دواعي استعمال سيفرول 0.18مجم 30 اقراص

Sifrol 0.18 mg tablets (pramipexole; 0.18 mg base = 0.25 mg pramipexole dihydrochloride monohydrate per EU SmPC) by Boehringer Ingelheim, a non-ergot dopamine agonist for Parkinson's disease and restless legs syndrome.

• Signs and symptoms of idiopathic Parkinson's disease, alone or with levodopa, through to late stages with motor fluctuations.الفئة: AdultsEuropean Medicines Agency (EMA)
• Symptomatic treatment of moderate to severe idiopathic restless legs syndrome (up to 0.54 mg base/day).الفئة: AdultsEuropean Medicines Agency (EMA)

• Parkinson's disease, most common (>=5%, more than placebo): nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache, fatigue; somnolence increases above 1.5 mg salt/day.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Hypersensitivity to the active substance or any excipient.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Sudden onset of sleep and somnolence during daily activities, sometimes without warning; caution with driving/operating machines.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Impulse control disorders (pathological gambling, increased libido, hypersexuality, compulsive spending/eating); monitor regularly.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Hallucinations, dyskinesia (with levodopa), axial dystonia, mania/delirium, psychotic disorders; reduce dose in renal impairment.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Postural hypotension especially at treatment start; augmentation in RLS; dopamine agonist withdrawal syndrome and neuroleptic malignant syndrome on abrupt withdrawal.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Dopamine antagonists (neuroleptics, metoclopramide)May diminish the effectiveness of pramipexole.DailyMed (U.S. National Library of Medicine)
• LevodopaWhen combined, a reduction of the levodopa dose should be considered.DailyMed (U.S. National Library of Medicine)

• Effect on human pregnancy not investigated; not teratogenic in rats/rabbits but embryotoxic in rats at maternotoxic doses; do not use during pregnancy unless clearly necessary.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Inhibition of lactation expected (prolactin suppression); excretion into human milk not studied; should not be used during breast-feeding, or breast-feeding should be discontinued if use is unavoidable.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• براميبيكسول: Non-ergot dopamine agonist binding with high selectivity to D2-subfamily receptors (preferentially D3); relieves parkinsonian motor deficits by stimulating striatal dopamine receptors.