Wonder Special Precautions

General recommendations: Dapoxetine tablet is only indicated in men with Premature Ejaculation who meet all the criteria listed in sections of therapeutic indications and pharmacodynamics. Dapoxetine tablet should not be prescribed to men who have not been diagnosed with Premature Ejaculation. Safety has not been established and there are no data on the ejaculation-delaying effects in men without Premature Ejaculation.
Other forms of sexual dysfunction: Before treatment, subjects with other forms of sexual dysfunction, including erectile dysfunction, should be carefully investigated by physicians. Dapoxetine tablet should not be used in men with erectile dysfunction (ED) who are using PDE5 inhibitors.
Orthostatic hypotension: Before treatment initiation, a careful medical examination including history of orthostatic events should be performed by the physician. An orthostatic test should be performed before initiating therapy (blood pressure and pulse rate, supine and standing). In case of a history of documented or suspected orthostatic reaction, treatment with dapoxetine should be avoided.
Orthostatic hypotension has been reported in clinical trials. The prescriber should counsel the patient in advance that if he experiences possibly prodromal symptoms, such as lightheadedness soon after standing, he should immediately lie down so his head is lower than the rest of his body or sit down with his head between his knees until the symptoms pass. The prescriber should also inform the patient not to rise quickly after prolonged lying or sitting.
Suicide/suicidal thoughts: Antidepressants, including SSRIs, increased the risk compared to placebo of suicidal thinking and suicidality in short-term studies in children and adolescents with Major Depressive Disorder and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24. In clinical trials with Wonder for the treatment of premature ejaculation, there was no clear indication of treatment-emergent suicidality in evaluation of possibly suicide-related adverse events evaluated by the Columbia Classification Algorithm of Suicide Assessment (C-CASA), Montgomery-Asberg Depression Rating Scale, or Beck Depression Inventory-II.
Syncope: Patients should be cautioned to avoid situations where injury could result, including driving or operating hazardous machinery, should syncope or its prodromal symptoms such as dizziness or lightheadedness occur.
Possibly prodromal symptoms such as nausea, dizziness/lightheadedness, and diaphoresis were reported more frequently among patients treated with Dapoxetine compared to placebo.
Patients with cardiovascular risk factors: Subjects with underlying cardiovascular disease were excluded from Phase 3 clinical trials. The risk of adverse cardiovascular outcomes from syncope (cardiac syncope and syncope from other causes) is increased in patients with underlying structural cardiovascular disease (e.g., documented outflow obstruction, valvular heart disease, carotid stenosis and coronary artery disease). There are insufficient data to determine whether this increased risk extends to vasovagal syncope in patients with underlying cardiovascular disease.
Use with recreational drugs: Patients should be advised not to use dapoxetine tablet in combination with recreational drugs.
Recreational drugs with serotonergic activity such as ketamine, methylene dioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) may lead to potentially serious reactions if combined with dapoxetine tablet. These reactions include, but are not limited to, arrhythmia, hyperthermia, and serotonin syndrome. Use of dapoxetine tablet with recreational drugs with sedative properties such as narcotics and benzodiazepines may further increase somnolence and dizziness.
Ethanol: Patients should be advised not to use dapoxetine tablet in combination with alcohol.
Combining alcohol with dapoxetine tablet may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking dapoxetine.
Medicinal products with vasodilatation properties: Dapoxetine tablet should be prescribed with caution in patients taking medicinal products with vasodilatation properties (such as alpha adrenergic receptor antagonists and nitrates) due to possible reduced orthostatic tolerance.
Moderate CYP3A4 inhibitors: Caution is advised in patients taking moderate CYP3A4 inhibitors and the dose is restricted to 30 mg.
Potent CYP2D6 inhibitors: 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, as this may increase exposure levels, which may result in a higher incidence and severity of dose dependent adverse events.
Mania: Dapoxetine tablet should not be used in patients with a history of mania/hypomania or bipolar disorder and should be discontinued in any patient who develops symptoms of these disorders.
Seizure: Due to the potential of SSRIs to lower the seizure threshold, dapoxetine tablet should be discontinued in any patient who develops seizures and avoided in patients with unstable epilepsy. Patients with controlled epilepsy should be carefully monitored.
Depression and/or psychiatric disorders: Men with underlying signs and symptoms of depression should be evaluated prior to treatment with dapoxetine tablet to rule out undiagnosed depressive disorders. Concomitant treatment of dapoxetine tablet with antidepressants, including SSRIs and SNRIs, is contraindicated. Discontinuation of treatment for ongoing depression or anxiety in order to initiate dapoxetine tablet for the treatment of PE is not recommended. Dapoxetine tablet is not indicated for psychiatric disorders and should not be used in men with these disorders, such as schizophrenia, or in those suffering with co-morbid depression, as worsening of symptoms associated with depression cannot be excluded. This could be the result of underlying psychiatric disorder or might be a result of medicinal product therapy. Physicians should encourage patients to report any distressing thoughts or feelings at any time and if signs and symptoms of depression develop during treatment, dapoxetine tablet should be discontinued.
Haemorrhage: There have been reports of bleeding abnormalities with SSRIs. Caution is advised in patients taking dapoxetine tablet, particularly in concomitant use with medicinal products known to affect platelet function (e.g., atypical antipsychotics and phenothiazines, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs [NSAIDs], anti-platelet agents) or anticoagulants (e.g., warfarin), as well as in patients with a history of bleeding or coagulation disorders.
Renal impairment: Dapoxetine tablet is not recommended for use in patients with severe renal impairment and caution is advised in patients with mild or moderate renal impairment.
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.
Eye disorders: The use of dapoxetine tablet has been associated with ocular effects such as mydriasis and eye pain. It should be used with caution in patients with raised intraocular pressure or those at risk of angle closure glaucoma.
Lactose intolerance: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on Ability to Drive and Use Machines: Dapoxetine tablet has minor or moderate influence on the ability to drive and use machines. Dizziness, disturbance in attention, syncope, blurred vision and somnolence has been reported in subjects receiving dapoxetine tablet in clinical trials. Therefore, patients should be warned to avoid situations where injury could result, including driving or operating hazardous machinery.
Combining alcohol with dapoxetine may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Wonder.
Use in Children: Dapoxetine tablet should not be used in individuals below 18 years of age.