ADARTREL

Package leaflet: Information for the user

Adartrel, 0.5 mg, coated tablets
Ropinirolum (as hydrochloride)
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet
1. What Adartrel is and what it is used for
2. What you need to know before taking 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 substance in Adartrel is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists work in the brain in a similar way to a naturally occurring substance called dopamine.
Adartrel is a medicine used to treat moderate to severe restless legs syndrome.
Restless legs syndrome is also known as Ekbom's syndrome. People with restless legs syndrome have an irresistible urge to move their legs, and sometimes their arms or other parts of the body. This is usually accompanied by unpleasant sensations in the limbs – sometimes described as "pins and needles" or "tingling" – which may begin as soon as the patient sits down or lies down and only subside after moving. Patients often have difficulty sitting still, and especially with sleeping.
Adartrel relieves these unpleasant sensations and reduces the urge to move the legs and other limbs.

2. What you need to know before taking Adartrel

When not to take Adartrel

• if you are allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney disease,
• if you have severe liver disease. You must inform your doctor if any of these situations apply.

Warnings and precautions
Before starting Adartrel, discuss with your doctor or pharmacist if:

• you are pregnant or think you may be pregnant,
• you are breast-feeding,
• you are under 18 years of age,
• you have liver disease,
• you have severe heart disease,
• you have severe psychiatric disorders,
• you have specific urges and (or) behaviours (uncontrollable urge to gamble or excessive sexual activity),
• you have sugar intolerance (e.g. lactose monohydrate).

If you develop symptoms such as depression, apathy, anxiety, fatigue, sweating or pain (known as dopamine agonist withdrawal syndrome (DAWS)) after stopping or reducing the dose of ropinirole, tell your doctor. If symptoms persist for longer than a few weeks, your doctor may decide to adjust the dose of the medicine.
You must inform your doctor if you, your family or caregiver notice the occurrence of sudden or any unusual behaviours, and if you are unable to resist an impulse, desire or urge to perform actions that may be harmful to yourself or others. This condition is known as impulse control disorders, which may include behaviours such as: gambling addiction, compulsive eating or shopping, excessive sexual activity or increased thoughts and feelings with a sexual basis. Your doctor may decide to adjust the dose or discontinue the medicine.
Tell your doctor if you or your family or caregiver notice episodes of excessive movement, excitement or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorders (see above). Your doctor may decide to adjust the dose or discontinue the medicine.
You must inform your doctor if any of these situations occur.
If your doctor decides that you may take Adartrel, they may recommend additional monitoring tests during treatment.

Adartrel and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including herbal and over-the-counter medicines, as well as any other medicines you plan to take. Remember to inform your doctor or pharmacist if you start taking another medicine while on Adartrel.
Some medicines may affect the action of Adartrel or increase the risk of side effects. Adartrel may also affect the action of other medicines.
These include:

• fluvoxamine (an antidepressant)
• medicines used for other psychiatric disorders, for example sulpiride
• metoclopramide, which is used to treat nausea and heartburn
• HTZ (hormone replacement therapy)
• antibiotics ciprofloxacin and enoxacin
• other medicines that block dopamine action in the brain.

Tell your doctor if you are taking or have recently taken any of these medicines.
Additional blood tests should be performed if you are taking the following medicines together with Adartrel:

• Medicines belonging to the vitamin K antagonist group (used to reduce blood clotting), such as warfarin (Coumadin).

Pregnancy and breast-feeding
Adartrel is not recommended during pregnancy, unless your doctor decides that the benefit of using Adartrel outweighs the risk to the unborn child. Adartrel is not recommended during breast-feeding, as it may affect milk production.
Inform your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will also advise you if you are breast-feeding or plan to breast-feed. Your doctor may recommend discontinuing Adartrel.

While taking Adartrel
Inform your doctor if you or a family member notice any unusual behaviours while taking Adartrel (such as uncontrollable urge to gamble or increased libido and (or) excessive sexual activity). Your doctor may recommend adjusting the dose or discontinuing the medicine.

• Driving and using machines
  Adartrel may cause drowsiness. In very rare cases, uncontrollable drowsiness may occur, sometimes accompanied by sudden and unexpected sleep attacks, even without prior warning of drowsiness. Hallucinations (seeing, hearing or feeling things that are not there) may also occur while taking Adartrel. If you experience hallucinations, you should not drive or operate machinery.

If you suspect such symptoms may occur: do not drive, operate machinery, or perform any activities where drowsiness or falling asleep could put you or others at risk of serious injury or death. Do not perform such activities until symptoms have resolved.
Talk to your doctor if this situation is a problem for you.

• Adartrel and smoking
  Inform your doctor if you start or stop smoking while taking Adartrel. Your doctor may need to adjust the dose.
• Adartrel with food and drink
  Taking Adartrel with food may reduce the likelihood of nausea and vomiting. Therefore, it is best to take Adartrel during a meal.
• If side effects worsen
  In some patients treated with Adartrel, symptoms of restless legs syndrome may worsen – for example, symptoms may begin earlier than usual, be more intense, affect limbs not previously involved (such as arms), or recur early in the morning.

Contact your doctor immediately if you experience any of these symptoms.

Important information about certain ingredients of Adartrel
Adartrel tablets contain a small amount of a sugar called lactose monohydrate. If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Adartrel

This medicine should always be used exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Adartrel must not be used in children. Adartrel is not usually prescribed for patients under
18 years of age.

