Is Priligy Safe?

Sex is a healthy, natural activity and central to most loving relationships. It is important to both men and women, whatever their age, their race, creed, colour or their sexual orientation. Our cultural and religious background may affect the way we perceive sex, but it will always be an important part of the human experience. Sexual health is just as important as other aspects of health and if you have a problem, you should not be afraid or embarrassed about seeking professional help.

Priligy

5.00 out of 5
(3 product reviews)

£24.00£114.00

Priligy has been proven to reduce premature ejaculation in clinical trials. It can increase the time until ejaculation by between 200% and 300%.

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Description

What is premature ejaculation?

Premature ejaculation is when a man experiences ejaculation soon after sexual contact; typically within two minutes of the beginning of sexual intercourse.  Average male ejaculatory latency time is seven minutes.  Men with PE often report emotional and relationship distress and it can be a difficult issue to talk about.

How do I take Priligy?

One Priligy tablet is to be taken with water one to three hours before sex.  Priligy can be taken with or without food but is not to be taken more than once per day.

In addition, Priligy is not intended for use every day, only when sexual activity is anticipated.

The recommended starting dose of Priligy is 30mg but if your condition does not improve after taking this dosage, you can be prescribed the 60mg dose.

Patient information leaflet

Always read the patient information leaflet before commencing treatment. Patient information can be found here.

3 reviews for Priligy

  1. habibi

    60mg Is the dogs, product very good and service is very good

  2. Chris

    This really works. 30g dose gave me a greater sense of control, but I still climaxed quickly. At 60g, however, I really noticed a difference. I felt like reaching orgasm very quickly (as normal!) then…decided not to and the drive to orgasm went away. More than a few minutes later I *decided* to orgasm. The second time shortly afterwards, I felt like a rock-star, just kept going. It was pretty miraculous. Also, it’s probably important to note that I felt no adverse effects. Not great for spontaneous use, of course–you have to plan ahead–but still a real game-changer for me. Recommended.

  3. Jonjoe

    This product works!

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Defining premature ejaculation(PE)

Due to some common misconceptions and misunderstanding, actually, there are many aspects of premature ejaculation that remain unclear.  The same goes for the treatment. It isn’t just a problem of young, sexually inexperienced men, but can affect older men who have not previously been affected, particularly those with co-existing problems with erection. It is often the subject of humour and ridicule, making it even more difficult for those men affected to seek help. 1
Depressed young man sitting on bed and having problems with his girlfriendThe underlying pathophysiology of premature ejaculation is not completely understood, although both physiological and psychological components could contribute to the condition. Psychopharmacological studies suggest that premature ejaculation might be related to diminished serotonergic neurotransmission through pathways that control ejaculation.2
In 2016, the International Society for Sexual Medicine recently developed a unified definition for lifelong and acquired premature ejaculation: “Premature ejaculation is a male sexual dysfunction characterized by:

  • ejaculation that always or nearly always occurs prior to or within about 1 minute of vaginal penetration from the first sexual experience (lifelong premature ejaculation), OR a clinically significant reduction in latency time, often to about 3 minutes or less (acquired premature ejaculation);
  • the inability to delay ejaculation on all or nearly all vaginal penetrations; and
  • negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy.” 3

We often look in silent envy at movies in their portrayal of sex, with beautiful but exhausted couples pounding away for countless uninterrupted minutes, the man looking quietly confident and the woman in raptures with multiple orgasms.

Life isn’t usually like that. Most couples are quite surprised to know that the average duration of intercourse, from penetration to orgasm, is around five minutes. Indeed, it can vary very considerably over time in a single sexual relationship; sometimes orgasm may occur within seconds, sometimes after five or more minutes, or sometimes after a much longer period. Provided that this is satisfactory to both partners, and it often is, it should not be seen as a problem. Both thirty seconds and ten minutes can be “great sex”.

Even if partners are longing for more, longer is not always better. Experts recommend that thirty seconds of intense excitement and intimacy is always better than ten minutes of routine and boredom.1

Patients with PE are advised to seek professional help because the results of treatment are often very good.

 

Management of patients with PE

PE requires a polyvalent approach. Biological, psychological and social aspects need to be addressed.

Enquiry about a partner, relationship, social, cultural and contextual issues related to PE is mandatory during clinical assessment for PE.

A physical examination is highly advisable.

Pharmacological, psychological/ behavioural, educational and combination treatment interventions may be appropriate, and choice should be guided by patient preference and the bio-psycho-social assessment.

The inclusion of the partner in the treatment process is an important but not a mandatory ingredient for treatment success. Where erectile dysfunction (ED) and PE co-exist, the ED should be treated and erections optimized first.

The sexologist must collect information related to intravaginal ejaculatory latency time, perceived degree of ejaculatory control, the degree of patient and partner distress, onset and duration of PE, medical history. Then, the treatment should be established in accordance with contemporary clinical guidance.

 

The recommended pharmacological treatments for premature ejaculation

In April 2013, the International Society for Sexual Medicine (ISSM) convened a two-day meeting to develop evidence-based clinical practice guidelines on the management of PE for physicians. The 20 participants, who included most of the world’s recognized experts on PE, were selected to provide a diversity of discipline, balance of opinion, knowledge, gender and cultural group. A comprehensive review of scientific literature on PE was conducted and the quality of evidence and the strength of any recommendations were graded using the Oxford Centre of Evidence-Based Medicine system.

Oral therapies recommended for the treatment of PE include dapoxetine, paroxetine, clomipramine, sertraline, fluoxetine, citalopram.

 

Short facts about Priligy

Priligy is a drug used with success in treating Premature Ejaculation and containing dapoxetine, a drug belonging to the selective serotonin reuptake inhibitors (SSRIs), which were developed to treat depression and other psychiatric disorders.

It has been granted marketing authorization in 33 countries worldwide, including 7 countries in the European Union (EU).

The approved indication in the EU is for the treatment of premature ejaculation in men 18 to 64 years of age.

Priligy is approved in doses of 30 mg and 60 mg in packages containing 1, 2, 3 or 4 film-coated tablets containing dapoxetine hydrochloride.

Dapoxetine has a unique pharmacokinetic profile, with a short time to maximum serum concentration (about 1 h) and rapid elimination (initial half-life of 1,2 h).         

Priligy’s efficacy and tolerability were tested in several clinical trials and the results confirmed that Priligy (dapoxetine) is effective, generating satisfaction in patients reported outcomes and improvement of intravaginal ejaculatory latency times (IELT).

We wrote an article on how Priligy works here.

 

What are the advantages of choosing Priligy?

Priligy increases the time it takes to ejaculate and can improve the control over the ejaculation. This may reduce the frustration or worry about fast ejaculation.Excited man in green shirt giving two thumbs up

Priligy is used to treat premature ejaculation, in men between 18 and 64 years old.

Priligy can be taken with or without food but you should take Priligy with at least one full glass of water.

 

Common adverse effects of Priligy from clinical studies

Is Priligy Safe?

The following side effects were associated with the administration of Priligy and are listed in the summary of product characteristics, labelling and package leaflet.

Very common side effects (affects more than 1 user in 10):

  • Feeling dizzy
  • A headache
  • Feeling sick.

Common side effects (affects 1 to 10 users in 100):

  • Feeling irritable, anxious, agitated or restless
  • Feeling numb or having ‘pins and needles’
  • Difficulty getting or keeping an erection
  • Sweating more than normal or flushing
  • Diarrhoea, constipation or having wind
  • Stomach pain, bloating or being sick
  • Problems sleeping or strange dreams
  • Feeling tired or sleepy, yawning
  • Blocked nose (nasal congestion)
  • A rise in blood pressure
  • Difficulty concentrating
  • Shaking or trembling
  • Lower interest in sex
  • Ringing in the ears
  • Blurred vision
  • Indigestion
  • Dry mouth.

Uncommon side effects (affects 1 to 10 users in 1,000) 6:

  • Fainting or feeling dizzy upon standing
  • Change in mood, feeling overly excited or feelings of paranoia
  • Feeling confused, disoriented or unable to think clearly
  • Slow or irregular heartbeat or increase in heart rate
  • Loss of sex drive, problems reaching orgasm
  • Feeling weak, sedated, lethargic or fatigued
  • Feeling depressed, nervous or indifferent
  • Feeling hot, jittery, abnormal or drunk
  • Vision problems or dilated pupils
  • Low or high blood pressure
  • Feeling itchy or cold sweat
  • Spinning sensation
  • Abnormal taste
  • Teeth grinding.

Rare side effects (affects 1 to 10 users in 10,000) 6:

  • Feeling dizzy following exertion
  • Sudden onset of sleep
  • Urgency of bowel action.

