Priligi

Leaflet attached to the packaging: information for the user

Priligy, 30 mg, film-coated tablets

Priligy, 60 mg, film-coated tablets

Dapoxetine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Priligy and what is it used for
• 2. Important information before taking 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 is Priligy and what is it used for

Priligy contains the active substance dapoxetine and belongs to a group of medicines called "selective serotonin reuptake inhibitors" (SSRIs). Priligy may also be known as a "urological" medicine.
Priligy prolongs the time it takes to ejaculate and helps control ejaculation.
This can reduce the frustration and distress caused by premature ejaculation.
Priligy is used to treat premature ejaculation in adult men aged 18 to 64 years.
Premature ejaculation is when a man ejaculates with minimal sexual stimulation, often within one to two minutes of penetration, and before the man wishes to ejaculate. It can cause various problems, including sexual relationship problems.

2. Important information before taking Priligy

When not to take Priligy

• if the patient is allergic to dapoxetine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has heart problems, such as heart failure or irregular heartbeats;
• if the patient has fainted in the past;
• if the patient has ever had mania (feeling overexcited, irritable, or unable to think clearly) or severe depression;
• if the patient is taking: o monoamine oxidase inhibitors (MAOIs) - medicines used to treat depression; o thioridazine - used to treat schizophrenia; o other medicines used to treat depression;

o lithium - a medicine used to treat bipolar affective disorder;
o linezolid - an antibiotic used to treat infections;
o tryptophan - a medicine that helps with sleep;
o St. John's Wort - a herbal medicine;
o tramadol - used to treat severe pain;
o medicines used to treat migraines.
Do not take Priligy at the same time as any of the above medicines. If the patient has taken any of the above medicines, they should wait 14 days before taking Priligy. After stopping Priligy, they should wait 7 days before taking any of the above medicines. In case of doubt, consult a doctor or pharmacist before taking this medicine (see "Priligy and other medicines").
o certain medicines used to treat fungal infections, including ketoconazole and itraconazole (see "Priligy and other medicines");
o certain medicines used to treat HIV, including ritonavir, saquinavir, nelfinavir, and atazanavir (see "Priligy and other medicines");
o certain antibiotics used to treat infections, including telithromycin (see "Priligy and other medicines");
o nefazodone - a medicine used to treat depression (see "Priligy and other medicines");

• if the patient has moderate or severe liver disease.

Do not take this medicine if any of the above points apply to the patient. In case of doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Priligy, the patient should discuss it with their doctor, pharmacist, or nurse if:

• the patient has not been diagnosed with premature ejaculation;
• the patient has other sexual problems, such as erectile dysfunction;
• the patient has had dizziness caused by low blood pressure in the past;
• the patient is taking recreational drugs, such as ecstasy, LSD, narcotics, or benzodiazepines;
• the patient drinks alcohol (see "Priligy with food, drink, and alcohol");
• the patient has had mental health problems, including depression, mania (feeling overexcited, irritable, or unable to think clearly), bipolar affective disorder (severe mood swings between mania and depression), or schizophrenia (a mental disorder);
• the patient has epilepsy;
• the patient has had bleeding or blood clotting problems;
• the patient has kidney problems;
• the patient has or is at risk of high pressure in the eye (glaucoma).

If any of the above situations apply to the patient (or if the patient is unsure), they should consult a doctor or pharmacist before taking this medicine.
Before taking this medicine, the doctor should perform an examination to ensure that the patient does not have a sudden drop in blood pressure when changing position from lying down to standing.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age.

Priligy and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription, such as herbal medicines. Priligy may affect the way other medicines work. Other medicines may affect the way Priligy works. Other medicines may affect the maximum dose of Priligy the patient 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 - a medicine used to treat bipolar affective disorder;
• linezolid - an antibiotic used to treat infections;
• tryptophan - a medicine that helps with 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 the patient has taken any of the above medicines, they should wait 14 days before taking Priligy. After stopping Priligy, they should wait 7 days before taking any of the above medicines. In case of doubt, consult a doctor or pharmacist before taking this medicine.
• certain medicines used to treat fungal infections, including ketoconazole and itraconazole;
• certain medicines used to treat HIV, including ritonavir, saquinavir, nelfinavir, and atazanavir;
• certain antibiotics used to treat infections, including telithromycin;
• nefazodone - a medicine used to treat depression.

Patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• medicines used to treat other mental disorders;
• non-steroidal anti-inflammatory medicines, including ibuprofen and acetylsalicylic acid;
• medicines that prevent blood clotting, including warfarin;
• certain medicines used to treat erectile dysfunction, such as sildenafil, tadalafil, or vardenafil, which may also lower blood pressure when standing up;
• certain medicines used to treat high blood pressure and chest pain (angina pectoris) (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, fosamprenavir;
• certain antibiotics used to treat infections, such as erythromycin and clarithromycin;
• aprepitant - used to treat nausea. If the patient is unsure whether any of the above points apply to them, they should consult a doctor or pharmacist before taking this medicine.

