Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. If a dose is missed, advise patients not to double their next dose. The initial dose of REQUIP XL should approximately match the total daily dose of the immediate-release formulation of ropinirole, as shown in Following conversion to REQUIP XL, the dose may be adjusted depending on therapeutic response and tolerability REQUIP XL is designed to release medication over a 24-hour period. Increased plasma concentrations of ropinirole have been observed in patients treated with high doses of oestrogens. The percentage of patients discontinuing prematurely because of an adverse reaction was 8% for REQUIP XL 2 mg, 5% for REQUIP XL 4 mg, 8% for REQUIP XL 8 mg, 5% for REQUIP XL 12 mg, and 15% for REQUIP XL 24 mgIn the fixed-dose trial in advanced Parkinson’s disease (Study 2), 11% of patients on REQUIP XL exhibited a shift in serum creatine phosphokinase (CPK) from normal at baseline to above the normal reference range during treatment, compared with 6% of patients on placebo. In the standing position, the frequency of systolic blood pressure increase (≥40 mm Hg) was 9% for REQUIP XL vs. 6% for placebo. Because somnolence is a frequent adverse reaction with potentially serious consequences, patients should not drive a car, operate machinery, or engage in other potentially dangerous activities until they have gained sufficient experience with REQUIP XL to gauge whether or not it adversely affects their mental and/or motor performance.
These lesions are considered to be a species specific phenomenon and do not constitute a hazard with regard to the clinical use of ropinirole.Hypromellose 2208, hydrogenated castor oil, carmellose sodium, povidone K29-32, maltodextrin, magnesium stearate, lactose monohydrate, anhydrous colloidal silica, mannitol (E421), ferric oxide yellow (E172) and glycerol dibehenate.2 mg: Hypromellose 2910, ferric oxide yellow (E172), titanium dioxide (E171), macrogol 400 and ferric oxide red (E172).4 mg: Hypromellose 2910, titanium dioxide (E171), macrogol 400, sunset yellow (E110) and indigo carmine (E132).8 mg: Hypromellose 2910, ferric oxide yellow (E172), titanium dioxide (E171), ferric oxide black (E172), macrogol 400 and ferric oxide red (E172).Do not store above 25°C.
In patients with early Parkinson’s disease who were treated with the immediate-release formulation of REQUIP, the most common adverse reactions (≥5% treatment difference from placebo presented in order of decreasing treatment difference frequency) were nausea (38%), somnolence (34%), dizziness (18%), syncope (11%), asthenic condition (11%), viral infection (8%), leg edema (6%), vomiting (5%), and dyspepsia (5%).In vitro metabolism studies showed that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of ropinirole.
In clinical trials it was shown that a reduction of the L-dopa dose may ameliorate dyskinesia (see also 4.8 Undesirable effects).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).Patients may be switched overnight from ropinirole immediate release tablets to ropinirole prolonged-release tablets.The dose of ropinirole prolonged-release tablets should be based on the total daily dose of immediate release formulation that the patient was receiving. The increase in systemic exposure (Cmax and AUC) to ropinirole is approximately proportional over the therapeutic dose range. The most common adverse reaction in patients treated with REQUIP XL causing discontinuation of treatment with REQUIP XL in Study 1 was hallucination (2%).Although this trial was not designed for optimally characterizing dose-related adverse reactions, there was a suggestion (based upon comparison of incidence of adverse reactions across dose ranges for REQUIP XL and placebo) that the incidence for dyskinesia, hypertension, and fall was dose-related to REQUIP XL.During the titration phase, the incidence of adverse reactions in descending order of percent treatment difference was dyskinesia, nausea, abdominal pain/discomfort, orthostatic hypotension, dizziness, vertigo, hypertension, peripheral edema, and dry mouth. In animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the MRHD for Parkinson’s disease.
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