PRILIGY 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Priligy 60mg film-coated tablets

dapoxetine

Read all of this leaflet carefully before you start 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 is Priligy and what is it used for
2. What you need to know before you take Priligy
3. How to take Priligy
4. Possible side effects
   1. Storage of Priligy

1. Contents of the pack and further information

1. What is Priligy and what is it used for

Priligy contains the active substance dapoxetine. 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 it takes to ejaculate and can improve control over ejaculation. This may reduce frustration or worry about 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 and before he wishes to. This can cause problems for the man and may affect his sexual relationships.

2. What you need to know before you take Priligy

Do not 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 a history of fainting
• if you have a history of mania (symptoms such as over-excitement, irritability, or inability to think clearly) or severe depression
• if you are taking:

• Medicines used to treat depression called monoamine oxidase inhibitors (MAOIs)
• Thioridazine for the treatment of schizophrenia
• Other medicines for depression
• Lithium – a medicine for bipolar disorder
• Linezolid – an antibiotic used to treat infections
• Tryptophan – a medicine that helps you sleep
• St. John's Wort – a herbal medicine
• Tramadol – used to treat severe pain
• Medicines used to treat migraine.

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

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

• If you have moderate or severe liver problems.

Do not take this medicine if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

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

• You have not been diagnosed with premature ejaculation
• You have any other sexual problems, such as erectile dysfunction
• You have a history of dizziness due to low blood pressure
• You take recreational drugs, such as ecstasy, LSD, narcotics, or benzodiazepines
• You drink alcohol (see section “Taking Priligy with food, drinks, and alcohol”)
• If you have ever had mental health problems, such as depression, mania (feeling over-excited, irritable, or unable to think clearly), bipolar disorder (these symptoms include severe mood swings between mania and depression), or schizophrenia (a psychiatric illness)
• 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 high blood pressure in the eyes (glaucoma).

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking this medicine.

Before you start taking this medicine, your doctor should perform a test to make sure your blood pressure does not drop too much when you stand up.

Children and adolescents

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

Other medicines and Priligy

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, such as herbal medicines. Priligy may interfere with the action of other medicines. Other medicines may also interfere with the action of Priligy. Therefore, the use of other medicines may affect the maximum dose of Priligy that you can take.

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

• Medicines for depression called monoamine oxidase inhibitors (MAOIs)
• Thioridazine, used for schizophrenia
• Other medicines for depression
• Lithium – a medicine for bipolar disorder

• Linezolid – an antibiotic used to treat infections
• Tryptophan – a medicine that helps you sleep
• St. John's Wort – a herbal medicine
• Tramadol – used to treat severe pain
• Medicines used to treat migraine.

Do not take Priligy at the same time as any of the medicines listed above. If you have taken any of these medicines, you will need to wait 14 days before starting to take Priligy. After taking Priligy, you will need to wait 7 days before taking any of these medicines listed above. If you are not sure what to do, consult your doctor or pharmacist before taking this medicine.

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

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

• Medicines for mental problems other than depression
• Non-steroidal anti-inflammatory medicines, such as ibuprofen or acetylsalicylic acid
• Medicines to thin the blood, such as warfarin
• Certain medicines used to treat erectile dysfunction, such as sildenafil, tadalafil, or vardenafil, as these medicines can lower your blood pressure, especially when standing up.
• Certain medicines used to treat high blood pressure and chest pain (angina) (such as verapamil and diltiazem), or an enlarged prostate, as these medicines can also lower your blood pressure, especially when standing up.
• Certain medicines for fungal infections, such as fluconazole
• Certain medicines for HIV, such as amprenavir and fosamprenavir
• Certain antibiotics 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, consult your doctor or pharmacist before taking this medicine.

Taking Priligy with food, drinks, and alcohol

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

Pregnancy, breast-feeding, and fertility

Women should not take this medicine.

