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ADARTREL 0.25 MG FILM-COATED TABLETS

Active substance: ROPINIROLE HYDROCHLORIDE

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film-coated tablets

ropinirole (as hydrochloride)

Read all of this leaflet carefully
before you start taking this
medicine.
Keep this leaflet. You may need to
read it again.
If you have any more 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 symptoms are the same as
yours.
If any of the side effects gets
serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

0.25 mg, 0.5 mg, 2 mg

Package Leaflet: Information for the User

1 What Adartrel is and
what it is used for

In this leaflet
1 What Adartrel is and what it is
used for
2 Before you take Adartrel
3 How to take Adartrel

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 Before you take Adartrel

4 Possible side effects

Do not take Adartrel:

5 How to store Adartrel

if you are allergic
(hypersensitive) to ropinirole or
any of the other ingredients of
Adartrel (see 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.

6 Further information

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

pregnant or think
you may be pregnant
breast-feeding
under 18 years old
liver disease
serious heart
complaint
serious mental
health problem
unusual urges and/or behaviours
(such as excessive gambling or
excessive sexual behaviour)
intolerance to
some sugars (such as lactose
monohydrate)
➔ Talk to your doctor if you think
any of these may apply to you. If
you and your doctor decide that
you can take Adartrel, your doctor
check-ups while you are taking it.

Taking other medicines
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:
anti-depressant
fluvoxamine
mental
health problems
sulpiride
metoclopramide, which is used
to treat nausea and heartburn

HRT (hormone replacement
therapy)
antibiotics ciprofloxacin or
enoxacin
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:
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.

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

While you are taking Adartrel

Some people taking Adartrel find
that their RLS symptoms get worse

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.

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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Important information about
some of the ingredients of
Adartrel
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 Adartrel exactly as
your doctor has told you to. You
should 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 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
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
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
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, Adartrel can
cause side effects, although not
everyone gets them.
The side effects of Adartrel 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
These may affect more than 1 in
10 people taking Adartrel:

Common side effects
These may affect up to 1 in 10
people taking Adartrel:

tiredness)
sensation)

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
falling asleep very suddenly
without feeling sleepy first
(sudden sleep onset episodes)

Some patients may have the
following 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)
urges to behave in a way
unusual for them such as an
unusual urge to gamble or

Do not store Adartrel above 25°C.
Store it in its original package.
Medicines should not be
disposed of via your waste water
or household waste. Ask your
pharmacist how to dispose of
medicines no longer required.
These measures will help to
protect the environment.

6 Further 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,
(E171), polysorbate 80 (E433)
0.5 mg tablet: hypromellose,

behaviours
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)

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)

If you get side effects
If any of the side effects become
serious or troublesome, or if you
notice any side effects not listed
in this leaflet, please tell your
doctor or pharmacist.

5 How to store Adartrel
Keep Adartrel out of the reach
and sight of children.
Do not use Adartrel after the

of that month.

carmine aluminium lake (E132)
2 mg tablet: hypromellose,

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:
UB11 1BT
Manufacturer
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
This is a service provided by the
Royal National Institute of Blind
People.
Leaflet date: June 2013
Adartrel is a registered trademark
companies
©
companies.

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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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