Xirect forte

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

Package leaflet: Information for the patient

Xirect Forte, 50 mg, film-coated tablets
Sildenafilum
Read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician or pharmacist.

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

Contents of the leaflet:

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

Xirect Forte 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.
Xirect Forte helps achieve an erection only if accompanied by sexual stimulation.
Xirect Forte 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. Important information before using Xirect Forte

When not to use Xirect Forte:

• 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, because their concomitant use may lead to a dangerous decrease 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 medicines that release nitric oxide, e.g., amyl nitrite (so-called poppers; inhaled nitrites used recreationally), because their concomitant use may also cause dangerous lowering of 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). PDE5 inhibitors, such as Xirect Forte, 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 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 sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with Xirect Forte, discuss this with your doctor, pharmacist, or nurse.

• If the patient has sickle cell anaemia (an abnormality affecting red blood cells), leukaemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• If the patient has been diagnosed with anatomical deformity of the penis 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 a stomach ulcer or blood clotting disorders (such as haemophilia).
• If the patient experiences sudden worsening of vision or sudden vision loss, treatment with Xirect Forte should be discontinued immediately and medical advice should be sought without delay.

Xirect Forte should not be used concomitantly with other oral or topical treatments for erectile dysfunction.
Xirect Forte should not be used together with arterial pulmonary hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Xirect Forte should not be taken if erectile dysfunction has not been diagnosed.
Xirect Forte should 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 renal or hepatic function should not take a dose of sildenafil higher than 25 mg.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered "sodium-free".

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

Xirect Forte and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Xirect Forte may interact with certain medicines, especially those used to treat chest pain. If your health deteriorates and immediate medical attention is required, inform the doctor, pharmacist, or nurse that you have taken Xirect Forte and when it was taken. Do not take Xirect Forte together with other medicines unless advised by a doctor.
Do not take Xirect Forte if you are taking nitrates, because their concomitant use may lead to a dangerous drop in blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking nitrates used to treat angina (chest pain).
Do not take Xirect Forte if you are taking medicines that release nitric oxide, such as amyl nitrite (so-called poppers), because their concomitant use may also cause dangerous lowering of blood pressure.
Inform your doctor or pharmacist if you are taking riociguat.
If you are taking protease inhibitors used in the treatment of HIV infection, your doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil.
Some patients taking α-adrenergic blocking agents (α-blockers) for high blood pressure or prostate enlargement may experience dizziness or lightheadedness when standing up or sitting down quickly, which may be symptoms of low blood pressure. Such symptoms have occurred in some patients taking sildenafil together with α-blockers. They are most likely to occur within 4 hours after taking sildenafil. To reduce the risk of these symptoms, patients should be on a stable dose of their α-blocker before starting treatment with Xirect Forte. The doctor may decide to start treatment with a lower initial dose (25 mg) of sildenafil. If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit and wait until symptoms subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. Avoid rapid standing or sitting.
Inform your doctor or pharmacist if you are taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Xirect Forte with food, drink, and alcohol
Xirect Forte can be taken with or without food. However, taking Xirect Forte 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 maximise the therapeutic effect of Xirect Forte, significant amounts of alcohol should not be consumed before taking the medicine.

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

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

3. How to use Xirect Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
If the patient has previously used medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, sildenafil 50 mg should only be used if the patient did not achieve the desired effect (i.e. an erection sufficient for sexual intercourse) after taking sildenafil 25 mg. If using a lower dose of sildenafil (25 mg) enabled the patient to achieve an erection sufficient for sexual intercourse, the 50 mg dose should not be used.
Xirect Forte must not be taken more than once a day.
Do not take Xirect Forte together with other medicines containing sildenafil.
Xirect Forte 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 Forte is too strong or too weak, consult your doctor or pharmacist.
Xirect Forte enables an erection only in the presence of sexual stimulation. The time required for Xirect Forte 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 no erection occurs after taking Xirect Forte, or if the duration of erection is insufficient for sexual intercourse.
Taking more Xirect Forte than recommended
Adverse effects may occur more frequently and may be more severe. Taking a dose higher than 100 mg does not increase the medicine's effectiveness.
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 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 experiences them.
Adverse reactions reported with the use of sildenafil are usually mild or
moderately severe and transient.
If any of the following adverse reactions occur, discontinue taking Xirect Forte and
seek immediate medical help:

• 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 uncommonly. If chest pain occurs during or after sexual intercourse, the patient:
  • Should sit in a semi-upright position and try to relax;
  • Must not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occur rarely (may occur in up to 1 in 1000 people). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden decrease or loss of vision – occur rarely
• Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, formation of blisters in the mouth, on the genitals and around the eyes, fever.
• Seizures or fits – 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 flushing of the face,
hot flushes (symptoms include a feeling of warmth in the upper body), indigestion, coloured vision,
blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye congestion, eye pain, seeing 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 arms 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 throat tightness, 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 particles or spots in the visual field, seeing halos around light sources, pupil dilation, abnormal discoloration of the sclera, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden hearing loss or deafness.
Since the medicine has been marketed, 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, heart problems were present before taking this medicine. It is not possible to determine whether these adverse reactions were related to the use of Xirect Forte.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Xirect Forte

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

6. Contents of the package and other information

What Xirect Forte contains

• The active substance is sildenafil. Each coated tablet contains 50 mg of sildenafil (as sildenafil citrate).
• Other ingredients of the medicine are:
• Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, anhydrous colloidal silicon dioxide.
• Coating: hypromellose (type 2910), titanium dioxide (E 171), macrogol 6000, talc, indigo carmine aluminium lake (E 132).

What Xirect Forte looks like and contents of the pack
Xirect Forte 50 mg coated tablets are blue, elongated in shape, with the imprint "50".
Xirect Forte 50 mg is supplied in blister packs containing 1 or 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 member states 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