Comparing Priligy to Other PE Treatment Options

For more information, including what to do if you have any side effects, see Section This leaflet provides important information about using PRILIGY. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using PRILIGY. Where to find information in this leaflet: PRILIGY contains the active ingredient dapoxetine hydrochloride.

Regulatory history

Concomitant treatment with serotonin re-uptake inhibitors [selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other medicinal/herbal products with serotonergic effects 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 Dapoxetine has been discontinued. General: Dapoxetine is only indicated in men with PE. 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 Dapoxetine in combination with recreational drugs.

If you take too much PRILIGY

Recreational drugs with serotonergic activity eg, ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) may lead to potentially serious reactions if combined with Dapoxetine. These reactions include, but are not limited to, arrhythmia, hyperthermia and serotonin syndrome. Use of Dapoxetine with recreational drugs with sedative properties eg, narcotics and benzodiazepines may further increase somnolence and dizziness. Ethanol: Combining alcohol with Dapoxetine may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events eg, syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine. Possibly prodromal symptoms eg, nausea, dizziness/lightheadedness and diaphoresis were reported more frequently among patients treated with Dapoxetine compared to placebo.

Things you should not do

Orthostatic Hypotension: An orthostatic test should be priligy ireland performed before initiating therapy. In case of a history of documented or suspected orthostatic reaction, treatment with Dapoxetine should be avoided. Dapoxetine is not indicated for psychiatric disorders and should not be used in men with these disorders eg, schizophrenia, or in those suffering with co-morbid depression, as worsening of symptoms associated with depression cannot be excluded. 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 (eg, paresthesias, electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania. Risk of serotonergic-associated effects w/ serotonergic medicinal/herbal products (including L-tryptophan, triptans, tramadol, linezolid, SSRIs, SNRIs, lithium & St. PRILIGY is a type of drug called a selective serotonin reuptake inhibitor (SSRI) and it is also known as a urological medicine.

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PRILIGY is a treatment for premature ejaculation (PE) in men 18 to 64 years old who have all of the following: ejaculation in less than 2 minutes following vaginal penetration, on most occasions, with little stimulation and before the man wishes to; and marked personal distress and interpersonal difficulty as a result of premature ejaculation (premature ejaculation troubles the man and his partner); and PRILIGY increases your time to ejaculation and can improve your control over ejaculation and reduce your distress over how fast you ejaculate. This may improve your satisfaction with sexual intercourse.

Frequently Questions & Answers

John's wort prep). Possible reduction of clearance w/ CYP2D6, CYP3A4 & flavin monooxygenase 1 inhibitors. Possible reduced orthostatic tolerance w/ PDE-5 inhibitors & ?-adrenergic receptor antagonists. Increases plasma conc of desipramine & other drugs metabolized by CYP2D6. Side effects of Dapoxetine : Syncope characterized as loss of consciousness has been reported.The majority of cases occurred during the first 3 hrs after dosing, after the 1st dose or associated with study-related procedures in the clinic setting (eg, blood draw and orthostatic maneuvers and blood pressure measurements).

Reporting side effects

Orthostatic hypotension has been reported in clinical trials. The most common adverse drug reactions (5%) reported during clinical trials were headache, dizziness, nausea, diarrhea, insomnia and fatigue. The most common events leading to discontinuation were nausea and dizziness. Dapoxetine selectively inhibits the reuptake of serotonin. It has limited direct action at other neurotransmitter sites including muscarinic receptors.

Cardiovascular safety

PRILIGY 60 mg Film-coated Tablet manufactured by MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA. Farmaco SA drug index information on PRILIGY Film-coated Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment. Saudi Arabian Japanese Pharmaceutical Co. Ltd (SAJA) Riyadh Pharma (Medical and Cosmetic Products Company Ltd.) Do not use if you have ever had an allergic reaction to dapoxetine hydrochloride or any of the ingredients listed at the end of the CMI. There are a number of circumstances in which a person should not take this medicine or may need to use caution. you are allergic to dapoxetine hydrochloride, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can take this medicine.

Medicine Overview of Dapoxen 30mg Tablet

It is important to understand if these apply to you before taking PRILIGY. Talk to your doctor or pharmacist if you have any concerns about taking this medicine. The recommended dose is one tablet (30 mg) taken when you need it, about 1 to 3 hours before sexual activity. Do not take more than one tablet in a 24 hour period. It is not intended for continuous daily use. you are taking a monoamine oxidase inhibitor (MAOI ) medicine used to treat depression, or have taken a MAOI within the last 14 days (see Section Once you stop taking PRILIGY you will need to wait 7 days before taking a MAOI.

