XIRECT 25 mg Tablets

Contents of the leaflet

1. Before taking the medicine, use the attached diagnostic tool (patient checklist)!
   1. Xirect, 25 mg, film-coated tablets
   2. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
2. What is Xirect and what is it used for
3. Important information before taking Xirect
   1. When not to take Xirect:
   2. Warnings and precautions
   3. Children and adolescents
   4. Xirect and other medicines
   5. Xirect with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
4. How to take Xirect
   1. Taking a higher dose of Xirect than recommended
5. Possible side effects
   1. If you experience any of the following side effects, you should stop taking Xirect and seek medical help immediately:
   2. Other side effects:
   3. Reporting side effects
6. How to store Xirect
7. Contents of the pack and other information
   1. What Xirect contains
   2. What Xirect looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet:

Before taking the medicine, use the attached diagnostic tool (patient checklist)!

Leaflet attached to the packaging: patient information

Xirect, 25 mg, film-coated tablets

Sildenafil

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

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should talk to your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If you do not experience improvement after taking the medicine or if you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is Xirect and what is it used for

Xirect contains the active substance sildenafil, which belongs to a group of phosphodiesterase type 5 inhibitors. The medicine works by supporting the relaxation of blood vessels in the penis, increasing blood flow to the penis during sexual arousal. Xirect helps achieve an erection only if there is simultaneous sexual stimulation. Xirect is used to treat erectile dysfunction in adult men, sometimes called impotence. This is the inability to achieve or maintain an erection of the penis sufficient for sexual intercourse.

2. Important information before taking Xirect

When not to take Xirect:

• -If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as their simultaneous intake may lead to a dangerous decrease in blood pressure. You should inform your doctor if you are taking any medicines from this group; these medicines are often used to relieve symptoms of angina pectoris (chest pain). In case of doubt, you should consult your doctor or pharmacist.
• If you are taking medicines that release nitric oxide, such as amyl nitrite (so-called poppers; nitrites used for recreational purposes), as their simultaneous intake may also cause a dangerous decrease in blood pressure.
• If you are 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). It has been shown that PDE5 inhibitors, such as Xirect, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.
• If you have severe heart or liver disease.
• If you have recently had a stroke or heart attack or if you have low blood pressure.
• If you have certain rare hereditary eye disorders (retinal pigmentosis).
• If you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Xirect, you should discuss it with your doctor, pharmacist, or nurse.

• If you have sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• If you have anatomical deformation of the penis or Peyronie's disease.
• If you have heart problems. Your doctor should assess whether your heart condition allows for the additional strain associated with sexual activity.
• If you have stomach ulcers or bleeding disorders (such as hemophilia).
• If you experience sudden vision loss or sudden blindness, you should stop taking Xirect and immediately contact your doctor.

Xirect should not be taken simultaneously with other oral or topical treatments for erectile dysfunction. Xirect should not be taken simultaneously with therapies for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. Xirect should not be taken if erectile dysfunction has not been diagnosed. Xirect should not be used in women. Special precautions for patients with renal or hepatic impairmentPatients with renal or hepatic impairment should inform their doctor, who may decide to administer a lower dose of the medicine. Patients with renal or hepatic impairment should not take a dose of sildenafil greater than 25 mg. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Children and adolescents

Xirect should not be used in persons under 18 years of age.

Xirect and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Xirect may interact with some medicines, especially those used to treat chest pain. If your condition worsens, requiring immediate medical attention, you should tell your doctor, pharmacist, or nurse about taking Xirect and the time of intake. You should not take Xirect with other medicines without your doctor's advice. You should not take Xirect if you are taking medicines called nitrates, as their simultaneous use may lead to a dangerous decrease in blood pressure. You should always inform your doctor, pharmacist, or nurse if you are taking nitrates, which are used to treat angina pectoris (chest pain). You should not take Xirect if you are taking medicines that release nitric oxide, such as amyl nitrite (so-called poppers), as their simultaneous use may also cause a dangerous decrease in blood pressure. You should inform your doctor or pharmacist if you are taking riociguat. If you are taking protease inhibitors used to treat HIV infections, your doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil. In some patients taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur when standing up or sitting down quickly, which can be symptoms of low blood pressure. Such symptoms occurred in some patients taking sildenafil and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking sildenafil. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting Xirect treatment. Your doctor may decide to use a lower initial dose (25 mg) of sildenafil. If symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint) occur, you should first lie down or sit and wait for the symptoms to pass; drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help. You should avoid standing up or sitting down quickly. You should inform your doctor or pharmacist if you are taking medicines containing sacubitril with valsartan, used to treat heart failure.