Priligy with food, drink, and alcohol

• Do not drink grapefruit juice for 24 hours before taking this medicine, as it may increase the levels of Priligy in the 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 this medicine.
• Taking this medicine with alcohol may increase the risk of dizziness, drowsiness, or slow reactions.
• Drinking alcohol while taking this medicine may increase the risk of injuries due to fainting or other side effects.

Pregnancy, breastfeeding, and fertility

Women should not take this medicine.

Driving and using machines

While taking this medicine, the patient may feel drowsy, dizzy, weak, have difficulty concentrating, or have blurred vision. If any of these symptoms occur, the patient should avoid driving or operating hazardous machinery. The effects of alcohol may be increased in patients taking this medicine, which may increase the risk of injuries due to fainting or other side effects that occur when taking Priligy with alcohol.

Priligy contains lactose

This medicine contains lactose (a type of sugar). If the patient has been told they have an intolerance to some sugars, they should consult their doctor before taking this medicine.

Priligy contains sodium

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

3. How to take Priligy

Always take this medicine exactly as the doctor has told the patient. If the patient is unsure, they should consult their doctor or pharmacist.

• The recommended dose is 30 mg. The doctor may increase the dose to 60 mg.
• Take the medicine 1 to 3 hours before sexual activity.

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

• Swallow the Priligy tablet whole with at least one full glass of water to avoid the bitter taste. This will help prevent fainting (see section 4 "Fainting and low blood pressure").
• This medicine can be taken with or without food.
• This medicine should not be taken by men under 18 years of age or men over 65 years of age.
• The patient should discuss their treatment with their doctor after the first 4 weeks or 6 doses of Priligy to see if treatment should continue. If treatment is continued, the patient should discuss it with their doctor every 6 months.

Taking more Priligy than prescribed

If the patient takes more of the medicine than they should, they should consult their doctor or pharmacist. The patient may feel nauseous or vomit.

Stopping Priligy

Consult a doctor before stopping Priligy. The patient may feel drowsy or dizzy after stopping this medicine, even if it was not taken every day.
In case of further doubts about taking this medicine, consult a 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 immediately if:

• the patient has seizures (fits);
• the patient faints or feels dizzy when standing up;
• the patient notices changes in mood;
• the patient has thoughts of suicide or self-harm.

If the patient experiences any of the above symptoms, they should stop taking Priligy and consult a doctor immediately.

Fainting and low blood pressure

Taking this medicine can cause fainting and low blood pressure when standing up. To reduce the risk of this side effect, the patient should:

• swallow the tablet with at least one full glass of water;
• not take this medicine if they are dehydrated (lack of water in the body). This can happen if:
• the patient has not drunk anything for the past 4-6 hours;
• the patient has been sweating a lot;
• the patient has a high fever, diarrhea, or vomiting.
• if the patient feels like they are going to faint (feeling nauseous, dizzy, disoriented, confused, sweating, or having an irregular heartbeat) or feels disoriented when standing up, they should lie down with their head lower than their body or sit with their head between their knees and wait until the symptoms pass. This will help prevent falling and injury if the patient faints;
• not stand up quickly if they have been sitting or lying down for a long time;
• not drive or use any tools or machines if they feel weak while taking this medicine;
• consult a doctor if the patient faints after taking Priligy.

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

• dizziness;
• headache;
• nausea.

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

• irritability, anxiety, agitation, or restlessness;
• numbness or tingling;
• difficulty getting or maintaining an erection;
• excessive sweating or sudden flushing;
• diarrhea, constipation, or gas;
• stomach pain, bloating, or vomiting;
• sleep problems or unusual dreams;
• feeling tired, sleepy, or yawny;
• nasal congestion (swelling of the nasal mucosa);
• increased blood pressure;
• difficulty concentrating;
• trembling or shaking;
• decreased 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 and excitement, or paranoia;
• confusion, disorientation, and inability to think clearly;
• slow or irregular heartbeat or rapid heartbeat;
• loss of sex drive, difficulty reaching orgasm;
• weakness, calmness, apathy, or fatigue;
• depression/mood depression, irritation, or apathy;
• feeling hot, feeling shaky, feeling abnormal, or feeling drunk;
• vision problems, eye pain, or dilated pupils;
• low or high blood pressure;
• itching or cold sweats;
• feeling dizzy;
• taste disorders;
• grinding teeth.

Rare side effects (may affect up to 1 in 1000 men):

• dizziness after exertion;
• sudden sleepiness;
• sudden need to urinate.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Priligy

• No special precautions.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
• Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This 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, sodium croscarmellose, silicon dioxide, 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