Princex

Before using the medicine, perform the diagnostic test included!

Package leaflet: Information for the patient

Princex, 25 mg, film-coated tablets
Sildenafilum
Please read the entire leaflet carefully 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 according to
the instructions provided by the doctor or pharmacist.

• Keep this leaflet so that it can be read again if necessary.
• If advice or additional information is needed, consult a doctor or pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement after using the medicine, or if the patient feels worse, contact the doctor.

Table of contents of the leaflet:

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

1. What Princex is and what it is 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 blood vessels in the penis, increasing blood flow to the penis during sexual stimulation.
Princex helps achieve an erection only if there is prior sexual stimulation.
Princex is used in the treatment of erectile dysfunction in adult men, i.e. impotence defined as the inability to obtain or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using Princex

When not to use 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, because their concomitant use may cause dangerous lowering of blood pressure. The patient should inform the doctor if taking any medicines from this group; these are often used to relieve symptoms of angina (i.e. chest pain). If in doubt, consult a doctor or pharmacist,
• if the patient is taking medicines that release nitric oxide, such as amyl nitrite ("poppers"), because their concomitant use may also cause dangerous lowering of blood pressure,
• if the patient is taking riociguat. This is a medicine 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). PDE5 inhibitors such as Princex have been shown to enhance the blood pressure-lowering effect of this medicine.

If the patient is taking riociguat or is unsure, they should inform their doctor.

• if the patient suffers from severe heart or liver diseases,
• if the patient has recently had a stroke or heart attack, or has low blood pressure,
• if the patient suffers from certain rare inherited eye diseases, such as retinitis pigmentosa,
• if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION),

Warnings and precautions
Before starting treatment with Princex, discuss the following with your doctor or pharmacist:

• if the patient has sickle cell anaemia (an abnormality of red blood cells), leukaemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow),
• if the patient has anatomical deformity of the penis or Peyronie's disease,
• if the patient has heart problems. In such cases, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity,
• if the patient suffers from peptic ulcer disease or bleeding disorders (such as haemophilia),
• if sudden decrease or loss of vision occurs, the patient should stop taking Princex and contact a doctor immediately.

Princex must not be used together with other oral or topical treatments for erectile dysfunction.
Princex must not be used together with arterial pulmonary hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Princex must not be used if the patient does not have erectile dysfunction.
Princex is not intended for use in women.

Special recommendations for patients with renal or hepatic impairment
If the patient has impaired kidney or liver function, they should inform their doctor. Patients with impaired kidney or liver function should not take a dose of Princex higher than 25 mg.

Children and adolescents
Princex must not be used in children and adolescents under 18 years of age.

Princex and other medicines
Tell your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Princex may interact with certain medicines, especially those used to treat chest pain. If the patient's condition worsens and requires immediate medical attention, inform the doctor, pharmacist, or nurse that Princex has been taken and when it was taken. Do not take Princex together with other medicines without medical advice.
Do not take Princex if the patient is taking nitrates, because their concomitant use may cause dangerous lowering of blood pressure. Always inform the doctor or pharmacist if the patient is taking nitrates used to treat angina (i.e. chest pain).
Do not take Princex if the patient is taking medicines that release nitric oxide, such as amyl nitrite ("poppers"), because their concomitant use may cause dangerous lowering of blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
If the patient is taking sacubitril with valsartan, used to treat heart failure, inform the doctor or pharmacist.
When taking protease inhibitors used in the treatment of HIV infection, it is recommended to start treatment with the lowest dose of Princex (25 mg).
In some patients taking α-adrenergic blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of orthostatic hypotension—low blood pressure upon standing up or sitting down quickly. Such symptoms have been observed in some patients taking Princex together with α-adrenergic blockers. This is most likely within 4 hours after taking Princex. To reduce the risk of such symptoms, the patient should be on a stable dose of their α-adrenergic blocker before starting treatment with Princex. The doctor may decide to initiate treatment with a starting dose of 25 mg of Princex. If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit until symptoms resolve. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing the legs may also help. Avoid standing up or sitting down quickly.

Princex with food, drink, and alcohol
Princex can be taken with or without food. However, taking Princex with a heavy meal may delay the onset of its effect.
The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic effect of Princex, significant alcohol consumption should be avoided before taking the medicine.