Xirect with food, drink, and alcohol

Xirect can be taken with or without food. However, taking Xirect during a heavy meal may prolong the time needed for the medicine to start working. The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of Xirect, you should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Xirect should not be used in women.

Driving and using machines

Xirect may cause dizziness and vision disturbances. Before driving or operating machinery, the patient should find out how they react to Xirect.

3. How to take Xirect

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If you are unsure, you should talk to your doctor or pharmacist. The recommended dose of the medicine is 25 mg (1 tablet). Your doctor may recommend a different dosing regimen after consultation. Xirect should not be taken more than once a day.You should not take Xirect with other medicines containing sildenafil. Xirect should be taken about an hour before planned sexual activity. The tablet should be swallowed whole with a glass of water. If you feel that the effect of Xirect is too strong or too weak, you should talk to your doctor or pharmacist. Xirect allows for an erection only if there is sexual stimulation. The time it takes for Xirect to work varies from person to person, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal. You should contact your doctor if you do not experience an erection after taking Xirect or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Xirect than recommended

Side effects may occur more frequently and may be more severe. Taking a dose greater than 100 mg does not increase the effectiveness of the medicine. You should not take more tablets than your doctor recommends.You should contact your doctor if you have taken more tablets than recommended. If you have any further doubts about using this medicine, you should talk to your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, you should stop taking Xirect and seek medical help immediately:

• Allergic reaction - occurs uncommonly(may occur in up to 1 in 100 people)

Symptoms include 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;
• Should not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may occur in up to 1 in 1000 people) If the erection lasts for more than 4 hours, you should contact your doctor immediately.
• Sudden vision loss or blindness - occurs rarely
• Severe skin reactions - occurs rarelySymptoms may include severe peeling and swelling of the skin, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occurs rarely

Other side effects:

Very common(may occur in more than 1 in 10 people): headache
Common(may occur in up to 1 in 10 people): nausea, sudden flushing, hot flushes (symptoms include a feeling of heat in the upper body), indigestion, seeing with a colored glow, blurred vision, disturbances in vision, stuffy nose, dizziness.
Uncommon(may occur in up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, sensitivity to light, eye watering, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation of touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing, and stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of heat, and feeling of tiredness.
Rare(may occur in up to 1 in 1000 people) include: fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to part of the brain, feeling of constriction in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensations in the eye, swelling of the eyes or eyelids, 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, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritability, and sudden hearing loss or deafness. After the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is important that most, but not all, men who experienced these side effects had pre-existing heart disease before taking this medicine. It is not possible to determine whether these side effects were related to the use of Xirect.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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, you can help provide more information on the safety of this medicine.

5. How to store Xirect

This medicine should be stored out of sight and reach of children. There are no special precautions for storing the medicine. You should not use Xirect after the expiry date stated on the carton and blister after "Expiry date" or "EXP". The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. You should 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 Xirect contains

• The active substance of Xirect is sildenafil. Each film-coated tablet contains 25 mg of sildenafil (as sildenafil citrate).
• Other ingredients of the medicine are:
• Core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica.
• Coating: hypromellose (type 2910), titanium dioxide (E 171), macrogol 6000, talc, and indigo carmine aluminum lake (E 132).

What Xirect looks like and contents of the pack

Xirect 25 mg film-coated tablets are blue, elongated, and marked with "25". Xirect 25 mg is available in blisters, in packs containing 4 tablets.

Marketing authorization holder:

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos – Madrid
Spain
LABORATORIOS LICONSA, S.A.
Avenida Miralcampo, 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria:
Silchemo 25/50/100 mg, Filmtabletten
Denmark:
Sildenafil Medical Valley
Netherlands:
Afilon 25/50/100 mg, Filmomhulde tablet
Iceland:
Sildenafil Medical Valley 50/100 mg filmuhúðuð tafla
Poland:
Xirect

Date of last revision of the leaflet: