Prospecto: Information for the User

Priligy 60Film-Coated Tablets

dapoxetine

Read this entire prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What is Priligy and for what it is used

2.What you need to know before starting to take Priligy

3.How to take Priligy

4.Possible adverse effects

1. Storage of Priligy

6.Contents of the package and additional information

Priligy contains an active ingredient called “dapoxetina”. It 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 until ejaculation and may improve control of ejaculation. This can reduce frustration or concern about the speed of ejaculation.

Priligy is used for the treatment of premature ejaculation in adult males aged 18 to 64 years.adultsof 18to 64years of age.

Premature ejaculation occurs when a male ejaculates with minimal sexual stimulation and before he desires it. This situation can cause problems for the man and may affect sexual relations with his partner.

Do not take Priligy

• if you are allergic to dapoxetine or any of the other ingredients in this medication (listed in section 6)
• if you have heart problems, such as heart failure or irregular heartbeat
• if you have a history of fainting
• if you have a history of mania (symptoms such as overexcitement, irritability, or inability to think clearly) or severe depression
• if you are taking:

• Medications used to treat depression called MAOIs (monoamine oxidase inhibitors)
• Tioridazine for the treatment of schizophrenia
• Other medications for depression
• Lithium – a medication for bipolar disorder
• Linezolid – an antibiotic used to treat infections
• Tryptophan – a medication that helps with sleep
• St. John's Wort – a herbal medication
• Tramadol – used to treat intense pain
• Medications used to treat migraines

Do not take Priligy at the same time as any of the medications listed above. If you have taken any of these medications, you will need to wait 14 days before starting to take Priligy. After stopping Priligy, you should wait 7 days before taking any of these medications listed. If you are unsure, consult your doctor or pharmacist before taking this medication. (see section “Other medications and Priligy”)

• Some medications for fungal infections, including ketoconazole and itraconazole (see section “Other medications and Priligy”)
• Certain medications for HIV, including ritonavir, saquinavir, nelfinavir, and atazanavir (see section “Other medications and Priligy”)
• Certain antibiotics for the treatment of infections, including telithromycin (see section “Other medications and Priligy”)
• Nefazodone – an antidepressant (see section “Other medications and Priligy”)

• if you have moderate to severe liver problems

Do not take this medication if you are in any of the above circumstances. If you are unsure, consult your doctor or pharmacist before receiving this medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Priligy if:

• You have not been diagnosed with premature ejaculation
• If you have any other sexual problems, such as erectile dysfunction
• If you have a history of dizziness due to low blood pressure
• If you take drugs such as ecstasy, LSD, narcotics, or benzodiazepines
• If you drink alcohol (see section “Taking Priligy with food, drinks, and alcohol”)
• If you have ever had mental health problems such as depression, mania (symptoms such as overexcitement, irritability, or inability to think clearly), bipolar disorder (these symptoms include severe mood swings between mania and depression), or schizophrenia (a psychiatric disorder)
• If you have epilepsy
• If you have a history of bleeding or blood clotting problems
• If you have kidney problems
• If you have or have had a predisposition to high eye pressure (glaucoma)

If any of the above circumstances affect you (or you are unsure), consult your doctor or pharmacist before taking this medication.

Before starting to take this medication, your doctor must perform a test to ensure that your blood pressure does not drop too low when you stand up.

Children and adolescents

This medication should not be used in children or adolescents under 18 years old.

Other medications and Priligy

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes those purchased without a prescription, such as herbal medications. Priligy may interfere with the action of other medications. Other medications may also interfere with the functioning of Priligy. Therefore, the use of other medications may affect the maximum dose of Priligy that you can take.

Do not take Priligy at the same time as any of the following medications:

• Medications for depression called “monoamine oxidase inhibitors” (MAOIs)
• Tioridazine, used for schizophrenia
• Other medications for depression
• Lithium – a medication for bipolar disorder

• Linezolid – an antibiotic used to treat infections
• Tryptophan – a medication that helps with sleep
• St. John's Wort – a herbal medication
• Tramadol – used to treat intense pain
• Medications used to treat migraines

Do not take Priligy at the same time as any of the medications listed above. If you have taken any of these medications, you will need to wait 14 days before starting to take Priligy. After stopping Priligy, you should wait 7 days before taking any of these medications listed. If you are unsure, consult your doctor or pharmacist before taking this medication.

• Some medications for fungal infections, including ketoconazole and itraconazole
• Certain medications for HIV, including ritonavir, saquinavir, nelfinavir, and atazanavir
• Certain antibiotics for the treatment of infections, including telithromycin
• Nefazodone – an antidepressant

Inform your doctor or pharmacist if you are taking any of the following medications:

• Medications for mental health problems other than depression
• Non-steroidal anti-inflammatory medications such as ibuprofen or aspirin
• Medications to thin the blood, such as warfarin
• Certain medications used to treat erectile dysfunction, such as sildenafil, tadalafil, or vardenafil, as these medications may reduce your blood pressure, especially when standing up or getting up
• Certain medications used to treat high blood pressure and chest pain (angina) (such as verapamil and diltiazem), or enlarged prostate, as these medications may also reduce your blood pressure, especially when standing up or getting up
• Certain medications for fungal infections, such as fluconazole
• Certain medications for HIV, such as amprenavir and fosamprenavir
• Certain antibiotics for the treatment of infections, such as erythromycin and clarithromycin
• Aprepitant – used to treat nausea

If you are unsure if any of the above circumstances affect you, consult your doctor or pharmacist before taking this medication.

