Silcontrol max

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

Package leaflet: Information for the patient

Silcontrol MAX,
50 mg, film-coated tablets
Sildenafilum
Please read this leaflet carefully 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.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any 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.

Contents of the leaflet:

1. What Silcontrol MAX is and what it is 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 package and other information

1. What Silcontrol MAX is and what it is 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 blood vessels in the penis, increasing blood flow to the penis during sexual stimulation.
Silcontrol MAX helps achieve an erection only if the patient is sexually stimulated.
Silcontrol MAX is used to treat erectile dysfunction in adult men, i.e. impotence defined as the inability to obtain or maintain a penile erection sufficient for sexual intercourse.
Before using the medicine, read the leaflet carefully and familiarize yourself with the enclosed
"Diagnostic Tool". To ensure safe use of the medicine, please answer all questions included in the diagnostic tool.

2. Important information before using Silcontrol MAX

When not to use 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, because their concomitant use may lead to a dangerous drop in blood pressure. The doctor should be informed if the patient is taking any medicines from this group; these medicines 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, commonly known as poppers), because their concomitant use may also lead to a dangerous drop in blood pressure.
• If the patient is taking riociguat. This medicine is used in the treatment of 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 MAX, 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 rare eye diseases (such as inherited retinal degeneration, e.g., retinitis pigmentosa).
• If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting Silcontrol MAX, discuss with a doctor or pharmacist if:

• The patient has sickle cell anemia (an abnormality affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• The patient has been diagnosed with anatomical penile deformity or Peyronie's disease.
• The patient has heart problems. The doctor should assess whether the patient's cardiac condition allows for the additional physical strain associated with sexual activity.
• The patient has peptic ulcer disease or bleeding disorders (such as hemophilia).
• The patient experiences sudden decrease in vision or sudden vision loss, in which case use of Silcontrol MAX should be stopped immediately and the patient should contact a doctor without delay.

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

Use of Silcontrol MAX in patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. Patients with impaired kidney or liver function should not take a dose higher than 25 mg.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., the medicine is considered "sodium-free".

Children and adolescents
Silcontrol MAX must not be used in individuals under 18 years of age.

Silcontrol MAX and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Silcontrol MAX may interact with certain medicines, especially those used to treat chest pain. If the patient's condition worsens and requires immediate medical attention, the doctor, pharmacist, or nurse must be informed about the intake of Silcontrol MAX and the time it was taken. Silcontrol MAX must not be taken with other medicines without a doctor's recommendation.
Do not take Silcontrol MAX if the patient is using nitrates, because their concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates used to treat angina (chest pain).
Do not take Silcontrol MAX if the patient is using drugs that release nitric oxide (such as amyl nitrite, commonly known as poppers), because their concomitant use may cause a dangerous drop 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.
Some patients taking α-adrenergic blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness, which may be symptoms of low blood pressure caused by a drop in blood pressure upon rapid standing or sitting. These symptoms have been observed in some patients taking sildenafil together with α-adrenergic blockers. This is most likely to occur within 4 hours after taking Silcontrol MAX. To reduce the likelihood of these symptoms, the patient should be on a stable dose regimen of their α-adrenergic blocker before starting Silcontrol MAX. The doctor may decide to initiate treatment with a lower starting dose of 25 mg of Silcontrol MAX. If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit until symptoms subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing the legs may also help. Rapid standing or sitting should be avoided.
If the patient is taking ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), consult a doctor before taking Silcontrol MAX.
Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Silcontrol MAX with food, drink, and alcohol
Silcontrol MAX can be taken with or without food. Taking Silcontrol MAX 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 MAX, significant alcohol intake should be avoided before taking the medicine.

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

Driving and operating machinery
Silcontrol MAX may cause dizziness and visual disturbances. Patients should be aware of how they react to Silcontrol MAX before driving or operating machinery.

3. How to use Silcontrol MAX

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose
If the patient has previously used medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, Silcontrol MAX at a dose of 50 mg should only be used if the patient did not achieve the desired effect (i.e. did not obtain an erection sufficient for sexual intercourse) after using sildenafil at a dose of 25 mg.

If using a lower dose of sildenafil (25 mg) enabled the patient to achieve an erection allowing sexual intercourse, the 50 mg dose should not be used.

Silcontrol MAX must not be taken more than once a day.

Do not take sildenafil in the form of coated tablets simultaneously with other medicines containing sildenafil.

If you feel that the effect of Silcontrol MAX is too strong or too weak, consult your doctor or pharmacist.

Silcontrol MAX enables an erection only in the presence of sexual stimulation. The time to onset of 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.

Contact your doctor if, after taking Silcontrol MAX, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.

If you take more Silcontrol MAX than recommended:
The patient 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 leaflet.
Contact your doctor if you have taken more tablets than recommended.

If you have any further doubts regarding 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 Silcontrol MAX are generally mild
or moderate in intensity and transient.
If any of the following adverse reactions occur, discontinue taking Silcontrol MAX and seek immediate medical help:

• Allergic reaction – occurs not commonly (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 not commonly. If it 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 – occurs rarely.
• Severe skin reactions – occur rarely. These may include severe peeling and swelling of the skin, blistering in the mouth, genital area 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 a feeling of warmth in the upper body), indigestion, seeing coloured halos, blurred vision, visual disturbances, stuffy nose, dizziness.
Not common (may affect 1 in 100 patients): vomiting, skin rash, eye irritation, eye congestion, eye pain, seeing flashes of light, bright vision, light sensitivity, tearing eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, 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 affect 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of 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 of the eye, penile bleeding, blood in semen, dry nose, nasal swelling, feeling of irritability, and sudden weakness or hearing loss.

After sildenafil-containing medicines were introduced into 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 adverse reactions, cardiac disorders were present before taking sildenafil-containing medicines. It is not possible to determine whether these adverse reactions were related to the use of Silcontrol MAX.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 authorisation holder or its representative.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Silcontrol MAX

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 marked as: EXP.
The expiry date refers to the last day of the stated month. The batch number is indicated on the carton and blister after: 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 MAX contains

• The active substance is sildenafil. Each Silcontrol MAX 50 mg tablet contains 50 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 MAX looks like and contents of the pack
Silcontrol MAX 50 mg film-coated tablets are available in PVC/Aluminium blisters packed in a cardboard box containing 1, 2 or 4 tablets.
Not all pack sizes may be marketed.

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Sildenafil Liconsa 50 mg Filmtabletten
Greece Sildenafil Bausch Health 50 mg Επικαλυμμένο με λεπτό υμένιο δισκίο
Poland Silcontrol MAX

For further information about this medicinal product, 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