Priligy online in Australia

Use

Therapeutic indications

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 the following criteria:

• Intravaginal ejaculation latency time (IELT) less than two minutes; Y
• Ejaculation that, permanently or recurrently, occurs with minimal sexual stimulation, before, during or shortly after penetration and before the patient wishes; Y
• Significant personal suffering or interpersonal difficulties as a consequence of PD; Y
• Poor control of ejaculation; Y
• A history of premature ejaculation in most sexual relationships in the last 6 months.

Priligy should only be given as treatment on demand before planned sexual activity. Priligy should not be prescribed to delay ejaculation in men who have not been diagnosed with PD.

Dosage and method of administration

Dose

Adult men (18 to 64 years old)

The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours before sexual activity. PRILIGY treatment should not be started with the 60 mg dose.

PRILIGY is not designed for continuous daily use. PRILIGY should only be taken when planning sexual activity. PRILIGY should not be taken more than once in 24 hours.

If the individual response to 30 mg is insufficient and the patient has experienced no moderate or severe adverse effects or possible precursor 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 before sexual activity. The incidence and severity of adverse events are greater with the 60 mg dose.

If the patient has experienced orthostatic reactions to the initial dose, the dose should not be increased to 60 mg (see section 4.4).

The physician should carefully evaluate the individual risk benefit of PRILIGY after the first four weeks of treatment (or at least after 6 doses of treatment) to determine if continued treatment with PRILIGY is appropriate.

Data on the efficacy and safety of PRILIGY beyond 24 weeks are limited. The clinical need to continue and the risk-benefit balance of PRILIGY treatment should be reassessed at least every six months.

Elderly (over 65 years old)

The efficacy and safety of PRILIGY in patients 65 years of age and older have not been established (see section Pharmacokinetic properties).

Pediatric population

There is no relevant use of PRILIGY in the pediatric population for the indication of premature ejaculation.

Patients with kidney failure.

Caution is recommended in patients with mild or moderate renal impairment. The use of PRILIGY is not recommended in patients with severe renal impairment (see sections 4.4 and 4.4).

Patients with liver failure.

PRILIGY is contraindicated in patients with moderate and severe hepatic impairment (Child Pugh - Class B and C) (see sections Contraindications and pharmacokinetic properties).

Known slow metabolizers of CYP2D6 or patients treated with strong CYP2D6 inhibitors

Caution is advised if the dose is increased to 60 mg in patients known to have a slow CYP2D6 metabolizer genotype or in patients treated concomitantly with strong CYP2D6 inhibitors (see sections 4.4 and 5.0). Interaction with other drugs and other forms of interaction and pharmacokinetic properties.

Patients treated with moderate or potent CYP3A4 inhibitors

Concomitant use of potent CYP3A4 inhibitors is contraindicated. In patients treated concomitantly with moderate CYP3A4 inhibitors, the dose should be limited to 30 mg and caution is recommended (see sections Contraindications, Warnings and precautions for use and Interactions with other medicinal products and other forms of interactions).

Administration form

Oral use. The tablets should be swallowed whole to avoid their bitter taste. It is recommended to take the tablets with at least a full glass of water. PRILIGY can be taken with or without food (see section Pharmacokinetic properties).

Precautions before handling or administering the medication.

Before starting treatment, see section 4.4 Warnings and precautions for use.

Prescription and delivery conditions

List I.

Duration and special precautions for conservation

Shelf life: 3 years.

Special precautions for storage: There are no special precautions for storage.

Preclinical safety data

A complete analysis of safety pharmacology, repeated administration toxicology, genotoxicity, carcinogenesis, risk of dependency / withdrawal symptoms, phototoxicity and toxicology of the reproductive and developmental functions of dapoxetine was performed in animal species (mouse, rat, rabbit, dog and monkey) up to the maximum tolerated dose for each species. In some studies, due to faster bioconversion in animal species than in humans, the pharmacokinetic exposure rates (Cmax and AUC0-24h) at the maximum tolerated doses were close to those observed in humans. However, standardized multiple doses for body weight were more than 100 times higher. In all these studies, no data showed clinically significant safety risks.

In studies with oral administration, dapoxetine showed no carcinogenic effects in rats when administered daily for approximately two years at doses up to 225 mg / kg / day, producing exposure (AUC) almost double that observed in men for whom it was administered. the maximum recommended human dose (DHMR) of 60 mg. Dapoxetine did not cause a tumor in the rasH2 transgenic mouse when administered at the maximum possible doses of 100 mg / kg for 6 months and 200 mg / kg for 4 months. At steady state, dapoxetine exposure in mice, after oral administration for 6 months at doses of 100 mg / kg / day, was lower than the clinically observed exposure after single 60 mg doses.

No effects on fertility, reproductive capacity, or reproductive system morphology were observed in male or female rats, and no adverse signs of embryotoxicity or fetotoxicity were observed in rats or rabbit. Reproductive toxicity studies have not included studies to assess risk. of adverse effects after exposure during the peri and postnatal period.

Incompatibilities

Aimlessly.

Employment precautions

Contraindications

• Hypersensitivity to the active substance or to any of the excipients included in the Composition section.
• Significant pathological cardiac conditions such as:

or heart failure (NYHA class II-IV),

o Conduction abnormalities, such as atrioventricular block or sinus dysfunction,

or significant ischemic heart disease,

or significant heart valve disease,

o A history of syncope.

• History of mania or severe depression.
• Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days after discontinuation of treatment with a MAOI. Similarly, MAOIs should not be administered within 7 days of stopping Priligy treatment (see section Interactions with other medicinal products and other forms of interaction).
• Concomitant treatment with thioridazine, or within 14 days after stopping treatment with thioridazine. Similarly, thioridazine should not be administered within 7 days after stopping Priligy treatment (see section Interactions with other medicinal products and other forms of interaction).
• Concomitant therapy with serotonin reuptake inhibitors (selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants) herbal medications / products with serotoninergic effects [eg, L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's wort (Hypericum perforatum)] or within 14 days of stopping treatment with these herbal medicines / products. Similarly, these medicinal products / herbal products should not be administered within 7 days after stopping Priligy treatment (see section Interactions with other medicinal products and other forms of interaction).
• Concomitant therapy with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, etc. (See section Interactions with other medications and other forms of interaction).
• Moderate and severe liver failure.

Pregnancy and lactation

Priligy is not indicated for use by women.

Animal studies do not indicate direct or indirect harmful effects on fertility, pregnancy, or embryonic or fetal development (see section Preclinical safety data).

It is not known whether dapoxetine or its metabolites are excreted in human milk.

Warnings and precautions for use

General recommendations

Priligy is indicated only for men suffering from premature ejaculation who combine all the criteria listed in the Therapeutic Indications and Pharmacodynamic Properties sections. Priligy should not be prescribed in men who have not been diagnosed with premature ejaculation. Safety has not been established and there is no data on the effect of delayed ejaculation on men who do not experience premature ejaculation.

Other forms of sexual dysfunction.

Before treatment, physicians should carefully examine subjects who have other forms of sexual dysfunction, including erectile dysfunction. Priligy should not be used in men with erectile dysfunction (ED) who use PDE5 inhibitors (see section Interactions with other medicinal products and other forms of interaction).

Orthostatic hypotension

Before starting treatment, the physician should perform a comprehensive medical examination, including a history of orthostatic events. An orthostatic test should be performed before starting treatment (blood pressure and pulse, lying down and standing). In the case of a documented or suspected history of an orthostatic reaction, treatment with Priligy should be avoided.

Orthostatic hypotension has been reported in clinical trials. The physician should inform the patient in advance that if there are any potential precursor symptoms, such as dizziness immediately after standing up, he should lie down immediately so that his head is lower than the rest of the body, or sit with his head between his knees until symptoms disappear. The doctor should also instruct the patient not to get up quickly after lying down or sitting for a long time.

Suicide / suicidal thoughts

In short-term studies in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders, antidepressants, including SSRIs, increased the risk of suicidal ideation and tendency compared to the placebo group. Short-term studies have not shown an increased risk of suicidality in adults older than 24 years taking antidepressants compared to the placebo group. In the Priligy clinical trials used as treatment for premature ejaculation, no evident evidence of suicidality was associated with treatment in the evaluation of adverse events related to suicide attempts as assessed by the Columbia Classification Suicide Algorithm Assessment ( C-CASA), the Montgomery-Asberg Depression Rating Scale, or the Beck-II Depression Inventory.