What dose of Adartrel should be used?
Determining the appropriate dose of Adartrel for a patient may take time.
The usual starting dose is 0.25 mg once daily. After two days, your doctor may increase this to 0.5 mg once daily for the next five days of the first week of treatment.
Your doctor may then gradually increase the dose over the following 3 weeks until reaching a dose of 2 mg per day.
If a dose of 2 mg per day does not adequately control symptoms of restless legs syndrome, your doctor may gradually increase the dose of the medicine up to the maximum dose of 4 mg per day. After three months of treatment with Adartrel, your doctor may adjust the dose or recommend discontinuation of treatment.
If a required dose cannot be achieved with this medicinal product, your doctor will check the availability of other suitable medicinal products containing ropinirole.

If you feel that the effect of Adartrel is too strong or too weak, consult your doctor or pharmacist. Do not take more tablets than prescribed by your doctor.

You should continue taking Adartrel as directed by your doctor, even if you do not feel improvement. It may take several weeks before the beneficial effect of Adartrel becomes noticeable.

Taking a dose of Adartrel
Adartrel tablets should be taken once daily.
Adartrel tablets should be swallowed with a glass of water.
Adartrel may be taken with or without food. Taking Adartrel with food may reduce the likelihood of nausea.

Adartrel is usually taken just before going to bed, but the dose may be taken up to 3 hours before bedtime.

Taking more Adartrel than recommended
Seek immediate advice from your doctor or pharmacist. If possible, show the Adartrel packaging.

In a person who has taken more than the recommended dose, symptoms may include nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical), fainting, or hallucinations.

Missing a dose of Adartrel
Do not take extra tablets or double the dose to make up for a missed dose. Take the next dose at the usual time.

If you have not taken Adartrel for more than a few days, consult your doctor about restarting treatment with Adartrel.

Stopping Adartrel treatment
Do not stop taking Adartrel unless instructed by your doctor.
Adartrel should be taken for as long as your doctor recommends. Do not stop taking it unless your doctor advises you to do so.

If Adartrel is stopped suddenly, symptoms of restless legs syndrome may rapidly worsen.

Sudden discontinuation of Adartrel may lead to the development of a condition known as neuroleptic malignant syndrome, which may be a serious health risk. Symptoms include: akinesia (loss of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (rapid heartbeat), confusion, and reduced level of consciousness (e.g. coma).

If it becomes necessary to discontinue Adartrel, your doctor will gradually reduce the dose.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects of this medicine usually occur most often when starting treatment or
shortly after increasing the dose. Adverse effects are usually mild and become less troublesome
after a short period of using the medicine at a stable dose.
If any adverse effects occur, including those not listed in this leaflet, you should inform your doctor or pharmacist.

Very common adverse effects:
May occur in more than 1 in 10 patients taking Adartrel.

• nausea
• vomiting

Common adverse effects:
May occur in up to 1 in 10 patients taking Adartrel.

• nervousness
• fainting
• drowsiness
• feeling of fatigue (mental or physical)
• dizziness
• abdominal pain
• worsening of restless legs syndrome (symptoms may start earlier than usual, may be more severe, may affect limbs not previously involved, such as arms, or may recur early in the morning)
• swelling of the legs, feet or hands

Uncommon adverse effects:
May occur in up to 1 in 100 patients taking Adartrel.

• disorientation
• hallucinations (seeing things that are not real)
• dizziness or fainting, particularly after sudden change to a standing position (caused by low blood pressure)
• low blood pressure (hypotension)
• hiccups

Very rare adverse effects:
Observed in a very small number of patients taking Adartrel (no more than 1 in 10,000):

• liver function disorders indicated by abnormal blood test results
• overwhelming daytime sleepiness (excessive sleepiness)
• sudden onset of sleep without prior warning of sleepiness (sudden sleep attacks)

The following adverse effects may occur in some patients (frequency unknown: cannot be estimated from the available data):

• allergic reactions such as: red, itchy skin swellings (urticaria), 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 associated with hallucinations such as: acute confusion (delirium), irrational thoughts (delusions) or irrational suspicion (paranoia)
• aggression
• compulsive use of Adartrel (irresistible urge to take large doses of dopaminergic medicines, larger than necessary to control motor symptoms, known as dopamine dysregulation syndrome)
• after stopping or reducing the dose of Adartrel, the following may occur: depression, apathy, anxiety, lack of energy, sweating or pain (referred to as dopamine agonist withdrawal syndrome or DAWS)
• spontaneous erection

The following adverse effects may also occur:

• inability to resist an impulse, drive or desire to carry out certain actions that may be harmful to the patient or others, including:
  • uncontrollable urge to gamble despite serious consequences for the patient or their family.
  • altered or increased interest in sex and behaviour causing concern to the patient and others, e.g. increased sexual drive.
  • uncontrolled excessive shopping and spending.
  • compulsive overeating (consuming large amounts of food in a short time) or compulsive eating (eating more food than needed to satisfy hunger).
• episodes of excessive motor activity, excitement and irritability.

If any of these behaviours occur, the patient should contact their doctor to discuss ways of reducing or eliminating these symptoms.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Adartrel

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
Do not store Adartrel above 25 °C.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Adartrel contains
The active substance is ropinirole (as hydrochloride).
Each tablet contains 0.5 mg of ropinirole (as hydrochloride).
The other ingredients are:

• tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose (type A), magnesium stearate
• coating: 0.5 mg tablets: hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine aluminium lake (E132)

What Adartrel looks like and contents of the pack
Adartrel 0.5 mg are yellow, pentagonal, bevelled-edge coated tablets,
marked “SB” on one side and “4891” on the other. The pack contains 28 tablets or
84 tablets.
Not all pack sizes may be available on the market.

Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Manufacturer
Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
France, Germany, Poland, Portugal, Slovakia, Spain, Sweden and United Kingdom (Northern Ireland): Adartrel

For further information, please contact the marketing authorisation holder:
GSK Services Sp. z o.o.
tel. +48 22 576 90 00