Priligy

• Effective in preventing premature ejaculation
• Only for men aged 18 to 64 years
• Take one to three hours before sexual activity
• May affect your reaction time
• Avoid alcohol

Priligy contains an active substance called dapoxetine. This substance belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).

Priligy may also be used as a urological medicine 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 feelings of shame and frustration for the man as well as problems in sexual relationships.

Priligy 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.

Always use Priligy exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose is 30 mg. Your doctor may increase the dose to 60 mg.

• Only take the medicine one to three hours before sexual activity is anticipated.
• Do not take this medicine more than once every 24 hours or every day.
• Swallow the tablets whole, with at least one full glass of water. This may help lower your chance of fainting (see section ‘Side effects’).
• Priligy can be taken with or without food.

Priligy should not be used by men under 18 or over 65 years of age.

Discuss your Priligy treatment with your doctor after the first four weeks or after six doses to see

whether you should continue treatment. If treatment is continued, you should see your doctor again to discuss this at least every six months.

Alcohol/driving

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.

Alcohol is likely to intensify these side effects. Avoid alcohol while taking this medicine.

Taken too much/stop taking Priligy

Tell your doctor or pharmacist if you have taken more tablets than you should. You may feel sick or be sick.

Talk to your doctor before you stop taking this medicine. You may have problems sleeping and feel dizzy after you stop taking this medicine, even if you have not taken it every day.

Priligy is not suitable for everyone. Do not take this medicine if:

• You are allergic to dapoxetine or any of the other ingredients in this medicine (see section ‘What Priligy contains').
• You have heart problems, such as heart failure or problems with the heart rhythm.
• You have a history of fainting.
• You have ever had mania (symptoms include feeling overexcited, irritable or not being able to think clearly) or severe depression.
• You are taking certain medicines (see section ‘Other medicines and Priligy’).
• You have moderate or severe liver problems.

When should Priligy be used with caution?

Talk to your doctor or pharmacist before taking Priligy if:

• You drink alcohol.
• You have not been diagnosed with premature ejaculation.
• You use recreational drugs such as ecstasy, LSD, narcotics or benzodiazepines.
• You have ever had a mental health problem such as depression, mania, bipolar disorder or schizophrenia.
• You have a history of bleeding or blood clotting problems.
• You have kidney problems.
• You have epilepsy.
• You have a history of dizziness from low blood pressure.
• You also have another sexual problem, such as erectile dysfunction.

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 lying down.

Pregnancy and breastfeeding

Priligy is not intended for use in women.

Other medicines and Priligy

Priligy may interact with some medicines. Some drug interactions can be harmful to you. Do NOT take Priligy at the same time as any of the following medicines:

• Medicines for depression called monoamine oxidase inhibitors (MAOIs).
• Other medicines for depression.
• Thioridazine.
• Lithium.
• Linezolid.
• Tryptophan.
• Herbal medicines containing St John’s Wort.
• Tramadol.
• Medicines used to treat migraine.

If you have taken any of these medicines, you will need to wait 14 days after you stop taking it before you can start taking Priligy.

Once you have stopped taking Priligy, you will need to wait seven days before taking any of the medicines listed above. If you are not sure about what to do, talk to your doctor or pharmacist before taking this medicine.

Also, do not take Priligy at the same time as any of the medicines listed below.

• Certain medicines for fungal infection, including ketoconazole and itraconazole.
• Certain medicines for HIV, including ritonavir, saquinavir, nelfinavir and atazanavir.
• Certain antibiotics for treating infections, including telithromycin.
• Nefazodone.

Some other medicines can also affect the way Priligy works. For a complete list of these medicines, see the package leaflet. The doctor will know what medicines you should avoid mixing Priligy with.

The side effects that are known to be associated with Priligy include:

• Fainting or a drop in blood pressure upon standing. Contact your doctor if you have this reaction. Drinking plenty of fluids can help to prevent fainting. Therefore, you should take this medicine with at least one full glass of water. Please refer to the package leaflet for more tips to prevent this side effect.

Other side effects of Priligy include:

• Headache.
• Nausea.
• Dizziness.
• Feeling irritable, anxious, agitated or restless.
• Feeling numb or having ‘pins and needles’.
• Difficulty getting or keeping an erection, decreased sexual drive (libido).
• Problems affecting the stomach and intestines.
• Problems sleeping or strange dreams.
• Feeling tired or sleepy, yawning.
• Nasal congestion.
• A rise in blood pressure.
• Shaking or trembling.
• Sweating more than normal or flushing.
• Ringing in the ears (tinnitus).
• Dry mouth.

See the package leaflet for a complete list of side effects. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

Stop taking Priligy and see your doctor straight away if you have severe side effects, such as fainting or fits (seizures), or if you notice any changes in your mood or have any thoughts of suicide or harming yourself.

The active substance is dapoxetine. Each tablet contains 30 mg or 60 mg dapoxetine as a hydrochloride salt.

The other ingredients are:

• Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
• Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron
• oxide black (E172), iron oxide yellow (E172).

The manufacturer of Priligy is:

Janssen - Cilag S.p.A. Via C. Janssen
04010 Borgo S. Michele
Italy

Read the package leaflet before use. The official package leaflet of Priligy is available for download here.