Do not take this medicine if you are allergic to any of these ingredients. PRILIGY 30 mg film-coated tablets are light grey, round and marked "30" inside a triangle on one side (AUST R 147946).

Common side effects include nausea, loss of balance, and dry mouth.
If serious side effects like irregular heartbeat occur, seek medical help immediately.
Dapoxetine may not be suitable for all men, especially those with cardiovascular issues.
Regular medical check-ups are important while using this medication long-term.

PRILIGY is supplied in blister packs containing 3 or 6 tablets.

Condition	Contraindicated?	Notes
Heart failure	Yes	Risk of worsening symptoms
Liver impairment	Yes	Metabolized in the liver, caution advised
Use with MAO inhibitors	Yes	Causes severe interactions
History of syncope	Yes	Due to risk of fainting
Allergic reactions to SSRIs	Yes	Allergic response possible

This leaflet was prepared in March 2024. Dalxet is a combination medication used to treat erectile dysfunction (ED) and premature ejaculation (PE) in men.

When Not to Use?

Dapoxetine is contraindicated in patients with known hypersensitivity to Dapoxetine or to any of the excipients. It is also contraindicated in patients with heart failure, conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease or significant valvular disease. It may also interact with SSRls, MAO ls, thioridazine, serotonin-norepinephrine reuptake inhibitors (SNRls}, tricyclic antidepressants (TCAs} and other serotonergic medicinal/herbal products. There were no unexpected events of overdose is reported with daily doses up to 240 mg (two 120 mg doses given 3 hours apart). In general, symptoms of overdose with SSRls include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness.

Pregnancy and breastfeeding

In cases of overdose, standard supportive measures should be adopted as required. Due to high protein binding and large volume of distribution of Dapoxetine, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for Dapoxetine are known. Store in a cool & dry place protected from light.

How much to take

Phosphodiesterase type 5 (PDE5) inhibitor + selective serotonin reuptake inhibitor (SSRI). Available in tablet form, in various pack sizes.

Product	Dosage	Quantity + Bonus	Price
Priligy Generic Dapoxetine	60mg	60 + 8 Pills	183.06€ 174.34€
Cialis Generic	20mg	270 + 10 Pills	335.21€ 319.25€
Levitra Original	20mg	64 + 4 Pills	298.45€ 284.24€
Priligy Generic Dapoxetine	60mg	30 + 6 Pills	106.65€ 101.57€
Priligy Generic Dapoxetine	60mg	120 + 10 Pills	341.26€ 325.01€
Priligy Generic Dapoxetine	60mg	10 Pills	47.63€ 45.36€
Priligy Generic Dapoxetine	60mg	180 + 10 Pills	494.76€ 471.20€
Cialis Generic	2.5mg	360 + 10 Pills	260.03€ 247.65€
Levitra Generic	60mg	270 + 10 Pills	714.53€ 680.50€
Priligy Generic Dapoxetine	60mg	90 + 10 Pills	265.64€ 252.99€
Priligy Generic Dapoxetine	60mg	20 + 4 Pills	77.31€ 73.63€

Take 1 tablet 1-3 hours before sexual activity, as needed. Store in a cool, dry place, away from direct sunlight. – Consult a doctor before use if you have a medical condition, take medication, or are prone to priapism. – Avoid using with nitrates, alpha-blockers, or other PDE5 inhibitors. – Do not take more than the recommended dose.

Dapoxetine is designed for on-demand use, not daily administration.
The medication can improve control over ejaculation and increase sexual satisfaction.
It is available by prescription only and should be used under medical supervision.
Pregnancy or breastfeeding women should avoid using dapoxetine without doctor consultation.

Other combination medications vardenafil with dapoxetine tablets for ED and PE, such as Cialis + Priligy. Department of Urologic Surgery, 420 Delaware Street, SE, MMC 394, University of Minnesota, Minneapolis, MN 55455, USA DOI: 10.1016/S0140-6736(06)69695-5 External LinkAlso available on ScienceDirect External Link Dapoxetine for treatment of premature ejaculationThe LancetNovember 11, 2006 With regard to Raimo Salokangas's question about the long-term effects of dapoxetine, adverse events seen in a 9-month open-label extension study (unpublished) were consistent with those seen in the published 3-month phase III studies. In particular, reports of depression, euphoria, and psychosis while on dapoxetine 60 mg occurred in nine (0·5%), three (0·2%), and one (0·1%) of the 1774 patients enrolled in the open-label phase, respectively; they also occurred at rates similar to those seen in the dapoxetine 60 mg treatment group of the phase III studies (table). Although studies of longer dapoxetine exposure have not been done, a recently completed randomised, double-blind, placebo-controlled safety study (as yet unpublished) showed no signs of discontinuation symptoms or psychiatric effects during 2 months of continuous daily dosing of dapoxetine, followed by abrupt discontinuation of treatment. Although there are no data to rule out the possibility of emergence of new adverse effects beyond 1 year, the short half-life of dapoxetine predicts little drug accumulation with repeated daily dosing,1 and would suggest that dapoxetine is associated with a low risk of increased adverse events or the emergence of psychiatric disorders such as those mentioned above. In response to Salokangas's second question, the effects of an SSRI in a man who becomes depressed subsequent to years of dapoxetine use are unknown.

