ROPINIROLE

Posology Adults Individual dose titration against efficacy and tolerability is recommended. Ropinirole should be taken three times a day, preferably with meals to improve gastrointestinal tolerance. 25 mg three times daily for one week.

25mg three times daily increments, according to the following regimen: Week 3 Unit dose (mg) of ropinirole 0. 7 5 Total daily dose (mg) of ropinirole 2. 5 to 3mg/day) of ropinirole may be given. A therapeutic response may be seen between 3 and 9 mg/day of ropinirole.

If sufficient symptomatic control is not achieved, or maintained after the initial titration as described above, the dose of ropinirole may be increased up to 24mg/day. Doses of ropinirole above 24 mg/day have not been studied. If treatment is interrupted for one day or more, re-initiation by dose titration should be considered (see above).

When ropinirole is administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be reduced gradually according to the symptomatic response. In clinical trials, the levodopa dose was reduced gradually by around 20% in patients treated with ropinirole as adjunct therapy.

In patients with advanced Parkinson’s disease receiving ropinirole in combination with L- dopa, dyskinesias can occur during the initial titration of ropinirole. 8). When switching treatment from another dopamine agonist to ropinirole, the manufacturer's guidance on discontinuation should be followed before initiating ropinirole.

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

25 mg three times a day. Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose of Ropinirole Tablets is 18 mg/day in patients receiving regular haemodialysis. 2). The use of ropinirole in patients with severe renal impairment (creatinine clearance <30ml/min) without regular haemodialysis has not been studied.

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.

Undesirable effects are listed below by system organ class and frequency. It is noted if these undesirable effects were reported in clinical trials as monotherapy or adjunct therapy to levodopa Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Immune system disorders Not known:

Hypersensitivity reactions (including urticaria, angioedema, rash, pruritus Psychiatric disorders Common: hallucinations. Uncommon: psychotic reactions (other than hallucinations) including delirium, delusio paranoia. Not known: aggression*, dopamine dysregulation syndrome *aggression has been associated with psychotic reactions as well as compulsive symptoms.

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. 4. 'Special warnings and precautions for use').

Use in adjunct therapy studies:

Common: confusion. Nervous system disorders Very common: somnolence. Common: dizziness (including vertigo). Uncommon: 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.

Use in monotherapy studies:

Very common: syncope.

Use in adjunct therapy studies:

Patients with major psychiatric or psychotic disorders, or a history of these disorders, should only be treated with dopamine agonists if the potential benefits outweigh the risks. Ropinirole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's Disease.

Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly. 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. Furthermore, a reduction of dosage or termination of therapy may be considered. Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders.

Patients and carers should be made aware that behavioural 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). Dopamine Dysregulation Syndrome Dopamine Dysregulation Syndrome (DDS) has been reported. Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.

2). 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). Co-administration of ropinirole with anti-hypertensive and anti-arrhythmic agents has not been studied.

1. Severe renal impairment (creatinine clearance <30ml/min) without regular haemodialysis. Hepatic impairment.