| Document Date: 2014-09-02 17:55:37
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City Reference / / Company GlaxoSmithKline / / Event Product Recall / FDA Phase / Product Issues / / IndustryTerm machinery / food / treatment of Parkinson’s disease / / MedicalCondition early Parkinson’s disease / Restless Legs Syndrome REQUIP / significant cardiovascular disease / viral infection / excessive drowsiness / headache / Hypotension/Orthostatic Hypotension / hallucinations / psychotic disorder / Nausea / dyskinesia / endstage renal disease / adverse event orthostatic hypotension / Parkinson's disease / Syncope / Melanoma / drowsiness / retinal dysfunction / Syncope Syncope / bradycardia / muscular rigidity / neuroleptic malignant syndrome / Hypersensitivity / early-stage Parkinson’s disease / Retinal Pathology Retinal degeneration / pleural fibrosis / end-stage renal disease / pruritus / pericarditis / Hypotension / Legs Syndrome / hallucination / May cause hallucinations / pulmonary infiltrates / INDICATIONS AND USAGE Parkinson’s Disease / disease / Restless Legs Syndrome / either Parkinson’s disease / pre-existing dyskinesia / Carcinogenesis / hypersensitivity/allergic reaction / frequently reported dizziness / disorientation / melanomas / Dyskinesia REQUIP / RLS / Retinal degeneration / orthostatic hypotension / vomiting / pleural effusion / urticaria / Parkinson’s disease / angioedema / delirium / dizziness / sleep disorders / symptomatic orthostatic hypotension / advanced Parkinson’s disease / rash / interstitial lung disease / retroperitoneal fibrosis / / MedicalTreatment concomitant therapy / HRT / Hormone replacement therapy / hemodialysis / dialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position General / Major / / Product REQUIP / ciprofloxacin / metoclopramide / RLS / capacity / / Technology Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / /
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----------------------- WARNINGS AND PRECAUTIONS --------------------- • Sudden onset of sleep and somnolence may occur (5.1) • Syncope may occur (5.2) • Hypotension, including orthostatic hypotension may occu