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Adverse Events – causality not establishedVery rare cases of the following adverse events have been reported in post-marketingexperience, but no causal link between these events and duloxetine has been established.Abnormal bleeding events e.g. intracerebral, gastrointestinal; blood dyscrasias; cardiacevents e.g., myocardial infarction and ventricular arrhythmias; pancreatitis; renalimpairment; rhabdomyolysis; skin reactions especially in regards to subcutaneous tissuedisorderDiscontinuation SymptomsThe most commonly reported symptoms following abrupt or tapered discontinuation ofduloxetine in clinical trials have included dizziness, nausea, headache, paraesthesia,fatigue vomiting, irritability, nightmares, insomnia, diarrhoea, anxiety, hyperhidrosis,vertigo, somnolence and myalgia. (see PRECAUTIONS).DOSAGE AND ADMINISTRATIONMajor Depressive DisorderCYMBALTA should be administered for the treatment of major depressive disorder at adose of 60 mg once daily, with or without food. There is no adequate evidencesuggesting that patients not responding to 60 mg once daily will benefit from having theirdose increased.Diabetic Peripheral Neuropathic PainThe starting and maintenance dose of CYMBALTA in diabetic peripheral neuropathicpain is 60 mg once daily. As the progression of diabetic neuropathy is highly variableand management of pain is empirical, effectiveness of CYMBALTA should be assessedon an individual basis.Generalised Anxiety DisorderThe recommended starting dose of CYMBALTA in patients with generalized anxietydisorder is 30 mg once daily with or without food. The daily dose should be increased in30 mg increments until the minimum effective dose is achieved. The maximum dose is120 mg per day, given as 120 mg once daily. Doses above 120 mg have not beensystematically evaluated.Initial TolerabilityFor patients in whom initial tolerability may be a concern, such as treatment-naïvepatients or those with a history of adverse events with other medications, use of a lowerstarting dose such as 30 mg once daily for one week before increasing the dose to 60 mgonce daily should be considered. A dose of 30 mg once daily should be used in patientswith end stage renal disease (see below). In addition, clinical studies have shown thattaking CYMBALTA with food may improve initial tolerability.Discontinuation of treatmentWhen discontinuing CYMBALTA after more than one week of therapy it is generallyCymbalta PI Nov 2012 v8.0 28