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ADARTREL 0.25 MG FILM-COATED TABLETS

Active substance: ROPINIROLE HYDROCHLORIDE

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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.

0.25 mg, 0.5 mg, 2 mg
film-coated tablets

What is in this leaflet

ropinirole (as hydrochloride)

Package Leaflet: Information for the User

1 What Adartrel is and
what it is used for

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

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.
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 (hypersensitive)
to ropinirole or any of the other
ingredients of this medicine
(listed in sections 4 and 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
• 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.

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
• metoclopramide, 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.

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Adartrel tablets contain a small
amount of sugar called lactose
monohydrate

Taking your dose of Adartrel

If you have an intolerance to
lactose monohydrate or any other
sugars, ask your doctor for advice
before you take Adartrel.

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.

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.

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.
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.

Take your Adartrel tablet(s) once
a day.

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 forget to take Adartrel
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.

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.

If you get any side effects, talk to your
doctor or pharmacist. This includes any
side effects not listed in this leaflet.

Some patients may have
the following side effects
(frequency not known)

Very common side effects

• 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
(see section 2)
• other psychotic reactions in
addition to hallucinations, such
as severe confusion (delirium),
irrational ideas (delusions) and
irrational suspiciousness (paranoia)
• aggression.
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.

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).

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 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

What Adartrel contains

Other formats

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)

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:
Adartrel 0.25 mg
Product name
Adartrel 0.5 mg
Adartrel 2 mg
Reference number 19494/0033
This is a service provided by the
Royal National Institute of Blind
People.
Leaflet date: July 2014
Adartrel is a registered trade mark
of the GSK group of companies
© 2014 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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