ROPIQUAL XL Prolonged-release tablet Ref.[8424] Active ingredients: Ropinirole

Oral use.

Adults

Individual dose titration against efficacy and tolerability is recommended. Ropinirole prolonged-release tablets should be taken once a day, at a similar time each day. The prolonged-release tablets may be taken with or without food (see section 5.2).

ROPIQUAL XL prolonged-release tablets must be swallowed whole and must not be chewed, crushed or divided.

Initial titration

The starting dose of ropinirole prolonged-release tablets is 2 mg once daily for the first week; this should be increased to 4 mg once daily from the second week of treatment. A therapeutic response may be seen at a dose of 4 mg once daily of ropinirole prolonged-release tablets.

Patients who initiate treatment with a dose of 2 mg/day of ropinirole prolonged-release tablets and who experience side effects that they cannot tolerate, may benefit from switching to treatment with ropinirole film-coated (immediate release) tablets at a lower daily dose, divided into three equal doses.

Therapeutic regimen

Patients should be maintained on the lowest dose of ropinirole prolonged-release tablets that achieve symptomatic control.

If sufficient symptomatic control is not achieved or maintained at a dose of 4 mg once daily of ropinirole prolonged-release tablets, the daily dose may be increased by 2 mg at weekly or longer intervals up to a dose of 8 mg once daily of ropinirole prolonged-release tablets.

If sufficient symptomatic control is still not achieved or maintained at a dose of 8 mg once daily of ropinirole prolonged-release tablets, the daily dose may be increased by 2 mg to 4 mg at two weekly or longer intervals. The maximum daily dose of ropinirole prolonged-release tablets is 24 mg.

It is recommended that patients are prescribed the minimum number of ropinirole prolonged-release tablets that are necessary to achieve the required dose by utilising the highest available strengths of ropinirole prolonged-release tablets.

If treatment is interrupted for one day or more, re-initiation by dose titration should be considered (see above).

When ROPIQUAL XL prolonged-release tablets are administered as adjunct therapy to levodopa, it may be possible to reduce gradually the levodopa dose, depending on the clinical response. In clinical trials, the levodopa dose was reduced gradually by approximately 30% in patients receiving ROPIQUAL XL prolonged-release tablets concurrently. In patients with advanced Parkinson’s disease receiving ROPIQUAL XL prolonged-release tablets in combination with levodopa, dyskinesias can occur during the initial titration of ROPIQUAL XL prolonged-release tablets. In clinical trials it was shown that a reduction of the levodopa dose may ameliorate dyskinesia (see section 4.8).

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).

Switching from ropinirole film-coated (immediate release) tablets to ropinirole prolonged-release tablets

Patients may be switched overnight from ropinirole film-coated (immediate release) tablets to ropinirole prolonged-release tablets. The dose of ropinirole prolonged-release tablets should be based on the total daily dose of ropinirole film-coated (immediate release) tablets that the patient was taking. The table below shows the recommended dose of ropinirole prolonged-release tablets for patients switching from ropinirole film-coated (immediate release) tablets:

Switching from ropinirole film-coated (immediate release) tablets to ropinirole prolonged-release tablets:

After switching to ropinirole prolonged-release tablets, the dose may be adjusted depending on the therapeutic response (see “Initial titration” and “Therapeutic regimen” above).

Children and adolescents

Ropinirole prolonged-release tablets are 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. In patients aged 75 years and above, slower titration during treatment initiation may be considered.

Renal impairment

In patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/min) no change in the clearance of ropinirole was observed, indicating that no dosage adjustment is necessary in this population.

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 ropinirole prolonged-release tablets is 2 mg once daily. Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose of ropinirole prolonged-release tablets is 18 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.

3 years.

Store below 25°C.

ROPIQUAL XL is supplied in white opaque PVC/PCTFE-Aluminum foil blister packs of 28, 30, 42 and 84 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.