Medical uses

Do not take this medicine if you are allergic to any of these ingredients. PRILIGY 30 mg film-coated tablets are light grey, round and marked "30" inside a triangle on one side (AUST R 147946). PRILIGY is supplied in blister packs containing 3 or 6 tablets. This leaflet was prepared in March 2024. Dalxet is a combination medication used to treat erectile dysfunction (ED) and premature ejaculation (PE) in men.

Mechanism of action

Phosphodiesterase type 5 (PDE5) inhibitor + selective serotonin reuptake inhibitor (SSRI). Available in tablet form, in various pack sizes. Take 1 tablet 1-3 hours before sexual activity, as needed. Store in a cool, dry place, away from direct sunlight. – Consult a doctor before use if you have a medical condition, take medication, or are prone to priapism.

Getting rid of any unwanted medicine

– Avoid using with nitrates, alpha-blockers, or other PDE5 inhibitors. – Do not take more than the recommended dose. Other combination medications vardenafil with dapoxetine tablets for ED and PE, such as Cialis + Priligy. Department of Urologic Surgery, 420 Delaware Street, SE, MMC 394, University of Minnesota, Minneapolis, MN 55455, USA DOI: 10.1016/S0140-6736(06)69695-5 External LinkAlso available on ScienceDirect External Link Dapoxetine for treatment of premature ejaculationThe LancetNovember 11, 2006 With regard to Raimo Salokangas's question about the long-term effects of dapoxetine, adverse events seen in a 9-month open-label extension study (unpublished) were consistent with those seen in the published 3-month phase III studies. In particular, reports of depression, euphoria, and psychosis while on dapoxetine 60 mg occurred in nine (0·5%), three (0·2%), and one (0·1%) of the 1774 patients enrolled in the open-label phase, respectively; they also occurred at rates similar to those seen in the dapoxetine 60 mg treatment group of the phase III studies (table). Antidepressant response is dependent on numerous factors, including the secondary properties of SSRIs that might contribute to differences in the efficacy and tolerability between members of this antidepressant class.2 However, it is important to note that men with psychiatric disorders were excluded from the dapoxetine clinical trials.

Medication Type	Interaction Effect	Notes
Other SSRIs/SNRIs	Increased Side Effects	Risk of serotonin syndrome
CYP3A4 inhibitors	Increased Dapoxetine levels	Potential toxicity
QT prolonging drugs	Additive effect	May cause heart rhythm issues
Alcohol	Increased sedative effects	Avoid alcohol during use
Monoamine oxidase inhibitors	Severe interactions	Contraindicated

Individuals who become depressed would be considered contraindicated for treatment with dapoxetine. I declare that I have no conflict of interest. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation Clinical effects of pharmacological variations in selective serotonin reuptake inhibitors: an overview bJohnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA cJohnson & Johnson Pharmaceutical Services, L.L.C., Raritan, NJ, USA dAP-HP, Neuro-Urology-Andrology, Raymond Poincaré Hospital, Garches, France Accepted January 13, 2009; Published online January 22, 2009 DOI: 10.1016/j.eururo.2009.01.025 External LinkAlso available on ScienceDirect External Link Addendum to: “Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial in 22 Countries” [Eur Urol 2009;55:957–68]European UrologyVol. Editorial Comment on: Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial in 22 CountriesEuropean UrologyVol. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation Efficacy and tolerability of dapoxetine in the treatment of premature ejaculation: integrated analysis of two randomized, double-blind, placebo-controlled trials Lack of withdrawal syndrome or effects on anxiety with dapoxetine (DPX) for the treatment of premature ejaculation (PE): results from 2 phase III trials [abstract] Premature ejaculation: an observational study of men and their partners Premature ejaculation: results from a five-country European observational study Improvement in sexual satisfaction of female partners of men with premature ejaculation (PE) treated with dapoxetine (DPX) [abstract] An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation Clinical trial methodology in premature ejaculation observational, interventional, and treatment preference studies—part II—study design, outcome measures, data analysis, and reporting Geometric mean IELT and premature ejaculation: appropriate statistics to avoid overestimation of treatment efficacy Perceived control over ejaculation is central to treatment benefit in men with premature ejaculation: results from phase III trials with dapoxetine New avenues in the pharmacological treatment of premature ejaculation Dapoxetine has no effects on hemodynamics or electrocardiographic assessments [abstract] Daxetin® is a preparation of Dapoxetine Hydrochloride which is a selective serotonin reuptake inhibitor (SSRI}. Daxetin® is indicated for the treatment of - Premature ejaculation Personal distress or interpersonal difficulty as a consequence of premature ejaculation Poor control over ejaculation Adult men (18 to 64 years of age) The recommended starting dose of Daxetin® for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.

Storage Condition	Temperature Range	Protect From	Additional Tips
Cool, dry place	20°C - 25°C	Moisture & Light	Keep out of reach of children
Away from heat	Up to 25°C	Sunlight	Store in original container
Humidity control	Avoid bathroom	Humid environments	Ensure proper sealing

Elderly (age 65 years and over) Safety and efficacy of Dapoxetine have not been established in patients age 65 years and over as limited data are available in this population. Children and adolescents Dapoxetine is not recommended for patients under 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.

Safety Advice

Dapoxetine is not recommended for use in patients with severe renal impairment. Patients with hepatic impairment No dose adjustment is required in patients with mild hepatic impairment.

Specialised Healthcare Solutions for Unique Needs

Although studies of longer dapoxetine exposure have not been done, a recently completed randomised, double-blind, placebo-controlled safety study (as yet unpublished) showed no signs of discontinuation symptoms or psychiatric effects during 2 months of continuous daily dosing of dapoxetine, followed by abrupt discontinuation of treatment. Although there are no data to rule out the possibility of emergence of new adverse effects beyond 1 year, the short half-life of dapoxetine predicts little drug accumulation with repeated daily dosing,1 and would suggest that dapoxetine is associated with a low risk of increased adverse events or the emergence of psychiatric disorders such as those mentioned above. In response to Salokangas's second question, the effects of an SSRI in a man who becomes depressed subsequent to years of dapoxetine use are unknown. Antidepressant response is dependent on numerous factors, including the secondary properties of SSRIs that might contribute to differences in the efficacy and tolerability between members of this antidepressant class.2 However, it is important to note that men with psychiatric disorders were excluded from the dapoxetine clinical trials. Individuals who become depressed would be considered contraindicated for treatment with dapoxetine.

Serious side effects

I declare that I have no conflict of interest. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation Clinical effects of pharmacological variations in selective serotonin reuptake inhibitors: an overview bJohnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA cJohnson & Johnson Pharmaceutical Services, L.L.C., Raritan, NJ, USA dAP-HP, Neuro-Urology-Andrology, Raymond Poincaré Hospital, Garches, France Accepted January 13, 2009; Published online January 22, 2009 DOI: 10.1016/j.eururo.2009.01.025 External LinkAlso available on ScienceDirect External Link Addendum to: “Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial in 22 Countries” [Eur Urol 2009;55:957–68]European UrologyVol. Editorial Comment on: Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial in 22 CountriesEuropean UrologyVol. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation Efficacy and tolerability of dapoxetine in the treatment of premature ejaculation: integrated analysis of two randomized, double-blind, placebo-controlled trials Lack of withdrawal syndrome or effects on anxiety with dapoxetine (DPX) for the treatment of premature ejaculation (PE): results from 2 phase III trials [abstract] Premature ejaculation: an observational study of men and their partners Premature ejaculation: results from a five-country European observational study Improvement in sexual satisfaction of female partners of men with premature ejaculation (PE) treated with dapoxetine (DPX) [abstract] An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation Clinical trial methodology in premature ejaculation observational, interventional, and treatment preference studies—part II—study design, outcome measures, data analysis, and reporting Geometric mean IELT and premature ejaculation: appropriate statistics to avoid overestimation of treatment efficacy Perceived control over ejaculation is central to treatment benefit in men with premature ejaculation: results from phase III trials with dapoxetine New avenues in the pharmacological treatment of premature ejaculation Dapoxetine has no effects on hemodynamics or electrocardiographic assessments [abstract] Daxetin® is a preparation of Dapoxetine Hydrochloride which is a selective serotonin reuptake inhibitor (SSRI}. Daxetin® is indicated for the treatment of - Premature ejaculation Personal distress or interpersonal difficulty as a consequence of premature ejaculation Poor control over ejaculation Adult men (18 to 64 years of age) The recommended starting dose of Daxetin® for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity.

