Priligy Patient Information Leaflet and Guide

Do not drink grapefruit juice within 24 hour prior to taking PRILIGY.

• 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.

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,

Renal Dose

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. 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.

If you forget to take PRILIGY

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. 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.

Who distributes PRILIGY

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, priligy 15 mg triptans, tramadol, linezolid, SSRIs, SNRIs, lithium & St. John's wort prep). Possible reduction of clearance w/ CYP2D6, CYP3A4 & flavin monooxygenase 1 inhibitors. abdominal pain, indigestion, intestinal gas, bloating ; excessive sweating; fatigue, sleepiness, yawning; difficulty paying attention, feeling irritable;

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erectile dysfunction (difficulty getting or keeping an erection); difficulty sleeping; anxiety, nervousness; decreased sexual desire; and abnormal dreams.

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

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. For more information, including what to do if you have any side effects, see Section This leaflet provides important information about using PRILIGY.

Human Sexual Inadequacy

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. 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.

Dapoxetine 30 mg: What are the common side effects?

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. 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.

What PRILIGY looks like

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. 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. 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.

Dapoxetine 30mg

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. Swallow the tablet whole with at least one full glass of water. PRILIGY can be taken with or without food. Where to find information in this leaflet: PRILIGY contains the active ingredient dapoxetine hydrochloride.

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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). 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.

Premature ejaculation

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. 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.

Sildenafil Combination Products

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. 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. PRILIGY is a type of drug called a selective serotonin reuptake inhibitor (SSRI) and it is also known as a urological medicine.

Dapoxetine (generic Priligy)

Specifically, rapid or premature ejaculation, delayed ejaculation, and arousal deficiency. One in three men experiences rapid ejaculation and an estimated 1-4% of men experience delayed ejaculation. [1][2] These conditions are underserved and undertreated but that can change. Many providers who are experts in male reproductive health specialize in combination therapies that are designed to take treatment beyond ED and address co-conditions like premature and delayed ejaculation. [1][2] Integrative solutions are key in helping men’s overall vitality.

Children and adolescents

PDE5, or phosphodiesterase type 5, is an enzyme in the body that affects smooth muscle contraction. So, when PDE5 is inhibited, muscles may remain contracted. Though FDA-approved treatments for erectile dysfunction exist, there are no commercially available options for rapid ejaculation or delayed ejaculation. For patient-specific options, providers may combine a unique variety of ingredients with some PDE5 inhibitors when they formulate treatments for conditions related to sexual health and overall quality of life. Urologists and men’s health practitioners have long used compounding pharmacies to source these options.

Check with your doctor if:

Prescribers using emerging therapies for male sexual health may often combine one or more of the following ingredients with PDE5 inhibitors: Prescribers may seek compounded PDE5 inhibitor medications because they are offered in a range of strengths, combinations and alternative dosage forms. Empower Pharmacy offers 22 different PDE5 inhibitor options ranging from capsules and oral disintegrating tablets (ODTs) to troches, many of which are listed below. Providers who already work with Empower may talk to their Clinic Liaison if they are interested in these or other options. 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 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

• Priligy helps improve control over ejaculation.
• It is generally well-tolerated with few side effects.
• Patients should avoid driving after use.
• Overdose can cause serious health issues.
• Use only as directed by your healthcare provider.
• Priligy is not recommended for women.
• It's effective for rapid ejaculation lasting less than 1 minute.
• The medication can be part of a broader treatment plan.
• Regular medical check-ups are advised during use.

marked personal distress and interpersonal difficulty as a result of premature ejaculation (premature ejaculation troubles the man and his partner); and

• Priligy is the brand name for dapoxetine.
• It is used to treat premature ejaculation.
• Dapoxetine is a selective serotonin reuptake inhibitor.
• The medication is taken 1 to 3 hours before sex.
• Common side effects include nausea and dizziness.
• Priligy is approved in many countries for PE.
• Do not take with alcohol or CYP inhibiting meds.
• Consult a doctor before starting Priligy.
• It is available in 30 mg and 60 mg doses.

PRILIGY increases your time to ejaculation and can improve your control over ejaculation and reduce your distress over how fast you ejaculate.

Interaction Partner	Effect on Priligy	Clinical Implication	Notes
CYP3A4 inhibitors	Increased levels	Higher risk of side effects	Dose adjustment needed
Other SSRIs	Serotonin syndrome	Severe, potentially life-threatening	Avoid concurrent use
Alcohol	Increased dizziness	Enhance side effects	Limit or avoid consumption
QT-prolonging drugs	Additive effect	Risk of arrhythmia	Monitor cardiac status