Driving and using machines

This medicine may make some people feel drowsy, dizzy, faint, have difficulty concentrating, and blurred vision. If you experience any of these effects or others similar, you should avoid driving and using machines. The effects of alcohol may be increased if taken with this medicine, increasing the risk of injury from fainting or other side effects.

Priligy contains lactose

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

Priligy contains sodium

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

3. How to take Priligy

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, consult your doctor or pharmacist again.

• The recommended dose is 30 mg. Your doctor may increase the dose to 60 mg.
• Take the medicine only 1 to 3 hours before you plan to have sex.
• Do not takethis medicinemore than once every 24 hours or once a day.
• Swallow the tablet whole to avoid a bitter taste, with at least a full glass of water, which can help reduce the chance of fainting (see “Fainting and low blood pressure” in section 4).
• This medicine can be taken with or without food.

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

• Talk to your doctor to determine if it is suitable to continue treatment with Priligy after the first 4 weeks of treatment or after 6 doses. If you continue, you should see your doctor for a review at least every 6 months.

If you take more Priligy than you should

If you take more tablets than you should, tell 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 Toxicology Information Service, phone: 91 562 04 20

If you stop taking Priligy

Consult your doctor before stopping this medicine. You may have problems sleeping and dizziness 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, this medicine can cause side effects, although not everybody gets them.

Stop taking Priligy and see your doctor straight away if:

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

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

Fainting and low blood pressure

This medicine can make you faint or feel dizzy when standing 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 drunk anything in the last 4 or 6 hours.
• You have been sweating for a long time.
• You have been ill with a high temperature, diarrhea, or vomiting.

• If you feel like you are going to faint (you feel sick, are dizzy, feel dizzy, confused, are sweating, or have an abnormal heartbeat) or feel dizzy when standing up, lie down immediately so that your head is lower than the rest of your body or sit with your head between your knees until you feel better. This will prevent you from falling and hurting yourself if you faint.
• Do not stand 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.
• Tell your doctor if you faint when taking this medicine.

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

• Dizziness
• Headache
• Nausea.

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

• Feeling irritable, anxious, agitated, or nervous
• Numbness or tingling
• Difficulty getting an erection or maintaining it
• Excessive sweating or flushing
• Diarrhea, constipation, or gas
• Abdominal pain, bloating, or vomiting
• Sleep problems or abnormal dreams
• Feeling tired or sleepy, yawning
• Stuffy nose (nasal congestion)
• High blood pressure
• Difficulty concentrating
• Tremors or shaking
• Decreased sex drive
• Ringing in the ears
• Blurred vision
• Indigestion
• Dry mouth.

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

• Fainting or dizziness when standing up (see above recommendations)
• Mood changes, euphoria, or paranoia
• Confusion, disorientation, or difficulty thinking clearly
• Slow or irregular heartbeat or increased heart rate
• Loss of sex drive, difficulty reaching orgasm
• Feeling weak, sedated, lethargic, or fatigued
• Depression, nervousness, or indifference
• Feeling hot, tense, abnormal, or drunk
• Vision problems, eye pain, or dilated pupils
• Low or high blood pressure
• Itching or cold sweat
• Dizziness
• Abnormal taste
• Teeth grinding.

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

• Dizziness after exercise
• Sudden drowsiness
• Urgent need to defecate.

Reporting of side effects

If you experience 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Priligy

• This medicine does not require any special storage conditions.
• 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. The expiry date is the last day of the month stated.
• 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. Package Contents and Additional Information

Composition of Priligy

The active ingredient is dapoxetine. Each tablet contains 60 mg 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, black iron oxide (E172), yellow iron oxide (E172).

Appearance of Priligy and Package Size

• The 60 mg 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 6 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Menarini, S.A.

Alfons XII, 587 – E 08918 Badalona (Barcelona)

Manufacturer

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

This medicinal product is authorized in the EEA Member States under 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

Date of the last revision of this leaflet: June 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/