Medication Guide App

ADARTREL 0.5MG TABLETS

Active substance: ROPINIROLE HYDROCHLORIDE

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CUSTOMER:

Waymade

PRODUCT:

Adartrel 0.25mg 0.5mg

CODE:

6464/2451 2452E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

05/03/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.1 - waymade - 05/03/14

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED DECEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

6. Further Information
What Adartrel Tablets contain:
Your medicine is called Adartrel Tablets.
The tablets are available in two strengths: 0.25mg and 0. 5mg.
Adartrel Tablets also contain the following:
Lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose, croscarmellose sodium,
macrogol 400 and titanium dioxide (E171).
The 0.25mg tablets also contain polysorbate 80.
The 0.5mg tablets also contain red iron oxide (E172), yellow iron oxide (E172) and indigo carmine aluminium
lake (E132)

ADARTREL® 0.25mg TABLETS
ADARTREL® 0.5mg TABLETS
(ropinirole hydrochloride)
Patient Information Leaflet

This medicine is available as the above names but will be referred to as Adartrel throughout this leaflet. Other
strengths (1mg and 2mg) are also available.

What Adartrel Tablets look like and the contents of the pack:
The 0.25mg tablet is a white, pentagonal shaped, film-coated tablet with a raised pentagon on both sides and
marked '4890' on one side and 'SB' on the reverse.

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.

The 0.5mg tablet is a yellow, pentagonal shaped, film-coated tablet with a raised pentagon on both sides and
marked '4891' on one side and 'SB' on the reverse.

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.

Adartrel 0.25mg Tablets are available as blister packs containing 12 tablets
Adartrel 0.5mg Tablets are available as blister packs of 28 and 84 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

POM

PL No: 6464/2451 Adartrel 0.25mg Tablets
PL No: 6464/2452 Adartrel 0.5mg Tablets

This product is manufactured by Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero,
Burgos, Spain and is procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision and issue date (Ref.) 05.03.2014
Adartrel is a registered trademark of GlaxoSmithKline.

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.
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER:

Waymade

PRODUCT:

Adartrel 0.25mg 0.5mg

CODE:

6464/2451 2452E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

05/03/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.1 - waymade - 05/03/14

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED DECEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 2

Tell your doctor if you are taking, or have recently taken, any of these.

Pg 3

If you have missed your dose for more than a few days, ask your doctor for advice on how to start taking it
again.

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).

4. Possible side effects

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 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.
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.
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

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).
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).
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

Take your Adartrel tablet(s) once a day.

Adartrel tablets should not be stored above 25°C. Keep the tablets in their original pack.
Do not use after the expiry date printed on the carton or blister label. The expiry date refers to the last day of
that month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take it back to the pharmacist for safe disposal. Only
keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your
pharmacist.
Medicines should not be disposed of in 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.

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.
Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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