Summary of the Safety Profile: Syncope and orthostatic hypotension have been reported in clinical trials (see Precautions).
The following adverse drug reactions were reported during Phase 3 clinical trials most commonly and were dose related: Nausea (11.0% and 22.2% in 30 mg and 60 mg prn dapoxetine groups, respectively), dizziness (5.8% and 10.9%), headache (5.6% and 8.8%), diarrhoea (3.5% and 6.9%), insomnia (2.1% and 3.9%) and fatigue (2.0% and 4.1%). The most common adverse events leading to discontinuation were nausea (2.2% of Priligy-treated subjects) and dizziness (1.2% of Priligy-treated subjects).
Tabulated List of Adverse Reactions: The safety of Priligy was evaluated in 4224 subjects with premature ejaculation who participated in five double-blind, placebo-controlled clinical trials. Of the 4224 subjects, 1616 received Priligy 30 mg as needed and 2608 received 60 mg, either as needed or once daily.
Table 3 presents the adverse reactions that have been reported (see Table 3).
Click on icon to see table/diagram/image
Adverse drug reactions reported in the 9-month long-term open-label extension trial were consistent with those reported in the double-blind studies and no additional adverse drug reactions were reported.
Description of Selected Adverse Reactions: Syncope characterized as loss of consciousness, with bradycardia or sinus arrest observed in patients wearing Holter monitors, has been reported in clinical trials and is considered medicinal product-related. The majority of cases occurred during the first 3 hours after dosing, after the first dose or associated with study-related procedures in the clinical setting (such as blood draw and orthostatic maneuvers and blood pressure measurements). Prodromal symptoms often preceded the syncope (see Precautions).
The occurrence of syncope and possibly prodromal symptoms appears dose dependent as demonstrated by higher incidence among patients treated with higher than recommended doses in Phase 3 clinical trials.
Orthostatic hypotension has been reported in clinical trials (see Precautions). The frequency of syncope characterized as loss of consciousness in the Priligy clinical development program varied depending on the population studied and ranged from 0.06% (30 mg) to 0.23% (60 mg) for subjects enrolled in the Phase 3 placebo-controlled clinical trials to 0.64% (all doses combined) for Phase 1 non-PE healthy volunteer studies.
Other Special Populations: Caution is advised if increasing the dose to 60 mg in patients taking potent CYP2D6 inhibitors or if increasing the dose to 60 mg in patients known to be of CYP2D6 poor metabolizer genotype (see Pharmacology: Pharmacokinetics under Actions, Dosage & Administration, Precautions and Interactions).
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 (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania.
Results of a safety study showed a slightly higher incidence of withdrawal symptoms of mild or moderate insomnia and dizziness in subjects switched to placebo after 62 days of daily dosing.
Reporting of Suspected Adverse Reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.