Treatment: symptomatic of Idiopathic Restless Legs Syndrome, moderate to severe (see section 5.1 Pharmacodynamic properties)
Oral use.

Adults

The dosage should be individually adjusted according to efficacy and tolerance

Ropinirole should be administered at bedtime but not more than 3 hours before bedtime. Ropinirole can be taken during the meal to improve gastrointestinal tolerance.



Introduction of treatment (week 1)

The recommended starting dose is 0.25 mg once daily (as indicated below) for two days. If this dose is well tolerated, it will be increased to 0.5 mg once daily until the end of the first week.
Continuation of treatment (from week 2)

After the initiation of treatment, the daily dose will be increased until an optimal therapeutic response is obtained. In clinical trials, the average dose used in patients with moderate to severe Restless Legs Syndrome was 2 mg once daily.

The dose may be increased up to 1 mg once daily by the second week. The dose may then be increased by 0.5 mg per week over the following two weeks to a dose of 2 mg once daily. In some patients, for optimum improvement, the dose may be increased gradually to a maximum of 4 mg, once daily. In clinical trials, the dose was increased by 0.5 mg weekly to a dose of 3 mg once daily and then 1 mg up to the maximum recommended dose of 4 Mg once daily.

Doses greater than 4 mg once daily have not been studied in patients with Restless Legs Syndrome

The efficacy of ropinirole therapy has not been demonstrated, beyond 12 weeks (see section 5.1 Pharmacodynamic properties). After 12 weeks of treatment, the patient's response and the need for further treatment should be re-evaluated.

If treatment is interrupted for more than a few days, treatment should be resumed according to the same dosage regimen as described above.
Children and adolescents

ADARTREL is not recommended in children under 18 years due to lack of tolerance and efficacy data.

Elderly subjects

The clearance of ropinirole is decreased by approximately 15% in patients 65 years of age and older. Although a dose adjustment is not necessary, the dosage of ropinirole should be individually adjusted for an optimal clinical response with close monitoring of tolerance.

Renal insufficiency

In patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml / min), the dosage does not need to be adjusted. >

A study on the use of ropinirole in patients with end-stage renal disease (hemodialysis patients) showed that a dose adjustment in these patients is required according to the following description: the initial dose; Recommended dose of ADARTREL is 0.25 mg once daily, then dose increases will be based on tolerance and efficacy. In patients with hemodialysis, the recommended maximum dose of ADARTREL is 3 mg per day, and, after hemodialysis, additional doses are not required (see section 5.2).

The use of ropinirole in patients with severe renal impairment (creatinine clearance, less than 30 ml / min) without regular hemodialysis has not been studied
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"SB" on one side and "4890" on the other side.

Pharmacotherapeutic group: dopaminergic agonist, ATC code: N04BC04.

Mechanism of Action

Ropinirole is a non-ergotated dopaminergic agonist of D2 / D3 receptors that stimulates dopaminergic receptors in the striatum.


ADARTREL should only be prescribed to patients with Moderate to Severe Idiopathic Restless Legs Syndrome. Patients with Moderate to Severe Idiopathic Restless Legs Syndrome generally complain of severe insomnia or discomfort at the limb level

In four randomized 12-week studies evaluating ropinirole, versus placebo in patients with Restless Legs Syndrome, the effects on the International Restless Syndrome Scale (IRLS) scores were compared to 12th week, compared to baseline. The mean dose of ropinirole in moderate to severe patients was 2 mg / day. In a pooled analysis of these four studies in patients with Moderate to Severe Restless Legs Syndrome, the adjusted difference between the two treatment groups for the IRLS score at week 12 , In the Last Observation Carried Forward (LOCF) analysis, the intent-to-treat population was, between baseline and week 12, -4.0 points (95% CI, [-5.6, -2 , 4], p

A 12-week, placebo-controlled polysomnography study in patients with Restless Legs Syndrome evaluated the effect of ropinirole treatment on periodic movements of the legs during sleep. Statistically significant differences were observed between initial and week 12 for the index of periodic movements of the legs during sleep

The pooled analysis of the four randomized 12-week studies evaluating ropinirole versus placebo in patients with Moderate-to-Severe Restless Legs Syndrome showed that patients treated with ropinirole showed improvement (Medical Outcome Study Sleep) (Scores from 0 to 100 for each domain, except for the amount of sleep). The adjusted differences between the ropinirole and placebo arms were: -15.2 (95% CI [-19.37, -10.94]; p