If any of the side effects gets serious, or if you notice any side effects not listed in the patient leaflet, please tell your doctor or pharmacist.

 

The Dapoxetine Study Group

As part of a development program, the Dapoxetine Study Group was involved in the design and performance of two large multicenter, randomized, double-blind, placebo-controlled, 12-week clinical trials of identical design, from June 2003 to June 2004.

The studies comprised 2614 males with premature ejaculation that consented to their participation in 121 clinical facilities in the United States of America.

The objectives of the study group were to analyze the effectiveness of Priligy and the safety profile of priligy/dapoxetine.

The Dapoxetine Study Group concluded that dapoxetine, given 1–3 h before intercourse, increased intravaginal ejaculatory latency times (IELT) significantly, even after administration of the first dose. Dapoxetine also improved patients’ perception of control over ejaculation, satisfaction with sexual intercourse, and overall impression of change in condition. Partners benefited through improved satisfaction with sexual intercourse. Thus, dapoxetine seemed to lead to improvements in ejaculatory function that have meaning for men with premature ejaculation and their partners.7

Thus, a blockbuster clinical trial with the objective to evaluate the long-term (6-month) efficacy and safety of dapoxetine in men with PE was conceived taking into study population from 22 countries affected by premature ejaculation. The selected countries were Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, the Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Mexico, the Netherlands, Norway, Poland, Portugal, South Africa, Spain, Sweden, and the United Kingdom.

More safety assessments were performed, including Holter monitoring (first dose; 10 min before to 3 h after), changes in clinical laboratory results (each 4-wk visit), and vital signs (from baseline to study endpoint). Known drug class effects were monitored at baseline and at week 4, week 12, and week 24 using clinical and study-specific scales.

Adverse events were reported by 38.4%, 56.2%, and 68.1% of men receiving placebo, dapoxetine 30 mg, and dapoxetine 60 mg, respectively.

Similar to previous studies, the most common treatment-emergent adverse events were nausea, dizziness, diarrhoea, and headache. Nausea with dapoxetine 30 mg and dapoxetine 60 mg was usually mild and intermittent. The most common adverse event leading to discontinuation was nausea. With dapoxetine 30 mg, ventricular tachycardia and transient ischemic attack were considered possibly related to treatment.

With dapoxetine 60 mg, one subject experienced sinus bradycardia and sinus arrest (both severe; very likely related to treatment) associated with syncope accompanied by loss of consciousness approximately 1 h after dosing on day 1 (prodromal symptom: nausea). Following this event, a protocol amendment required a modified consent form and new patient instructions for minimizing the risk of syncope.

Another subject receiving dapoxetine 60 mg experienced syncope accompanied by a loss of consciousness on day 63.

No reports of syncope with loss of consciousness occurred with dapoxetine 30 mg.

No clinically relevant effects on clinical laboratory tests were noted, nor was there any clear effect of dapoxetine on mean supine and standing blood pressure.

Dr Emmanuelle A. Jannini8, in an editorial comment after the publication of the study results, expressed her opinion about the safety profile of dapoxetine.

“Due to its particularly short half-life, dapoxetine should have a better safety profile, leading to a
risk-benefit ratio definitively in favour of the benefits. In fact, dapoxetine was well tolerated in this study: adverse events appeared early in treatment, were usually dose dependent, and generally did not lead to discontinuation. This is very important information for the clinician treating premature ejaculation.”

 

Safety issues reported from European Medicines Agency

Against a background of a post-marketing exposure estimated to 850,000 patients only 9 events of syncope have been spontaneously reported, 5 of which are medically confirmed and 4 of which are unconfirmed. These events were of short duration and spontaneously resolved.

Interim data (4,002 patients treated with Priligy) from the observational post-marketing safety study (R096769-PRE-4001) show:

  • No events of syncope have been reported;
  • 92% of patients were prescribed treatment according to the summary of product characteristics, i.e. initiation of treatment with 30 mg;
  • More than 98% of the patients prescribed Priligy found that the Patient Brochure was understandable and felt that the information regarding Priligy dosing and Priligy safety was helpful.

