Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets)

1. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) © Clearsky Pharmacy ( www.clearskypharmacy.biz )

2. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Everlast Tablets contains an active substance called ‘Dapoxetine Hydrochloride’. This belongs to a group of medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs). Everlast 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. Everlast is used to treat premature ejaculation in adult men aged 18 to 64 years. Premature ejaculation is when a man ejaculates with little sexual stimulation and before the man wants. This can cause problems for the man and may cause problems in sexual relationships. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

3. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Active Ingredient The active ingredient present in Everlast tablets is Dapoxetine Hydrochloride. Each film- coated tablet contains Dapoxetine Hydrochloride equivalent to 30 mg or 60 mg Dapoxetine. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

4. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Chemical Structure The structure of Dapoxetine Hydrochloride is given below: © Clearsky Pharmacy ( www.clearskypharmacy.biz )

5. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Everlast Tablets are manufactured by Alpha Pharma Healthcare Private limited, India in the strength of 60 mg. (Website: https://www.alpha-pharma.com/ ) URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

6. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Dapoxetine Hydrochloride Tablets – Brand Names Dapoxetine Hydrochloride tablets are available under various drug trade names that include Priligy, Everlast, Poxet, Dapotime, Dapox, Dasutra, Duralast, Ejalong, Kutub and Sustinex. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

7. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Uses of Everlast 60mg Tablets Everlast (Generic Dapoxetine Hydrochloride tablets) is a selective serotonin reuptake inhibitors (SSRIs) is used to treat premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following: 1)An intravaginal ejaculatory latency time (IELT) of less than two minutes; 2)Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes 3)Marked personal distress or interpersonal difficulty as a consequence of PE; 4)Poor control over ejaculation; 5)A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months. Dapoxetine Hydrochloride, a short-acting SSRI, is the first medicine to be marketed for premature ejaculation. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

8. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Everlast Tablets Dosage Everlast tablets (Generic Dapoxetine Hydrochloride tablets) should be swallowed whole. The recommended starting dose for all patients (men aged 18 to 64 years) is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the individual response to 30 mg is insufficient and the patient has not experienced moderate or severe adverse reactions or prodromal symptoms suggestive of syncope, the dose may be increased to a maximum recommended dose of 60 mg taken as required approximately 1 to 3 hours prior to sexual activity. The maximum recommended dose is one 60 mg tablets every 24 hours. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

9. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Everlast Tablets Dosage It is recommended that the tablet be taken with at least one full glass of water. Elderly (age 65 years and over): The efficacy and safety of Dapoxetine Hydrochloride Tablets have not been established in patients age 65 years and over. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

10. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Contraindications Everlast tablets are contraindicated in persons with a hypersensitivity (allergy) to Dapoxetine Hydrochloride or any of the other ingredients of this medicine. The other contraindications are: Significant pathological cardiac conditions such as: Heart failure (NYHA class II- IV), Conduction abnormalities such as AV block or sick sinus syndrome, Significant ischemic heart disease, Significant valvular disease and a history of syncope. A history of mania or severe depression. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI. Similarly, an MAOI should not be administered within 7 days after Everlast tablets have 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 Everlast has been discontinued. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

11. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Contraindications Concomitant treatment with thioridazine, or within 14 days of discontinuing treatment with thioridazine. Similarly, thioridazine should not be administered within 7 days after Everlast has been discontinued. Concomitant treatment with serotonin reuptake inhibitors [selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other medicinal/herbal products with serotonergic effects [e.g., L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)] 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 Everlast has been discontinued. Concomitant treatment of potent CYP3A4 inhibitors such as Ketoconazole, Itraconazole, Ritonavir, Saquinavir, Telithromycin, Nefazadone, Nelfinavir, Atazanavir, etc. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

12. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Storage Instructions Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

13. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Warnings Everlast tablets are only indicated in men with Premature Ejaculation (PE). Safety has not been established and there are no data on the ejaculation-delaying effects in men without PE. Patients with moderate and severe hepatic impairment must not take more than one tablet once every 24 hours due to increased risk of side effects and lack of additional benefit. Patients should be advised not to use Everlast tablets in combination with recreational drugs. Recreational drugs with serotonergic activity such as ketamine, methylenedioxy- methamphetamine (MDMA) and lysergic acid diethylamide (LSD) may lead to potentially serious reactions if combined with Everlast tablets. Combining alcohol with Everlast tablets 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 Everlast tablets. The number and percentage of subjects with syncope (characterized as loss of consciousness) was greater in Everlast-treated subjects than in those who were treated with placebo. A dose-response relationship for syncope is suggested based on subject incidence across all studies. Subjects with underlying cardiovascular disease were excluded from Phase 3 clinical trials. The risk of adverse cardiovascular outcomes from syncope is increased in patients with underlying structural cardiovascular disease. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

14. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Warnings Alteration in cardiac conduction was observed only in preclinical isolated in vitro/ ex vivo models, and not in whole-animal testing. In clinical studies, supraventricular beats and arrhythmias were slightly higher on Dapoxetine Hydrochloride tablets. An orthostatic test should be performed before initiating therapy. In case of a history of documented or suspected orthostatic reaction, treatment with Dapoxetine (Everlast tablets) should be avoided. Orthostatic hypotension has been reported in clinical trials. Caution is advised in all patients concomitantly treated with moderate CYP3A4 inhibitors. Unless the patient is known to be a CYP2D6 extensive metaboliser, caution is advised when used concomitantly with moderate CYP3A4 inhibitors. Caution is advised in patients taking potent CYP2D6 inhibitors or in patients known to be of CYP2D6 poor metaboliser genotype, as this may increase exposure levels, which may result in a higher incidence and severity of dose dependent adverse events. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

15. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Warnings SSRIs have been shown to increase the risk compared to placebo of suicidal thinking and suicidality in short-term studies in children and adolescents with Major Depressive Disorder and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24. Everlast tablets 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. Due to the potential of SSRIs to lower the seizure threshold, Everlast tablets should be discontinued in any patient who develops seizures and avoided in patients with unstable epilepsy. Patients with controlled epilepsy should be carefully monitored. Everlast tablets should not be used in individuals below 18 years of age. Men with underlying signs and symptoms of depression should be evaluated prior to treatment with Everlast to rule out undiagnosed depressive disorders. Concomitant treatment of Everlast with antidepressants, including SSRIs and SNRIs, is contraindicated. There have been reports of bleeding abnormalities with SSRIs. Caution is advised in patients taking Everlast, particularly in concomitant use with medicinal products known to affect platelet function. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

16. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Warnings Everlast is not recommended for use in patients with severe renal impairment and caution is advised in patients with mild or moderate renal impairment 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 (e.g., paraesthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. As with other SSRIs, the use of Everlast has been associated with ocular effects such as mydriasis and eye pain. Everlast should be used with caution in patients with raised intraocular pressure or those at risk of angle closure glaucoma. In Phase 3 studies, Dapoxetine 30 mg was associated with a higher incidence of mood related AEs, such as insomnia (2.2%), anxiety (1.1%) euphoric mood (0.2%), and depression (0.2%) compared to placebo (1.5%, 0.5%, 0%, 0.3%, respectively). In Phase 3 studies, Dapoxetine 30 mg was associated with a higher incidence of sexual AEs, such as erectile dysfunction (2.3%) and libido decreased (0.5%) compared to placebo (1.6% and 0.3%, respectively). © Clearsky Pharmacy ( www.clearskypharmacy.biz )

17. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Warnings In Phase 3 studies, Dapoxetine30 mg was associated with a higher incidence of accidental injuries (2.7%) compared to placebo (1.8%). While some accidents were reported to be related to syncope occurrence, there was no clear correlation between accidental injury adverse events and events of dizziness or changes in alertness associated with Dapoxetine (Everlast tablets) administration. Safety and efficacy of Dapoxetine have not been established in patients age 65 years and over as limited data are available in this population. You may feel sleepy, dizzy, faint, have difficulty concentrating and blurred vision while taking this medicine. If you experience any of these or similar effects, you should avoid driving or operating hazardous machinery. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

18. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Side Effects The Possible Side effects of Dapoxetine Hydrochloride tablets (Everlast tablets) are listed below. The very common side effects ( more than 10%) of Dapoxetine Hydrochloride (Everlast tablets) are Dizziness, Headache, Nausea. The common side effects (More than 1% to less than 10%) of Dapoxetine tablets are Anxiety, Agitation, Restlessness, Insomnia, Abnormal dreams, Libido decreased, Somnolence, Disturbance in attention, Tremor, Paraesthesia, Vision blurred, Tinnitus, Flushing, Sinus congestion, Yawning, Diarrhoea, Vomiting, Constipation, Abdominal pain, Abdominal pain upper, Dyspepsia, Flatulence, Stomach discomfort, Abdominal distension, Dry mouth, Hyperhidrosis, Erectile dysfunction, Fatigue, Irritability and Blood pressure increased. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

19. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Overdose There have been no reports of Dapoxetine overdose during clinical trials. There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine Hydrochloride with daily doses up to 240 mg (two 120 mg doses given 3 hours apart). In general, symptoms of overdose with SSRIs include serotonin- mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

20. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Overdose In cases of overdose, standard supportive measures should be adopted as required. Due to high protein binding and large volume of distribution of Dapoxetine Hydrochloride, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for Everlast Tablets(Generic Dapoxetine Hydrochloride) are known. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

21. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) Everlast Tablets During Pregnancy Dapoxetine Hydrochloride (Everlast Tablets) is classified by the US FDA as Pregnancy Category C. Everlast Tablets are not indicated for use by women. Neonates exposed to other SSRIs and SNRIs (serotonin and noradrenaline reuptake inhibitors) late in the third trimester have developed complications requiring prolonged hospitalisation, respiratory support and tube feeding. Such complications can arise immediately upon delivery. There is no evidence to suggest that Dapoxetine exposure has an effect on a partner's pregnancy based on limited observational data from the clinical trial database. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

22. Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) For more details on Everlast Tablets click here Everlast Tablets (Generic Dapoxetine Hydrochloride Tablets) by Alpha Pharma Healthcare Private limited, India. URL: https://www.clearskypharmacy.biz/generic-dapoxetine-hydrochloride.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )