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Dapoxetine as hydrochloride. Each Priligy 30 mg film-coated tablet contains 30 mg of dapoxetine base as hydrochloride. Excipient with known effect. For the full list of excipients, see Section 6. 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. Precautions to be taken before handling or administering the medicinal product.

Before treatment is initiated, see Section 4. Patients should be cautioned to avoid situations where injury could result should syncope or its prodromal symptoms such as dizziness or lightheadedness occur see Section 4. Priligy has minor or moderate influence on the ability to drive and use machines. Dizziness, disturbance in attention, syncope, blurred vision and somnolence have been reported in subjects receiving Priligy in clinical trials.

Therefore, patients should be warned to avoid situations where injury could result, including driving or operating hazardous machinery.

Adult men 18 to 64 years of age. Patients must not take more than one tablet once every 24 hours due to increased risk of side effects see Boxed Warnings and lack of additional benefit. The recommended dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Priligy is not intended for continuous daily use. Priligy should be taken only when sexual activity is anticipated. The maximum recommended dosing frequency is once every 24 hours.

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. Elderly age 65 years and over. Safety and efficacy of Priligy have not been established in patients age 65 years and over as limited data are available in this population see Section 5.

Children and adolescents. Priligy should not be used in individuals below 18 years of age. Patients with renal impairment. No dose adjustment is required but caution is advised in patients with mild or moderate renal impairment.

Priligy is not recommended for use in patients with severe renal impairment see Section 5. Patients with hepatic impairment. No dose adjustment is required in patients with mild hepatic impairment. Priligy is contraindicated in patients with moderate and severe hepatic impairment Child-Pugh class B and C see Section 4. Patients treated with moderate or potent inhibitors of CYP3A4. Concomitant use of potent CYP3A4 inhibitors is contraindicated. Similarly, thioridazine should not be administered within 7 days after Priligy has been discontinued see Section 4.

L-tryptophan, triptans, tramadol, linezolid, lithium, St. Priligy is only indicated in men with PE who meet all the criteria listed, see Section 4. Priligy should be administered only as on-demand treatment before anticipated sexual activity. 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 PE. 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, methylenedioxy methamphetamine 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 Priligy 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 Section 4.

The number and percentage of subjects with syncope characterized as loss of consciousness was greater in Priligy treated subjects than in those who were treated with placebo.

A dose response relationship for syncope is suggested based on subject incidence across all studies. In phase 3 studies involving randomized subjects, the frequency of syncope characterised as a loss of consciousness was 0. In phase 3 studies, three cases of syncope with bradycardia and sinus arrest 2 events, 5 seconds each; one event 28 seconds in duration were observed during Holter monitor recording. Each subject spontaneously recovered normal sinus rhythm. In patients receiving 30 mg Priligy in phase 3 clinical trials, nausea was reported in Syncope characterized as loss of consciousness, with bradycardia or sinus arrest observed in patients wearing Holter monitors in the clinical trials 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 manoeuvres and blood pressure measurements.

Possible prodromal symptoms, such as nausea, dizziness, light-headedness, 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. Combining alcohol with Priligy may enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol with taking Priligy.

Cardiovascular disease. 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. There are insufficient data to determine whether this increased risk extends to vasovagal syncope in patients with underlying disease.

Cardiac conduction. In clinical studies, supraventricular beats and arrhythmias were slightly higher on Priligy. A review of Holter data in over subjects in phase 3 clinical trials demonstrated asymptomatic nonsustained ventricular tachycardia occurring in 0. In addition, no effect on QTc prolongation was detected in two phase I thorough QT studies designed to investigate the effect of Priligy on cardiac repolarization.

Orthostatic hypotension. Before treatment initiation, a careful medical examination including priligy 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 light-headedness 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. 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, nitrates due to possible reduced orthostatic tolerance see Section 4.

Moderate CYP3A4 inhibitors. Caution is advised in all patients concomitantly treated with moderate CYP3A4 inhibitors. Potent CYP2D6 inhibitors.

Caution is advised in patients taking potent CYP2D6 inhibitors or in patients known to be of CYP2D6 poor metaboliser genotype, as this may increase exposure levels, which may result in a higher incidence and severity of dose dependent adverse events see Section 4. Antidepressants, including SSRIs have been shown to increase 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 In clinical trials with Priligy for the treatment of premature ejaculation, there was no clear indication of treatment-emergent suicidality. 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. Co-morbid depression and psychiatric disorders. Men with underlying signs and symptoms of depression should be evaluated prior to treatment with Priligy to rule out undiagnosed depressive disorders. 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. Use in renal impairment. 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 Section 4.

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. 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 reported in subjects switched to placebo after daily dosing see Section 5.

Consistent results were seen in a second double blind clinical trial with a 24 week treatment phase of 30 and 60 mg doses as needed followed by a 1 week withdrawal assessment period. Eye disorders. As with other SSRIs, the use of Priligy has been associated with ocular effects such as mydriasis and eye pain.

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