Priligi

Package Leaflet: Information for the User

Priligy, 30 mg, film-coated tablets

Priligy, 60 mg, film-coated tablets

Dapoxetine

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Priligy is and what it is used for
• 2. What you need to know before you take Priligy
• 3. How to take Priligy
• 4. Possible side effects
• 5. How to store Priligy
• 6. Contents of the pack and other information

1. What Priligy is and what it is used for

Priligy contains the active substance dapoxetine and belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRI). Priligy may also be known as a urological medication.
Priligy prolongs the time it takes to ejaculate and can improve control over ejaculation.
This may reduce the frustration or worry about fast ejaculation.
Priligy is used to treat premature ejaculation in adult men aged 18 to 64 years.
Premature ejaculation is when a man ejaculates within a short period of sexual stimulation, often before or shortly after penetration, and before the man wishes to ejaculate.

2. What you need to know before you take Priligy

When not to take Priligy

• if you are allergic to dapoxetine or any of the other ingredients of this medicine (listed in section 6);
• if you have heart problems, such as heart failure or problems with your heart rhythm;
• if you have ever had a fainting episode;
• if you have ever had mania (symptoms include excessive excitement, irritability, or a reduced need for sleep) or severe depression;
• if you are taking any of the following medicines: monoamine oxidase inhibitors (MAOIs) - used to treat depression; thioridazine - used to treat schizophrenia; other medicines used to treat depression; lithium - used to treat bipolar disorder; linezolid - an antibiotic used to treat infections; tryptophan - a medicine used to help you sleep; St. John's Wort - a herbal medicine; tramadol - used to treat severe pain; medicines used to treat migraines.
  Do not take Priligy at the same time as any of the medicines listed above. If you have taken any of these medicines, wait 14 days after stopping the medicine before taking Priligy. After stopping Priligy, wait 7 days before starting any of the above medicines. If you are not sure what to do, talk to your doctor or pharmacist before taking Priligy (see section "Priligy with other medicines").
• if you have moderate or severe liver problems.

Do not take Priligy if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Priligy.

Warnings and precautions

Before taking Priligy, talk to your doctor, pharmacist, or nurse if:

• you have not been diagnosed with premature ejaculation;
• you have other sexual problems, such as erectile dysfunction;
• you have ever had dizziness when standing up;
• you are taking recreational drugs, such as ecstasy, LSD, or amphetamines;
• you drink alcohol (see section "Priligy with food, drink, and alcohol");
• you have had mental health problems, such as depression, mania (symptoms include excessive excitement, irritability, or a reduced need for sleep), bipolar disorder (symptoms include extreme mood swings between mania and depression), or schizophrenia (a mental disorder);
• you have epilepsy;
• you have ever had bleeding or blood clotting problems;
• you have kidney problems;
• you have high blood pressure in the eyes (glaucoma).

If any of the above applies to you (or if you are not sure), talk to your doctor or pharmacist before taking Priligy.
Your doctor should perform a test to make sure you do not have a sudden drop in blood pressure when changing positions from lying down to standing up.

Children and adolescents

Do not take Priligy if you are under 18 years of age.

Priligy with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, including those you have bought without a prescription, such as herbal medicines. Priligy may interact with other medicines. Other medicines may interact with Priligy. Other medicines may affect the maximum dose of Priligy you can take.

Do not take Priligy with:

• medicines used to treat depression, called monoamine oxidase inhibitors (MAOIs);
• thioridazine - used to treat schizophrenia;
• other medicines used to treat depression;
• lithium - used to treat bipolar disorder;
• linezolid - an antibiotic used to treat infections;
• tryptophan - a medicine used to help you sleep;
• St. John's Wort - a herbal medicine;
• tramadol - used to treat severe pain;
• medicines used to treat migraines. Do not take Priligy with any of the above medicines at the same time. If you have taken any of the above medicines, wait 14 days before taking Priligy. After stopping Priligy, wait 7 days before taking any of the above medicines. If you are not sure, talk to your doctor or pharmacist before taking Priligy.
• certain medicines used to treat fungal infections, such as ketoconazole and itraconazole (see section "Priligy with other medicines");
• certain medicines used to treat HIV, such as ritonavir, saquinavir, nelfinavir, and atazanavir (see section "Priligy with other medicines");
• certain antibiotics used to treat infections, such as telithromycin (see section "Priligy with other medicines");
• nefazodone - used to treat depression (see section "Priligy with other medicines").

Tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines used to treat other mental health problems;
• non-steroidal anti-inflammatory medicines, such as ibuprofen and aspirin;
• medicines used to prevent blood clots, such as warfarin;
• certain medicines used to treat erectile dysfunction, such as sildenafil, tadalafil, or vardenafil, which may increase the risk of low blood pressure when standing up;
• certain medicines used to treat high blood pressure and angina (chest pain), such as verapamil and diltiazem, or enlarged prostate, as these medicines may also lower blood pressure when standing up.
• certain medicines used to treat fungal infections, such as fluconazole;
• certain medicines used to treat HIV, such as amprenavir and fosamprenavir;
• certain antibiotics used to treat infections, such as erythromycin and clarithromycin;
• aprepitant - used to treat nausea. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Priligy.

Priligy with food, drink, and alcohol

• Do not drink grapefruit juice for 24 hours before taking Priligy, as it may increase the levels of Priligy in your body.
• This medicine can be taken with or without food.
• Swallow the tablet with at least one full glass of water.
• Avoid drinking alcohol while taking Priligy.
• Taking Priligy with alcohol may increase the risk of dizziness, drowsiness, or slow reactions.
• Drinking alcohol while taking Priligy may increase the risk of injury due to fainting or other side effects.