Syncope

Patients should be warned to avoid situations that may expose them to injury, such as driving or operating dangerous machinery, in case of syncope or warning symptoms such as dizziness or lightheadedness (see section 4.8).

Potential warning symptoms such as nausea, dizziness / dizziness, and diaphoresis were reported more frequently in patients treated with Priligy compared to the placebo group.

In clinical trials, syncope cases, characterized as loss of consciousness, with bradycardia or sinus arrest observed in patients using Holter monitors, were considered to be of vasovagal etiology and most cases occurred within the first 3 hours after taking the medication. , after the first dose or following the procedures related to the clinical study (such as blood samples, orthostatic maneuvers and blood pressure measurements).

Possible warning symptoms, such as nausea, dizziness, dizziness, palpitations, asthenia, confusion, and diaphoresis, generally occurred within the first 3 hours after taking the medication, and often preceded fainting. Patients should be informed that they may pass out at any time with or without warning symptoms while taking Priligy. Prescribers should inform patients of the importance of maintaining adequate hydration. They should also educate them on how to recognize warning signs and symptoms to reduce the likelihood of serious injury associated with a fall from unconsciousness.

If the patient has potential precursor symptoms, he should lie down immediately so that his head is lower than the rest of his body or sit with his head between his knees until the symptoms disappear. The patient should be advised of the need to avoid situations that could expose him or her to injury in the event of syncope or other CNS effects, such as driving or operating dangerous machinery (see section Effects on ability to drive and use machines).

Patients with cardiovascular risk factors.

Subjects with underlying cardiovascular disease were excluded from phase 3 clinical trials. The risk of adverse cardiovascular events due to syncope (cardiac syncope and syncope of different etiology) increases in patients with underlying structural cardiovascular disease (eg, documented ejection pathway, valvular heart disease, carotid stenosis and coronary heart disease). There is 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, methylenedioxymethylafetamine (MDMA), and lysergic acid diethylamide (LSD), can cause potentially serious reactions when combined with Priligy. These reactions include, but are not limited to, arrhythmia, hyperthermia, and serotonin syndrome. The use of Priligy with recreational drugs with sedative properties, such as narcotics and benzodiazepines, can further increase drowsiness and dizziness.

Ethanol

Patients should be cautioned not to use Priligy in combination with alcohol.

The combination of alcohol and dapoxetine can increase alcohol related neurocognitive effects and can also increase neurocardiogenic adverse events, such as syncope, increasing the risk of accidental injury; therefore patients should be informed of the need to avoid alcohol during treatment with Priligy (see sections Interactions with other medicinal products and other forms of interaction and Effects on ability to drive and use machines).

Medicines with vasodilatory properties.

Priligy should be prescribed with caution in patients taking medicinal products with vasodilatory properties (such as alpha-adrenergic receptor antagonists and nitrates) due to the possible decrease in orthostatic tolerance (see section Interactions with other medicinal products and other forms of interaction)

Moderate CYP3A4 inhibitors

Caution is advised in patients taking moderate CYP3A4 inhibitors and the dose is limited to 30 mg (see sections 4.2 and 4.3 and Interactions with other medicinal products and other forms of interaction).

Strong CYP2D6 inhibitors

Caution is advised when increasing the dose to 60 mg in patients taking potent CYP2D6 inhibitors or in patients known to be of the slow metabolizing CYP2D6 genotype, as this may increase exposure levels, which may lead to increased incidence and severity of dose-dependent adverse reactions (see sections 4.2 and 4.2, Pharmacokinetic properties).

Manias

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.

Epilepsy attacks

Due to the risk associated with SSRIs of lowering the epileptogenic threshold, Priligy should be discontinued in any patient who develops seizures and avoided in patients with unstable epilepsy. Patients with controlled epilepsy should be closely monitored.

Pediatric population

Priligy should not be used in people under the age of 18.

Depression and / or psychiatric disorders

Men with underlying signs and symptoms of depression should be evaluated before prescribing Priligy treatment to rule out undiagnosed depressive disorders. Concomitant treatment with Priligy and antidepressants, including SSRIs and SNRIs, is contraindicated (see section 4.3). It is not recommended to stop the current treatment for depression or anxiety to start Priligy in the treatment of PD. Priligy is not indicated for psychiatric disorders and should not be used in men with these disorders, such as schizophrenia, or in those suffering from concomitant depression, as worsening of depression-related symptoms cannot be excluded. . This could be the result of an underlying psychiatric disorder or medication.

Physicians should encourage patients to report any thoughts or feelings of suffering at any time, and if signs and symptoms of depression develop during treatment, PRILIGY should be discontinued.

Hemorrhage

Bleeding disorders have been reported with SSRIs. Caution is advised in patients taking Priligy, especially when concomitant use of medicinal products that affect platelet function (eg, atypical antipsychotics and phenothiazines, acetylsalicylic acid, non-steroidal anti-inflammatory drugs [NSAIDs], and antiplatelet agents) anticoagulants (eg warfarin) , as well as in patients with a history of bleeding or bleeding disorders (see section Interactions with other medications and other forms of interaction).

Renal insufficiency

Priligy is not recommended for use in patients with severe renal impairment, and caution is recommended in patients with mild or moderate renal impairment (see sections 4.2 and 5.2).

Effects of withdrawal

Long-term abrupt discontinuation of SSRIs for the treatment of chronic depressive disorders has been shown to cause the following symptoms: dysphoria, irritability, agitation, dizziness, sensory disturbances (eg, paresthesias such as feelings of electric shock) , anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania.

A double-blind clinical study in PD subjects designed to assess the effects of withdrawal after a daily dose of Priligy 60 mg daily or as needed for 62 days revealed mild withdrawal symptoms, with a slightly higher incidence of insomnia and dizziness. in subjects switching from daily administration to placebo (see section Pharmacodynamic properties).

Vision problems

Priligy use has been associated with eye effects such as mydriasis and eye pain. PRILIGY should be used with caution in patients with elevated intraocular pressure or risk of angle-closure glaucoma.

Lactose intolerance

This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency, or malabsorption of glucose or galactose (rare inherited diseases).

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions

Possible interaction with monoamine oxidase inhibitors

Serious, sometimes fatal, reactions have been reported in patients taking an SSRI in combination with a monoamine oxidase inhibitor (MAOI). These reactions included hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations in vital signs, and changes in mental status, including extreme restlessness that could develop into delirium and coma. These reactions have also been reported in patients who started taking an MAOI soon after stopping an SSRI. Some cases had characteristics similar to those of a neuroleptic malignant syndrome. Data from animal experiments on the effects of combining an SSRI and an MAOI indicate that these drugs can act synergistically by increasing blood pressure and causing very restless behavior. Therefore PRILIGY should not be used in combination with an MAOI or within 14 days after stopping treatment with a MAOI. Similarly, MAOIs should not be administered within 7 days of stopping PRILIGY treatment (see Contraindications section).

Possible interaction with thioridazine

Thioridazine administration alone causes prolongation of the QTc interval, which is associated with severe ventricular arrhythmias. Medications like PRILIGY, which inhibit the CYP2D6 isozyme, appear to inhibit thioridazine metabolism. The resulting elevated thioridazine levels are expected to increase QTc interval prolongation. PRILIGY must not be used in combination with thioridazine or within 14 days after stopping thioridazine treatment. Similarly, thioridazine should not be administered within 7 days after stopping PRILIGY treatment (see section Contraindications).

Medicines / herbal products with serotonergic effects.

As with other SSRIs, co-administration of serotonergic medicinal products / herbal products (including MAOIs, L-tryptophan, triptans, tramadol, linezolid, SSRIs, SNRIs, lithium, and St. John's wort (Hypericum perforatum) preparations) may result for serotonin-related effects. PRILIGY should not be used in combination with other SSRIs, MAOIs, or other serotonergic medicinal products / herbal products or within 14 days of stopping treatment with these medicinal products / herbal products. Similarly, these herbal medicinal products / products should not be administered within 7 days of stopping PRILIGY treatment (see section 4.3).

Active drugs in the CNS

The use of PRILIGY in combination with CNS active drugs (eg antiepileptics, antidepressants, antipsychotics, anxiolytics, sedative hypnotics) has not been systematically evaluated in patients with premature ejaculation. Therefore, caution is recommended if concomitant administration of PRILIGY and these medicinal products is necessary.

