REQUIP 5MG

Active substance: ROPINIROLE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
2
10000000111418
GSK-ESP-Aranda-ESARA
United Kingdom-GBR

Package Leaflet: Information for the User

Requip
1

1 mg, 2 mg, 5 mg film-coated tablets
ropinirole (as the hydrochloride)
Read right through this leaflet before you start
taking these tablets.
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.

K

Keep this leaflet. You may need to read it again.
02-01-XX-273-11

If you have any more questions, ask your doctor
or pharmacist (chemist).
If you have serious side effects, or if you notice
any side effects not listed in this leaflet, tell
your doctor or pharmacist.
In this leaflet
1 What ReQuip is and what it is used for

1 What ReQuip is and what it is used for

2 Before you take ReQuip

ReQuip is used to treat Parkinson’s disease.

Don’t take ReQuip:

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.

• if you’re allergic (hypersensitive) to ropinirole
or any of the other ingredients of ReQuip
(see Section 5 and 7)

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 serious kidney disease
• if you have liver disease
➔ Tell your doctor if you think any of these may
apply to you.

Take special care with ReQuip
Your doctor needs to know before you take
ReQuip:

2 Before you take ReQuip

• if you are pregnant or think you may be
pregnant

3 While you’re taking ReQuip

• if you are breast-feeding

4 How to take ReQuip

• if you are under 18 years old

5 Possible side effects

• if you have a serious heart complaint

6 How to store ReQuip

• if you have a serious mental health problem

7 Further information

• if you have experienced any unusual urges
and/or behaviours (such as excessive
gambling or excessive sexual behaviour)

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.
You also need to be careful with ReQuip if you
drive or operate machinery. Please read the
warning in Section 3 of this leaflet.

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.

• if you have an intolerance to some sugars
(such as lactose).
10000000111418

TYPE SIZE: 9/11
HORIZONTAL SCALE: 100%

Page 1 of 4

PHARMA CODE N° 4358

SIDE 1

2
10000000111418
GSK-ESP-Aranda-ESARA
United Kingdom-GBR
Requip
1

Other medicines and ReQuip
Tell your doctor or pharmacist if you’re taking,
or have recently taken, any other medicines
including any herbal remedies or other
medicines you bought without a prescription.
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.
These include:
• the anti-depressant fluvoxamine
• HRT (hormone replacement therapy)

K

• the antibiotics ciprofloxacin or enoxacin
• medication for other mental health
problems, for example sulpiride

02-01-XX-273-11

• metoclopramide, which is used to treat
nausea and heartburn
• cimetidine, used in the treatment of stomach
ulcers
• any other medicine for Parkinson’s disease.
➔ 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.

• if you’re breast-feeding or planning to
breast-feed.
Your doctor may advise you to stop taking
ReQuip.

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

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

4 How to take ReQuip
Always take ReQuip exactly as your doctor has
told you to. Check with your doctor or
pharmacist if you’re 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 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.

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.

Food and drink with ReQuip

How much ReQuip will you need to take?

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.

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

Smoking and ReQuip

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

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).
10000000111418

TYPE SIZE: 9/11
HORIZONTAL SCALE: 100%
SIDE 2

Page 2 of 4

2
10000000111418
GSK-ESP-Aranda-ESARA
United Kingdom-GBR

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.

Requip
1

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).

K

If someone takes too much ReQuip
02-01-XX-273-11

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
Don’t take extra tablets or a double dose to
make up for a missed 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.

If you suddenly stop taking ReQuip your
Parkinson’s disease symptoms may quickly get
much worse.
If you need to stop taking ReQuip your doctor
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 can have side effects,
but 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.
If you’re worried about side effects, talk to your
doctor.

Very common side effects
These may affect more than 10 in 100 people
taking ReQuip:
• fainting
• feeling drowsy
• feeling sick (nausea)

Common side effects
These may affect more than 1 in 100 people
taking ReQuip:
• hallucinations (sensing things that are not
real)

• feeling very sleepy during the day (extreme
somnolence)
• falling asleep very suddenly without feeling
sleepy first (sudden sleep onset episodes)
• mental problems such as delirium (severe
confusion), delusions (unreasonable ideas) or
paranoia (unreasonable suspicions)

You may experience the following side
effects:
• inability to resist the impulse, drive or
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)

• feeling dizzy (a spinning sensation)

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

• heartburn

Very rare side effects

• stomach pain

A very small number of people taking ReQuip
(less than 1 in 10,000) have had:

• being sick (vomiting)

• swelling of the legs

Uncommon side effects

Don’t stop taking ReQuip without advice

These may affect more than 1 in 1,000 people
taking ReQuip:

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

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

• 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
10000000111418

TYPE SIZE: 9/11
HORIZONTAL SCALE: 100%
SIDE 3

Page 3 of 4

2

PHARMA CODE N° 4358

10000000111418
GSK-ESP-Aranda-ESARA
United Kingdom-GBR
Requip
1

If you’re taking ReQuip with L-dopa
People who are taking ReQuip with L-dopa may
develop other side effects over time:
• uncontrollable 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
• feeling confused is a common side effect

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

K

6 How to store ReQuip

7 Further information
What ReQuip contains
The active substance in ReQuip is ropinirole
(as the hydrochloride) as 1 mg, 2 mg or 5 mg
tablets.

Don’t use ReQuip after the expiry date shown
on the carton.
Don’t store ReQuip above 25°C. Keep in a dry
place, away from light.
If you have any unwanted ReQuip 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.

The Manufacturer is Glaxo Wellcome S.A.,
Avendia de Extremadura 3, 09400 Aranda de
Duero, Burgos, Spain

The other ingredients are:

Keep ReQuip out of the sight and reach of
children.

The Marketing Authorisation Holder is
GlaxoSmithKline UK, Stockley Park West,
Uxbridge, Middlesex UB11 1BT

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:

• tablet cores: lactose monohydrate,
microcrystalline cellulose, croscarmellose
sodium, magnesium stearate
• film coats:
1 mg tablet: hypromellose, macrogol
400, titanium dioxide (E171), iron oxide
yellow (E172), indigo carmine aluminium
(E132).

➔ Tell your doctor or pharmacist.

2 mg tablet: hypromellose, macrogol
400, titanium dioxide (E171), iron oxide
yellow (E172), iron oxide red (E172).

02-01-XX-273-11

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

What ReQuip looks like and contents of the
pack

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:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name

ReQuip 1 mg
ReQuip 2 mg
ReQuip 5 mg

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

Reference number 10592/0087

ReQuip 1 mg: green tablets marked ‘4892’ on
reverse side.

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

ReQuip 2 mg: pink tablets marked ‘4893’ on
reverse side.

Leaflet date: November 2012

ReQuip 5 mg: blue tablets marked ‘4894’ on
reverse side.

ReQuip and the ReQuip tablet shape are
registered trademarks of the GlaxoSmithKline
group of companies

All strengths are supplied in blister packs of
84 tablets.

© 2012 GlaxoSmithKline group of companies.
All rights reserved

10000000111418

TYPE SIZE: 9/11
HORIZONTAL SCALE: 100%
SIDE 4

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
(web5)