

ReQuip is used to treat Parkinson’s disease.
The active ingredient in ReQuip 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.

Do not take ReQuip:

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.

• if you have liver disease

• if you are allergic to ropinirole or any of the
other ingredients of this medicine (listed in
section 6)
• if you have serious kidney disease
➔ Tell your doctor if you think any of these may
apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before
taking ReQuip:
• 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 serious mental health problem
• if you have experienced any unusual urges
and/or behaviours (such as excessive gambling
or excessive sexual behaviour)
• if you have an intolerance to some sugars
(such as lactose).

SIDE 1

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 if you think any of these
may apply to you. Your doctor may decide
that ReQuip isn’t suitable for you or that you
need extra check-ups while you’re taking it.

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

62000000002041

PHARMA CODE N° 5200

02-01-XX-273-11

9.0pt

11.0pt
9.0pt

100%
N

Page 1 of 4

2
62000000002041
GSK-ESP-Aranda-ESARA

Other medicines and ReQuip

United Kingdom-GBR

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines including any herbal remedies or other
medicines you bought without a prescription.

Requip

Some medicines can affect the way ReQuip
works or make it more likely that you’ll have
side effects. ReQuip can also affect the way
some other medicines work.

N/A

These include:

02-01-XX-273-11

• the anti-depressant fluvoxamine
• HRT (hormone replacement therapy)
• the antibiotics ciprofloxacin or enoxacin

N/A

• m
 edication for other mental health
problems, for example sulpiride

N/A
1
K

• m
 etoclopramide, which is used to treat
nausea and heartburn
• c imetidine, used in the treatment of
stomach ulcers
• any other medicine for Parkinson’s disease.

0

➔ Tell your doctor if you’re taking, or have
recently taken, any of these.
Remember to tell your doctor if you start taking
any other medicine while you’re taking ReQuip.

ReQuip with food and drink
0

If you take ReQuip with food, you may be less
likely to feel sick or be sick (vomit). So it’s best
to take it with food if you can.

Pregnancy and breast-feeding
ReQuip is not recommended if you are
pregnant, unless your doctor advises that the
benefit to you taking ReQuip is greater than
the risk to your unborn baby. ReQuip 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.
Your doctor may advise you to stop taking ReQuip.

Driving and using machines
ReQuip can make you feel drowsy. 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 no longer affected.
➔ Talk to your doctor if this causes problems
for you.

ReQuip contains lactose
ReQuip tablets contain a small amount of a
sugar called lactose. If you have an intolerance
to lactose or any other sugars, ask your doctor
for advice before you take ReQuip.

Smoking and ReQuip
Tell your doctor or nurse if you start smoking, or
give up smoking, while you’re taking ReQuip.
Your doctor or nurse may need to adjust
your dose.

3 How to take ReQuip
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
You may be given ReQuip on its own to treat
the symptoms of your Parkinson’s disease, or
you may be given ReQuip as well as another
medicine called L-dopa (also called levodopa).
If you are taking L-dopa you may experience some
uncontrollable movements (dyskinesias) when you
first start taking ReQuip. 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. Your doctor may need to adjust
or stop your dose.

How much ReQuip will you need to take?
It may take a while to find out the best dose of
ReQuip for you.
The usual starting dose is 0.25 mg of ropinirole
three times each day for the first week. Then your
doctor will increase your dose each week, for the
next three weeks. After that, your doctor will
gradually increase the dose until you are taking the
dose that is best for you. The usual is 1 mg to 3 mg
three times each day (making a total daily dose of
3 mg to 9 mg). If your Parkinson’s disease symptoms
have not improved enough, your doctor may decide
to gradually increase your dose some more.
Some people take up to 8 mg of ReQuip three
times a day (24 mg daily altogether).
If you are also taking other medicines for
Parkinson’s disease, your doctor may advise you to
gradually reduce the dose of the other medicine.

Don’t take any more ReQuip than your doctor
has recommended.
It may take a few weeks for ReQuip to work for you.

Taking your dose of ReQuip
Take ReQuip three times a day.
Swallow your ReQuip tablets whole, with a
glass of water. It’s best to take ReQuip with
food, because that makes it less likely that you’ll
feel sick (nauseous).

If you take more ReQuip than you should
Contact a doctor or pharmacist immediately.
If possible, show them the ReQuip pack.
Someone who has taken an overdose of ReQuip
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
Do not take a double dose to make up for a
forgotten dose. Just take your next dose at the
usual time.
If you have missed taking ReQuip for more than
a few days, ask your doctor for advice on how
to start taking it again.

62000000002041

SIDE 2

9.0pt

11.0pt
9.0pt

100%
N

Page 2 of 4

2
62000000002041
GSK-ESP-Aranda-ESARA

If you stop taking ReQuip
Do not stop taking ReQuip without advice.

United Kingdom-GBR

Take ReQuip for as long as your doctor
recommends. Don’t stop unless your doctor
advises you to.

Requip

If you suddenly stop taking ReQuip your
Parkinson’s disease symptoms may quickly get
much worse. A sudden stop could cause you to
develop a medical condition called neuroleptic
malignant syndrome which may represent a major
health risk. The symptoms include: akinesia (loss of
muscle movement), rigid muscles, fever, unstable
blood pressure, tachycardia (increased heart rate),
confusion, drepressed level of consciousness (e.g.
coma).

N/A
02-01-XX-273-11

N/A

If you need to stop taking ReQuip your doctor
will reduce your dose gradually.

N/A
1
K

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side
effects, although not everyone gets them.
The side effects of ReQuip 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 have taken the dose for a while.

Very common side effects:
may affect more than 1 in 10 people
• fainting
• feeling drowsy
• feeling sick (nausea)
may affect up to 1 in 10 people

• feeling dizzy (a spinning sensation)
• heartburn
• stomach pain
• swelling of the legs, feet or hands

0

may affect up to 1 in 10,000 people

• f eeling dizzy or faint, especially when you
stand up suddenly (this is caused by a drop in
blood pressure)

• c hanges in liver function, which have shown
up in blood tests

• f alling asleep very suddenly without feeling
sleepy first (sudden sleep onset episodes)

• a
 llergic 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

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

Some patients may have the following side
effects (frequency not known: cannot be
estimated from the available data)

You may experience the following side effects:

• aggression

• inability to resist the impulse, drive or
temptation to perform an action that could be
harmful to you or others, which may include:

• e
 xcessive use of ReQuip (craving for large
doses of dopaminergic drugs in excess of that
required to control motor symptoms, known
as dopamine dysregulation syndrome).

• s trong impulse to gamble excessively despite
serious personal or family consequences

Common side effects:
• hallucinations (sensing things that are not real)

0

Very rare side effects:

may affect up to 1 in 100 people

• f eeling very sleepy during the day (extreme
somnolence)

If you are worried about side effects,
talk to your doctor.

• being sick (vomiting)

Uncommon side effects:

• a
 ltered or increased sexual interest and
behaviour of significant concern to you or
to others, for example, an increased
sexual drive

If you are taking ReQuip with L-dopa
People who are taking ReQuip with L-dopa may
develop other side effects over time:
• u
 ncontrollable movements (dyskinesias) are a
very common side effect. Tell your doctor if this
happens, as your doctor may need to adjust
the doses of the medicines you are taking

• u
 ncontrollable excessive shopping or
spending
• b
 inge 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.

• 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.

62000000002041

SIDE 3

9.0pt

11.0pt
9.0pt

100%
N

Page 3 of 4

2

PHARMA CODE N° 5200

62000000002041
GSK-ESP-Aranda-ESARA

5 How to store ReQuip
Keep this medicine out of the sight and reach
of children.

United Kingdom-GBR
Requip
N/A
02-01-XX-273-11

N/A
1
K

0

0

All strengths are supplied in blister packs.
0.25 mg strength carton contain 21 tablets and
1, 2 and 5 mg strength carton contain 84 tablets.

What ReQuip contains

Do not use this medicine after the expiry
date which is stated on the blister and on the
carton. The expiry date refers to the last day of
that month.

The active substance in ReQuip is ropinirole
(as the hydrochloride) as 0.25 mg, 1 mg, 2 mg or
5 mg tablets.

Do not store this medicine above 25°C. Keep in
a dry place, away from light.

• t ablet cores: lactose monohydrate,
microcrystalline cellulose, croscarmellose sodium,
magnesium stearate

Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

N/A

6 Contents of the pack and other
information

The other ingredients are:

• film coats:

0.25 mg tablet: hypromellose, macrogol 400,
titanium dioxide (E171), polysorbate 80 (E433).
1 mg tablet: hypromellose, macrogol 400,
titanium dioxide (E171), iron oxide yellow (E172),
indigo carmine aluminium (E132).
2 mg tablet: hypromellose, macrogol 400,
titanium dioxide (E171), iron oxide yellow (E172),
iron oxide red (E172).

The Marketing Authorisation Holder is
SmithKline Beecham Limited, Stockley Park West,
Uxbridge, Middlesex UB11 1BT
The Manufacturer is Glaxo Wellcome S.A.,
Avendia 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 0.25 mg



ReQuip 1 mg



ReQuip 2 mg



ReQuip 5 mg

5 mg tablet: hypromellose, macrogol 400,
titanium dioxide (E171), indigo carmine
aluminium (E132), polysorbate 80 (E433).

Reference number 10592/0085

What ReQuip looks like and contents
of the pack

This leaflet was last revised in 12/2015

This is a service provided by the Royal National
Institute of Blind People.

ReQuip (all strengths) is provided as pentagonal,
film-coated tablets, marked ‘SB’ on one side.

ReQuip and the ReQuip tablet shape are
registered trade marks of the GSK group of
companies

ReQuip 0.25 mg: white tablets marked ‘4890’ on
reverse side.

© 2015 GSK group of companies. All rights
reserved

ReQuip 1 mg: green tablets marked ‘4892’ on
reverse side.
ReQuip 2 mg: pink tablets marked ‘4893’ on
reverse side.
ReQuip 5 mg: blue tablets marked ‘4894’ on
reverse side.
62000000002041

SIDE 4

9.0pt

11.0pt
9.0pt

100%
N

Page 4 of 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.

Hide