ROPINIROLE

Oral use. 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. 0 Therapeutic regimen: After the initial titration, weekly increments of up to 3 mg/day may be given.

Ropinirole is usually given in divided doses three times per day. A therapeutic response may be seen between 3 and 9 mg/day, although adjunct therapy patients may require higher doses. If sufficient symptomatic control is not achieved, or maintained, the dose of ropinirole may be increased until an acceptable therapeutic response is established.

Doses above 24 mg/day have not been investigated in clinical trials and this dose should not be exceeded. If treatment is stopped for one or more days it should be considered to re-initiate the treatment by dose titration (see above).

When ropinirole is administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be reduced gradually by around 20% in total. 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. Ropinirole should be discontinued gradually by reducing the number of daily doses over the period of one week.

4). In parkinsonian 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. The use of ropinirole in patients with severe renal (creatinine clearance <30 ml/min) or hepatic impairment has not been studied.

Administration of ropinirole to such patients is not recommended.

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.

Children:

Adverse drug reactions are listed below by system organ class and frequency.

Frequencies are defined as:

Very Common (> 1/10), Common (> 1/100, < 1/10), Uncommon (> 1/1000, < 1/100), Rare (> 1/10,000, < 1/1000), Very Rare (<1/10,000) or not known (frequency cannot be estimated from the data) including isolated reports. Common and uncommon events were generally determined from pooled safety data from clinical trial populations of ropinirole and are quoted as excess incidence over placebo.

Rare and Very Rare events were generally determined from post-marketing data and refer to reporting rate rather than the true frequency. The most commonly reported undesirable effects are nausea, somnolence, dyskinesia and syncope. Adverse drug reactions reported from patients taking ropinirole Immune system disorders Very Rare: Hypersensitivity reactions (including urticaria, angioedema, rash, pruritis)3 Psychiatric Disorders Common: Confusion1, Hallucinations Uncommon: Psychotic reactions (other than hallucinations) including delusion, and paranoia, delirium.

4) * In patients with advanced Parkinson's disease, dyskinesias can occur during the initial titration of ropinirole. 4 ‘Special warnings and precautions for use’).

General Disorders and Administration Site Conditions Not known:

Dopamine agonist withdrawal syndrome including apathy, anxiety, depression, fatigue, sweating and pain. 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.

Due to the pharmacological action of ropinirole, patients with severe cardiovascular disease should be treated with caution. Co-administration of ropinirole with anti-hypertensive and anti-arrhythmic agents has not been studied. Caution should be exercised when these compounds are given concomitantly with ropinirole because of the unknown potential for the occurrence of hypotension, bradycardias or other arrhythmias.

5). 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. 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. Ropinirole Film-Coated Tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine.

Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy. 2). 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.

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