Wonder Adverse Reactions

Summary of the safety profile: 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 Wonder-treated subjects) and dizziness (1.2% of Wonder-treated subjects).
Very common (>1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to 1/100), Rare ( ≥ 1/10000 to < 1/1000).
Psychiatric disorders: Common: Anxiety, Agitation, Restlessness, Insomnia, Abnormal dreams, Libido decreased.
Uncommon: Depression, Depressed mood, Euphoric mood, Mood altered, Nervousness, Indifference, Apathy, Confusional state, Disorientation, Thinking abnormal, Hypervigilance, Sleep disorder, Initial insomnia, Middle insomnia, Nightmare, Bruxism, Loss of libido, Anorgasmia .
Nervous system disorders: Very common: Dizziness, Headache.
Common: Somnolence, Disturbance in attention, Tremor, Paraesthesia.
Uncommon: Syncope, Syncope vasovagal, Dizziness postural, Akathisia, Dysgeusia, Hypersomnia, Lethargy, Sedation, Depressed level of consciousness.
Rare: Dizziness exertional, Sudden onset of sleep.
Eye disorders: Common: Vision blurred.
Uncommon: Mydriasis, Eye pain, Visual disturbance.
Ear and labyrinth disorders: Common: Tinnitus.
Uncommon: Vertigo.
Cardiac disorders: Uncommon: Sinus arrest, Sinus bradycardia, Tachycardia.
Vascular disorders: Common: Flushing.
Uncommon: Hypotension, Systolic hypertension, Hot flush.
Respiratory, thoracic and mediastinal disorders: Common: Sinus congestion, Yawning.
Gastrointestinal disorders: Very common: Nausea.
Common: Diarrhoea, Vomiting, Constipation, Abdominal pain, Abdominal pain upper, Dyspepsia, Flatulence, Stomach discomfort, Abdominal distension, Dry mouth.
Uncommon: Abdominal discomfort, Epigastric discomfort.
Rare: Defaecation urgency.
Skin and subcutaneous tissue disorders: Common: Hyperhidrosis.
Uncommon: Pruritis, Cold sweat.
Reproductive system and breast disorders: Common: Erectile dysfunction.
Uncommon: Ejaculation failure, Male orgasmic disorder, Paraesthesia of genital male.
General disorders and administration site conditions: Common: Fatigue, Irritability.
Uncommon: Asthenia, Feeling hot, Feeling jittery, Feeling abnormal, Feeling drunk.
Investigations: Common: Blood pressure increased.
Uncommon: Heart rate increased, Blood pressure diastolic increased, Blood pressure orthostatic increased.
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.
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.
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 authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.