 

Contraindications

Do not take Priligy if:

  • You are allergic (hypersensitive) to dapoxetine or any of the other ingredients of Priligy
  • You have heart problems, such as heart failure or problems with the heart rhythm
  • You have a history of fainting
  • You have ever had mania (symptoms include feeling over-excited, irritable or not being able to think clearly) or severe depression
  • You are taking:
  • Medicines for depression called ‘monoamine oxidase inhibitors’ (MAOIs)
  • Thioridazine used for schizophrenia
  • Other medicines for depression
  • Lithium – a medicine for bipolar disorder
  • Linezolid – an antibiotic used to treat infections
  • Tryptophan – a medicine to help you sleep
  • St John’s wort – a herbal medicine
  • Tramadol – used to treat serious pain
  • Medicines used to treat migraines.

 

Are there any other methods to treat PE?

Yes. There are a number of strategies men use to handle PE. They include:

Masturbating before intercourse. Many men find they have better control if they ejaculate shortly before starting sexual activity.

Using condoms. For some men, a condom makes the penis less sensitive.

Local anaesthetics. Creams can be applied to the head of the penis before sex to reduce sensitivity.

Distraction. Some men think about non-sexual topics during sex.

Stop-start method. When a man thinks he is about to ejaculate, stimulation stops for thirty seconds. Then, stimulation continues.

Squeeze method. The penis tip is gently squeezed by a partner when a man is about to ejaculate and stimulation stops for 30 seconds.

Counselling. Sex therapy may help with the anxiety and frustration associated with PE.

Antidepressants. Some medications have sexual side effects which might alleviate PE.9

Before trying any treatment strategy, men should consult their physician.

 

In summary…

  • PE is a couple’s problem
  • PE can be lifelong or acquired
  • Despite much speculation, the causes of premature ejaculation are not known. There is evidence that genetic factors are relevant in some men but, to date, no biological factor has been shown to be causative in the majority of men.
  • PE is often described as the most common male sexual problem, affecting between 3% and 30% of men.
  • The results of oral medication are often very good
  • Priligy increases the time it takes to ejaculate and can improve the control over the ejaculation
  • Take Priligy 1 to 3 hours before sexual activity.
  • Take with at least 1 full glass of water.
  • Do not take Priligy more than once every 24 hours

 

What Priligy looks like and contents of the pack

  • Priligy 30 mg film-coated tablets are light grey, round, convex and marked “30” inside a triangle on one side.priligy-60mg-6-tablets_1
  • Priligy 60 mg film-coated tablets are grey, round, convex and marked “60” inside a triangle on one side.
  • The tablets are provided in compliance multi-fold blister packs containing 1, 2, 3 and 6 film-coated tablets

If you are intending to use Priligy, or if you have questions related to side-effects, please address directly to our pharmacy and to our doctor at phone number 01625 460 621, or consult our site https://www.assuredpharmacy.co.uk.

 

 

 

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References:

  1. http://www.issm.info/images/uploads/ISSM_Patient_Information_Sheet_on_PE_-_website_JAN_2015.pdf
  2. Waldinger MD, Berendsen HH, Blok BF, Olivier B, Holstege G. Premature ejaculation and serotonergic antidepressants-induced delayed ejaculation: the involvement of the serotonergic system. Behav Brain Res. 1998; 92: 111–18.
  3. Shechter A, Lowenstein L, Serefoglu EC, Reisman Y. Attitudes of Sexual Medicine Specialists Toward Premature Ejaculation Diagnosis and Therapy. Sex Med. 2016 Sep;4(3):e209-16. doi: 10.1016/j.esxm.2016.05.001. Epub 2016 Jun 23. PubMed PMID: 27346231; PubMed Central PMCID: PMC5005309.
  4. http://www.issm.info/images/uploads/ISSM_Quick_Reference_Guide_to_PE_-_website_JAN_2015.pdf
  5. Pryor JL, Althof SE, Steidle C, Rosen RC, Hellstrom WJ, Shabsigh R, Miloslavsky M, Kell S; Dapoxetine Study Group. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Lancet. 2006 Sep 9;368(9539):929-37. PubMed PMID: 16962882.
  6. http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Priligy_29/WC500124577.pdf
  7. Pryor JL, Althof SE, Steidle C, Rosen RC, Hellstrom WJ, Shabsigh R, Miloslavsky M, Kell S; Dapoxetine Study Group. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Lancet. 2006 Sep 9;368(9539):929-37. PubMed PMID: 16962882.
  8. Jannini EA, Lenzi A. Ejaculatory disorders: epidemiology and current approaches to definition, classification and subtyping. World J Urol 2005;23:68–75.
  9. http://www.issm.info//sexual-health-qa/#premature-ejaculation/

 

Assured Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected]