Priligy

PACKAGE LEAFLET

Package leaflet: information for the user

Priligy 30 mg film-coated tablets, 60 mg film-coated tablets

dapoxetine
Please read 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Priligy is and what it is used for
2. What you need to know 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 an active substance called "dapoxetine", which belongs to a group of medicines known as "selective serotonin re-uptake inhibitors" (SSRIs). Priligy may also be known as a "urological" medicine.
Priligy increases the time required for ejaculation and may improve control over ejaculation. This can reduce the frustration or distress caused by premature ejaculation.
Priligy is used for the treatment of premature ejaculation in adult men aged between 18 and 64 years.
Premature ejaculation occurs when a man ejaculates with minimal sexual stimulation and before he wishes to do so. This may cause distress to the man and may lead to problems during sexual intercourse.

2. What you need to know before taking Priligy

Do not take Priligy

• If you are allergic to dapoxetine or any of the ingredients of this medicine (listed in section 6).
• If you have heart problems, such as heart failure or rhythm-related heart conditions.
• If you have a history of fainting (syncope).
• If you have had a history of mania (symptoms include over-excitement, irritability, or confusion) or severe depression.
• If you are taking:
  – Medicines for depression called “monoamine oxidase inhibitors” (MAOIs), or thioridazine used for schizophrenia, or other antidepressants, or lithium (a medicine for bipolar disorder), or linezolid (an antibiotic used to treat infections), or tryptophan (a sleep aid), or St. John’s wort (a herbal remedy), or tramadol (used to treat severe pain), or medicines used to treat migraine.

Do not take Priligy together with any of the medicines listed above. If you have taken any of these medicines, you must wait 14 days after stopping them before you can take Priligy. After stopping Priligy, you must wait 7 days before taking any of the medicines listed above. If you are in any doubt, consult your doctor or pharmacist before taking this medicine (see section “Other medicines and Priligy”).
– Certain antifungal medicines, 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 used to treat 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 any of the points listed above apply to you. If you are in any doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Priligy if:

• You have not been diagnosed with premature ejaculation.
• You have another sexual problem, such as erectile dysfunction.
• You have a history of dizziness due to low blood pressure.
• You use recreational drugs, such as ecstasy, LSD, narcotics or benzodiazepines.
• You drink alcohol (see section “Priligy with food, drink and alcohol”).
• You have had a mental health condition, such as depression, mania (symptoms include feeling over-excited, irritable or unable to think clearly), bipolar disorder (symptoms include extreme mood swings between mania and depression), or schizophrenia (a psychiatric illness).
• You have epilepsy.
• You have a history of bleeding disorders or blood clotting problems.
• You have kidney problems.
• You have or are at risk of high pressure in the eye (glaucoma).

If any of the above apply to you (or if you are in any doubt), consult your doctor or pharmacist before taking this medicine.

Before starting this medicine, your doctor should perform an examination to ensure that your blood pressure does not drop too much when you move from lying down to standing up.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Priligy

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription and herbal medicines. This is because Priligy may interfere with the way other medicines work, and other medicines may interfere with the way Priligy works. Therefore, taking other medicines may affect the maximum dose of Priligy that you are allowed to take.

Do not take Priligy together with 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 sleep aid
• St. John’s wort, a herbal remedy
• Tramadol, used to treat severe pain
• Medicines used to treat migraine

Do not take Priligy together with any of the medicines listed above. If you have taken any of these medicines, you must wait 14 days after stopping them before you can take Priligy. After stopping Priligy, you must wait 7 days before taking any of the medicines listed above. If you are in any doubt, consult your doctor or pharmacist before taking this medicine.

• Certain antifungal medicines, including ketoconazole and itraconazole
• Certain medicines for HIV, including ritonavir, saquinavir, nelfinavir and atazanavir
• Certain antibiotics used to treat infections, including telithromycin
• Nefazodone, an antidepressant

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

• Medicines for mental health conditions other than depression
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or acetylsalicylic acid
• Anticoagulant medicines, such as warfarin
• Some medicines used to treat erectile dysfunction, such as sildenafil, tadalafil and vardenafil, as these medicines may lower blood pressure when you stand up
• Some medicines used to treat high blood pressure and chest pain (angina) (such as verapamil and diltiazem), or enlarged prostate, as these medicines may also lower your blood pressure when you stand up
• Certain other antifungal medicines, such as fluconazole
• Certain other medicines for HIV, such as amprenavir and fosamprenavir
• Certain other antibiotics used to treat infections, such as erythromycin and clarithromycin
• Aprepitant, used to treat nausea

If you are in any doubt about whether any of the above apply to you, consult your doctor or pharmacist before taking this medicine.

