PRINCEX 25 mg Tablets

Contents of the leaflet

1. Before using the medicine, perform the attached diagnostic test!
2. Leaflet attached to the packaging: patient information
3. Princex, 25 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
   3. Table of contents of the leaflet:
4. What is Princex and what is it used for
5. Important information before taking Princex
   1. When not to take Princex:
   2. Warnings and precautions
   3. Children and adolescents
   4. Princex and other medicines
   5. Princex with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Princex contains lactose
   9. Princex contains sodium
6. How to take Princex
   1. Princex should not be taken more than once a day.
   2. Taking a higher dose of Princex than recommended
7. Possible side effects
   1. If the patient experiences any of the following side effects, they should stop taking Princex and seek medical attention immediately:
   2. Very common side effects (may affect more than 1 in 10 people):
   3. Common side effects (may affect up to 1 in 10 people):
   4. Uncommon side effects (may affect up to 1 in 100 people):
   5. Rare side effects (may affect up to 1 in 1000 people):
   6. Other side effects reported after the medicine was marketed
   7. Reporting side effects
8. How to store Princex
   1. The medicine should be stored out of sight and reach of children.
9. Contents of the pack and other information
   1. What Princex contains
   2. What Princex looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. Date of last revision of the leaflet: January 2025

Before using the medicine, perform the attached diagnostic test!

Leaflet attached to the packaging: patient information

Princex, 25 mg, film-coated tablets

Sildenafil

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a doctor or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If the patient's condition does not improve or worsens after taking the medicine, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Princex and what is it used for
• 2. Important information before taking Princex
• 3. How to take Princex
• 4. Possible side effects
• 5. How to store Princex
• 6. Contents of the pack and other information

1. What is Princex and what is it used for

Princex contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Princex helps to achieve an erection only if the patient is sexually stimulated. Princex is used to treat erectile dysfunction in adult men, which is defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Princex

When not to take Princex:

• if the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking nitrates, as their simultaneous intake may cause a dangerous drop in blood pressure. The patient should inform their doctor if they are taking any medicines from this group, which are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, the patient should consult their doctor or pharmacist,
• if the patient is taking medicines that release nitric oxide, such as amyl nitrite ("poppers"), as their simultaneous intake may also cause a dangerous drop in blood pressure,
• if the patient is taking riociguat. This medicine is used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). It has been shown that PDE5 inhibitors, such as Princex, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

This medicine should not be taken if the patient has severe heart or liver disease, if the patient has recently had a stroke or heart attack, or if the patient has low blood pressure.

• if the patient has certain rare hereditary eye diseases, such as retinitis pigmentosa,
• if the patient has ever had a sudden loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION),

Warnings and precautions

Before starting to take Princex, the patient should discuss it with their doctor or pharmacist:

• if the patient has sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a blood cancer),
• if the patient has a physical deformity of the penis or Peyronie's disease,
• if the patient has heart problems. In this case, the doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity,
• if the patient has stomach ulcers or bleeding disorders (such as hemophilia),
• if the patient experiences sudden vision loss or sudden hearing loss, they should stop taking Princex and seek medical attention immediately.

Princex should not be taken with other oral or topical treatments for erectile dysfunction. Princex should not be taken with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or other PDE5 inhibitors. Princex should not be taken if the patient does not have erectile dysfunction. Princex is not intended for women.

Special recommendations for patients with kidney or liver function disorders

If the patient has kidney or liver function disorders, they should inform their doctor. Patients with kidney or liver function disorders should not take a dose of Princex higher than 25 mg.

Children and adolescents

Princex should not be taken by children and adolescents under the age of 18.

Princex and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Princex may interact with some medicines, especially those used to treat chest pain. If the patient's condition worsens and requires immediate medical attention, they should inform their doctor, pharmacist, or nurse about taking Princex and the time of intake. The patient should not take Princex with other medicines without their doctor's advice.

Princex with food, drink, and alcohol

Princex can be taken with or without food. However, taking Princex with a large meal may prolong the time it takes for the medicine to start working. The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic effects of Princex, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Princex is not intended for use by women.

Driving and using machines

Princex may cause dizziness and visual disturbances. Patients should be aware of how they react to Princex before driving or operating machinery.

Princex contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking Princex.

Princex contains sodium

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

3. How to take Princex

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist. The recommended dose of Princex is 25 mg. The doctor may recommend a different dosage after consultation.

Princex should not be taken more than once a day.

The patient should not take Princex with other medicines containing sildenafil. Princex should be taken about an hour before planned sexual activity. The tablet should be swallowed whole with a glass of water. If the patient feels that the effect of Princex is too strong or too weak, they should consult their doctor or pharmacist. Princex allows for an erection only if the patient is sexually stimulated. The time it takes for Princex to start working varies from patient to patient, usually between half an hour and one hour. The effect may occur later if the medicine is taken after a large meal. The patient should consult their doctor if they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse after taking Princex.

Taking a higher dose of Princex than recommended

The patient may experience more frequent or severe side effects. Taking a dose higher than 100 mg does not increase the effectiveness of the medicine. The patient should not take more tablets than indicated in the patient leaflet.The patient should consult their doctor if they have taken more tablets than recommended. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Princex can cause side effects, although not everybody gets them. The side effects reported in connection with the use of Princex are usually mild or moderate and short-lived.

If the patient experiences any of the following side effects, they should stop taking Princex and seek medical attention immediately:

• Allergic reaction - occurs uncommonly(may affect up to 1 in 100 people) Symptoms: sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - occurs uncommonlyIf it occurs during or after sexual intercourse:
• the patient should sit half-up and try to relax,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may affect up to 1 in 1000 people) If the erection lasts for more than 4 hours, the patient should seek medical attention immediately.
• Sudden vision loss or hearing loss - occurs rarely
• Severe skin reactions - occur rarelySymptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur rarely

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

• headache

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

• flushing
• hot flushes (symptoms include a sudden feeling of heat in the upper body)
• nausea
• indigestion
• visual disturbances (seeing a blue glow, sensitivity to light, blurred vision, or decreased sharpness of vision)
• stuffy nose
• dizziness

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

• vomiting
• skin rash
• eye irritation
• eye redness
• eye pain
• seeing flashes of light
• abnormal vision
• light sensitivity
• palpitations
• rapid heartbeat
• high blood pressure
• low blood pressure
• muscle pain
• drowsiness
• reduced sense of touch
• dizziness
• ringing in the ears
• dry mouth
• stuffy or runny sinuses
• nasal congestion (symptoms include a runny nose, sneezing, and a stuffy nose)
• upper abdominal pain
• gastroesophageal reflux disease (symptoms include heartburn)
• feeling tired
• feeling hot
• arm or leg pain
• nosebleeds
• blood in the urine
• excessive tearing

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

• heart attack
• irregular heartbeat
• fainting
• stroke
• temporary reduction in blood flow to part of the brain
• feeling of pressure in the throat
• numbness of the lips
• bleeding in the back of the eye
• double vision
• reduced visual acuity
• abnormal sensations in the eye
• eye or eyelid swelling
• small particles or spots in the field of vision
• seeing halos around light sources
• pupil dilation
• abnormal discoloration of the white of the eye
• penile bleeding
• blood in the semen
• dry nose
• nose swelling
• feeling irritable
• sudden hearing loss

Other side effects reported after the medicine was marketed

• unstable angina (heart disease)
• sudden death

In most, but not all, cases, the patients had heart problems before taking Princex. It is not possible to determine whether these side effects were related to the use of Princex.

Reporting side effects

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

5. How to store Princex

The medicine should be stored out of sight and reach of children.

The medicine does not require special storage conditions. Princex should not be taken after the expiry date stated on the carton and blister pack, which is indicated by the expiry date (EXP). The expiry date refers to the last day of the month stated. The batch number is stated after: Batch number (Lot). Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Princex contains

The active substance of Princex is sildenafil. Each tablet contains 25 mg of sildenafil (as sildenafil citrate).

• other ingredients of the medicine are:
• - Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, hypromellose 2910 (5cp), magnesium stearate.
• - Coating:hypromellose 2910 (15 cp), titanium dioxide (E 171), lactose monohydrate, triacetin, indigo carmine, lake (E 132)

What Princex looks like and contents of the pack

Princex, 25 mg, are blue, biconvex, film-coated tablets in the shape of an almond, approximately 10 mm long and 6 mm wide, with the inscription "25" on one side and smooth on the other. The tablets are packaged in PVC/Aluminum blisters placed in a carton box. The pack may contain 2 or 4 film-coated tablets.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw, Tel: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare Polska Sp. z o.o., ul. Lutomierska 50, 95-200 Pabianice

Date of last revision of the leaflet: January 2025