Priligy

Package leaflet: Information for the user

Priligy, 30 mg, film-coated tablets
Priligy, 60 mg, film-coated tablets
Dapoxetine
Please 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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the 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 Priligy is and what it is used for

Priligy contains an active substance called dapoxetine and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). Priligy may also be known as a urological medicine.
Priligy prolongs the time it takes to reach ejaculation and helps improve control over ejaculation. This may reduce feelings of frustration and distress caused by premature ejaculation.
Priligy is used to treat premature ejaculation in adult men aged 18 to 64 years.
Premature ejaculation occurs when ejaculation happens shortly after minor sexual stimulation, regardless of the man's control. It may lead to various problems, including difficulties in sexual relationships.

2. Important information before using Priligy

When not to use 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 heart rhythm disorders;
• if the patient has previously experienced fainting;
• if the patient has ever had mania (including feelings of excessive excitement, irritability, or inability to think logically) or severe depression;
• if the patient is taking:
  • monoamine oxidase inhibitors (MAOIs) – medicines used to treat depression;
  • thioridazine – used to treat schizophrenia;
  • other medicines used to treat depression;
  • lithium – a medicine used to treat bipolar 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 together with any of the medicines listed above.
If the patient has taken any of the medicines listed above, they should wait 14 days before starting Priligy.
After stopping Priligy, wait 7 days before starting any of the medicines listed above.
If in doubt, consult a doctor or pharmacist before using this medicine (see section "Priligy and other medicines").

• certain medicines used to treat fungal infections, including ketoconazole and itraconazole (see section "Priligy and other medicines");

• certain medicines used to treat HIV, including ritonavir, saquinavir, nelfinavir, and atazanavir (see section "Priligy and other medicines");

• certain antibiotics used to treat infections, including telithromycin (see section "Priligy and other medicines");

• nefazodone – a medicine used to treat depression (see section "Priligy and other medicines");

• if the patient has moderate or severe liver disease.

Do not use this medicine if any of the above conditions apply to the patient.
If in doubt, consult a doctor or pharmacist before using this medicine.

Warnings and precautions

Before starting Priligy, discuss with a doctor, pharmacist, or nurse if:

• premature ejaculation has not been diagnosed in the patient;
• the patient has other sexual problems, such as erectile dysfunction;
• the patient has previously experienced dizziness due to low blood pressure;
• the patient uses psychoactive substances such as ecstasy, LSD, narcotics, or benzodiazepines;
• the patient drinks alcohol (see section "Priligy, food, drink, and alcohol");
• the patient has had psychiatric problems, including depression, mania (symptoms include excessive excitement, irritability, or inability to think logically), bipolar disorder (symptoms include severe mood swings between mania and depression), or schizophrenia (a mental disorder);
• the patient has epilepsy;
• the patient has previously had bleeding problems or issues with blood clotting;
• the patient has kidney problems;
• the patient has or is at risk of increased intraocular pressure (glaucoma).

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

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age.

Priligy and other medicines

Tell your doctor or pharmacist about all medicines currently or recently taken, including those obtained without a prescription, such as herbal remedies. Priligy may affect the action of other medicines. Other medicines may also affect the action of Priligy. Taking other medicines may influence the maximum dose of Priligy the patient can take.

Do not take Priligy together with:

• medicines used to treat depression called monoamine oxidase inhibitors (MAOIs);
• thioridazine – used to treat schizophrenia;
• other antidepressant medicines;
• lithium – a medicine used to treat bipolar 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 medicines listed above, wait 14 days before starting Priligy.
After stopping Priligy, wait 7 days before starting any of the medicines listed above.
If in doubt, consult a doctor or pharmacist before starting 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.

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

• medicines used to treat psychiatric disorders other than depression;
• non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and acetylsalicylic acid;
• anticoagulant medicines, including warfarin;
• some medicines used to treat erectile dysfunction, such as sildenafil, tadalafil, or vardenafil, which may potentially lower blood pressure upon standing;
• some medicines used to treat high blood pressure and chest pain (angina pectoris) (such as verapamil and diltiazem) or benign prostatic hyperplasia, as these medicines may also lower blood pressure when standing up;
• some antifungal medicines, such as fluconazole;
• some medicines used to treat HIV, such as amprenavir, fosamprenavir;
• some 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, they should consult a doctor or pharmacist before using this medicine.

Priligy, food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

Women should not use this medicine.

