Dapoxetine for treatment of premature ejaculation – Authors' reply

To help lower the chance of this happening: Take PRILIGY with at least one full glass of water. Do not take PRILIGY if you are dehydrated (you do not have enough water in your body). 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. Remind any cheapest priligy 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. 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.

Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)

Taking PRILIGY together with these medications can increase the risk of bleeding abnormalities. you have a history of dizziness from low blood pressure you have or have had heart and blood vessel problems you have a history of bleeding or blood clotting problems you have or have had any thoughts of suicide or harming yourself. All thoughts of suicide must be taken seriously. Tell your doctor or a mental health professional immediately if you have any suicidal thoughts or other mental/mood changes. you have or have had psychiatric disorders, such as schizophrenia you have history of mania (great excitement, hallucinations, difficulty in concentrating or staying still) or bipolar disorder (extreme mood swings between mania and depression) or develop these disorders you have or have had seizures (fits) or have uncontrolled epilepsy you have moderate or severe liver problems you have or have had other forms of sexual problems such as erectile dysfunction.

How much to take

It is not known whether PRILIGY can worsen these conditions. you have eye problems such as glaucoma, (high pressure in the eye ) During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. PRILIGY has been studied for use by men with premature ejaculation. Its safety in women has not been established. 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 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.

Some other brands of Dapoxetine :

Do not drink grapefruit juice within 24 hours prior to taking PRILIGY. Grapefruit juice can increase the level of this medicine in your body. PRILIGY should be taken as needed, when sexual activity is anticipated. As PRILIGY is only taken when needed, it is not a problem if you forget to take it. Tell your doctor or pharmacist if you have taken more PRILIGY tablets than you should.

Getting rid of any unwanted medicine

Symptoms of overdose in PRILIGY are drowsiness, nausea, vomiting, rapid heartbeat, tremor, agitation and dizziness. If you think that you have taken too much PRILIGY, you may need urgent medical attention. phone the Poisons Information Centre (by calling 13 11 26), or go to the Emergency Department at your nearest hospital. You should do this even if there are no signs of discomfort or poisoning. WARNING: PRILIGY can make you faint or make you feel dizzy or light-headed. 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.

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.

Dapoxetine (generic Priligy)

medicines for mental health problems other than depression medicines to thin your blood, such as warfarin certain medicines for fungal infections, including ketoconazole, itraconazole and fluconazole certain medicines for HIV, including ritonavir, saquinavir and atazanavir certain medicines used to treat high blood pressure and chest pain (angina), enlarged prostate, or erectile dysfunction (impotence), as these medicines may lower your blood pressure, possibly upon standing anti-inflammatory medicines such as ibuprofen or aspirin certain antibiotics for treating infection, such as erythromycin, telithromycin and clarithromycin Do not drink grapefruit juice within 24 hours prior to taking PRILIGY narcotics (strong pain medicines) or benzodiazepines such as valium. Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PRILIGY. These medicines may be affected by PRILIGY or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Other medicines not listed here may be affected by PRILIGY or may affect how well it works.

Neurocognitive safety

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine. The recommended dose is one tablet (30mg), taken when you need it, about 1 to 3 hours before sexual activity. Do not take more than one tablet once every 24 hours due to increased risk of side effects and lack of additional benefit. Swallow the tablet whole to avoid a bitter taste, with at least one full glass of water. PRILIGY may be taken with or without food. 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.

6. Are there any side effects?

Do not take PRILIGY if you are under 18 years of age, or over 65 years of age. Safety and effectiveness in patients under 18 years or over 65 years have not been established. This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Who distributes PRILIGY

Some medicines and PRILIGY may interfere with each other. linezolid, an antibiotic used to treat infection tryptophan, used to help your mood and help you sleep St John's wort (Hypericum perforatum), a herbal preparation. PRILIGY should not be taken with the above listed medicines/ herbal preparations or within 14 days of stopping these medicines. Once you stop taking PRILIGY you will need to wait 7 days before taking these medicines/ herbal preparations. Other medicines or food and PRILIGY may interfere with each other. [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.

• Priligy is designed to delay ejaculation.
• The medication can improve confidence in sexual activity.
• Not all men respond equally to Priligy.
• A healthcare provider can assess if it’s suitable.
• It does not provide protection against STDs.
• Side effects are usually mild and temporary.
• Patients should report any unusual symptoms.
• It’s important to follow safe sex practices.
• Combining Priligy with other ED medications is not recommended.

[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.

• The safety of Priligy has been evaluated in multiple studies.
• It’s recommended to start at the lowest dose.
• Dose adjustments may be necessary based on response.
• Use is contraindicated in certain health conditions.
• It’s important to disclose all medical history.
• Patients should be aware of the potential for side effects.
• Priligy is part of a broader therapy approach.
• Use caution if combining with other serotonergic drugs.
• Always store medications out of children’s reach.

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.