Priligy with food, drink and alcohol

• Do not drink grapefruit juice within 24 hours before taking this medicine, as it may increase the level of the medicine in your body.
• This medicine can be taken with or without food.
• Take this medicine with at least one full glass of water.
• Avoid alcohol when taking this medicine.
• The effects of alcohol, such as dizziness, drowsiness and slow reactions, may worsen if you also take this medicine.
• Drinking alcohol while taking this medicine may increase the risk of injury due to fainting or other side effects.

Pregnancy, breastfeeding and fertility

This medicine is not intended for use in women.

Driving and using machines

While taking this medicine, you may feel drowsy, dizzy, or faint, or have difficulty concentrating or blurred vision. Do not drive or operate machinery if you experience any of these effects or similar symptoms. The effects of alcohol may be increased if you take this medicine at the same time, and you may be at greater risk of injury from fainting or other adverse effects if you take this medicine with alcohol.

Priligy contains lactose

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

Priligy contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Priligy

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose is 30 mg. Your doctor may increase the dose to 60 mg.
• Take the medicine only 1 to 3 hours before sexual activity.
• Do not take this medicine more than once every 24 hours or on a daily basis.
• Swallow the tablets whole, to avoid a bitter taste, with at least one full glass of water. This may reduce the risk of fainting (see “Fainting and low blood pressure” in section 4).
• This medicine can be taken with or without food.
• This medicine must not be used by men under 18 years of age or by men aged 65 years or older.
• Review your treatment with Priligy with your doctor after the first 4 weeks or after 6 doses to determine whether continued treatment is necessary. If treatment is continued, you must review the therapy with your doctor at least 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 experience nausea or vomiting.
If you stop taking Priligy
Talk to your doctor before stopping treatment with this medicine. You may experience sleep problems and dizziness after stopping treatment with this medicine, even if you have not taken it every day.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking Priligy and contact your doctor immediately if:

• you have seizures
• you faint or feel lightheaded when standing up
• you notice any change in your mood
• you have thoughts of suicide or self-harm. If you notice any of the above side effects, stop taking Priligy and contact your doctor immediately.

Fainting and low blood pressure
This medicine can cause fainting or lower your blood pressure when you stand up. To reduce the likelihood of this happening:

• take this medicine with at least one full glass of water
• do not take this medicine if you are dehydrated (do not have enough water in your body). This may occur if:
  o you have not drunk anything for the last 4-6 hours, or
  o you have been sweating heavily, or
  o you have an illness with high temperature, diarrhoea or vomiting.
• If you feel faint (for example, you feel nauseous, dizzy, lightheaded, confused, sweaty, or have an irregular heartbeat) or feel lightheaded when standing up, lie down immediately with your head lower than the rest of your body, or sit down and put your head between your knees, until you feel better. This will help prevent you from falling and injuring yourself if you faint.
• Do not stand up quickly after sitting or lying down for a long time.
• Do not drive or operate tools or machinery if you feel faint during treatment with this medicine.
• Inform your doctor if you faint while taking Priligy.

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 restless
• tingling or numbness sensations ("pins and needles")
• difficulty getting or maintaining an erection
• excessive sweating or hot flushes
• diarrhoea, constipation or flatulence
• stomach ache, bloating or vomiting
• insomnia or unusual dreams
• feeling tired or drowsy, yawning
• stuffy nose (nasal congestion)
• increased blood pressure
• difficulty concentrating
• chills or tremors
• reduced interest in sex
• 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)
• mood changes, feeling overexcited or paranoid
• feeling confused, disoriented or unable to think clearly
• slow, irregular or rapid heartbeat
• loss of sexual desire, difficulty reaching orgasm
• feeling weak, exhausted, lethargic or fatigued
• feeling depressed, nervous or indifferent
• feeling warm, restless, strange or intoxicated
• vision problems, eye pain or dilated pupils
• low or high blood pressure
• itching or cold sweats
• vertigo
• altered taste
• teeth grinding.

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

• dizziness following physical exertion
• sudden sleep attacks
• urgent need to defecate.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 stated on the carton after “Exp”. The expiry date refers to the last day of the month.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Priligy contains
The active substance is dapoxetine. Each tablet contains 30 mg or 60 mg of dapoxetine as the
hydrochloride salt.
The excipients are:

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

Description of the appearance of Priligy and pack contents

• Priligy 30 mg film-coated tablets are light grey, round, convex, approximately 6.5 mm in diameter, with "30" printed inside a triangle on one side.
• Priligy 60 mg film-coated tablets are grey, round, convex, approximately 8 mm in diameter, with "60" printed inside a triangle on one side. The tablets are supplied in blister packs containing 1, 2, 3 or 6 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Phoenix Labs Unlimited Company, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee,
County Meath, Ireland
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 brand 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, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Priligy