Silcontrol Fc

Package Leaflet: Information for the Patient

Silcontrol FC 100 mg, Film-Coated Tablets

Sildenafil in the form of citrate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Silcontrol FC and what is it 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 is Silcontrol FC and what is it 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 the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Silcontrol FC helps achieve an erection only if there is prior sexual stimulation.
Silcontrol FC 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.

2. Important information before taking Silcontrol FC

When not to take 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 simultaneous intake 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, consult a doctor or pharmacist.
• If the patient is taking medicines that release nitric oxide (e.g., amyl nitrite), as their simultaneous intake 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). It has been shown that PDE5 inhibitors, such as Silcontrol FC, 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 certain rare eye diseases (such as 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 FC, the patient should discuss it with their doctor, pharmacist, or nurse in the following cases:

• Sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), 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 FC and contact their doctor immediately.

Silcontrol FC should not be taken simultaneously with other oral or topical treatments for erectile dysfunction.
Silcontrol FC should not be taken simultaneously with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.
Silcontrol FC should not be taken if erectile dysfunction has not been diagnosed.
Silcontrol FC is not intended for women.
Use of Silcontrol FC in patients with kidney or liver function disorders
Patients with kidney or liver function disorders should inform their doctor, who may decide to administer a lower dose of Silcontrol FC.
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 FC should not be used in persons under 18 years of age.

Silcontrol FC 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 FC may interact with some medicines, especially those used to treat chest pain. In case of a worsening condition that requires immediate medical attention, the patient should inform their doctor, pharmacist, or nurse about taking Silcontrol FC. The patient should not take Silcontrol FC with other medicines without their doctor's advice.
The patient should not take Silcontrol FC if they are taking nitrate medicines, as their simultaneous 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 often used to treat angina pectoris ("chest pain").
The patient should not take Silcontrol FC if they are taking medicines that release nitric oxide (e.g., amyl nitrite), as their simultaneous use may also cause a dangerous decrease in blood pressure.
If the patient is already taking riociguat, they should inform their doctor or pharmacist.
In the case of taking protease inhibitors used to treat HIV infections, the doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil.
In some patients who take alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of orthostatic hypotension, characterized by a drop in blood pressure when standing up or sitting down quickly. Such symptoms occurred in some patients taking Silcontrol FC and alpha-adrenergic blockers. This is most likely to happen within 4 hours of taking Silcontrol FC. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Silcontrol FC. The doctor may decide to use a lower initial dose of 25 mg of sildenafil.
The patient should tell their doctor or pharmacist if they are taking medicines containing sacubitril with valsartan, used to treat heart failure.

Taking Silcontrol FC with food, drink, and alcohol

Silcontrol FC can be taken with or without food.
Although taking Silcontrol FC while eating 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 FC, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Silcontrol FC is not intended for use by women.

Driving and using machines

Silcontrol FC may cause dizziness and vision disturbances. Before driving or operating machinery, patients should find out how Silcontrol FC affects them.

3. How to take Silcontrol FC

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. The recommended starting dose is 50 mg.
Silcontrol FC should not be taken more than once a day.
The patient should not take sildenafil in the form of film-coated tablets in combination with another sildenafil in the form of orodispersible 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 the patient feels that the effect of Silcontrol FC is too strong or too weak, they should consult their doctor or pharmacist.
Silcontrol FC enables an erection only if there is prior sexual stimulation.
The time after which the effect of Silcontrol FC occurs varies from person to person, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal. The patient should tell their doctor if, after taking Silcontrol FC, 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 FC 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 prescribed by their doctor.
The patient should contact their doctor in case of taking more tablets than prescribed.
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

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

In case of experiencing any of the following side effects, the patient should stop taking Silcontrol FC and seek immediate medical attention:

• 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 the following occur 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 for more than 4 hours, the patient should contact their doctor immediately.

• Sudden vision loss or blindness - occurs rarely.
• Severe skin reactions - occur rarelySymptoms may include severe peeling and swelling of the skin, blisters 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 tinge, blurred vision, disturbances in vision, 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 of touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, nasal congestion (symptoms include a runny nose, sneezing, and a stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain in the 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 in blood flow to part of the brain, feeling of pressure 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, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden loss of hearing.
After the medicine was placed on 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 Silcontrol FC. It is not possible to determine whether these side effects were related to the use of Silcontrol FC.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Silcontrol FC

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 that month.
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 FC contains

• The active substance is sildenafil. Each Silcontrol FC 100 mg tablet contains 100 mg of sildenafil (in the form of 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), lacquer.

What Silcontrol FC looks like and contents of the pack

Silcontrol FC 100 mg film-coated tablets are available in PVC/Aluminum blisters in a cardboard box containing 4, 8, or 12 tablets.
Not all pack sizes may be marketed in each country.

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

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

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

For further information, please contact the representative of the Marketing Authorization Holder in Poland:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
Tel. +48 22 375 92 00
Date of last revision of the leaflet:July 2023