PRILIGY is a treatment for premature ejaculation (PE) in men aged 18 to 64 years who experience ejaculation in less than 2 minutes following penetration and poor control over ejaculation.
Priligy (dapoxetine) is the first oral medication approved for "on-demand" treatment of Premature Ejaculation (PE). The reported proportion of men affected by PE at some point in their lives has ranged from 4 to 30 percent compared to 10 to 20 percent for erectile dysfunction (ED).
Men with PE appear to go through the same process of ejaculation as other men, but it happens more quickly and with a reduced feeling of control. A combination of physiological and psychological factors are believed to impact on ejaculation time, and research suggests that serotonin plays a central role.
Sexual arousal and/or stimulation of the penis leads to messages being sent along the nerves to the brain. This results in various neurotransmitters being produced in the brain, including serotonin. Serotonin has an influence on ejaculation time; higher levels make it longer, low levels quicker.
Priligy is a unique, short-acting, selective serotonin reuptake inhibitor (SSRI) designed to be taken only when needed - one to three hours before sexual intercourse is anticipated - rather than every day.
Priligy contains the active ingredient dapoxetine and will increase the time to ejaculation as well as improving the control over ejaculation. Because of its SSRI activity Priligy also reduces the distress caused over the speed of ejaculation and thus improves the satisfaction of sexual intercourse for both partners.
The recommended starting dose of Priligy is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity.
Priligy is not intended for continuous daily use and should be taken only when sexual activity is anticipated.
Priligy must not be taken more frequently than once every 24 hours.
Treatment with Priligy should not be started with the 60 mg dose.
If the individual response to 30 mg is insufficient and there has been no moderate or severe adverse reactions, light-headedness or fainting, the dose may be increased to a maximum of 60 mg.
Note that the incidence and severity of adverse events is higher with the 60 mg dose.
Swallow the tablets whole with at least one full glass of water.
PRILIGY may be taken with or without food.
Avoid alcohol when taking PRILIGY.
Medicines and their possible side effects can affect individual people in different ways. Just because a side effect is stated here it does not mean that all people using Priligy will experience that or any side effect. The following are some of the side effects that are known to be associated with Priligy:
Very common (affect more than 1 in 10 people)
- Feeling sick.
Common (affect between 1 in 10 and 1 in 100 people)
- Anxiety, irritability, restlessness or agitation.
- Difficulty concentrating.
- Difficulty sleeping (insomnia).
- Abnormal dreams.
- Reduced sex drive.
- Erectile dysfunction (impotence).
- Feeling tired or sleepy.
- Sensation of pins and needles.
- Ringing or other noise in the ears (tinnitus).
- Blurred vision.
- Sinus congestion.
- Disturbances for the gut such as diarrhoea, vomiting, constipation, abdominal pain and discomfort, indigestion, flatulence and dry mouth.
- Excessive sweating.
- Increased blood pressure.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Dizziness and fainting.
- Mood changes, including depression and nervousness.
- Feeling confused or disorientated.
- Feeling weak, jittery or abnormal.
- Slower or faster heartbeat.
- Dilated pupils.
- Teeth grinding.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
Priligy should not be used in men with moderate to severe hepatic impairment and in those receiving CYP3A4 inhibitors such as ketoconazole, ritonavir, and telithromycine.
Priligy can also not 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 Priligy. If a patient stops taking Priligy, he should wait for 7 days before receiving these drugs.
Do not take PRILIGY:
- If you are taking a MAOI (monoamine oxidase inhibitor) used to treat depression, or have taken a MAOI within the last 14 days.
- If you are taking thioridazine (Aldazine®) used to treat schizophrenia, or have taken thioridazine within the last 14 days.
- If you are taking a selective serotonin reuptake inhibitor (SSRI), other medicines used to treat depression or other medicinal/ herbal products with serotonergic effects (St. John’s Wort), or have taken these medicines within the last 14 days.
- If you are taking certain medicines to treat fungal infections or medicines to treat HIV.
- If you have heart problems, such as heart failure or problems with the heart rhythm.
- If you have moderate to severe liver problems.
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.
Do not take PRILIGY if you are a woman. Safety and effectiveness in women have not been established.
Data regarding the efficacy and safety of Priligy beyond 24 weeks are limited. The clinical need of continuing and the benefit risk balance of treatment with Priligy should be re-evaluated at least every six months.
The patient information leaflet (PIL) is a leaflet containing specific information about medical conditions, doses and side effects. You can download a copy of the PIL here:
Patient Info Leaflet