Pregnancy, breastfeeding, and fertility
Princex is not intended for use in women.

Driving and operating machinery
Princex may cause dizziness and visual disturbances. Patients should assess how they react to Princex before driving or operating machinery.

Princex contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Princex contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free."

3. How to take Princex

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 25 mg. Your doctor may recommend a different dosing regimen after consultation.
Princex must not be taken more than once a day.
Do not take Princex together with other medicines containing sildenafil.
Take Princex approximately one hour before planned sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of Princex is too strong or too weak, consult your doctor or pharmacist.
Princex enables an erection to occur only in the presence of sexual stimulation. The time required for Princex to take effect varies between patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal.
Contact your doctor if, after taking Princex, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Princex
Adverse effects may occur more frequently and may be more severe.
Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than indicated in the patient information leaflet.
Contact your doctor if you have taken more tablets than recommended.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported with the use of Princex are usually mild to moderate in intensity and short-lived.
If any of the following adverse reactions occur, stop taking Princex and seek immediate medical help:

• Allergic reaction – occurs not commonly (may occur in 1 out of 100 patients)
  Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs not commonly
  If chest pain occurs during or after sexual intercourse:
  • sit half-upright and try to relax,
  • do not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occur rarely (may occur in 1 out of 1000 patients)
  If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden worsening or loss of vision – occurs rarely
• Severe skin reactions – occur rarely
  Symptoms may include severe skin peeling and swelling, blistering in the mouth, on genital organs and around the eyes, fever.
• Seizures or convulsions – occur rarely

Very common adverse reactions (may occur in more than 1 out of 10 patients):

• headache

Common adverse reactions (may occur in 1 out of 10 patients):

• facial flushing
• hot flushes (symptoms include sudden feeling of warmth in the upper body)
• nausea
• indigestion
• visual disturbances (seeing coloured tinge, light sensitivity, blurred vision or reduced visual acuity)
• stuffy nose
• dizziness

Uncommon adverse reactions (may occur in 1 out of 100 patients):

• vomiting
• skin rash
• eye irritation
• eye hyperaemia
• eye pain
• seeing flashes of light
• bright vision
• light sensitivity
• palpitations
• rapid heartbeat
• hypertension
• hypotension
• muscle pain
• drowsiness
• reduced sense of touch
• dizziness
• ringing in the ears
• dry mouth
• blocked or stuffy sinuses
• nasal mucosal inflammation (symptoms include runny nose, sneezing and nasal congestion)
• upper abdominal pain
• gastroesophageal reflux disease (symptoms include heartburn)
• feeling of fatigue
• feeling of warmth
• pain in hands or feet
• nosebleeds
• blood in urine
• watery eyes

Rare adverse reactions (may occur in 1 out of 1000 patients):

• myocardial infarction
• irregular heartbeat
• fainting
• stroke
• transient ischaemic attack (temporary reduction of blood flow to part of the brain)
• throat tightness
• numbness of lips
• bleeding into the back of the eye
• double vision
• reduced visual acuity
• abnormal sensations inside the eye
• swelling of eyes or eyelids
• small particles or spots in the field of vision
• seeing halos around light sources
• pupil dilation
• abnormal discoloration of the sclera
• penile bleeding
• blood in semen
• dry nose
• swelling inside the nose
• feeling of irritability
• sudden hearing loss

Other adverse reactions reported after marketing authorization

• unstable angina (heart disease)
• sudden death

Most, but not all, patients who experienced cardiac events had pre-existing heart conditions before taking Princex. It is not possible to determine whether these adverse reactions were related to the use of Princex.

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

5. How to store Princex medicine

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use Princex after the expiry date stated on the cardboard packaging and foil blister, marked with the symbol Expiry date (EXP).
The expiry date refers to the last day of the stated month. The batch number follows: Batch No. (Lot).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

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

• Other ingredients in the medicine are:
• Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose, hypromellose 2910 (5 cp), 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 almond-shaped tablets approximately 10 mm long and 6 mm wide, with the imprint '25' on one side and smooth on the other side.
The tablets are packed in PVC/Aluminium blisters placed in a cardboard box.
The pack may contain 2 or 4 film-coated tablets.

Marketing Authorisation 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