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ROPINIROLE SR is a brand name for Ropinirole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ropinirole SR is indicated in adults for Treatment of Parkinson's disease under the following conditions: • Initial treatment as monotherapy, in order to delay the introduction of levodopa • In combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Individual dose titration against efficacy and tolerability is recommended. The prolonged-release tablets should be taken once a day and at a similar time each day. The tablets may be taken with or without food. 2). Adults Initial titration The starting dose is 2 mg ropinirole once daily for the first week; this should be increased to 4 mg ropinirole once daily from the second week of treatment.
A therapeutic response may be seen at a dose of 4 mg once daily of 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.
Therapeutic regimen 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 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.
When ropinirole 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 ropinirole prolonged-release tablets concurrently.
In patients with advanced Parkinson's disease receiving ropinirole prolonged-release tablets in combination with L-dopa, dyskinesias can occur during the initial titration of ropinirole prolonged-release tablets. 8). When switching treatment from another dopamine agonist to ropinirole, the marketing authorisation holder's guidance on discontinuation should be followed before initiating ropinirole.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
During clinical trials, the most commonly reported undesirable effects for ropinirole prolonged-release tablets were during monotherapy and dyskinesia during adjunctive therapy with levodopa. The following adverse events were reported during clinical trials with Ropinirole prolonged-release tablet up to 24 mg/day.
In monotherapy In adjunct therapy Psychiatric disorders Common Hallucinations Hallucinations Nervous system disorders Very common Somnolence Dyskinesia In patients with advanced Parkinson's disease, dyskinesias can occur during the initial titration of ropinirole.
2). Common Dizziness (including vertigo), sudden onset of sleep Somnolence, dizziness (including vertigo), sudden onset of sleep Vascular disorders Common Postural hypotension, hypotension Uncommon Postural hypotension, hypotension Gastrointestinal disorders Very common Nausea Common Constipation Nausea, constipation General disorders and administration site conditions Common Oedema peripheral Oedema peripheral In addition to the above adverse drug reactions, the following events have been reported with Ropinirole film-coated (immediate-release) tablets in patients during clinical trials (at doses up to 24 mg/day) and/or post-marketing reports In monotherapy In adjunct therapy Immune system disorders Not known Hypersensitivity reactions (including urticaria, angioedema, rash, pruritus).
Psychiatric disorders Common Confusion Uncommon Psychotic reactions (other than hallucinations) including delirium, delusion, paranoia. Psychotic reactions (other than hallucinations) including delirium, delusion, paranoia. 4). 4) Nervous system disorders Very common Syncope Somnolence Uncommon Sudden onset of sleep, excessive daytime somnolence Sudden onset of sleep, excessive daytime somnolence Ropinirole is associated with somnolence and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes.
Somnolence and episodes of sudden sleep onset Ropinirole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease. 8). Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with ropinirole.
Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Reduction of dose or termination of therapy may be considered. 5). Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders.
Patients and carers should be made aware that behavioral symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating, and compulsive eating can occur in patients treated with dopamine agonists including ropinirole.
Dose reduction/tapered discontinuation should be considered if such symptoms develop. Impulse control disorders were reported especially at high doses and were generally reversible upon reduction of the dose or treatment discontinuation.
8). Mania Patients should be regularly monitored for the development of mania. Patients and carers should be made aware that symptoms of mania can occur with or without the symptoms of impulse control disorders in patients treated with ropinirole.
Dose reduction/tapered discontinuation should be considered if such symptoms develop. Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
2). Rapid gastrointestinal transit Ropinirole SR prolonged released tablets are designed to release ropinirole over a 24hr period. If rapid gastrointestinal transit occurs, there may be risk of incomplete release of the active substance, and of residue of the medicinal product being passed in the stool.
1. • Severe renal impairment (creatinine clearance <30 ml/min) without regular haemodialysis. • Hepatic impairment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). Switching from ropinirole immediate release tablets to ropinirole prolonged-release tablets Patients may be switched overnight from ropinirole immediate release tablets to ropinirole prolonged-release tablets. : The table below shows the recommended dose of ropinirole prolonged-release tablets for patients switching from ropinirole immediate-release tablets.
5 - 9 8 12 12 15 - 18 16 21 20 24 24 After switching to ropinirole prolonged-release tablets, the dose may be adjusted depending on the therapeutic response (see “Initial titration” and “Therapeutic regimen” above). Dose interruption or discontinuation If treatment is interrupted for one day or more,re-initiation by dose titration should be considered.
If it is necessary to discontinue ropinirole treatment, this should be done gradually by reducing the daily dose over the period of one week. Renal impairment In parkinsonian 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 dose 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 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 haemodialysis. Supplemental doses after dialysis are not required The use of ropinirole in patients with severe renal impairment (creatinine clearance less than 30 ml/min) without regular haemodialysis has not been studied.
Hepatic impairment The use of ropinirole in patients with hepatic impairment has not been studied. Administration of ropinirole to such patients is not recommended. Special populations 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.
Paediatric population The safety and efficacy of Ropinirole SR in children and adolescents below 18 years of age have not been established. Ropinirole SR is not recommended for use in this age group. […]
4). Impulse control disorders Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Ropinirole SR prolonged release tablets.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Hypotension Due to the risk of hypotension, blood pressure monitoring is recommended, particularly at the start of treatment, in patients with severe cardiovascular disease (in particular coronary insufficiency). 8). 2).. Limited data suggests that patients with impulse control disorders and those receiving high daily dose and/or high cumulative doses of dopamine agonists may be at higher risk for developing DAWS.
Withdrawal symptoms include apathy, anxiety, depression, fatigue, sweating and pain and do not respond to levodopa. Prior to tapering off and discontinuing ropinirole, patients should be informed about potential withdrawal symptoms.
Patients should be closely monitored during tapering and discontinuation. In case of severe and/or persistent withdrawal symptoms, temporary re-administration of ropinirole at the lowest effective dose may be considered. Hallucinations Hallucinations are known as an undesirable effect of treatment with dopamine agonists and levodopa.
Patients should be informed that hallucinations can occur. Ropinirole SR 2 mg and 3 mg prolonged release tablets The prolonged-release tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Ropinirole SR 3 mg and 4 mg prolonged release tablets The prolonged-release tablets contain the azo colouring agent sunset yellow (E110), which may cause allergic reactions.