Adartrel

Package leaflet: Information for the user

Adartrel, 0.25 mg, coated tablets
Adartrel, 0.5 mg, coated tablets
Adartrel, 2 mg, coated tablets
Ropinirole (as hydrochloride)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions 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. Important information 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 act in the brain similarly 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 and other parts of the body. This is usually accompanied by unpleasant sensations in the limbs—sometimes described as "pins and needles" or "tingling"—which typically begin as soon as the patient sits down or lies down and only subside with movement. Patients often therefore 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. Important information before taking Adartrel

When not to take Adartrel

• if the patient is allergic to ropinirole or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe kidney disease,
• if the patient has severe liver disease. Please inform your doctor if any of these conditions apply.

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

• if the patient is pregnant or suspects she may be pregnant,
• if the patient is breast-feeding,
• if the patient is under 18 years of age,
• if the patient has liver disease,
• if the patient has severe heart disease,
• if the patient has severe psychiatric disorders,
• if the patient has specific tendencies and (or) behaviours (uncontrolled gambling or excessive sexual activity),
• if the patient has intolerance to sugars (e.g. lactose monohydrate).

If the patient experiences 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, inform your doctor. If symptoms persist for more than a few weeks, your doctor may decide to modify the dose of the medicine.
Please inform your doctor if the patient, their family, or caregiver notice the occurrence of sudden or any unusual behaviours in the patient, and the patient cannot resist an impulse, desire, or craving to perform certain actions that may be harmful to themselves 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 frequency of sexual thoughts and feelings. The doctor may decide to adjust the dose or discontinue the medicine.
Tell your doctor if the patient or their family or caregiver notice episodes of excessive motor activity, excitement, or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorders (see above). The doctor may decide to adjust the dose or discontinue the medicine.
Please inform your doctor if any of these conditions occur.
If your doctor decides that the patient may use Adartrel, they may recommend additional monitoring tests during treatment.

Adartrel with other medicines
Tell your doctor or pharmacist if the patient is currently taking, has recently taken, or plans to take any other medicines, including herbal remedies and over-the-counter medicines. Remember to inform your doctor or pharmacist if starting any new medicine while taking Adartrel.
Some medicines may affect how Adartrel works or increase the risk of side effects. Adartrel may also affect how other medicines work.
These include:

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

Please inform your doctor if the patient is taking or has recently taken any of these medicines.
Additional blood tests should be performed if the patient is taking the following medicines together with Adartrel:

• Medicines in the group of vitamin K antagonists (used to reduce blood clotting), such as warfarin (Coumadin).

Pregnancy and breast-feeding
Adartrel is not recommended during pregnancy, unless the doctor determines that the benefit to the patient outweighs the risk to the unborn child. Adartrel is not recommended during breast-feeding, as it may affect milk production in the patient.
Please inform your doctor immediately if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant. Your doctor will also provide advice if the patient is breast-feeding or plans to breast-feed. The doctor may recommend discontinuing Adartrel.

• While taking Adartrel
  Please inform your doctor if the patient or a family member observes any unusual behaviours in the patient while taking Adartrel (such as uncontrolled gambling or increased libido and (or) excessive sexual activity). The doctor may recommend adjusting the dose or discontinuing the medicine.

• Driving and using machines
  Adartrel may cause drowsiness. In very rare cases, sudden sleep attacks may occur, sometimes without prior warning of excessive sleepiness. Hallucinations (seeing, hearing, or feeling things that are not there) may also occur while taking Adartrel. If the patient experiences hallucinations, they should not drive or operate machinery.

If the patient suspects such symptoms may occur: do not drive, operate machinery, or perform any activity where drowsiness or falling asleep could put the patient or others at risk of serious injury or death. Do not perform such activities until symptoms have resolved.
Please talk to your doctor if this situation is problematic for the patient.

• Adartrel and smoking
  Please inform your doctor if the patient starts or stops smoking while taking Adartrel. The doctor may decide that a dose adjustment is necessary.
• 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, become more intense, affect limbs not previously involved (such as the arms), or recur early in the morning.

Contact your doctor immediately if the patient experiences any of these symptoms.

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

3. How to use Adartrel

This medicine should always be used exactly as recommended by the doctor or pharmacist.
If in doubt, 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, the doctor may increase it to 0.5 mg once daily for the next five days of the first week of treatment.
Then, the doctor may gradually increase the dose over the following 3 weeks until reaching a dose of 2 mg per day.

If the 2 mg daily dose does not sufficiently control symptoms of restless legs syndrome, the 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, the doctor may adjust the dose or recommend discontinuation of treatment.

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.

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.

How to take Adartrel
Take the Adartrel tablet(s) once daily.
Swallow the Adartrel tablet(s) 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; however, 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 of Adartrel, the following may occur: nausea, vomiting, dizziness, drowsiness, feeling of fatigue (mental or physical), fainting, hallucinations.

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

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

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

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 called 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 discontinuation of Adartrel is necessary, your doctor will gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects of this medicine may occur most frequently when starting treatment or
shortly after increasing the dose. Adverse effects are usually mild and become less troublesome
after a short period of taking the medicine at the same dose.
If any adverse effects occur, including any adverse effects not listed in this leaflet, 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 not more than 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, be more intense, affect limbs not previously involved, such as arms, or recur early in the morning)
• swelling of the legs, feet or hands

Uncommon adverse effects:
May occur in not more than 1 in 100 patients taking Adartrel.

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

Very rare adverse effects:
In a very small number of patients taking Adartrel (not more than 1 in 10,000), the following have been observed:

• liver function disorders, indicated by abnormal blood test results
• excessive daytime sleepiness (sudden 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 swellings on the skin (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 impulses or urges, or desires 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.
  • changed or increased interest in sex and behaviour causing concern to the patient and others, e.g. increased sexual drive.
  • uncontrolled excessive desire to shop and spend money.
  • overeating (consuming excessive amounts of food in a short time) or compulsive eating (consuming larger amounts of food than needed to satisfy hunger).
• episodes of excessive motor activity, excitement and irritability.

Contact the treating doctor if any of these behaviours occur in the patient,
to discuss ways to reduce or eliminate these symptoms.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, 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 authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 0.25 mg, 0.5 mg or 2 mg of ropinirole (as hydrochloride).
The other ingredients are:

• Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose (type A), magnesium stearate
• Coating:
  0.25 mg tablets: hypromellose, polyethylene glycol 400, titanium dioxide (E171), polysorbate 80 (E433)
  0.5 mg tablets: hypromellose, polyethylene glycol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine aluminium lake (E132)
  2 mg tablets: hypromellose, polyethylene glycol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)

What Adartrel looks like and contents of the pack
Adartrel 0.25 mg are white, pentagon-shaped, film-coated tablets with bevelled edges,
marked “SB” on one side and “4890” on the other. The pack contains 12 tablets.
Adartrel 0.5 mg are yellow, pentagon-shaped, film-coated tablets with bevelled edges,
marked “SB” on one side and “4891” on the other. The pack contains 28 tablets or
84 tablets.
Adartrel 2 mg are pink, pentagon-shaped, film-coated tablets with bevelled edges,
marked “SB” on one side and “4893” on the other. The pack contains 28 tablets or
84 tablets.
Not all pack sizes may be available on the market.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

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

This medicinal product is authorised in the Member States of 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 representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
tel. + 48 22 576 90 00