Managing Side Effects and Maximizing Treatment Tolerability

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.

Storage and disposal

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. you have a history of mania or severe depression. you have heart problems, such as heart failure or problems with the heart rhythm.

Pregnancy and breastfeeding

you have moderate to severe liver problems. you are prone to fainting or passing out caused by a temporary drop in blood pressure (Syncope). 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. you have not been diagnosed with premature ejaculation you use recreational drugs such as ecstasy or LSD (lysergic acid diethylamide). Taking PRILIGY with these drugs can cause serious reactions. Other medicines not listed here may be affected by PRILIGY or may affect how well it works.

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.

• Dapoxetine is designed for on-demand use, not daily administration.
• The medication can improve control over ejaculation and increase sexual satisfaction.
• It is available by prescription only and should be used under medical supervision.
• Pregnancy or breastfeeding women should avoid using dapoxetine without doctor consultation.

PRILIGY may be taken with or without food.

How to Order

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

Less serious side effects

This may improve your satisfaction with sexual intercourse. 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. 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. you are taking thioridazine used to treat schizophrenia, or have taken thioridazine within the last 14 days. Do not drink grapefruit juice within 24 hours prior to taking PRILIGY.

See also

you take narcotics (strong pain medicines) or benzodiazepines such as Valium. These medicines can increase the drowsiness and dizziness of PRILIGY. Alcohol can increase the risk of fainting and should be avoided while taking PRILIGY. you are currently using medications to treat fungal infections you are currently taking medicine that thins your blood such as aspirin, anticoagulants such as warfarin, non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, or medicine used to treat psychiatric conditions such as depression. Taking PRILIGY together with these medications can increase the risk of bleeding abnormalities.

Do not take PRILIGY if:

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. It is not known whether PRILIGY can worsen these conditions. 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. 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. 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 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.

Before taking dapoxetine

linezolid, an sildenafil and dapoxetine 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. 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. 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.

• Dapoxetine 30 mg is often used as part of a broader treatment plan for PE.
• Combining therapy with behavioral techniques may enhance treatment outcomes.
• Immediate effects may vary, but consistent use can improve control over ejaculation.
• Avoid combining with other SSRIs without medical advice to prevent interactions.

Do not take PRILIGY to treat any other complaints unless your doctor tells you to.

Regulatory history

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. Do not take PRILIGY if you are under 18 years of age, or over 65 years of age.

Driving or using machines

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. Some medicines and PRILIGY may interfere with each other. 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.