Xirect

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

Package leaflet: Information for the patient

Xirect, 25 mg, film-coated tablets
Sildenafilum
Please read the entire 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 the physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after using the medicine, or if the patient feels worse, contact the doctor.

Leaflet contents:

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

Xirect 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, thereby increasing blood flow to the penis during sexual stimulation.
Xirect helps achieve an erection only if the patient is sexually stimulated.
Xirect is used to treat erectile dysfunction in adult men, sometimes referred to as impotence. This is the inability to obtain or maintain an erection sufficient for sexual intercourse.

2. Information before using Xirect

When not to use Xirect:

• 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 medicines called nitrates, as their concomitant use may lead to a dangerous drop in blood pressure. The doctor should be informed if the patient is taking any medicines from this group; these medicines are often used to relieve symptoms of angina (chest pain). If in doubt, consult a doctor or pharmacist.
• If the patient is taking drugs that release nitric oxide, e.g., amyl nitrite (so-called "poppers"; inhaled nitrites used recreationally), as 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 lung pressure caused by blood clots). PDE5 inhibitors such as Xirect have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, the doctor should be informed.
• If the patient has severe heart or liver disease.
• If the patient has recently had a stroke or heart attack, or has low blood pressure.
• If the patient has certain rare inherited eye disorders (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 Xirect, discuss this with your doctor, pharmacist, or nurse.

• If the patient has sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• If the patient has been diagnosed with penile anatomical deformity or Peyronie's disease.
• If the patient has heart problems. The doctor should assess whether the condition of the heart muscle allows for the additional strain associated with sexual activity.
• If the patient has peptic ulcer disease or bleeding disorders (such as hemophilia).
• If the patient experiences sudden decrease in vision or sudden vision loss, treatment with Xirect should be stopped immediately and the patient should contact a doctor without delay.

Xirect must not be used together with other oral or topical treatments for erectile dysfunction.
Xirect must not be used together with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Xirect should not be taken if erectile dysfunction has not been diagnosed.
Xirect must not be used in women.

Special precautions for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor, who may decide to prescribe a lower dose. Patients with impaired kidney or liver function should not take a dose of sildenafil higher than 25 mg.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Children and adolescents
Xirect must not be used in individuals under 18 years of age.

Xirect and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Xirect may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and immediate medical attention is required, inform the doctor, pharmacist, or nurse that Xirect was taken and when it was taken. Do not take Xirect together with other medicines without medical advice.

Do not take Xirect if the patient is taking medicines called nitrates, as their concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates, which are used to treat angina (chest pain).

Do not take Xirect if the patient is taking drugs that release nitric oxide, such as amyl nitrite (so-called "poppers"), as their concomitant use may also cause dangerous lowering of blood pressure.

Inform the doctor or pharmacist if the patient is taking riociguat.

If the patient is taking protease inhibitors used in the treatment of HIV infection, the doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil.

Some patients taking α-adrenergic blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness when standing up or sitting down quickly, which may be signs of low blood pressure. Such symptoms have occurred in some patients taking sildenafil together with α-adrenergic blockers. These symptoms are most likely to occur within 4 hours after taking sildenafil. To reduce the risk of such symptoms, the patient should be on a stable dose regimen of their α-adrenergic blocker before starting treatment with Xirect. The doctor may decide to use a lower starting dose (25 mg) of sildenafil. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit until symptoms resolve. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. Avoid rapid changes in posture such as standing up or sitting down quickly.

Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Xirect with food, drink, and alcohol
Xirect may be taken with or without food. However, taking Xirect with a heavy meal may delay the onset of the medicine's effect.

The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic benefit of Xirect, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding, and fertility
Xirect must not be used in women.

Driving and operating machinery
Xirect may cause dizziness and visual disturbances. Before driving a vehicle or operating machinery, the patient should be aware of how they react to Xirect.

3. How to use Xirect

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 25 mg (1 tablet). Your doctor may, after consultation, recommend a different dosage regimen.
Xirect must not be taken more than once a day.
Do not take Xirect together with other medicines containing sildenafil.
Xirect should be taken approximately one hour before planned sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of Xirect is too strong or too weak, consult your doctor or pharmacist.
Xirect enables an erection only in the presence of sexual stimulation. The time required for Xirect to take effect varies between patients, but usually ranges 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 Xirect, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Use of a higher than recommended dose of Xirect
Adverse effects may occur more frequently and may be more severe. Taking a dose higher than 0\0 mg does not increase the effectiveness of the medicine.
Do not take more tablets than prescribed by your doctor.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts 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 sildenafil are usually mild or
moderately severe and transient.
If any of the following adverse reactions occur, stop taking Xirect and seek immediate medical help:

• Allergic reaction – occurs uncommonly (may occur in no more than 1 in 100 people)

Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.

• Chest pain – occurs uncommonly If chest pain occurs during or after sexual intercourse, the patient:
  • Should adopt a semi-sitting position and try to relax;
  • Should not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occur rarely (may occur in no more than 1 in 1000 people) If an erection lasts more than 4 hours, contact a doctor immediately.
• Sudden worsening or loss of vision – occurs rarely
• Severe skin reactions – occur rarely Symptoms may include severe peeling and swelling of the skin, formation of blisters in the mouth, on genital organs and around the eyes, fever.
• Seizures or convulsions – occur rarely

Other adverse reactions:
Very common (may affect more than 1 in 10 people): headache
Common (may affect up to 1 in 10 people): nausea, sudden facial flushing,
hot flushes (symptoms include a feeling of warmth in the upper body), dyspepsia, coloured vision, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, perception of flashes of light, bright vision, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and blocked nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in hands or legs, nosebleeds, feeling of warmth and feeling of fatigue.
Rare (may affect up to 1 in 1000 people): fainting, stroke, heart attack,
irregular heartbeat, transient reduction in blood flow to part of the brain, sensation of tightness in the throat, numbness of the lips, bleeding into the back of the eye, double vision, reduced visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids, small specks or spots in the visual field, seeing halos around light sources, dilated pupils, abnormal discoloration of the sclera, rectal bleeding, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden hearing loss.
Since 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 adverse reactions, cardiac disorders were present prior to taking Xirect. It is not possible to determine whether these adverse reactions were related to the use of Xirect.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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 181 C, 02-222 Warsaw, 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 Xirect

This medicine should be stored out of the sight and reach of children.
No special precautions for storage of the medicine are required.
Do not use Xirect after the expiry date stated on the outer carton and blister pack after "Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Xirect contains

• The active substance is sildenafil. Each coated tablet contains 25 mg of sildenafil (as sildenafil citrate).
• Other components of the medicine are:
• Tablet 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 aluminium lake (E 132).

What Xirect looks like and contents of the pack
Xirect 25 mg film-coated tablets are blue, elongated in shape, with the imprint “25”.
Xirect 25 mg is supplied in blisters, in packages containing 4 tablets.
Marketing Authorisation 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 authorised in the European Economic Area countries 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