When to take PRILIGY

If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours. Elderly (age 65 years and over) Safety and efficacy of Dapoxetine have not been established in patients age 65 years and over as limited data are available in this population. Children and adolescents Dapoxetine is not recommended for patients under 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. Dapoxetine is not recommended for use in patients with severe renal impairment. Dapoxetine is sildenafil dapoxetine tablets contraindicated in patients with moderate and severe hepatic impairment. Pregnancy Dapoxetine is pregnancy category C.

The medication’s effectiveness varies based on individual health and response.
Dapoxetine does not increase libido or sexual desire directly.
Maintain a healthy lifestyle to support the benefits of dapoxetine therapy.
Always complete the prescribed course unless advised otherwise by a healthcare provider.

Dapoxetine is not indicated for use by women. There are no adequate and well-controlled studies of Dapoxetine in pregnant women. Lactation Dapoxetine is not indicated for use by women. It is not known if either Dapoxetine or its metabolites are excreted in human breast milk. General Dapoxetine is only indicated in men with premature ejaculation. Safety has not been established and there are no data on the ejaculation-delaying effects in men without premature ejaculation. Use with recreational drugs Patients should be advised not to use Dapoxetine in combination with recreational drugs with serotonergic activity such as ketamine, methylenedioxymethamphetamine (MOMA) and lysergic acid diethylamide (LSD) because these may lead to potentially serious reactions if combined with Dapoxetine.

Dapoxetine 30 mg is a fast-acting medication used to treat premature ejaculation.
It belongs to the selective serotonin reuptake inhibitors (SSRIs) class.
The recommended starting dose is typically 30 mg taken 1-3 hours before intimacy.
Consult a doctor before using dapoxetine to ensure proper dosage and safety.

How to take Dapoxetine tablets

Orthostatic hypotension An orthostatic test should be performed before initiating therapy.

6. Are there any side effects?

Patients with hepatic impairment No dose adjustment is required in patients with mild hepatic impairment. Dapoxetine is sildenafil dapoxetine tablets contraindicated in patients with moderate and severe hepatic impairment. Pregnancy Dapoxetine is pregnancy category C. Dapoxetine is not indicated for use by women. There are no adequate and well-controlled studies of Dapoxetine in pregnant women.

Priligy Dapoxetine 30 mg Tablets: Efficiency

Lactation Dapoxetine is not indicated for use by women. It is not known if either Dapoxetine or its metabolites are excreted in human breast milk. General Dapoxetine is only indicated in men with premature ejaculation. Safety has not been established and there are no data on the ejaculation-delaying effects in men without premature ejaculation. Use with recreational drugs Patients should be advised not to use Dapoxetine in combination with recreational drugs with serotonergic activity such as ketamine, methylenedioxymethamphetamine (MOMA) and lysergic acid diethylamide (LSD) because these may lead to potentially serious reactions if combined with Dapoxetine.

Cardiovascular safety

Syncope The occurrence of syncope and possibly prodromal symptoms appears dose dependent as demonstrated by higher incidence among patients treated with doses higher than 60 mg, dapoxetin sildenafil the recommended maximum daily dose. Orthostatic hypotension An orthostatic test should be performed before initiating therapy. In case of a history of documented or suspected orthostatic reaction, treatment with Dapoxetine should be avoided. Warning 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 Dapoxetine. The most common reported side effects are loss of consciousness, orthstatic hypotension, headache, dizziness, nausea, diarrhoea, insomnia and fatigue. In case of a history of documented or suspected orthostatic reaction, treatment with Dapoxetine should be avoided. Warning 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 Dapoxetine. The most common reported side effects are loss of consciousness, orthstatic hypotension, headache, dizziness, nausea, diarrhoea, insomnia and fatigue. Dapoxetine is contraindicated in patients with known hypersensitivity to Dapoxetine or to any of the excipients. It is also contraindicated in patients with heart failure, conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease or significant valvular disease. It may also interact with SSRls, MAO ls, thioridazine, serotonin-norepinephrine reuptake inhibitors (SNRls}, tricyclic antidepressants (TCAs} and other serotonergic medicinal/herbal products. There were no unexpected events of overdose is reported with daily doses up to 240 mg (two 120 mg doses given 3 hours apart). In general, symptoms of overdose with SSRls include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required. Due to high protein binding and large volume of distribution of Dapoxetine, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for Dapoxetine are known. Store in a cool & dry place protected from light.

Comparing Dapoxetine 30mg to Other PE Treatment Options