Pregnancy, breastfeeding, and fertility

Women should not take Priligy.

Driving and using machines

While taking Priligy, you may feel drowsy, dizzy, weak, or have difficulty concentrating, or have blurred vision. If you experience any of these symptoms, do not drive or operate machinery. The effects of alcohol may be increased in patients taking Priligy, which may increase the risk of injury due to fainting or other side effects.

Priligy contains lactose

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.

Priligy contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Priligy

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

• The recommended dose is 30 mg. Your doctor may increase the dose to 60 mg.
• Take Priligy 1 to 3 hours before you have sex.

Do not take Priligy more than once every 24 hours (once a day).

• Swallow the tablet whole with at least one full glass of water to avoid a bitter taste. This will help prevent fainting (see section 4 "Fainting and low blood pressure").
• This medicine can be taken with or without food.
• Do not take Priligy if you are under 18 years of age or over 65 years of age.
• Talk to your doctor about your treatment with Priligy after the first 4 weeks or 6 doses, to see if you should continue treatment. If you continue treatment, you should see your doctor every 6 months.

What to do if you take more Priligy than you should

If you take more Priligy than you should, talk to your doctor or pharmacist. You may feel sick or be sick.

What to do if you stop taking Priligy

Talk to your doctor before stopping Priligy. You may feel drowsy or dizzy when you stop taking Priligy, even if you have not taken it every day.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Priligy can cause side effects, although not everybody gets them.

Stop taking Priligy and see a doctor straight away if:

• you have fits (seizures);
• you faint or feel dizzy when standing up;
• you notice any changes in your mood;
• you have thoughts of suicide or harming yourself.

If you notice any of the above, stop taking Priligy and see a doctor straight away.

Fainting and low blood pressure

Taking Priligy may cause you to feel faint or dizzy when standing up. To reduce the risk of this happening:

• swallow the tablet with at least one full glass of water;
• do not take Priligy if you are dehydrated (lack of water in the body). This may happen if:
• you have not drunk anything for the past 4-6 hours;
• you have been sweating a lot;
• you have an illness with a high temperature, diarrhea, or vomiting.
• if you feel like you are going to faint (you feel sick, dizzy, confused, sweaty, or have an irregular heartbeat), or if you feel faint when standing up, sit or lie down with your head lower than your body until the feeling passes. This will help prevent you from falling and hurting yourself if you faint;
• do not get up quickly from a sitting or lying position;
• do not drive or use machinery if you feel weak while taking Priligy;
• tell your doctor if you faint while taking Priligy.

Very common side effects (may affect more than 1 in 10 men):

• dizziness;
• headache;
• feeling sick.

Common side effects (may affect up to 1 in 10 men):

• irritability, anxiety, or restlessness;
• numbness or tingling;
• difficulty getting or keeping an erection;
• excessive sweating or flushing;
• diarrhea, constipation, or gas;
• stomach pain, bloating, or vomiting;
• sleep problems or unusual dreams;
• feeling tired, sleepy, or yawny;
• stuffy nose (nasal congestion);
• high blood pressure;
• difficulty concentrating;
• shakiness or tremors;
• reduced sex drive;
• ringing in the ears;
• blurred vision;
• indigestion;
• dry mouth.

Uncommon side effects (may affect up to 1 in 100 men):

• fainting or dizziness when standing up (see above for advice);
• mood changes, increased alertness, or excitement, or paranoia;
• confusion, disorientation, or difficulty thinking;
• slow or irregular heartbeat or fast heartbeat;
• loss of sex drive or difficulty getting an orgasm;
• weakness, calmness, apathy, or fatigue;
• depression/mood depression, agitation, or apathy;
• feeling hot, feeling unsteady, or feeling drunk;
• vision problems, eye pain, or dilated pupils;
• low or high blood pressure;
• itching or cold sweats;
• feeling dizzy or lightheaded;
• taste problems;
• grinding teeth.

Rare side effects (may affect up to 1 in 1,000 men):

• dizziness after exercise;
• sudden sleepiness;
• sudden need to have a bowel movement.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in the "Contact details" section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Priligy

• No special requirements.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Priligy contains

• The active substance is dapoxetine. Each film-coated tablet contains 30 mg or 60 mg of dapoxetine as hydrochloride.
• The other ingredients are:

o Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
o Tablet coating: lactose monohydrate, hypromellose 15 cP, titanium dioxide (E171), triacetin, iron oxide black (E172), iron oxide yellow (E172).

What Priligy looks like and contents of the pack

• Priligy 30 mg film-coated tablets are light grey, round, convex, approximately 6.5 mm in diameter, marked with "30" inside a triangle on one side.
• Priligy 60 mg film-coated tablets are grey, round, convex, approximately 8 mm in diameter, marked with "60" inside a triangle on one side.

PVC/PE/PVDC/Aluminium blister pack in a cardboard box.
Priligy 30 mg film-coated tablets: 3, 6.
Priligy 60 mg film-coated tablets: 1, 2, 3, 6.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer:

Menarini - Von Heyden GmbH,
Leipziger Strasse 7-13, 01097 Dresden,
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria, Belgium, Bulgaria, Cyprus, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Priligy

Date of last revision of the leaflet: 06/2021