Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Treatment of Parkinson’s disease under the following conditions:
Individual dose titration against efficacy and tolerability is recommended.
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 undesirable effects that they cannot tolerate, may benefit from switching to treatment with ropinirole immediate release tablets at a lower daily dose, divided into three equal doses.
Patients should be maintained on the lowest dose of ropinirole prolonged‑release tablets that achieves 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 Rolpryna SR prolonged‑release tablets are administered as adjunct therapy to levodopa, it may be possible to gradually reduce the levodopa dose, depending on the clinical response. In clinical trials, the levodopa dose was reduced gradually by approximately 30% in patients receiving Rolpryna SR prolonged‑release tablets concurrently. In patients with advanced Parkinson’s disease receiving ropinirole prolonged-release tablets in combination with levodopa, dyskinesias can occur during the initial titration of ropinirole 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).
Patients may be switched overnight from ropinirole immediate‑release tablets to Rolpryna SR prolonged‑release tablets. The dose of Rolpryna SR prolonged‑release tablets should be based on the total daily dose of ropinirole immediate‑release tablets that the patient was taking. The table below shows the recommended dose of Rolpryna SR prolonged-release tablets for patients switching from ropinirole immediate‑release tablets:
Switching from ropinirole immediate‑release tablets to Rolpryna SR prolonged‑release tablets:
| Ropinirole immediate‑release tablets Total daily dose (mg) | Rolpryna SR prolonged‑release tablets Total daily dose (mg) |
|---|---|
| 0,75–2,25 | 2 |
| 3–4,5 | 4 |
| 6 | 6 |
| 7,5–9 | 8 |
| 12 | 12 |
| 15–18 | 16 |
| 21 | 20 |
| 24 | 24 |
After switching to Rolpryna SR prolonged‑release tablets, the dose may be adjusted depending on the therapeutic response (see “Initial titration” and “Therapeutic regimen” above).
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.
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 is 18 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis 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.
Rolpryna SR 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.
Oral use.
Rolpryna SR 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).
Rolpryna SR prolonged‑release tablets must be swallowed whole and must not be chewed, crushed or divided because the coating is intended to ensure a prolonged release.
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.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Tablets are available in cartons of 10, 21, 28, 30, 42, 60, 84 and 90 prolonged-release tablets in OPA/Alu/PVC//Alu blisters.
Not all pack sizes may be marketed.
No special requirements.
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