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ADARTREL 0.25MG FILM COATED TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE

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Adartrel® 0.25mg Film-coated Tablets
(ropinirole hydrochloride)
Your medicine is known by one of the above name, but will be referred to as
Adartrel throughout this:
Patient Information Leaflet
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.
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 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.
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.
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.

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:
o strong impulse to gamble excessively despite serious personal or family
consequences
o altered or increased sexual interest and behaviour of significant concern
to you or to others, for example, an increased sexual drive
o uncontrollable excessive shopping or spending
o 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).

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
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)
• 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.



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 all medicines out of the sight and reach of children.
• Do not take Adartrel after the expiry date printed on the carton, label or
blister strip. The expiry date refers to the last day of the month.
• Do not store above 25°C. Store in the original package.
• If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
• 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 ingredient in Adartrel film-coated tablets is ropinirole (as
hydrochloride). Each film-coated tablet contains 0.25mg ropinirole (as
hydrochloride).
Each film-coated tablet also contains the following:
Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose
sodium, and magnesium stearate.
Film coat: hypromellose, macrogol 400, titanium dioxide (E171) and
polysorbate 80 (E433).
What Adartrel looks like and contents of the pack
Adartrel 0.25mg Film-coated Tablets are white pentagonal-shaped and
marked ‘SB’ on one side and ‘4890’ on the other.
Adartrel 0.25mg Film-coated Tablets are available as blister packs of 12
tablets.
PL 10383/1714

0.25mg Film-coated Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Glaxo Wellcome S.A., Avenida de
Extremadura 3, 09400 Aranda de Duero, Burgos, Spain. Procured from within
the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 26.10.2015
Adartrel® is a registered trademark of GlaxoSmithKline group of 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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