Taking Priligy with food, drinks, and alcohol

• Do not drink grapefruit juice in the 24 hours before taking this medication, as it may increase the concentration of this medication in the body.
• This medication can be taken with or without food.
• This medication should be taken with at least a full glass of water.
• Avoid alcohol while taking this medication.
• The effects of alcohol, such as dizziness, drowsiness, and slowness of movement, may increase if taken with this medication.
• Drinking alcohol while taking this medication may increase the risk of injury from fainting or other side effects.

Pregnancy, breastfeeding, and fertility

Women should not take this medication.

Driving and operating machinery

This medication may cause some people to feel drowsiness, dizziness, fainting, difficulty concentrating, and blurred vision. If you experience any of these effects or similar ones, you should avoid driving and operating machinery. The effects of alcohol may increase if taken with this medication, increasing the risk of injury from fainting or other side effects.

Priligy contains lactose

This medication contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Priligy contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is 30 mg. Your doctor may increase the dose to 60 mg.
• Take the medication only 1 to 3 hours before the time you plan to have sex.
• Do not take this medication more than once every 24 hours or once a day.
• Swallow the tablet whole to avoid a bitter taste, with at least one full glass of water that may help reduce the risk of fainting (see "Fainting and Decreased Blood Pressure" in section 4).
• This medication can be taken with or without food.

• Men under 18 years and men over 65 years should not use this medication.

• Discuss with your doctor to determine if it is appropriate to continue treatment with Priligy after the first 4 weeks of treatment or after 6 doses. If you continue, you should visit your doctor's office to discuss it again at least once every six months.

If you take more Priligy than you should

If you take more tablets than you should, inform your doctor or pharmacist. You may feel dizzy or vomit.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20

If you interrupt treatment with Priligy

Consult your doctor before stopping this medication. You may experience problems sleeping and dizziness when stopping Priligy, even if you have not taken it daily.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking Priligy and see your doctor immediately if:

• You experience seizures
• You faint or feel dizzy when getting up
• You notice any change in mood
• You have any suicidal thoughts or self-harm.

If you notice any of the above, stop taking this medicine and see your doctor immediately.

Dizziness and low blood pressure

This medicine may cause you to faint or have low blood pressure when getting up.To avoid this:

• Take this medicine with at least a full glass of water.
• Do not take this medicine if you are dehydrated (do not have enough water in your body).

This can happen if:

• You have not had anything to drink in the last 4or 6hours.
• You have been sweating a lot.
• You have been sick with a high fever, diarrhea, or vomiting.

• If you feel like you are going to faint (have nausea, are dizzy, feel vertigo, confusion, sweating, or an irregular heartbeat) or feel dizzy when getting up, lie down immediately with your head below the rest of your body or sit with your head between your knees until you feel better. This will help you avoid falling and getting hurt if you faint.
• Do not get up quickly if you have been sitting or lying down for a long time.
• When taking this medicine, do not drive or use any tools or machines if you feel like you are going to faint.
• See your doctor if you faint when taking this medicine.

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

• Dizziness
• Headache
• Nausea.

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

• Sensation of irritability, anxiety, agitation, or nervousness
• Numbness or tingling
• Difficulty achieving an erection or maintaining it
• Excessive sweating or flushing
• Diarrhea, constipation, or gas
• Abdominal pain, bloating, or vomiting
• Difficulty sleeping or abnormal dreams
• Fatigue or drowsiness, yawning
• Stuffy nose (nasal congestion)
• Increased blood pressure
• Difficulty concentrating
• Tremors or shakiness
• Reduced libido
• Ringing in the ears
• Blurred vision
• Indigestion
• Dry mouth.

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

• Loss of consciousness or dizziness after getting up (see previous recommendations)
• Change in mood, euphoria, or paranoia
• Confusion, disorientation, or difficulty thinking clearly
• Slow or irregular heartbeat or increased heart rate
• Loss of appetite, difficulty achieving orgasm
• Sensation of weakness, sedation, lethargy, or fatigue
• Depression, nervousness, or indifference
• Feeling hot, tense, abnormal, or drunk
• Visual problems, eye pain, or dilated pupils
• Low or high blood pressure
• Cold sweat or prickling
• Dizziness
• Abnormal taste
• Grinding of teeth.

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

• Dizziness after exercise
• Sudden drowsiness
• Urgency to defecate.

Reporting of side effects

If you experience any type of side effect, see your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• This medication does not require special storage conditions.
• Keep this medication out of sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. . By doing so, you will help protect the environment.

Composition of Priligy

The active ingredient is dapoxetine. Each tablet contains 60mg of dapoxetine as dapoxetine hydrochloride.

The other components are:

• Core of the tablets: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.
• Coating of the tablets: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide black (E172), iron oxide yellow (E172).

Appearance of Priligy and packaging size

• The 60mg film-coated tablets are gray, round, convex, approximately 8 mm in diameter, and have a "60" inside a triangle engraved on one side.

The tablets are supplied in a blister pack of 1, 2, 3, and 6film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Menarini, S.A.

Alfons XII, 587 – E 08918 Badalona (Barcelona)

Responsible manufacturer

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

This medicine is authorized in the EEA member states with the following names:

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

Last review date of this leaflet: June 2021

Further information and updates on this medicine are available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/