Silcontrol

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

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

Leaflet attached to the packaging: patient information

Silcontrol,

25 mg, film-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 the patient leaflet or as directed by a 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 consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not experience an improvement after taking the medicine or if you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is Silcontrol and what is it used for

Silcontrol 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 helps achieve an erection only if there is prior sexual stimulation.

Silcontrol 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 "Diagnostic Tool". To use the medicine safely, please answer all the questions contained in the diagnostic tool.

2. Important information before taking Silcontrol

When not to take Silcontrol

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates, as their simultaneous use may lead to a dangerous decrease in blood pressure. You should inform your doctor if you are taking any medicines from this group, as they 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 (e.g., amyl nitrite, so-called "poppers"), as their simultaneous use may also lead to 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 Silcontrol, 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, as well as in cases of low blood pressure.
• If you have certain rare eye diseases (such as hereditary degenerative changes in the retina, e.g., retinitis pigmentosa).
• If you have ever experienced vision loss due to non-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Silcontrol, you should discuss it with your doctor or pharmacist in the following cases:

• Sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), multiple myeloma (a bone marrow cancer).
• 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 loss of vision, you should stop taking Silcontrol and contact your doctor immediately.

Silcontrol should not be used with other oral or topical treatments for erectile dysfunction.

Silcontrol should not be used with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

Silcontrol should not be taken if you do not have erectile dysfunction.

Silcontrol is not intended for women.

Use in patients with renal or hepatic impairment

Patients with renal or hepatic impairment should inform their doctor, who may decide to administer a lower dose of Silcontrol.

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

Children and adolescents

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

Silcontrol and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Silcontrol may interact with certain medicines, especially those used to treat chest pain. In case of a worsening condition requiring immediate medical attention, you should inform your doctor, pharmacist, or nurse about taking Silcontrol and the time of its administration. You should not take Silcontrol with other medicines without your doctor's advice.

You should not take Silcontrol if you are taking 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 often used to relieve symptoms of angina pectoris ("chest pain").

You should not take Silcontrol if you are taking medicines that release nitric oxide (e.g., amyl nitrite), as their simultaneous use may also lead to a dangerous decrease in blood pressure.

If you are already taking riociguat, you should inform your doctor or pharmacist.

In the case of taking protease inhibitors used to treat HIV infection, your doctor may recommend starting treatment with the lowest dose (25 mg) of Silcontrol.

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, resulting from a drop in blood pressure when standing up or sitting down quickly. Such symptoms have occurred in some patients taking sildenafil and alpha-adrenergic blockers. This is most likely to happen within 4 hours of taking Silcontrol. To reduce the possibility of these symptoms, you should regularly take your fixed dose of alpha-adrenergic blocker before starting Silcontrol. Your doctor may decide to use a lower initial dose (25 mg) of Silcontrol.

You should tell your doctor or pharmacist if you are taking medicines containing sacubitril with valsartan, used to treat heart failure.

Taking Silcontrol with food, drink, and alcohol

Silcontrol can be taken with or without food.

Taking Silcontrol with a large meal may prolong the time to the start of its action.

The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of Silcontrol, you should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Silcontrol is not intended for use by women.

Driving and using machines

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

3. How to take Silcontrol

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult your doctor or pharmacist. The recommended dose is 25 mg. Your doctor may, after consultation, recommend a different dosage regimen.

Silcontrol should not be taken more than once a day.

You should not take sildenafil in the form of film-coated tablets at the same time as another sildenafil in the form of orally disintegrating tablets.

Silcontrol 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 Silcontrol is too strong or too weak, you should consult your doctor or pharmacist.

Silcontrol allows for an erection only if there is prior sexual stimulation.

The time to the onset of Silcontrol's action varies from person to person, usually ranging from half an hour to one hour. The action may occur later if the medicine is taken after a large meal.

You should contact your doctor if, after taking Silcontrol, you do not experience an erection or if the duration of the erection is not sufficient for sexual intercourse.

In case of taking a higher dose of Silcontrol 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.

Do not take more tablets than indicated in the patient leaflet

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, you should consult your doctor or pharmacist.

