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Heat and dampness can destroy some medicines. Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines. If you no longer need to take this medicine or it is out of date, take it to any pharmacy for safe disposal. Do not use this medicine after the expiry date. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention. See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects. Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell. Other side effects not listed here may occur in some people. After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at By reporting side effects, you can help provide more information on the safety of this medicine. Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines. This medicine is only available with a doctor's prescription. This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes. 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. Dapoxetine, sold under the brand name Priligy among others, is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of premature ejaculation (PE) in men ages 18 to 64 years old.
The effects of alcohol, such as dizziness, drowsiness, slow reflexes or impaired judgement, may be increased if taken with PRILIGY. Follow the instructions on the carton on how to take care of your medicine properly. Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well. Store it in a cool dry place below 25°C and away from moisture, heat or sunlight; for example, do not store it: in the bathroom or near a sink, or in the car or on window sills. [3][4][5] Dapoxetine works by inhibiting the serotonin transporter, increasing serotonin's action at the postsynaptic cleft, and as a consequence promoting ejaculatory delay. [6] As a member of the SSRI family, dapoxetine was initially created as an antidepressant. However, unlike other SSRIs, dapoxetine is absorbed and eliminated rapidly in the body. Its fast-acting property makes it suitable for the treatment of PE, but not as an antidepressant. Originally created by Eli Lilly pharmaceutical company, dapoxetine was sold to Johnson & Johnson in 2003 and submitted as a New Drug Application to the US Food and Drug Administration (FDA) for the treatment of PE in 2004. [8] Dapoxetine is sold in several European and Asian countries, and in Mexico. In the US, dapoxetine has been in phase III development. In May 2012, US-based Furiex Pharmaceuticals reached an agreement with ALZA Corp and Janssen Pharmaceuticals to market dapoxetine in the United States, Japan, and Canada, while selling the rights to market the drug in Europe, most of Asia, Africa, Latin America, and the Middle East to Menarini. Randomized, double-blind, placebo-controlled trials have confirmed the efficacy of dapoxetine for the treatment of PE. [10] Different dosages have different impacts on different types of PE. Dapoxetine 60 mg significantly improves the mean intravaginal ejaculation latency time (IELT) compared to that of dapoxetine 30 mg in men with lifelong PE, but no difference is seen in men with acquired PE. [11] Dapoxetine, given 1–3 hours before sexual episode, prolongs IELT and increases the sense of control and sexual satisfaction in men of 18 to 64 years of age with PE. Since PE is associated with personal distress and interrelationship difficulty, dapoxetine provides help for men with PE to overcome this condition. With no drug approved specifically for treatment for PE in the US and some other countries, other SSRIs such as fluoxetine, paroxetine, sertraline, fluvoxamine, and citalopram have been used off-label to treat PE. Waldinger's meta-analysis shows that the use of these conventional antidepressants increases IELT two- to nine-fold above baseline, compared to three- to eight-fold when dapoxetine is used. [11] However, these SSRIs may need to be taken daily to achieve meaningful efficacy, and their comparatively longer half-lives increase the risk of drug accumulation and a corresponding increase of adverse effects such as reduced libido. [13] Dapoxetine, though, is generally categorized as a fast-acting SSRI. It is more rapidly absorbed and mostly eliminated from the body within a few hours.
Remind any doctor, dentist or pharmacist you visit that you are taking PRILIGY. Keep all of your doctor's appointments so that your progress can be checked. Talk to your doctor before you stop taking this medicine. You may have problems sleeping and feel dizzy after you stop taking it, even if you have not taken it every day. Do not take PRILIGY to treat any other complaints unless your doctor tells you to. These pharmacokinetics are more favorable in that they might minimize drug accumulation in the body, habituation, and side effects. Dapoxetine was initially considered unsuccessful in its intended use as an antidepressant; however, it has since been investigated as a possible aid to an approach to depression treatment focused on stress reduction, based on an animal model of depression. Dapoxetine should not be used in men with moderate to severe hepatic impairment and in those receiving CYP3A4 inhibitors such as ketoconazole, ritonavir, and telithromycin. Dapoxetine also cannot be used in patients with heart failure, permanent pacemaker, or other significant ischemic heart disease. Caution is advised in men receiving thioridazine, monoamine oxidase inhibitors, SSRIs, serotonin-norepinephrine reuptake inhibitors, or tricyclic antidepressants. If a patient stops taking one of these drugs, he should wait for 14 days before taking dapoxetine. If a patient stops taking dapoxetine, he should wait for 7 days before receiving these drugs. The most common effects when taking dapoxetine are nausea, dizziness, dry mouth, headache, diarrhea, and insomnia. [16][17] Discontinuation rates due to adverse effects and costs are very high, as demonstrated in a study in Asia which showed that cumulative discontinuation rates within one year are as high as 87%. [18] Unlike other SSRIs used to treat depression, which have been associated with high incidences of sexual dysfunction,[19] dapoxetine is associated with low rates of sexual dysfunction. Taken as needed, dapoxetine has very mild adverse effects of decreased libido (<1%) and erectile dysfunction (<4%). No case of drug overdose has been reported during clinical trials. Many men who have PE also suffer from erectile dysfunction (ED). Treatment for these patients should consider the drug–drug interaction between dapoxetine and PDE5 inhibitors such as tadalafil (Cialis) or sildenafil (Viagra). In Dresser study (2006), plasma concentration of 24 subjects was obtained. Half of the sample pool were treated with dapoxetine 60 mg plus tadalafil 20 mg; the other half were treated with dapoxetine 60 mg plus sildenafil 100 mg. These plasma samples were then analyzed using liquid chromatography-tandem mass spectrometry.
Do not give your medicine to anyone else, even if they have the same condition as you. Be careful before you drive or use any machines or tools until you know how PRILIGY affects you. This medicine may cause dizziness, light-headedness, tiredness, drowsiness, fainting, having difficulty concentrating and blurred vision in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous. Avoid alcohol while you are taking this medicine. The results showed that dapoxetine does not alter the pharmacokinetics of tadalafil or sildenafil. Alcohol does not affect the pharmacokinetics of dapoxetine when taking concurrently.
You have not had water to drink in the past 4 to 6 hours You have been sweating for a long time You have an illness where you have a high temperature, diarrhoea or being sick If you feel like you might faint (such as feeling sick, feeling dizzy, light-headed, feeling weak, confused, sweaty or an abnormal heart beat), or feel light-headed when you stand up, immediately lie down so your head is lower than the rest of your body or sit down with your head between your knees until you feel better. This will stop you from falling and hurting yourself if you do faint. Do not stand up quickly after you have been sitting or lying down for a long time. Do not drive or use any tools or machines if you feel faint when taking this medicine. Tell your doctor if you faint when taking this medicine. The mechanism through which dapoxetine affects premature ejaculation is still unclear, but dapoxetine is presumed to work by inhibiting serotonin transporter (SERT) and subsequently increasing serotonin's action at pre- and postsynaptic receptors. [22] Human ejaculation is regulated by various areas in the central nervous system (CNS). These signals are passed on to the brain stem, which then is influenced by a number of nuclei in the brain such as medial preoptic and paraventricular nuclei. [24] Clement's study performed on anaesthetized male rats showed that acute administration of dapoxetine inhibits ejaculatory expulsion reflex at supraspinal level by modulating activity of lateral paragigantocellular nucleus (LPGi) neurons. These effects cause an increase in pudendal motoneuron reflex discharge (PMRD) latency, though whether dapoxetine acts directly on LPGi or on the descending pathway in which LPGi located is unclear.