Repinex XL (Ropinirole) Prolonged-Release Tablets prescribing information
(please refer to the full SmPC before prescribing)
Indications: Initial treatment in adults of Parkinson’s disease as monotherapy to delay the introduction of levodopa or in combination with levodopa, over the course of the disease, when levodopa effect wears off or becomes inconsistent and fluctuations in therapeutic effect occur. Available strengths: Repinex XL (ropinirole) 2, 4, and 8mg x 28 tablets. Dosage and method of use: Tablets to be taken once daily, at similar time each day, with or without food, and swallowed whole. Starting dose is 2mg once daily for first week, then increased to 4mg once daily from the second week of treatment. If symptomatic control not achieved, daily dose may be increased by 2mg at weekly or longer intervals up to 8mg once daily; if symptomatic control still not achieved, daily dose may be increased by 2-4mg at 2 weekly or longer intervals. Maximum daily dose is 24mg. Patients should be maintained on the lowest dose that achieves symptomatic control. When given as adjunct to levodopa, may be able to gradually reduce levodopa dose, depending on response. In advanced Parkinson’s Disease patients taking Repinex XL tablets in combination with levodopa, dyskinesias can occur during initial titration of Repinex XL tablets. In clinical trials, a reduction in levodopa dose was shown to potentially ameliorate dyskinesia. In end stage renal disease where on haemodialysis, recommended initial dose 2mg once daily. Escalate dose according to tolerability and efficacy. Recommended maximum dose 18mg/day. Consider slower titration in patients aged 75 years or older. Contraindications: Hypersensitivity to active substance or excipients; severe renal impairment (creatinine clearance <30 ml/min) without regular haemodialysis; hepatic impairment. Special warnings and precautions for use: Inform patients that ropinirole is associated with somnolence and episodes of sudden sleep onset during daily activities, particularly in Parkinson’s disease. Advise caution while driving or operating machines. If have experienced somnolence and/or an episode of sudden sleep onset, must refrain from driving or operating machines and consider dose reduction or termination. Due to risk of hypotension, blood pressure monitoring recommended, especially at start of treatment, in patients with severe cardiovascular disease (especially coronary insufficiency). If history of major psychotic disorders, only treat with dopamine agonists if benefits outweigh risks. Regularly monitor for development of impulse control disorders, including pathological gambling, increased libido, hypersexuality, compulsive spending/buying, binge or compulsive eating and if symptoms develop, consider dose reduction/tapered discontinuation. If rapid gastrointestinal transit, risk of incomplete release of active substance and residue being passed in the stool. Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy – therefore recommend tapering treatment. Dopamine agonist withdrawal syndrome: May occur when tapering or discontinuing dopamine agonists including ropinirole – possible higher risk with impulse control disorders and those on high daily dose and/or high cumulative doses. Symptoms include apathy, anxiety, depression, fatigue, sweating and pain and do not respond to levodopa – inform patients before tapering off and discontinuing ropinirole and closely monitor. If severe and/or persistent symptoms, consider temporary re-administration of ropinirole at lowest effective dose. 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 Repinex XL tablets. Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Inform patients that hallucinations can occur. Repinex XL 2mg contains lactose – not to be used in patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Repinex XL 4mg contains sunset yellow (E110) – may cause allergic reactions in patients with sunset yellow sensitivity. Interactions: Concomitant treatment with neuroleptics and other centrally active dopamine antagonists e.g. sulpiride or metoclopramide, should be avoided. Increased plasma concentrations of ropinirole have been observed in patients treated with high doses of oestrogens. In patients already receiving hormone replacement therapy (HRT), ropinirole treatment may be initiated in the normal manner. However, it may be necessary to adjust the ropinirole dose, in accordance with clinical response, if HRT is stopped or introduced during treatment with ropinirole. Ropinirole principally metabolised by CYP1A2 – in patients on ropinirole, dose may need to be adjusted when medicines known to inhibit CYP1A2, e.g., ciprofloxacin, enoxacin, or fluvoxamine, are introduced or withdrawn. Smoking induces CYP1A2 metabolism – if patients stop or start smoking during treatment with Repinex XL, dose adjustment may be required. In patients receiving the combination of vitamin K antagonists and ropinirole, cases of unbalanced INR have been reported. Increased clinical and biological surveillance (INR) is warranted Pregnancy and lactation: Repinex XL not recommended during pregnancy and should not be used during lactation. Not recommended for children below 18 years of age. Ability to drive: May have major effect on ability to drive/use machines. Refrain from driving/using machines if presenting with hallucinations, somnolence or sudden sleep episodes. Side effects: When Repinex XL is used as a monotherapy, side effects include: Very Common (≥1/10): somnolence, syncope, nausea; Common (≥1/100 to <1/10): dizziness (including vertigo), sudden onset of sleep, hallucinations, constipation, vomiting, heartburn, abdominal pain, peripheral oedema, leg oedema; Uncommon (≥1/1,000 to <1/100): excessive daytime somnolence, psychotic reactions (other than hallucinations) including delirium, delusion, paranoia, postural hypotension, hypotension; Not known (cannot be estimated from the available data): Impulse control disorders e.g. pathological gambling, increased libido, hypersexuality, compulsive shopping, binge eating, aggression, hypersensitivity reactions (including urticaria, angioedema, rash, pruritus), hepatic reactions, mainly increased liver enzymes, dopamine dysregulation syndrome, dopamine agonist withdrawal syndrome When Repinex XL is used as an adjunct therapy, side effects include: Very Common (>1/10): dyskinesia, somnolence, nausea; Common (≥1/100 to <1/10): dizziness (including vertigo), somnolence, sudden onset of sleep, hallucinations, confusion, postural hypotension, hypotension, heartburn, nausea, constipation, peripheral oedema; Uncommon (≥1/1,000 to <1/100): excessive daytime somnolence, psychotic reactions (other than hallucinations) including delirium, delusion, paranoia, postural hypotension, hypotension, hiccups; Not known (cannot be estimated from the available data): Impulse control disorders e.g. pathological gambling, increased libido, hypersexuality, compulsive shopping, binge eating, hypersensitivity reactions (including urticaria, angioedema, rash, pruritus), hepatic reactions, mainly increased liver enzymes, dopamine agonist withdrawal syndrome, spontaneous penile erection. MA number: PL 35533/0023-0025. Cost: £6.20 for 2mg x 28 pack, £12.50 for 4mg x 28 pack, £21.00 for 8mg x 28 pack. MAH: Aspire Pharma Limited, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom. Legal Category: POM. Date last reviewed: July 2023 Version number: 1010112063 v 12.0
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148
Revision reference – Repinex XL_24_01.02.24