Driving and using machines

While taking this medicine, the patient may experience drowsiness, dizziness, weakness, difficulty concentrating, or blurred vision. If any of these symptoms occur, the patient should avoid driving or operating dangerous machinery. The effects of alcohol may be enhanced in patients taking this medicine, increasing the risk of injury due to fainting or other adverse effects that may occur when taking Priligy with alcohol.

Priligy contains lactose

This medicine contains lactose (a type of sugar). If the patient has been previously diagnosed with an intolerance to certain 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, meaning the medicine is considered "sodium-free".

3. How to use Priligy

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

• The recommended dose is 30 mg. Your doctor may increase the dose to 60 mg.
• This medicine should be taken only 1 to 3 hours before engaging in sexual activity.
• Do not take this medicine more than once every 24 hours (once daily).
• Priligy tablets should be swallowed whole to avoid their bitter taste, with at least one glass of water. This is intended to 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 used in men under 18 years of age or in men aged 65 years and older.
• You should speak with your doctor about treatment with Priligy after the first 4 weeks or after 6 doses, to determine whether treatment should continue. If treatment continues, the patient should discuss it with the doctor every 6 months.

Taking more Priligy than prescribed
If you take more than the recommended dose, contact your doctor or pharmacist. You may experience nausea or vomiting.
Stopping Priligy
Contact your doctor before stopping Priligy. Drowsiness and dizziness may occur after discontinuing this medicine, even if it was not taken daily.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
You should stop taking Priligy and contact your doctor immediately if:

• the patient has experienced seizures (fits);
• the patient has experienced fainting or dizziness upon standing;
• the patient has noticed mood changes;
• the patient has thoughts of suicide or self-harm.

If any of the symptoms listed above occur, treatment with Priligy should be discontinued immediately and the patient should contact their doctor without delay.
Fainting and low blood pressure
Taking this medicine may lead to loss of consciousness and a drop in blood pressure when standing up. To reduce the risk of this effect, the following should be observed:

• take the tablet with at least one full glass of water;
• do not take this medicine if the patient is dehydrated (lack of fluids in the body). This may occur if:
• the patient has not consumed any fluids for the past 4–6 hours;
• the patient has been sweating heavily for a prolonged period;
• the patient has an illness with high fever, diarrhoea, or vomiting.
• if the patient feels as if they are about to lose consciousness (nausea, dizziness, lightheadedness, confusion, sweating, irregular heartbeat) or experiences lightheadedness when standing up, they should immediately lie down with their head lower than their body or sit down with their head between their knees and wait until symptoms subside. This action can help prevent falls and injuries in case of fainting;
• do not stand up suddenly after sitting or lying down for a prolonged period;
• do not drive or operate any tools or machinery if the patient feels weak while taking the medicine;
• contact your doctor if fainting occurs after taking Priligy.

Very common adverse effects (may occur in more than 1 in 10 men):

• dizziness;
• headache;
• nausea.

Common adverse effects (may occur in less than 1 in 10 men):

• irritability, anxiety, restlessness, or agitation;
• numbness or tingling;
• difficulty achieving or maintaining an erection;
• excessive sweating or sudden flushing of the face;
• diarrhoea, constipation, or flatulence;
• abdominal pain, bloating, or vomiting;
• sleep problems or unusual dreams;
• feeling tired, drowsiness, yawning;
• nasal congestion (swelling of the nasal mucosa);
• increased blood pressure;
• difficulty concentrating;
• tremor or shakiness;
• reduced sexual desire;
• ringing in the ears;
• blurred vision;
• indigestion;
• dry mouth.

Uncommon adverse effects (may occur in less than 1 in 100 men):

• fainting or dizziness upon standing (see advice above);
• mood changes, increased alertness and excitement, or paranoia;
• confusion, disorientation, and inability to think logically;
• slowed or irregular heartbeat, or rapid heartbeat;
• loss of sexual desire, difficulty reaching orgasm;
• weakness, calmness, apathy, or fatigue;
• depression/depressed mood, irritability, or emotional blunting;
• feeling hot, feeling shaky, feeling strange, or feeling intoxicated;
• visual disturbances, eye pain, or dilated pupils;
• low or high blood pressure;
• itching or cold sweats;
• sensation of spinning;
• taste disturbances;
• teeth grinding.

Rare adverse effects (may occur in less than 1 in 1000 men):

• dizziness occurring after exertion;
• sudden onset of sleep;
• sudden urge to defecate.

Reporting adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Priligy

• No special requirements.
• Keep the 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 stated month.
• Medicines must not be disposed of via wastewater or household waste. Ask your 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 dapoxetine hydrochloride.
• The other ingredients are:

o Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose,
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.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
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 authorised in the European Economic Area countries 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