Pharmacokinetic interactions

Effects of co-administered drugs on the pharmacokinetics of dapoxetine

In vitro studies with human liver, kidney, and intestinal microsomes indicate that dapoxetine is primarily metabolized by CYP2D6, CYP3A4, and flavin monooxygenase (FMO1). Therefore, inhibitors of these enzymes can reduce dapoxetine clearance.

CYP3A4 inhibitors

Strong CYP3A4 inhibitors.

Administration of ketoconazole (200 mg twice daily for 7 days) increased dapoxetine Cmax and AUCinf (60 mg single dose) by 35% and 99%, respectively. Taking into account the contribution of unbound dapoxetine and desmethyldapoxetine, the Cmax of the active fraction can be increased by approximately 25% and the AUC of the active fraction can be doubled if potent CYP3A4 inhibitors are administered concomitantly.

The increase in Cmax and AUC of the active fraction can be considerably increased in the population group with absence of functional CYP2D6, for example, slow CYP2D6 metabolizers, or in association with strong inhibitors. CYP2D6.

Therefore, concomitant use of PRILIGY and potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, and atazanavir, is contraindicated (see section Contraindications).

Moderate CYP3A4 inhibitors.

The concomitant use of moderate CYP3A4 inhibitors (for example, erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem) can also cause a significant increase in exposure to dapoxetine and desmethyldapoxetine6, including slow CY6 metabolizers. If dapoxetine is used in combination with one of these medicinal products, the maximum dose of dapoxetine should be 30 mg (see sections 4.2 and 4.4).

These two measures apply to all patients, unless you have verified by genotypic or phenotypic analysis that the patient is a very good CYP2D6 metabolizer. In patients who have shown to be very good metabolizers of CYP2D6, a maximum dose of 30 mg is recommended if dapoxetine is combined with a strong CYP3A4 inhibitor, and caution is recommended if dapoxetine 60 mg is taken concomitantly with an inhibitor. CYP3A4 moderate.

Strong CYP2D6 inhibitors

Dapoxetine Cmax and ASCinf (60 mg single dose) increased by 50% and 88%, respectively, in the presence of fluoxetine (60 mg / day for 7 days). Taking into account the contribution of unbound dapoxetine and desmethyldapoxetine, the Cmax of the active fraction can be increased by approximately 50% and the AUC of the active fraction can be doubled if potent CYP2D6 inhibitors are administered concomitantly. These increases in Cmax and AUC of the active fraction are similar to those expected in slow CYP2D6 metabolizers and may lead to an increase in the incidence and severity of dose-dependent adverse reactions (see Warnings and precautions for use) .

PDE5 inhibitors

PRILIGY should not be used in patients using PDE5 inhibitors due to the possible decrease in orthostatic tolerance (see section 4.4).

The pharmacokinetics of dapoxetine (60 mg) in combination with tadalafil (20 mg) and sildenafil (100 mg) was evaluated in a single-dose crossover study. Tadalafil does not affect the pharmacokinetics of dapoxetine. Sildenafil causes slight variations in dapoxetine pharmacokinetics (22% increase in ASCinf and 4% increase in Cmax), which are not expected to be clinically significant.

Concomitant use of PRILIGY with PDE5 inhibitors can cause orthostatic hypotension (see section 4.4). The efficacy and safety of PRILIGY has not been established in patients with premature ejaculation and erectile dysfunction, treated simultaneously with PRILIGY inhibitors and PDE5.

Effects of dapoxetine on the pharmacokinetics of co-administered drugs

Tamsulosin

Co-administration of single or multiple doses of 30 mg or 60 mg dapoxetine in patients receiving daily doses of tamsulosin did not affect tamsulosin pharmacokinetics. The addition of dapoxetine to tamsulosin did not modify the orthostatic profile and no difference in orthostatic effects was observed between tamsulosin associated with dapoxetine doses of 30 or 60 mg and tamsulosin administered alone; however, PRILIGY should be prescribed with caution in patients taking alpha-adrenergic receptor blockers, due to the possible decrease in orthostatic tolerance (see section 4.4).

Drugs metabolized by CYP2D6

Multiple doses of dapoxetine (60 mg / day for 6 days) followed by a single 50 mg dose of desipramine increased the Cmax and AUCinf of desipramine by approximately 11% and 19%, respectively, compared to desipramine administered alone . Dapoxetine can cause a similar increase in plasma concentrations of other drugs metabolized by CYP2D6. The clinical importance is probably low.

Drugs metabolized by CYP3A4

Multiple doses of dapoxetine (60 mg / day for 6 days) decreased the AUCinf of midazolam (8 mg as a single dose) by approximately 20% (range - 60 to + 18%). The clinical significance of the effect on midazolam is likely to be low for most patients. The increase in CYP3A activity may be clinically significant in some individuals concomitantly treated with a drug primarily metabolized by CYP3A with a narrow therapeutic window.

Drugs metabolized by CYP2C19

Multiple doses of dapoxetine (60 mg / day for 6 days) did not inhibit the metabolism of a single 40 mg dose of omeprazole. Dapoxetine is unlikely to affect the pharmacokinetics of other CYP2C19 substrates.

Drugs metabolized by CYP2C9

Multiple doses of dapoxetine (60 mg / day for 6 days) did not affect the pharmacokinetics or pharmacodynamics of a single 5 mg dose of glyburide. Dapoxetine is unlikely to affect the pharmacokinetics of other CYP2C9 substrates.

Warfarin and medications known to affect clotting and / or platelet function

There are no data evaluating the effect of chronic warfarin use with dapoxetine; therefore, caution is recommended when dapoxetine is used in patients taking warfarin chronically (see section 4.4). In a pharmacokinetic study, dapoxetine (60 mg / day for 6 days) did not affect the pharmacokinetics or pharmacodynamics (TP or INR) of warfarin after a single 25 mg dose.

Abnormal bleeding has been reported with SSRIs (see section 4.4).

Ethanol

Coadministration of a single dose of ethanol, 0.5 g / kg (ie, approximately 2 glasses of alcoholic beverage), did not affect the pharmacokinetics of dapoxetine (60 mg as a single dose); however, dapoxetine combined with ethanol increased drowsiness and significantly decreased their own alertness. Pharmacodynamic measures of cognitive decline (digit vigilance rate, digit symbol substitution test) have also shown an additive effect when dapoxetine was co-administered with ethanol. Concomitant use of alcohol and dapoxetine increases the risk or severity of side effects, such as dizziness, drowsiness, slow reflexes, or poor judgment. The combination of alcohol and dapoxetine may increase these alcohol related effects and may also exacerbate neurocardiogenic adverse effects such as syncope, increasing the risk of accidental injury; therefore patients should be instructed to avoid alcohol while taking PRILIGY (see sections 4.4 and 4.5 and the effects on the ability to drive and use machines).

Caution

Undesirable effects

Summary of the safety profile

Syncope and orthostatic hypotension have been reported in clinical trials (see section 4.4).

The following side effects were reported more frequently in phase 3 clinical studies and were dose related: nausea (11.0% and 22.2% for 30 mg and 60 mg doses administered on demand, respectively), dizziness (5.8% and 10.9%), headache (5.6% and 8.8%), diarrhea (3.5% and 6.9%), insomnia (2.1% and 3.9%) and fatigue (2.0% and 4.1%). The most frequent adverse events that led to discontinuation of treatment were nausea (2.2% of the subjects treated with PRILIGY) and dizziness (1.2% of the subjects treated with PRILIGY).

Tabulated list of adverse reactions

The safety of PRILIGY was evaluated in 4,224 subjects with premature ejaculation who participated in five double-blind, placebo-controlled clinical studies. Of these 4,224 subjects, 1,616 received a dose of PRILIGY 30 mg as needed and 2,608 received a dose of PRILIGY 60 mg as needed or once daily.

Table 1 shows the reported side effects.

Table 1: Frequency of adverse reactions (MedDRA)

Organ system classes

Very common

(plus 1/10)

Frequent

(³1 / 100, minus 1/10)

Rare

(³1 / 1,000, minus 1/100)

Rare

(³1 / 10,000, minus 1/1000)

Psychiatric disorders

Anxiety, restlessness, impatience, insomnia, abnormal dreams, decreased libido.

