Silcontrol fc

Package leaflet: Information for the patient

Silcontrol FC 100 mg, coated tablets
Sildenafil as citrate
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

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

Silcontrol FC 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. Silcontrol FC helps achieve an erection only if sexual stimulation is present.
Silcontrol FC 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.

2. Important information before using Silcontrol FC

When not to use Silcontrol FC

• 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). In case of doubt, consult a doctor or pharmacist.
• If the patient is taking medicines that release nitric oxide (e.g., amyl nitrate), as 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 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 FC 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 suffered a stroke or heart attack, or has low blood pressure.
• If the patient has certain rare eye diseases (such as pigmentary retinal degeneration 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 Silcontrol FC, discuss this with a 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).
• The patient has been diagnosed with penile anatomical deformity or Peyronie's disease.
• 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.
• The patient has peptic ulcer disease or bleeding disorders (such as hemophilia).
• Sudden decrease or loss of vision occurs, treatment with Silcontrol FC should be stopped immediately and the patient should contact a doctor without delay.

Silcontrol FC should not be used concomitantly with other oral or topical treatments for erectile dysfunction.
Silcontrol FC should not be used together with arterial pulmonary hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Silcontrol FC should not be taken if erectile dysfunction has not been diagnosed.
Silcontrol FC is not a medicine intended for use in women.

Use of Silcontrol FC 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 FC.

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

Silcontrol FC and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Silcontrol FC may interact with certain medicines, especially those used to treat chest pain (angina). If the patient's health deteriorates and requires immediate medical attention, inform the doctor, pharmacist, or nurse that Silcontrol FC has been taken. Do not take Silcontrol FC together with other medicines without medical advice.
Do not take Silcontrol FC if the patient is taking nitrates, as 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 FC if the patient is taking medicines that release nitric oxide (e.g., amyl nitrate), as their concomitant use may also cause a dangerous decrease in blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
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.
In some patients taking α-adrenergic blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of orthostatic hypotension (a drop in blood pressure upon standing up or sitting down quickly). Such symptoms have been observed in some patients taking Silcontrol FC together with α-adrenergic blockers. This is most likely within 4 hours after taking Silcontrol FC. To reduce the possibility of these symptoms, the patient should be on a stable dose regimen of their α-adrenergic blocker before starting Silcontrol FC. The doctor may decide to start with a lower initial dose of 25 mg of sildenafil.
Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Use of Silcontrol FC with food, drink, and alcohol
Silcontrol FC can be taken with or without food. However, taking Silcontrol FC with a heavy meal may delay the onset of its effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of Silcontrol FC, significant alcohol intake should be avoided before taking the medicine.

Pregnancy, breastfeeding, and fertility
Silcontrol FC is not intended for use in women.

Driving and operating machinery
Silcontrol FC may cause dizziness and visual disturbances. Patients should assess how they react to Silcontrol FC before driving or operating machinery.

3. How to use Silcontrol FC

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist. The recommended starting dose is 50 mg.
Silcontrol FC must not be taken more than once a day.
Do not take sildenafil in the form of coated tablets in combination with another
sildenafil formulation in the form of orally disintegrating tablets.
Silcontrol FC should be taken approximately one hour before planned sexual
activity. The tablet should be swallowed whole with a glass of water.
If you feel the effect of Silcontrol FC is too strong or too weak, consult your
doctor or pharmacist.
Silcontrol FC enables an erection to occur only in the presence of sexual
stimulation.
The time it takes for Silcontrol FC to take effect varies between patients, usually
ranging from half an hour to one hour. The effect may occur later if the medicine is
taken after a heavy meal. Inform your doctor if, after taking Silcontrol FC, an erection
does not occur or if the duration of erection is insufficient for sexual intercourse.
If you take more Silcontrol FC 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, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them. Adverse reactions reported with the use of Silcontrol FC are usually mild or moderate in intensity and transient.
If any of the following adverse reactions occur,
discontinue taking SILCONTROL FC and seek immediate medical help:

• 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 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 in 1000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.

• Sudden worsening 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 genital organs and around the eyes, fever.
• Seizures or convulsions – occur rarely.

Other adverse reactions:
Very common (may affect more than 1 in 10 patients): headache.
Common (may affect 1 in 10 patients): nausea, sudden flushing, hot flushes (symptoms include feeling of warmth in the upper body), dyspepsia, seeing coloured tinges, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon (may affect 1 in 100 patients): vomiting, skin rash, eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity, tearing of the eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, drowsiness, reduced sense of touch, dizziness, tinnitus, dry mouth, stuffy or blocked 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 affect 1 in 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, decreased 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, pupil dilation, abnormal discoloration of the white part of the eye, rectal bleeding, presence of blood in semen, dry nose, nasal swelling, feeling of irritation, and sudden weakness or loss of hearing.

Since the medicine has been marketed, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that in most, but not all, men who experienced these adverse reactions, cardiac disorders were present prior to taking Silcontrol FC. It is not possible to determine whether these adverse reactions were related to the use of Silcontrol FC.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Silcontrol FC

Keep this medicine out of the 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 after:
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. Such measures help protect the environment.

6. Package contents and other information

What Silcontrol FC contains

• The active substance is sildenafil. Each Silcontrol FC 100 mg tablet contains 100 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), lac.

What Silcontrol FC looks like and contents of the pack
Silcontrol FC 100 mg film-coated tablets are available in PVC/aluminium blisters
in a cardboard carton containing 4, 8 or 12 tablets.
Not all pack sizes may be marketed in a given country.

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

Manufacturers
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 authorised in the following names in the European Economic Area:

Austria: Sildenafil Liconsa 100 mg Filmtabletten
Greece: Sildenafil Bausch Health 100 mg Επικαλυμμένο με λεπτό υμένιο δισκίο
Poland: Silcontrol FC

For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00