4. Possible side effects

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

In case of experiencing any of the following side effects, you should stop taking Silcontrol and seek medical attention 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 uncommonly. If they occur during or after sexual intercourse:
• you should sit half-up and try to relax,
• do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in 1 in 1000 patients). If an erection lasts for more than 4 hours, you should contact your doctor immediately.
• Sudden vision loss or blindness - occurs rarely.
• Severe skin reactions - occur rarely. They 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 with a colored glow, blurred vision, disturbances in vision, stuffy nose, dizziness.
Uncommon(may occur in 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctival hyperemia, eye pain, seeing flashes of light, bright vision, sensitivity to light, lacrimation, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, drowsiness, decreased sensation of touch, dizziness, ringing in the ears, dry mouth, stuffy or blocked sinuses, rhinitis (symptoms include runny nose, sneezing, and stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, arm or leg pain, nosebleeds, feeling hot, and feeling tired.
Rare(may occur in 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of compression in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased visual acuity, 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 eye white, penile bleeding, presence of blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden hearing loss.

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 in most, but not all, men who experienced these side effects, heart function disorders existed before taking the medicine. It is not possible to determine whether these side effects were related to the use of sildenafil.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your 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.

By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Silcontrol

The medicine should be stored out of sight and reach of children.

There are no special precautions for storage.

Do 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. You should ask your 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 contains

• The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).
• The medicine also contains:
• Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium croscarmellose,
• Coating: hypromellose, titanium dioxide (E 171), macrogol 6000, talc, indigo carmine (E 132), lac.

What Silcontrol looks like and contents of the pack

Silcontrol 25 mg, film-coated tablets are available in PVC/Aluminum blisters in a cardboard box, containing 2, 4, or 8 tablets.

Marketing authorization holder and manufacturer

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

To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, you should contact:

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:July 2023

DIAGNOSTIC TOOL

ATTENTION!

Silcontrol is intended for the treatment of erectile dysfunction, i.e., the inability to achieve or maintain penile stiffness sufficient for sexual intercourse. This medicine is for you if you are an adult (≥ 18 years old) male and have problems with erections that make it difficult for you to have sexual intercourse. If you check at least one answer: YES or NO

I KNOW, this medicine is NOT for you!

Does any of the following situations apply to you?

YES
NO
I DON'T KNOW
NO

• in the last 6 months, you have had a heart attack or stroke □ □ □
• in the past, you have experienced loss of consciousness when changing body position rapidly □ □ □
• you have penile deformation, which makes penetration difficult, or diagnosed Peyronie's disease (penile fibrosis) □ □ □
• you are already using other methods to treat erectile dysfunction than medicines containing sildenafil □ □ □
• you are being treated for HIV infection □ □ □
• you have lost vision in one eye due to a cause other than injury, cataract, or glaucoma □ □ □
• you have been diagnosed with hereditary retinal disorders (such as retinitis pigmentosa) □ □ □
• you have been diagnosed with rare hereditary disorders affecting the shape of red blood cells (such as sickle cell anemia) □ □ □
• you have been diagnosed with liver cirrhosis □ □□
• you have experienced sudden hearing loss □ □□

Do you currently have:

YES
NO
I DON'T KNOW
NO
□
□
□

• stomach ulcers, whose symptoms have worsened in the last week (stomach pain, nausea, vomiting)
• severe bleeding disorders (e.g., hemophilia) □ □ □
• leukemia (a blood cancer) □ □ □
• multiple myeloma (a bone marrow cancer) □ □ □
• hepatitis (viral liver inflammation) □ □ □
• pulmonary hypertension (i.e., high blood pressure in the lungs) □ □ □

REMEMBER!

Erectile dysfunction can be caused by other medicines you are taking or other diseases you are suffering from. Proper treatment of some diseases may cause erectile dysfunction to disappear. The occurrence of erectile dysfunction is also an important clue for your doctor, which can help him diagnose certain diseases, including heart disease.

Therefore, during periodic visits, you should always inform your doctor about problems with erections and the fact that you are taking Silcontrol.