Depression, depressed mood, euphoric mood, altered mood, nervousness, indifference, apathy, confusion, disorientation, abnormal thoughts, hypervigilance, sleep disorders, initial insomnia, nighttime insomnia, nightmares, bruxism, loss of libido, anorgasmia

Nervous system disorders

Dizziness, headache

Drowsiness, attention deficit disorder, tremor, paresthesia.

Syncope, vasovagal syncope, postural vertigo, akathisia, dysgeusia, hypersomnia, lethargy, sedation, decreased level of consciousness.

Vertigo exercise, sudden sleep

Eye conditions

Blurry vision

Mydriasis (see section 4.4), eye pain, visual disturbance

Ear and labyrinth disorders.

Tinnitus

Dizziness

Heart conditions

Sinus arrest, sinus bradycardia, tachycardia

Vascular disorders

Blush

Hypotension, systolic hypertension, hot flashes

Respiratory, thoracic and mediastinal disorders.

Stuffy nose, yawning

Gastrointestinal disorders.

Sickness

Diarrhea, vomiting, constipation, abdominal pain, upper abdominal pain, dyspepsia, flatulence, stomach discomfort, bloating, dry mouth.

Abdominal discomfort, epigastric discomfort.

Urgent need to defecate

Skin and subcutaneous tissue disorders.

Hyperhidrosis

Itching, cold sweats.

Reproductive system and breast disorders.

Erectile dysfunction

Ejaculation failure, male orgasmic disorder, male genital paresthesia

General disorders and administration site conditions.

Fatigue, irritability.

Asthenia, feeling of heat, feeling of nervousness, feeling of being abnormal, feeling of intoxication.

Research

Increased blood pressure

Increased heart rate, increased diastolic blood pressure, increased orthostatic blood pressure

The side effects reported in the 9-month long-term open-label extension study were consistent with those reported in the double-blind studies, and no other side effects were reported.

Description of some side effects.

Syncope, characterized as loss of consciousness, with bradycardia or sinus arrest seen in patients using Holter monitors, has been reported in clinical trials and is considered to be drug related. Most of the cases occurred during the first 3 hours after taking, after the first dose or after the procedures related to the clinical study (such as blood samples, orthostatic maneuvers and blood pressure measurements). Precursor symptoms often preceded syncope (see Warnings and Precautions for Use section).

The onset of syncope and possible precursor symptoms appear to be dose dependent, as evidenced by a higher incidence in patients treated with higher doses than those recommended in phase 3 clinical trials.

Orthostatic hypotension has been reported in clinical trials (see section 4.4). Syncope frequency, characterized as loss of consciousness in the PRILIGY clinical development program, varied by study population and ranged from 0.06% (30 mg) to 0.23% (60 mg) in subjects enrolled in Phase placebo-controlled clinical trials. 3 and 0.64% (all doses combined) in Phase 1 studies conducted in healthy volunteers without PD.

Other special populations.

Caution is advised when increasing the dose to 60 mg in patients taking strong CYP2D6 inhibitors or increasing the dose to 60 mg in patients with a slow metabolism CYP2D6 genotype (see sections 4.2 and 5.0). (Administration, warnings and precautions for use, interactions with other medicinal products and other forms of interaction and pharmacokinetic properties).

Effects of withdrawal

Long-term abrupt discontinuation of SSRIs for the treatment of chronic depressive disorders has been shown to cause the following symptoms: dysphoria, irritability, agitation, dizziness, sensory disturbances (eg, paresthesias such as feelings of electric shock) , anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania.

The results of a safety study revealed a slightly higher incidence of withdrawal symptoms, such as mild or moderate insomnia and dizziness in subjects who switched from daily administration for 62 days to placebo.

Overdose

No cases of overdose have been reported.

In a clinical pharmacological study, no unexpected adverse events occurred with daily Priligy doses up to 240 mg (two 120 mg doses administered 3 hours apart). In general, the symptoms of an SSRI overdose include serotonin-related side effects such as drowsiness, gastrointestinal disorders such as nausea and vomiting, tachycardia, tremor, restlessness, and dizziness.

In the event of an overdose, the usual symptomatic treatment measures should be implemented as necessary. Due to the high protein binding and large volume of distribution of dapoxetine hydrochloride, forced diuresis, dialysis, hemoperfusion, and blood transfusion are probably not beneficial. No specific antidote is known for Priligy.

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