General: Dapoxetine is only indicated in men with PE. Safety has not been established and there are no data on the ejaculation-delaying effects in men without PE. Use with Recreational Drugs: Patients should be advised not to use Dapoxetine in combination with recreational drugs. Recreational drugs with serotonergic activity eg, ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) may lead to potentially serious reactions if combined with Dapoxetine. These reactions include, but are not limited to, arrhythmia, hyperthermia and serotonin syndrome. Use of Dapoxetine with recreational drugs with sedative properties eg, narcotics and benzodiazepines may further increase somnolence and dizziness. Ethanol: Combining alcohol with Dapoxetine may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events eg, syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine. Possibly prodromal symptoms eg, nausea, dizziness/lightheadedness and diaphoresis were reported more frequently among patients treated with Dapoxetine compared to placebo. Orthostatic Hypotension: An orthostatic test should be performed before initiating therapy. In case of a history of documented or suspected orthostatic reaction, treatment with Dapoxetine should be avoided. Dapoxetine is not indicated for psychiatric disorders and should not be used in men with these disorders eg, schizophrenia, or in those suffering with co-morbid depression, as worsening of symptoms associated with depression cannot be excluded. Withdrawal Effects: Abrupt discontinuation of chronically administered SSRIs used to treat chronic depressive disorders has been reported to result in the following symptoms: Dysphoric mood, irritability, agitation, dizziness, sensory disturbances (eg, paresthesias, electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania.