Silcontrol Max

Before using the medicine, read the leaflet carefully and familiarize yourself

with the attached "Diagnostic Tool". To ensure safe use of the medicine, please answer all questions contained in the diagnostic tool.

Leaflet attached to the packaging: patient information

Silcontrol MAX,

50 mg, coated tablets

Sildenafil

You should carefully 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 this 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 contact your pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If the patient's condition does not improve or worsens after taking the medicine, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Silcontrol MAX and what is it used for

Silcontrol MAX contains the active substance sildenafil, which belongs to a group of medicines called 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. Silcontrol MAX helps achieve an erection only if there is prior sexual stimulation. Silcontrol MAX is used to treat erectile dysfunction in adult men, which is defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

Before taking the medicine, read the leaflet carefully and familiarize yourself with the attached "Diagnostic Tool". To ensure safe use of the medicine, please answer all questions contained in the diagnostic tool.

2. Important information before taking Silcontrol MAX

When not to take Silcontrol MAX

• 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, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medicines from this group, which are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, the patient should consult their doctor or pharmacist.

If the patient is taking medicines that release nitric oxide (e.g., amyl nitrite, so-called "poppers"), as their concurrent use may also lead to a dangerous decrease in 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). It has been shown that PDE5 inhibitors, such as Silcontrol MAX, 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, as well as in cases of low blood pressure.
• If the patient has rare eye diseases (such as hereditary degenerative changes in the retina, e.g., retinitis pigmentosa).
• If the patient has ever experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting to take Silcontrol MAX, the patient should discuss it with their doctor or pharmacist in the following cases:

• Sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• If the patient has anatomical deformation of the penis or Peyronie's disease.
• If the patient has heart problems. The doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity.
• If the patient has stomach ulcers or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden blindness, they should stop taking Silcontrol MAX and seek medical help immediately.

Silcontrol MAX should not be used in combination with other oral or topical treatments for erectile dysfunction. Silcontrol MAX should not be used in combination with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. Silcontrol MAX should not be taken if the patient has not been diagnosed with erectile dysfunction. Silcontrol MAX is not intended for women. Using Silcontrol MAX in patients with kidney or liver function disordersPatients with kidney or liver function disorders should inform their doctor. Patients with kidney or liver function disorders should not take a dose of the medicine higher than 25 mg. Sodium This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Children and adolescents

Silcontrol MAX should not be used in individuals under the age of 18.

Silcontrol MAX and other medicines:

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Silcontrol MAX may interact with some medicines, especially those used to treat chest pain. In case of a worsening condition requiring immediate medical attention, the patient should inform their doctor, pharmacist, or nurse about taking Silcontrol MAX and the time of its administration. The patient should not take Silcontrol MAX with other medicines without their doctor's recommendation. The patient should not use Silcontrol MAX if they are taking nitrate medicines, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should always inform their doctor, pharmacist, or nurse if they are taking nitrates, which are used to treat angina pectoris ("chest pain"). The patient should not use Silcontrol MAX if they are taking medicines that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concurrent use may cause a dangerous decrease in blood pressure. If the patient is already taking riociguat, they should inform their doctor or pharmacist. When taking medicines from the protease inhibitor group used to treat HIV infections, the 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, which can be symptoms of low blood pressure caused by a decrease in blood pressure during rapid standing or sitting. Such symptoms occurred in some patients taking sildenafil and alpha-adrenergic blockers. This is most likely to happen within 4 hours of taking Silcontrol MAX. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Silcontrol MAX. The doctor may decide to use a lower initial dose of 25 mg of Silcontrol MAX. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling of impending faint), the patient 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. The patient should avoid rapid standing or sitting. If the patient is taking ketokonazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), they should consult their doctor before taking Silcontrol MAX. The patient should tell their doctor or pharmacist if they are taking medicines containing sacubitril with valsartan, used to treat heart failure.

Silcontrol MAX with food, drink, and alcohol

Silcontrol MAX can be taken with or without food. Taking Silcontrol MAX during a heavy meal may prolong the time to the start of the medicine's action. The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of Silcontrol MAX, the patient should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Silcontrol MAX is not intended for use by women.

Driving and using machines

Silcontrol MAX may cause dizziness and visual disturbances. Before driving or operating machines, patients should be aware of how they react to Silcontrol MAX.

3. How to take Silcontrol MAX

This medicine should always be used exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. Recommended dose If the patient has previously taken medicines containing sildenafil in a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, Silcontrol MAX 50 mg should only be used if the patient did not experience the desired effect after taking sildenafil in a dose of 25 mg (i.e., did not achieve an erection sufficient for sexual intercourse). If taking a lower dose of sildenafil (25 mg) allowed the patient to achieve an erection enabling sexual intercourse, they should not take a dose of 50 mg. Silcontrol MAX should not be used more than once a day.The patient should not take sildenafil in the form of coated tablets at the same time as other medicines containing sildenafil. If the patient feels that the action of Silcontrol MAX is too strong or too weak, they should consult their doctor or pharmacist. Silcontrol MAX allows for an erection only if there is prior sexual stimulation. The time after which the action of Silcontrol MAX occurs varies from patient to patient, usually ranging from half an hour to one hour. The action may occur later if the medicine is taken after a heavy meal. The patient should contact their doctor if, after taking Silcontrol MAX, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

In case of taking a higher dose of Silcontrol MAX than recommended:

The patient may experience more frequent side effects, and they may be more severe. Taking a dose higher than 100 mg does not increase the efficacy of the medicine.

The patient should not take more tablets than indicated in the patient leaflet.

The patient should contact their doctor if they have taken more tablets than recommended. In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

In case of experiencing any of the following side effects, the patient should stop taking Silcontrol MAX and seek medical help immediately:

• Allergic reaction - occurs uncommonly(may occur in 1 in 100 patients) Symptoms: 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,
• not take nitratesto relieve chest pain.

Prolonged and sometimes painful erections - occur rarely(may occur in 1 in 1000 patients). If the erection lasts more than 4 hours, the patient should seek medical help immediately.

• Sudden vision loss or blindness - occur rarely.
• Severe skin reactions - occur rarelyThey may include severe skin peeling and swelling, 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 patients): headache. Common(may occur in 1 in 10 patients): nausea, sudden flushing, hot flushes (symptoms include a feeling of heat in the upper body), indigestion, seeing a blue tint on objects, blurred vision, visual disturbances, stuffy nose, dizziness. Uncommon(may occur in 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctivitis, eye pain, seeing flashes of light, increased sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation, dizziness, ringing in the ears, dry mouth, blocked or stuffy nose, sinusitis (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 hot, and feeling tired. Rare(may occur in 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat, temporary reduction of blood flow to part of the brain, feeling of tightness 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, blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden loss of hearing. After the introduction of sildenafil-containing medicines to 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 function disorders existed before taking the sildenafil-containing medicine. It is not possible to determine whether these side effects were related to the use of Silcontrol MAX.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 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 or its representative. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Silcontrol MAX

The medicine should be stored out of sight and reach of children. There are no special precautions for storage. The patient should not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month stated. The batch number is stated on the carton and blister after: Lot. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Silcontrol MAX contains

• The active substance is sildenafil. Each Silcontrol MAX 50 mg tablet contains 50 mg of sildenafil (in the form of citrate).
• The medicine also contains:
• Core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, croscarmellose sodium,
• Coating: hypromellose, titanium dioxide (E 171), macrogol 6000, talc, indigo carmine (E 132), lacquer.

What Silcontrol MAX looks like and contents of the pack

Silcontrol MAX 50 mg, coated tablets are available in PVC/Aluminum blisters in a cardboard box, containing 1, 2, or 4 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s. U kabelovny 130 Dolní Měcholupy 102 37 Prague 10 Czech Republic

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 Genericon Pharma Gesellschaft m.b.H. Hafnerstrasse 211 8054 Graz, Austria

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

Austria Sildenafil Liconsa 50 mg Filmtablette Greece Sildenafil Bausch Health 50 mg Επικαλυμμένο με λεπτό υμένιο δισκίο Poland Silcontrol MAX

For more information about this medicine, the patient should contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw Tel. +48 22 375 92 00

Date of last revision of the leaflet: