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ROPINIROLE is a brand name for Ropinirole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used 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 fluctuations in the therapeutic effect…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Treatment of idiopathic Parkinson’s Disease 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 1 3 Unit dose (mg) of ropinirole 0 . 2 5 0 . 7 5 Total daily dose (mg) of ropinirole 0 . 7 5 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:
g. caused by renal failure, iron deficiency anaemia or pregnancy). Paradoxical worsening of Restless Legs Syndrome symptoms described as augmentation (either earlier onset, increased intensity, or spread of symptoms to previously unaffected limbs), or early morning rebound, (reoccurrence of symptoms in the early morning hours) have been observed during treatment with ropinirole.
8). 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.
1. Severe renal impairment (creatinine clearance <30ml/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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Paediatric population Ropinirole tablets is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy. Symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome Adults Individual dose titration against efficacy and tolerability is recommended.
Ropinirole should be taken just before bedtime, however the dose can be taken up to 3 hours before retiring. Ropinirole may be taken with food, to improve gastrointestinal tolerance. 25 mg once daily (administered as above) for 2 days.
5 mg once daily for the remainder of week 1. Therapeutic regimen (week 2 onwards) Following treatment initiation, the daily dose should be increased until optimal therapeutic response is achieved. The average dose in clinical trials, in patients with moderate to severe Restless Legs Syndrome, was 2 mg once a day.
The dose may be increased to 1 mg once a day at week 2. 5 mg per week over the next two weeks to a dose of 2 mg once a day. In some patients, to achieve optimal improvement, the dose may be increased gradually up to a maximum of 4 mg once a day.
5 mg each week to 3 mg once a day and then by 1 mg up to the maximum recommended dose of 4 mg once a day as shown in table 1. Doses above 4 mg once daily have not been investigated in Restless Legs Syndrome patients. 5 3 4 * To achieve optimal improvement in some patients.
1). At this time the dose prescribed and the need for continued treatment should be considered. If treatment is interrupted for more than a few days it should be re initiated by dose titration carried out as above. Paediatric population Ropinirole is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.
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.
Renal impairment No dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/min). 25 mg […]
Very common: dyskinesia. In patients with advanced Parkinson's disease, dyskinesias can occur during the initial titration of ropinirole. 2) Vascular disorders Uncommon: postural hypotension, hypotension. Postural hypotension or hypotension is rarely severe.
Gastrointestinal disorders Very Common: nausea. Common: heartburn. Use in monotherapy studies Common: vomiting, abdominal pain. Hepatobiliary disorders Not known: hepatic reactions, mainly increased liver enzymes.
General disorders Use in monotherapy studies:
Common: oedema peripheral (including leg oedema).
Not known:
Dopamine agonist withdrawal syndrome including apathy, anxiety, depression, fatigue, sweating and pain. Use of ropinirole in Restless Legs Syndrome In Restless Legs Syndrome clinical trials the most common adverse drug reaction was nausea (approximately 30% of patients).
Undesirable effects were normally mild to moderate and experienced at the start of therapy or on increase of dose and few patients withdrew from the clinical studies due to undesirable effects. 0% above the placebo rate or those reported uncommonly but known to be associated with ropinirole.
4). Hallucinations were reported uncommonly in the open label long-term studies. Paradoxical worsening of Restless Legs Syndrome symptoms occurring with earlier onset (augmentation), and reoccurrence of symptoms in the early morning hours (early morning rebound), may be observed during treatment with ropinirole.
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.
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.
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. 2). Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including ropinirole.
Symptoms include apathy, anxiety, depression, fatigue, sweating and pain which may be severe. Patients should be informed about this before tapering the dopamine agonist, and monitored regularly thereafter. 8).
Hallucinations:
Hallucinations are known as a side effect of treatment with dopamine agonists and levodopa. Patients should be informed that hallucinations can occur. This medicinal product also contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.