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Package leaflet: Information for the User

Adartrel® 0.5mg and 2mg film-coated tablets (ropinirole)

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 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 symptoms are the same as yours.

•    The name of this medicine is Adartrel 0.5mg or Adartrel 2mg film-coated tablets but will be referred to as Adartrel throughout the remainder of this leaflet. Adartrel is also available in 0.25mg and 1mg film-coated tablets.

•    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.

In this leaflet:

1)    What Adartrel is and what it is used for

2)    Before you take Adartrel

3)    How to take Adartrel

4)    Possible side effects

5)    How to store Adartrel

6)    Further 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)    BEFORE YOU TAKE ADARTREL Do not take 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.

Take special care with Adartrel

Your doctor needs to know before you take 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)

^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.

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:

•    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.

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.

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 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, 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:

•    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

•    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 increased sexual urges and/or behaviours

•    inability to resist the 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 normal and more 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.

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 out of the sight and reach of children.

•    Do not use Adartrel after the expiry date printed on the blister and on the carton. The expiry date refers to the last day of that month.

•    Do not store Adartrel above 25°C.

•    Store in its original package.

•    If the tablets become discoloured or show any sign of deterioration return them to your pharmacist.

•    Medicines should not be disposed of in your waste water or household waste. Ask your pharmacist to dispose of medicines no longer required. These measures will help to protect the environment.

6)    FURTHER INFORMATION What Adartrel contains

The active substance in Adartrel is ropinirole (as hydrochloride).

Each tablet contains 0.5 or 2mg of ropinirole (as hydrochloride).

The other ingredients are:

•    tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate

•    film coat:

0.5mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), indigo carmine aluminium lake (E132)

2mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172)

What Adartrel looks like and contents of the pack 0.5mg tablet is provided as yellow, oval, film-coated tablets, marked ‘GS' on one side and ‘TES' on the other. Each pack contains 28 tablets 2mg tablet is provided as pink, oval, film-coated tablets, marked ‘GS' on one side and ‘GYG' on the other. Each pack contains 28 tablets

The manufacturer is SmithKlineBeecham Pharmaceuticals, Manor Royal, Crawley, West Sussex, RH10 9QJ, UK. They are procured from within the EU by Product Licence holder: CST Pharma Ltd, Westgate Business Park, Unit 5-7, Tintagel Way, Aldridge, Walsall, WS9 8ER.

PL 18773/0134 PL 18773/0135

Leaflet date 17^th September 2012 Leaflet code XXXXXXXXXXXXX

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