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Activation of ManiaIn placebo-controlled trials in patients with major depressive disorder, activation ofhypomania or mania occurred in 0.1% of duloxetine treated patients and 0.1% of placebotreated patients. No activation of mania or hypomania was reported in DPNP or GADplacebo controlled trials. Activation of mania/hypomania has been reported in a smallproportion of patients with mood disorders who were treated with other marketed drugseffective in the treatment of major depressive disorder. As with these other drugs,duloxetine should be used cautiously in patients with a history of mania.SeizuresDuloxetine has not been systematically evaluated in patients with a seizure disorder. Inplacebo-controlled clinical trials, seizures/convulsions occurred in 0.03% (3/9445) ofpatients treated with duloxetine and 0.01% (1/6770) of patients with placebo. As withsimilar CNS active drugs, duloxetine should be used cautiously in patients with a historyof seizure disorder.MydriasisMydriasis has been reported in association with duloxetine. Caution should be exercisedin patients with raised intraocular pressure or those at risk of acute narrow-angleglaucoma.HyponatraemiaCases of hyponatremia (some with serum sodium lower than 110mmol/Liter) have beenreported very rarelywhen administering CYMBALTA. The majority of these casesoccurred in elderly patients, especially when coupled with a recent history of altered fluidbalance or conditions pre-disposing to altered fluid balance. Hyponatremia may presentwith nonspecific signs and symptoms (such as dizziness, weakness, nausea, vomiting,confusion, somnolence, and lethargy). Signs and symptoms associated with more severecases have included syncopal episodes, falls, and seizure. Caution is required in patientsat increased risk for hyponatraemia; such as elderly, cirrhotic, or dehydrated patients orpatients treated with diuretics. Hyponatraemia may be due to a syndrome of inappropriateanti-diuretic hormone secretion (SIADH).Abnormal BleedingSSRIs and SNRIs, including duloxetine, may increase the risk of bleeding events,including gastrointestinal bleeding (see ADVERSE REACTIONS). Therefore, caution isadvised in patients taking duloxetine concomitantly with anticoagulants and/or medicinalproducts known to affect platelet function (e.g., NSAIDs, aspirin) and in patients withknown bleeding tendencies.Use in Patients with Concomitant IllnessClinical experience with duloxetine in patients with concomitant systemic illnesses islimited. Caution is advisable in using duloxetine in patients with diseases or conditionsthat produce altered metabolism or haemodynamic responses.Duloxetine has not been systematically evaluated in patients with a recent history ofCymbalta PI Nov 2012 v8.0 14