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Each film−coated tablet contains dapoxetine hydrochloride equivalent to 30 mg or 60 mg dapoxetine.
Excipient with known effect: Lactose. Each 30 mg tablet contains 45.88 mg of lactose. Each 60 mg tablet contains 91.75 mg of lactose.
Priligy is indicated for the treatment of premature ejaculation (PE) in adult men aged 18 to 64 years.
Priligy should only be prescribed to patients who meet all the following criteria:
• An intravaginal ejaculatory latency time (IELT) of less than two minutes; and
• Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes; and
• Marked personal distress or interpersonal difficulty as a consequence of PE; and
• Poor control over ejaculation; and
• A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months.
Priligy should be administered only as on-demand treatment before anticipated sexual activity. Priligy should not be prescribed to delay ejaculation in men who have not been diagnosed with PE.
Posology and method of administration
Adult men (aged 18 to 64 years)
The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Treatment with Priligy should not be initiated with the 60 mg dose.
Priligy is not intended for continuous daily use. Priligy should be taken only when sexual activity is anticipated. Priligy must not be taken more frequently than once every 24 hours.
If the individual response to 30 mg is insufficient and the patient has not experienced moderate or severe adverse reactions or prodromal symptoms suggestive of syncope, the dose may be increased to a maximum recommended dose of 60 mg taken as needed approximately 1 to 3 hours prior to sexual activity. The incidence and severity of adverse events is higher with the 60 mg dose.
If the patient experienced orthostatic reactions on the starting dose, no dose escalation to 60 mg should be performed (see section 4.4).
A careful appraisal of individual benefit risk of Priligy should be performed by the physician after the first four weeks of treatment (or at least after 6 doses of treatment) to determine whether continuing treatment with Priligy is appropriate.
Data regarding the efficacy and safety of Priligy beyond 24 weeks are limited. The clinical need of continuing and the benefit risk balance of treatment with Priligy should be re-evaluated at least every six months.
Elderly (age 65 years and over)
The efficacy and safety of Priligy have not been established in patients age 65 years and over (see section 5.2).
There is no relevant use of Priligy in this population in the indication of premature ejaculation.
Patients with renal impairment
Caution is advised in patients with mild or moderate renal impairment. Priligy is not recommended for use in patients with severe renal impairment (see sections 4.4 and 5.2).
Patients with hepatic impairment
Priligy is contraindicated in patients with moderate and severe hepatic impairment (Child−Pugh Class B and C) (see sections 4.3 and 5.2).
Known CYP2D6 poor metabolizers or patients treated with potent CYP2D6 inhibitors
Caution is advised if increasing the dose to 60 mg in patients known to be of CYP2D6 poor metabolizer genotype or in patients concomitantly treated with potent CYP2D6 inhibitors (see sections 4.4, 4.5 and 5.2).
Patients treated with moderate or potent inhibitors of CYP3A4
Concomitant use of potent CYP3A4 inhibitors is contraindicated. The dose should be restricted to 30 mg in patients concomitantly treated with moderate CYP3A4 inhibitors and caution is advised (see sections 4.3, 4.4 and 4.5).
Method of administration
For oral use. Tablets should be swallowed whole to avoid the bitter taste. It is recommended that tablets be taken with at least one full glass of water. Priligy may be taken with or without food (see section 5.2).
Precautions to be taken before handling or administering the medicinal product
Before treatment is initiated, see section 4.4 regarding orthostatic hypotension.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Significant pathological cardiac conditions such as:
• Heart failure (NYHA class II-IV)
• Conduction abnormalities such as AV block or sick sinus syndrome
• Significant ischemic heart disease
• Significant valvular disease
• A history of syncope.
A history of mania or severe depression.
Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI. Similarly, an MAOI should not be administered within 7 days after Priligy has been discontinued (see section 4.5).
Concomitant treatment with thioridazine, or within 14 days of discontinuing treatment with thioridazine. Similarly, thioridazine should not be administered within 7 days after Priligy has been discontinued (see section 4.5).
Concomitant treatment with serotonin reuptake inhibitors [selective serotonin reuptake inhibitors (SSRIs), serotonin−norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other medicinal/herbal products with serotonergic effects [e.g., L−tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)] or within 14 days of discontinuing treatment with these medicinal/herbal products. Similarly, these medicinal/herbal products should not be administered within 7 days after Priligy has been discontinued (see section 4.5).
Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc. (see section 4.5).
Moderate and severe hepatic impairment.
Special warnings and precautions for use
Priligy is only indicated in men with Premature Ejaculation who meet all the criteria listed in sections 4.1 and 5.1. Priligy 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. Priligy should not be used in men with erectile dysfunction (ED) who are using PDE5 inhibitors (see section 4.5).
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 Priligy 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.
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 Priligy 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 Algorhythm of Suicide Assessment (C-CASA), Montgomery-Asberg Depression Rating Scale, or Beck Depression Inventory-II.
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 (see section 4.8).
Possibly prodromal symptoms such as nausea, dizziness/lightheadedness, and diaphoresis were reported more frequently among patients treated with Priligy compared to placebo.
In the clinical trials, cases of syncope characterized as loss of consciousness, with bradycardia or sinus arrest observed in patients wearing Holter monitors,were considered vasovagal in etiology and the majority occurred during the first 3 hours after dosing, after the first dose, or associated with study−related procedures in the clinic setting (such as blood draw and orthostatic maneuvers and blood pressure measurements). Possibly prodromal symptoms, such as nausea, dizziness, lightheadedness, palpitations, asthenia, confusion and diaphoresis generally occurred within the first 3 hours following dosing, and often preceded the syncope. Patients need to be made aware that they could experience syncope at any time with or without prodromal symptoms during their treatment with Priligy. Prescribers should counsel patients about the importance of maintaining adequate hydration and about how to recognize prodromal signs and symptoms to decrease the likelihood of serious injury associated with falls due to loss of consciousness. If the patient experiences possibly prodromal symptoms, the patient 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, and be cautioned to avoid situations where injury could result, including driving or operating hazardous machinery, should syncope or other CNS effects occur (see section 4.7).
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 Priligy in combination with recreational drugs.
Recreational drugs with serotonergic activity such as ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) may lead to potentially serious reactions if combined with Priligy. These reactions include, but are not limited to, arrhythmia, hyperthermia, and serotonin syndrome. Use of Priligy with recreational drugs with sedative properties such as narcotics and benzodiazepines may further increase somnolence and dizziness.
Patients should be advised not to use Priligy in combination with alcohol.
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 Priligy (see sections 4.5 and 4.7).
Medicinal products with vasodilatation properties
Priligy 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 (see section 4.5).
Moderate CYP3A4 inhibitors
Caution is advised in patients taking moderate CYP3A4 inhibitors and the dose is restricted to 30 mg (see sections 4.2 and 4.5).
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 (see sections 4.2, 4.5 and 5.2).
Priligy 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.
Due to the potential of SSRIs to lower the seizure threshold, Priligy should be discontinued in any patient who develops seizures and avoided in patients with unstable epilepsy. Patients with controlled epilepsy should be carefully monitored.
Priligy should not be used in individuals below 18 years of age.
Depression and/or psychiatric disorders
Men with underlying signs and symptoms of depression should be evaluated prior to treatment with Priligy to rule out undiagnosed depressive disorders. Concomitant treatment of Priligy with antidepressants, including SSRIs and SNRIs, is contraindicated (see section 4.3). Discontinuation of treatment for ongoing depression or anxiety in order to initiate Priligy for the treatment of PE is not recommended. Priligy 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, Priligy should be discontinued.
There have been reports of bleeding abnormalities with SSRIs. Caution is advised in patients taking Priligy, 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 (see section 4.5).
Priligy is not recommended for use in patients with severe renal impairment and caution is advised in patients with mild or moderate renal impairment (see sections 4.2 and 5.2).
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.
A double−blind clinical trial in subjects with PE designed to assess the withdrawal effects of 62 days of daily or as needed dosing with 60 mg Priligy showed mild withdrawal symptoms with a slightly higher incidence of insomnia and dizziness in subjects switched to placebo after daily dosing (see section 5.1).
The use of Priligy has been associated with ocular effects such as mydriasis and eye pain. Priligy should be used with caution in patients with raised intraocular pressure or those at risk of angle closure glaucoma.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose−galactose malabsorption should not take this medicine.
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