Silcontrol
Poland
Table of Contents
Before using the medicine, please 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.
Package leaflet: information for the patient
Silcontrol, 25 mg, coated tablets
Sildenafilum
Please read the entire leaflet carefully before taking this 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 physician or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after using the medicine, or if you feel worse, contact your doctor.
Table of contents of the leaflet:
- What Silcontrol is and what it is used for
- What you need to know before taking Silcontrol
- How to take Silcontrol
- Possible side effects
- How to store Silcontrol
- Contents of the pack and other information
1. What Silcontrol is and what it is used for
Silcontrol contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Silcontrol works by helping to relax blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation. Silcontrol helps achieve an erection only if sexual stimulation occurs.
Silcontrol is used in the treatment of erectile dysfunction in adult men, defined as the inability to achieve or maintain a penile erection sufficient for sexual intercourse.
Before using the medicine, please 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 using Silcontrol
When not to use Silcontrol
- 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 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 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"), because their concomitant use may also lead to a dangerous decrease in blood pressure.
- If the patient is taking riociguat. This is a medicine used to treat pulmonary arterial 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 Silcontrol, 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 eye diseases (such as inherited retinal degenerative disorders, e.g. retinitis pigmentosa).
- If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy.
Warnings and precautions
Before starting to take Silcontrol, the patient should discuss this with their doctor or pharmacist if:
- They have sickle cell anemia (an abnormality affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
- They have been diagnosed with anatomical deformity of the penis or Peyronie's disease.
- They have heart problems. The doctor should assess whether the condition of the heart muscle allows for the additional strain associated with sexual activity.
- They have peptic ulcer disease or bleeding disorders (such as hemophilia).
- They experience sudden worsening of vision or sudden vision loss, in which case they should stop taking Silcontrol immediately and contact their doctor without delay.
Silcontrol must not be used concomitantly with other oral or topical treatments for erectile dysfunction.
Silcontrol must not be used concomitantly with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Silcontrol should not be taken if erectile dysfunction has not been diagnosed.
Silcontrol is not a medicine intended for use in women.
Use in 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 of Silcontrol.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Children and adolescents
Silcontrol must not be used in individuals under 18 years of age.
Silcontrol and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Silcontrol may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and requires immediate medical attention, the doctor, pharmacist, or nurse must be informed about the intake of Silcontrol and the time it was taken. Silcontrol must not be taken with other medicines unless prescribed by a doctor.
Do not take Silcontrol if the patient is taking nitrates, because their concomitant use may lead to a dangerous decrease 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 Silcontrol if the patient is taking drugs that release nitric oxide (e.g. amyl nitrite), because their concomitant use may also cause a dangerous decrease in blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
For patients taking protease inhibitors used in the treatment of HIV infection, the doctor may recommend starting treatment with the lowest dose (25 mg) of Silcontrol.
In some patients taking α-adrenolytic agents for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of low blood pressure, such as a drop in blood pressure upon rapid standing or sitting up. Such symptoms have been reported in some patients taking sildenafil and α-adrenolytic agents concomitantly. This is most likely within 4 hours after taking Silcontrol. To reduce the possibility of these symptoms, the patient should be on a stable dose regimen of their α-adrenolytic agent before starting Silcontrol. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of Silcontrol.
Tell your doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.
Taking Silcontrol with food, drink, and alcohol
Silcontrol may be taken with or without food. Taking Silcontrol 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 Silcontrol, significant amounts of alcohol should be avoided before taking the medicine.
Pregnancy, breastfeeding, and fertility
Silcontrol is not intended for use in women.
Driving and operating machinery
Silcontrol may cause dizziness and visual disturbances. Patients should assess how they react to Silcontrol before driving or operating machinery.
3. How to take Silcontrol
This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist. The recommended dose is 25 mg. Your doctor may, after consultation, recommend a different dosing regimen.
Do not take Silcontrol more than once a day.
Do not take sildenafil coated tablets together with sildenafil tablets intended to disintegrate in the oral cavity.
Silcontrol 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 Silcontrol is too strong or too weak, consult your doctor or pharmacist.
Silcontrol enables an erection to occur only in the presence of sexual stimulation.
The time it takes for Silcontrol 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 Silcontrol, an erection is not achieved or if the duration of erection is insufficient for sexual intercourse.
If you take more Silcontrol than recommended
You may experience adverse effects more frequently and they may be more severe.
Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than indicated in the patient information leaflet.
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 the use of Silcontrol are usually mild or moderate in intensity and transient.
If any of the following adverse reactions occur, stop taking Silcontrol and seek immediate medical help:
- Allergic reaction – occurs not commonly (may occur in 1 out of 100 patients). Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.
- Chest pain – occurs not commonly. If chest pain occurs during or after sexual intercourse:
- adopt a semi-sitting position and try to relax,
- do not take nitrates to relieve chest pain.
