XIRECT 50 mg Tablets

Contents of the leaflet

1. Before taking the medicine, use the attached diagnostic tool
   1. Leaflet attached to the packaging: patient information
   2. Xirect Forte, 50 mg, coated tablets
   3. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   4. Table of contents of the leaflet:
2. What is Xirect Forte and what is it used for
3. Important information before taking Xirect Forte
   1. When not to take Xirect Forte:
   2. Warnings and precautions
   3. Children and adolescents
   4. Xirect Forte and other medicines
   5. Xirect Forte with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
4. How to take Xirect Forte
   1. Taking a higher dose of Xirect Forte than recommended
5. Possible side effects
   1. In case of any of the following side effects, you should stop taking Xirect Forte and seek medical help immediately:
   2. Other side effects:
   3. Reporting side effects
6. How to store Xirect Forte
7. Contents of the pack and other information
   1. What Xirect Forte contains
   2. What Xirect Forte 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: 01/2025

Before taking the medicine, use the attached diagnostic tool

(patient checklist)!

Leaflet attached to the packaging: patient information

Xirect Forte, 50 mg, 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 used exactly as described in the patient leaflet or as directed 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 additional information, you should consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If your condition does not improve or you feel worse after taking the medicine, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is Xirect Forte and what is it used for

Xirect Forte contains the active substance sildenafil, which belongs to a group of 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. Xirect Forte helps achieve an erection only if there is sexual stimulation. Xirect Forte 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 Forte

When not to take Xirect Forte:

• -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, 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 Forte, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, 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 (retinitis pigmentosa).
• If you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Xirect Forte, 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 hearing loss, you should stop taking Xirect Forte and seek medical help immediately.

Xirect Forte should not be used in combination with other oral or topical treatments for erectile dysfunction. Xirect Forte should not be used in combination with therapies for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. Xirect Forte should not be taken if you have not been diagnosed with erectile dysfunction. Xirect Forte 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 it is essentially 'sodium-free'.

Children and adolescents

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

Xirect Forte 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 Forte may interact with some medicines, especially those used to treat chest pain. In case of worsening of your condition, requiring immediate medical attention, you should tell your doctor, pharmacist, or nurse about taking Xirect Forte and the time of its intake. You should not take Xirect Forte with other medicines without your doctor's advice. You should not take Xirect Forte 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 Forte 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. When 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 quickly or sitting down, 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 treatment with Xirect Forte. 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, taking fresh air, tensing abdominal muscles, or crossing legs may also help. You should avoid standing up quickly or sitting down. You should inform your doctor or pharmacist if you are taking medicines containing sacubitril with valsartan, used to treat heart failure.

Xirect Forte with food, drink, and alcohol

Xirect Forte can be taken with or without food. However, taking Xirect Forte while eating a large 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 effects of Xirect Forte, you should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Xirect Forte should not be used in women.

Driving and using machines

Xirect Forte may cause dizziness and visual disturbances. Before driving vehicles or operating machinery, you should find out how you react to Xirect Forte.

3. How to take Xirect Forte

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist. If you have previously taken medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, sildenafil at a dose of 50 mg should only be used if you did not experience the desired effect (i.e., you did not achieve an erection sufficient for sexual intercourse) after taking sildenafil at a dose of 25 mg. If taking a lower dose (25 mg) of sildenafil allowed you to achieve an erection that enabled you to have sexual intercourse, you should not take a dose of 50 mg. Xirect Forte should not be used more than once a day.You should not take Xirect Forte with other medicines containing sildenafil. Xirect Forte 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 Forte is too strong or too weak, you should consult your doctor or pharmacist. Xirect Forte enables an erection only if there is sexual stimulation. The time it takes for Xirect Forte 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 large meal. You should contact your doctor if you do not achieve an erection after taking Xirect Forte or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Xirect Forte than recommended

Side effects may occur more frequently and may be more severe. Taking a dose greater than 100 mg does not increase the efficacy 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. In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xirect Forte 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-lived.

In case of any of the following side effects, you should stop taking Xirect Forte and seek medical help immediately:

• An 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, you:
• Should sit half-up and try to relax;
• Should not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in up to 1 in 1000 people) If an erection lasts more than 4 hours, you should seek medical help immediately.
• Sudden vision loss or hearing loss - occur rarely
• Severe skin reactions - occur 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 - occur 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 a blue tinge, blurred vision, disturbance in color perception, stuffy nose, dizziness. Uncommon(may occur in up to 1 in 100 people): vomiting, skin rash, eye irritation, conjunctivitis, eye pain, seeing flashes of light, increased sensitivity to light, lacrimation, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, somnolence, decreased tactile sensitivity, dizziness, ringing in the ears, dry mouth, stuffy or blocked sinuses, nasal inflammation (symptoms include runny nose, sneezing, and stuffy nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and feeling of fatigue. Rare(may occur in up to 1 in 1000 people) include: fainting, stroke, heart attack, irregular heartbeat, transient 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, dilated pupils, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritability, and sudden loss of hearing. After the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is important to note that in most, but not all men who experienced these side effects, heart problems existed before taking the medicine. It is not possible to determine whether these side effects were related to the use of Xirect Forte.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 Forte

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 Forte 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 stated. 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 Forte contains

• The active substance of Xirect Forte is sildenafil. Each coated tablet contains 50 mg of sildenafil (as sildenafil citrate).
• Other ingredients of the medicine are:
• Core: microcrystalline cellulose, calcium phosphate anhydrous, 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 Forte looks like and contents of the pack

Xirect Forte 50 mg coated tablets are blue, elongated, and marked with "50". Xirect Forte 50 mg is available in blisters, in packs containing 1 or 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 Forte

Date of last revision of the leaflet: 01/2025