ADARTREL Film-coated tablet Ref.[49681] Active ingredients: Ropinirole

Oral use.

Adults

Individual dose titration against efficacy and tolerability is recommended. Ropinirole should be taken just before bedtime, however the dose can be taken up to 3 hours before retiring. Ropinirole may be taken with food, to improve gastrointestinal tolerance.

Treatment initiation (week 1)

The recommended initial dose is 0.25 mg once daily (administered as above) for 2 days. If this dose is well tolerated the dose should be increased to 0.5 mg once daily for the remainder of week 1.

Therapeutic regimen (week 2 onwards)

Following treatment initiation, the daily dose should be increased until optimal therapeutic response is achieved. The average dose in clinical trials, in patients with moderate to severe Restless Legs Syndrome, was 2 mg once a day.

The dose may be increased to 1 mg once a day at week 2. The dose may then be increased by 0.5 mg per week over the next two weeks to a dose of 2 mg once a day. In some patients, to achieve optimal improvement, the dose may be increased gradually up to a maximum of 4 mg once a day. In clinical trials the dose was increased by 0.5 mg each week to 3 mg once a day and then by 1 mg up to the maximum recommended dose of 4 mg once a day as shown in table 1.

Doses above 4 mg once daily have not been investigated in Restless Legs Syndrome patients.

Table 1. Dose titration:

^* To achieve optimal improvement in some patients.

The efficacy of ropinirole treatment has not been shown beyond 12 weeks (see section 5.1). Patient response should be evaluated after 12 weeks treatment and the need for treatment continuation reconsidered. If treatment is interrupted for more than a few days, it should be re-initiated by dose titration as noted above.

When switching treatment from another dopamine agonist to ropinirole, the marketing authorisation holder’s guidance on discontinuation should be followed before initiating ropinirole.

As with other dopamine agonists, it is necessary to discontinue ropinirole treatment gradually by reducing the daily dose over the period of one week (see section 4.4).

Children and adolescents

ADARTREL is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.

Elderly

The clearance of ropinirole is decreased by approximately 15% in patients aged 65 years or above. Although a dose adjustment is not required, ropinirole dose should be individually titrated, with careful monitoring of tolerability, to the optimal clinical response.

Renal impairment

No dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 mL/min).

A study into the use of ropinirole in patients with end stage renal disease (patients on haemodialysis) has shown that a dose adjustment in these patients is required as follows: the recommended initial dose of ADARTREL is 0.25 mg once daily. Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose of ADARTREL is 3 mg/day in patients receiving regular haemodialysis. Supplemental doses after haemodialysis 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 haemodialysis has not been studied.

The symptoms of ropinirole overdose are related to its dopaminergic activity. These symptoms may be alleviated by appropriate treatment with dopamine antagonists such as neuroleptics or metoclopramide.

2 years.

Do not store above 25°C.

Store in the original package in order to protect from light.

0.25 mg: PVC/PE/PVdC-Aluminium /paper child-resistant blister in cartons of 2 or 12 tablets.

0.5 mg: PVC/PE/PVdC-Aluminium/paper child-resistant blister in cartons of 28 or 84 tablets.

2.0 mg: PVC/PE/PVdC-Aluminium/paper child-resistant blister in cartons of 28 or 84 tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.