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ROPINIROLE 0.5MG FILM COATED TABLETS

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Package Leaflet: Information for
the User

ADARTREL® 0.5mg
Film-coated Tablets
(ropinirole)
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.
The name of your medicine is
ADARTREL 0.5mg Film-coated
Tablets but will be referred to as
Adartrel throughout this leaflet. Please
note that this leaflet also contains
information about the other strengths
such as ADARTREL 0.25mg and 2mg
Film-coated Tablets.

1. What Adartrel is and
what it is used for
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:


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

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
 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.

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).

Taking Adartrel with food and
drink

Pregnancy and breast-feeding

If your symptoms get worse

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 breastfeeding, 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.

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.

Other medicines and Adartrel

While you are taking 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.

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.

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.

Adartrel 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.

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 0.25mg
once a day. After two days, your
doctor will probably increase your
dose to 0.5mg 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 2mg.
If a 2mg daily dose does not improve
your RLS symptoms enough, your
doctor may gradually increase your
dose some more, up to a maximum of
4mg 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.

Taking your dose of Adartrel
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 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.

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

Very common side effects
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)







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
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 out of the sight and reach of
children.
Do not store above 25°C.
Store in the original package.
Do not take the tablets after the expiry
date which is stated on the carton and
blister label after 'Éxp'. The expiry date
refers to the last day of that month.
If the tablets become discoloured or
show any signs of deterioration, seek
the advice of your pharmacist.
Remember if your doctor tells you to
stop taking this medicine, return any
unused medicine to your pharmacist
for safe disposal. Only keep this
medicine if your doctor tells you to.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose of
medicines no longer required. These
measures will help to protect the
environment.

6. Contents of the pack
and other information
What Adartrel contains
The active substance in Adartrel is
ropinirole (as hydrochloride).
Each tablet contains 0.5mg of
ropinirole (as hydrochloride).
The other ingredients are:
 tablet core: lactose monohydrate,
microcrystalline cellulose,
croscarmellose sodium,
magnesium stearate
 film coat: hypromellose, macrogol
400, titanium dioxide (E171),
yellow iron oxide (E172),
red iron oxide (E172) and indigo
carmine (E132).

What Adartrel looks like and
contents of the pack
Adartrel is yellow, pentagonal, filmcoated tablet, marked ‘SB’ on one side
and ‘4891’ on the other.
Each pack contains 84 tablets.
Manufactured by: Glaxo Wellcome
S.A., Avenida de Extremadura 3,
09400 Aranda de Duero, Burgos
Spain.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
®

ADARTREL 0.5mg Film-coated
Tablets; PL 18799/2070
POM
Leaflet date: 09.05.2017

Blind or partially
sighted?
Is this leaflet hard
to see or read?
Call 0208 515
3763 to obtain the
leaflet in a format
suitable for you.

Expand Transcript

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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