• Clinical trials have shown Priligy effective for PE.
• It’s designed specifically for men experiencing early ejaculation.
• The onset of action is typically within an hour.
• There are generic versions of dapoxetine available.
• The cost of Priligy varies by country and pharmacy.
• It does not affect sexual desire or performance directly.
• Use caution with grapefruit juice, which may interfere.
• Pre-existing health issues should be reviewed before use.
• Ongoing research continues into PE treatments like Priligy.

you are taking thioridazine used to treat schizophrenia, or have taken thioridazine within the last 14 days. Once you stop taking PRILIGY you will need to wait 7 days before taking thioridazine. you are taking a serotonin reuptake inhibitor (such as a selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant (TCA)), and certain other medicines and herbal products to treat depression or have taken these medicines within the last 14 days (see Section for examples of serotonin reuptake inhibitors and other medicines used to treat depression). Once you stop taking PRILIGY you will need to wait 7 days before taking these medications/herbal products.

Currency	Average Price (per 30 tablets)	Factors Affecting Cost	Insurance Coverage
USD	$50 - $100	Brand vs. generic, pharmacy	Often covered partially
EUR	€45 - €90	Regional pricing	Varies across countries
RUB	3000 - 6000 RUB	Local availability	Limited coverage
GBP	£40 - £80	Prescription requirements	May be covered in some health plans

you have a history of mania or severe depression.

Quick Tips

Providers who are interested in partnering with Empower may contact us about these products and anything else we can offer their practices and patients. Expert providers may turn to custom combination therapies to potentially address patients’ multiple issues, including ED. PRILIGY Film-coated Tablet is used for: Premature ejaculation Oral Premature Ejaculation Adult: 18-64 yr Initially, 30 mg approx 1-3 hr before sexual activity, subsequent doses adjusted according to response. Dose should not be taken more than once in 24 hr. Review treatment after 4 wk (6 doses) and at least 6 mthly thereafter.

Depression and anxiety

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 the patients with severe renal impairment. May be taken with or without food. Swallow tab whole & take w/ a full glass of water. Known hypersensitivity to dapoxetine HCl or to any of the excipients.

Priligy Dapoxetine 30 mg: Mechanism of Action or How does it work against premature ejaculation (PE)?

Patients with significant pathological cardiac conditions [eg, heart failure (NYHA class II-IV), conduction abnormalities (2nd- or 3rd-degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease or significant valvular disease]. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with a MAOI. Similarly, a MAOI should not be administered within 7 days after Dapoxetine has been discontinued. Concomitant treatment with thioridazine, or within 14 days of discontinuing treatment with thioridazine. Similarly, thioridazine should not be administered within 7 days after Dapoxetine has been discontinued. you have heart problems, such as heart failure or problems with the heart rhythm.

Contraindication	Explanation	Alternative Treatments
Use with Monoamine Oxidase Inhibitors	Risk of hypertensive crisis	Other PPED medications
Cardiac conditions	Risk of arrhythmias	Consultation with cardiologist
Liver impairment	Altered drug metabolism	Dose adjustment or avoid
Allergies to Dapoxetine	Hypersensitivity reactions	Avoid use

you have moderate to severe liver problems.

• Prescriptions are required for Priligy in many regions.
• The medication is usually taken on an as-needed basis.
• It can be used on a short-term or long-term basis.
• Priligy may increase the risk of suicidal thoughts.
• Discuss any ongoing medications with your doctor.
• It’s important to follow prescribed dosage instructions.
• Avoid taking Priligy with other antidepressants.
• People with certain health conditions should avoid it.
• Combining Priligy with other drugs may increase side effects.

you are prone to fainting or passing out caused by a temporary drop in blood pressure (Syncope).

Some other brands of Dapoxetine :

Swallow the tablet whole with at least one full glass of water. PRILIGY order priligy 60mg can be taken with or without food. Do not drink grapefruit juice within 24 hour prior to taking PRILIGY. Common side effects include nausea; headache; dizziness; fainting or feeling dizzy upon standing; increased blood pressure; flushing; trembling; tingling or numbness; blurred vision, eye pain; ringing in ears; nasal congestion; dry mouth, vomiting, diarrhoea, constipation, abdominal pain, indigestion, intestinal gas, bloating ; excessive sweating; fatigue, sleepiness, yawning; difficulty paying attention, feeling irritable; erectile dysfunction (difficulty getting or keeping an erection); difficulty sleeping; anxiety, nervousness; decreased sexual desire; and abnormal dreams. Serious side effects requiring medical attention include fits (seizures); changes in your mood, thoughts of suicide or harming yourself; an allergic reaction; unusual bruising and bleeding. Before you start taking this medicine, your doctor should perform a test to make sure that your blood pressure doesn’t drop too much when you stand up from sitting or lying down.

Advice	Rationale	Additional Notes
Avoid alcohol	Enhances side effects, impairs judgment	For optimal safety
Report adverse effects	Ensures proper management	Contact healthcare provider swiftly
Do not double dose	Risk of overdose and side effects	Follow prescribed instructions
Use only as directed	Prevent misuse or dependence	Not for daily use or recreational use