- Prolonged and sometimes painful erections – occur rarely (may occur in 1 out of 1000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.
- Sudden decrease or loss of vision – occurs rarely.
- Severe skin reactions – occur rarely. These may include severe skin peeling and swelling, formation of blisters in the mouth, on the genital organs, and around the eyes, fever.
- Seizures or convulsions – occur rarely.
Other adverse reactions:
Very common (may occur in more than 1 out of 10 patients): headache.
Common (may occur in 1 out of 10 patients): nausea, sudden flushing of the face, hot flushes (symptoms include a feeling of warmth in the upper body), dyspepsia, colored vision, blurred vision, visual disturbances, stuffy nose, dizziness.
Not common (may occur in 1 out of 100 patients): vomiting, skin rash, eye irritation, eye hyperemia, eye pain, seeing flashes of light, bright vision, light sensitivity, tearing of the eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, somnolence, reduced sense of touch, dizziness, tinnitus, dry mouth, blocked or stuffy sinuses, nasal mucositis (symptoms include runny nose, sneezing, and blocked nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in hands or feet, nosebleeds, feeling of warmth, and feeling of fatigue.
Rare (may occur in 1 out of 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, throat tightness, lip numbness, 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 white part of the eye, penile bleeding, blood in semen, dry nose, nasal swelling, feeling of irritation, and sudden hearing loss or hearing impairment.
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, cardiac disorders were present prior to taking the medicine. It is not possible to determine whether these adverse reactions were related to the use of sildenafil.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.
5. How to store the medicine Silcontrol
Keep this medicine out of sight and reach of children.
No special precautions for storage are required.
Do not use this medicine after the expiry date stated on the carton and blister (EXP). The expiry date refers to the last day of the stated month.
The batch number is indicated on the carton and blister (Lot).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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).
- Other ingredients are:
- 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), lacquer.
What Silcontrol looks like and contents of the pack
Silcontrol 25 mg film-coated tablets are available in PVC/Aluminium blisters
packed in a cardboard box containing 2, 4 or 8 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
For further information about the medicinal product and its names in the
European Economic Area countries, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
DIAGNOSTIC TOOL
WARNING!
Silcontrol is intended for the treatment of erectile dysfunction, i.e. the inability to achieve or maintain penile rigidity sufficient for sexual intercourse. This medicine is for you if you are an adult (≥ 18 years of age) male and erectile problems are interfering with your sexual activity. If you answer YES or NO at least once, this medicine is NOT for you!
| Are you taking medications used to relieve symptoms of coronary heart disease (angina, chest pain), the use of which together with Silcontrol may endanger your life? | YES DON'T KNOW | NO |
| □ □ □ □ □ □ □ □ □ □ □ □ □ □ | □ □ □ □ □ □ □ |
| Are you taking the following medications? | YES DON'T KNOW | NO |
| □ □ □ □ □ □ □ □ □ □ | □ □ □ □ □ |
Do you experience any of the following symptoms?
| YES NO DON'T KNOW □ □ □ □ □ □ □ □ □ □ □ □ □ □ | NO □ □ □ □ □ □ □ |
Does any of the following situations apply to you?
YES NO DO NOT
KNOW
- you have had a heart attack or stroke in the last 6 months □ □ □
- you have previously experienced loss of consciousness with sudden body □ □ □ position changes
- you have penile curvature that interferes with penetration or diagnosed □ □ □ Peyronie's disease (penile fibrosis)
- you are already using other treatments for erectile dysfunction besides drugs containing □ □ □ sildenafil
- you are being treated for HIV infection □ □ □
- you have lost vision in one eye due to causes other than injury, cataract, □ □ □ or glaucoma
- you have been diagnosed with hereditary retinal disorders (such as □ □ □ retinitis pigmentosa)
- you have been diagnosed with rare, inherited abnormalities in the shape of red blood cells (such as sickle cell □ □ □ anemia)
- you have been diagnosed with liver cirrhosis □ □ □
- you have experienced sudden hearing loss □ □ □
Are you currently suffering from:
YES NO DO NOT
KNOW
- peptic ulcer disease with symptoms worsening in the past week (abdominal □ □ □ pain, nausea, vomiting)
- severe blood coagulation disorders (e.g. hemophilia) □ □ □
- leukemia (blood cancer) □ □ □
- multiple myeloma (bone marrow cancer) □ □ □
- viral hepatitis □ □ □
- pulmonary hypertension (i.e. high blood pressure in the lungs) □ □ □
REMEMBER!
Erectile problems may be caused by other medications you are taking or by other
medical conditions you have. Proper treatment of certain diseases may resolve
erectile dysfunction. The presence of erectile problems is also an important clue for your doctor,
which may help in diagnosing certain diseases, including heart disease.
Therefore, during regular visits, always inform your doctor about erectile problems and that you are taking Silcontrol.