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ADARTREL 2 MG FILM-COATED TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE / ROPINIROLE HYDROCHLORIDE

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62000000007373
GSK-ESP-Aranda-ESARA

1 What Adartrel is and
what it is used for

United Kingdom-GBR
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 or pharmacist.
This medicine has been prescribed for
you. 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 of the side effects, talk
to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.

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

0.25 mg, 0.5 mg, 2 mg

N/A

1

film-coated tablets

0

What is in this leaflet
1 What Adartrel is and what it is
used for
2 What you need to know before
you take Adartrel
3 How to take Adartrel
4 Possible side effects
5 How to store Adartrel
6 Contents of the pack and other
information

Adartrel is used to treat the
symptoms of moderate to severe
restless legs syndrome.
Restless legs syndrome (RLS) is also
called Ekbom syndrome. People
with restless legs syndrome have
an irresistible urge to move their
legs, and sometimes their arms and
other parts of their bodies. Usually,
they have unpleasant sensations in
their limbs - sometimes described as
‘crawling’ or ‘bubbling’ - which can
begin as soon as they sit or lie down,
and are relieved only by movement.
So they often have problems with
sitting still and especially with sleeping.
Adartrel relieves the unpleasant
sensations, and so reduces the urge to
move the legs and other limbs.

2 What you need to know
before you take Adartrel
Do not take Adartrel:

· 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
· if you have serious liver 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 Adartrel:
· 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 liver disease

Other medicines and Adartrel
Please tell your doctor or pharmacist if
you are taking, or have recently taken,
any other medicines, including any
herbal medicines or other medicines
you obtained without a prescription.
Remember to tell your doctor or
pharmacist if you begin taking a new
medicine while you are taking Adartrel.
Some medicines can affect the way
Adartrel works or make it more
likely that you will have side effects.
Adartrel can also affect how some
other medicines work.
These include:
· the anti-depressant fluvoxamine
· medication for other mental health
problems, for example sulpiride

· m
 etoclopramide, which is used to
treat nausea and heartburn
· HRT (hormone replacement therapy)
· the antibiotics ciprofloxacin or
enoxacin
· any other drug which blocks the
action of dopamine in the brain.
➔ Tell your doctor if you are taking, or
have recently taken, any of these.
You will require additional blood
tests if you are taking these
medicines with Adartrel:
· Vitamin K antagonists (used to
reduce blood clotting) such as
Warfarin (coumadin).

Pregnancy and breast-feeding

Adartrel is not recommended if you are
pregnant, unless your doctor advises
that the benefit to you of taking it is
greater than the risk to your unborn
baby. Adartrel is not recommended if
you are breast-feeding, as it can affect
your milk production.
➔ Talk to your doctor immediately
if you are pregnant, if you think
you might be pregnant, or if you
are planning to become pregnant.
Your doctor will also advise you if
you are breast-feeding or planning
to do so. Your doctor may advise
you to stop taking Adartrel.

While you are taking Adartrel

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 Adartrel. Your doctor
may need to adjust or stop your dose.
· Driving and using machines
Adartrel can make you feel drowsy.
In very rare cases, Adartrel can make
people feel extremely sleepy, and it
sometimes makes people fall asleep
very suddenly without warning.
If you could be affected: do not
drive, do not operate machines
and do not put yourself in any
situation where feeling sleepy

or falling asleep could put you
(or other people) at risk of serious
injury or death. Do not take part
in these activities until you are no
longer affected.
➔ Talk to your doctor if this causes
problems for you.
· Smoking and Adartrel
Tell your doctor if you start
smoking, or give up smoking, while
you are taking Adartrel. Your doctor
may need to adjust your dose.

Taking Adartrel with food and
drink

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

If your symptoms get worse

Some people taking Adartrel
find that their RLS symptoms get
worse - for example, symptoms may
start earlier than usual or be more
intense, or affect other previously
unaffected limbs, such as the arms or
return in the early morning.
➔ Tell your doctor as soon as possible
if you get any of these symptoms.

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

3 How to take Adartrel
Always take this medicine exactly
as your doctor or pharmacist has
told you. Check with your doctor or
pharmacist if you are not sure.
Do not give Adartrel to children.
Adartrel is not normally prescribed
for people under 18.

62000000007373

PHARMA CODE N° 5754

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Package Leaflet: Information for the User

K

ropinirole (as hydrochloride)

N/A

The active ingredient in Adartrel
is ropinirole, which belongs to a
group of medicines called dopamine
agonists. Dopamine agonists act in
a similar way to a natural substance
called dopamine, in the brain.

· 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
monohydrate).
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.
➔ Talk to your doctor if any of these
may apply to you. If you and your
doctor decide that you can take
Adartrel, your doctor will probably
ask you to have extra check-ups
while you are taking it.

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How much Adartrel will you
need to take?

It may take a while to find out what is
the best dose of Adartrel for you.
The usual starting dose is 0.25 mg
once a day. After two days, your
doctor will probably increase your
dose to 0.5 mg daily for the rest of the
week. Then your doctor may gradually
increase your dose over the next three
weeks, up to a daily dose of 2 mg.
If a 2 mg daily dose does not improve
your RLS symptoms enough, your
doctor may gradually increase your
dose some more, up to a maximum
of 4 mg daily. After you have been
taking Adartrel for three months,
your doctor may adjust your dose or
advise you to stop taking it.

United Kingdom-GBR
Adartrel
N/A
02-01-XX-273-02

N/A
N/A
1
K

If you feel that the effects of Adartrel
are too strong or too weak, talk to
your doctor or your pharmacist. Do
not take more Adartrel than your
doctor has recommended.
Carry on taking Adartrel as your
doctor advises, even if you do not feel
better. Adartrel may take a few weeks
to work for you.

Taking your dose of Adartrel
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0

Take your Adartrel tablet(s) once a day.
Swallow the tablet(s) whole, with a
glass of water. Do not chew or crush
the tablets.
You can take Adartrel with or without
food. If you take it with food, you may
be less likely to feel sick (nauseous).
Adartrel is usually taken just before
bedtime, but you can take it up to
3 hours before you go to bed.

If you take more Adartrel than
you should

Contact a doctor or pharmacist
immediately. If possible, show them
the Adartrel pack.
Someone who has taken an overdose
of Adartrel 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 get any side effects, talk to your
doctor or pharmacist. This includes any
side effects not listed in this leaflet.

If you forget to take Adartrel

Very common side effects

Do not 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 your dose for
more than a few days, ask your
doctor for advice on how to start
taking it again.

If you stop taking Adartrel
Do not stop taking Adartrel without
advice.
Take Adartrel for as long as your
doctor recommends. Do not stop
unless your doctor advises you to.
If you suddenly stop taking Adartrel,
your Restless leg syndrome 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, depressed level of
consciousnesss (e.g. coma).
If you need to stop taking Adartrel,
your doctor will reduce your dose
gradually.
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.
Side effects with this medicine 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.

These may affect more than 1 in 10
people taking Adartrel:
· feeling sick (nausea)
· being sick (vomiting).

Common side effects

These may affect up to 1 in 10 people
taking Adartrel:
· nervousness
· fainting
· drowsiness
· fatigue (mental or physical
tiredness)
· dizziness (a ‘spinning’ sensation)
· stomach pain
· worsening of RLS (symptoms may
start earlier than usual or be more
intense, or affect other previously
unaffected limbs, such as the arms
or return in the early morning)
• swelling of the legs, feet or hands.

Uncommon side effects

These may affect up to 1 in 100
people taking Adartrel:
· confusion
· hallucinations (‘seeing’ things that
are not really there)
· feeling dizzy or faint, especially
when you stand up suddenly (this is
caused by a drop in blood pressure).

Very rare side effects
A very small number of people taking
Adartrel (up to 1 in 10,000) have had:
· changes in liver function, which
have shown up in blood tests
· feeling very sleepy during the day
(extreme somnolence)
· falling asleep very suddenly
without feeling sleepy first (sudden
sleep onset episodes).

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

· 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
(see section 2)
· other psychotic reactions in
addition to hallucinations, such
as severe confusion (delirium),
irrational ideas (delusions) and
irrational suspiciousness (paranoia)
· aggression
· excessive use of Adartrel (craving
for large doses of dopaminergic
drugs in excess of that required
to control motor symptoms,
known as dopamine dysregulation
syndrome).
You may experience the following
side effects:
· inability to resist that impulse,
drive or temptation to perform an
action that could be harmful to you
or others, which may include:
· strong impulse to gamble
excessively despite serious
personal or family consequences
· altered or increased sexual
interest and behaviour of
significant concern to you or
to others, for example, an
increased sexual drive
· uncontrollable excessive
shopping or spending
· binge eating (eating large
amounts of food in a short time
period) or compulsive eating
(eating more food 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.

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.

5 How to store Adartrel
Keep this medicine out of the sight
and reach of children.
Do not use this medicine after the expiry
date which is stated on the carton and
blister after EXP. The expiry date refers
to the last day of that month.
Do not store Adartrel above 25°C.
Store it in its original package.
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 to protect
the environment.

6 Contents of the pack
and other information
What Adartrel contains

The active substance is ropinirole (as
hydrochloride).
Each tablet contains 0.25, 0.5 or 2 mg
of ropinirole (as hydrochloride).
The other ingredients are:
· tablet core: lactose monohydrate,
microcrystalline cellulose,
croscarmellose sodium, magnesium
stearate
· film coat:
0.25 mg tablet: hypromellose,
macrogol 400, titanium dioxide
(E171), polysorbate 80 (E433)
0.5 mg tablet: hypromellose,
macrogol 400, titanium dioxide
(E171), iron oxide yellow (E172),
iron oxide red (E172), indigo
carmine aluminium lake (E132)

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

What Adartrel looks like and
contents of the pack

Adartrel 0.25 mg is provided as white,
pentagonal-shaped film-coated
tablets, marked ‘SB’ on one side
and ‘4890’ on the other. Each pack
contains 12 tablets.
Adartrel 0.5 mg is provided as yellow,
pentagonal-shaped film-coated
tablets marked ‘SB’ on one side
and ‘4891’ on the other. Each pack
contains 28 tablets.
Adartrel 2 mg is provided as pink,
pentagonal-shaped film-coated
tablets marked ‘SB’ on one side
and ‘4893’ on the other. Each pack
contains 28 tablets.
Marketing Authorisation Holder:
GlaxoSmithKline UK Limited,
Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer: Glaxo Wellcome S.A.,
Avenida 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
Adartrel 0.25 mg
Adartrel 0.5 mg
Adartrel 2 mg
Reference number 19494/0033
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in 12/2015
Adartrel is a registered trade mark of
the GSK group of companies
© 2015 GSK group of companies.
All rights reserved.
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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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