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ADARTREL 0.5MG FILM COATED TABLETS

Active substance(s): ROPINIROLE

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Patient Information Leaflet
®

Adartrel 0.5mg Film Coated Tablets
(ropinirole hydrochloride)
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 more questions, ask your doctor or your 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.
The name of your medicine is Adartrel 0.5mg Film-Coated Tablets but will
be referred to as Adartrel throughout the remainder of this leaflet.
Your medicine is also available in the following strengths 0.25mg, and
2mg film-coated Tablets.
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
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 Leg 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
Æ 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.
Î 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 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.

Æ 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.
ÆTalk 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.
Î 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.
ÎTell your doctor as soon as possible if you get any of these
symptoms.
Adartrel contains 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 taking 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 0.25 mg once a day. After two days your doctor
will probably increase your dose to 0.5 mg once 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 any more tablets 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody 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)

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)
Î 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 use after expiry date on the carton box or blister strip. If the tablets
show any signs of discolouration or deterioration consult your pharmacist
for advice.
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 informaiton
What Adartrel contains
Each film coated tablet contains 0.5mg of the active ingredient ropinirole
(as the hydrochloride).
Also contains lactose monohydrate, microcrystalline cellulose,
croscarmellose sodium, magnesium stearate, opadry OY-S-22907 yellow:
hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide
(E172), red iron oxide (E172), indigo carmine aluminum lake (E132).
Adartrel 0.5mg are pale yellow, pentagonal-shaped film-coated tablets
marked ‘SB’ on one side and ‘4891’ on the other.
Available in blister packs of 28 tablets.
This medicine is manufactured by SmithKline Beecham Pharmaceuticals,
Manor Royal, Crawley, West Sussex, RH10 9QJ or Glaxo Wellcome S.A.
Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Procured from within the EU. Product Licence Holder: Quadrant
Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton
BL6 4SA. Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
Adartrel 0.5mg Film-coated Tablets

PL 20774/1024

POM

Adartrel is a registered trademark of the GlaxoSmithKline group of
companies
th

Leaflet prepared date: 19 February 2015

PP7/1024/V1

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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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