Package leaflet: information for the patient

SILDEROS, 25 mg, film-coated tablets
Sildenafilum
Read the entire leaflet carefully before using 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 the physician or pharmacist.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
If you experience any adverse reactions, including any possible side effects 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

What SILDEROS is and what it is used for
Important information before taking SILDEROS
How to take SILDEROS
Possible side effects
How to store SILDEROS
Contents of the pack and other information

1. What SILDEROS is and what it is used for

SILDEROS contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation. SILDEROS helps achieve an erection only if sexual stimulation is present beforehand.
SILDEROS is used in the treatment of erectile dysfunction in adult men, also known as impotence. This condition is defined as the inability to achieve or maintain a penile erection sufficient for sexual intercourse.

2. Important information before taking SILDEROS

When not to take SILDEROS:

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 medicines containing 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; they are often used to relieve symptoms of angina (or "chest pain"). If in doubt, consult a doctor or pharmacist.
If the patient is taking drugs that release nitric oxide, such as 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 hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high lung pressure caused by blood clots). PDE5 inhibitors such as SILDEROS 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 hereditary degenerative retinal disorders, i.e. 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 SILDEROS, discuss this with a doctor or pharmacist if:

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

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

Special considerations for 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 of SILDEROS higher than 25 mg.

Children and adolescents
SILDEROS should not be used in individuals under 18 years of age.

SILDEROS and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
SILDEROS may interact with certain medicines, particularly those used to treat chest pain.
If the patient's health deteriorates and requires immediate medical attention, inform the doctor, pharmacist, or nurse about taking SILDEROS and the time of its intake.
Do not take SILDEROS together with other medicines without a doctor's recommendation.
Do not take SILDEROS 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 used to treat angina ("chest pain").
Do not use SILDEROS if the patient is taking drugs that release nitric oxide, such as amyl nitrite, 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, consult a doctor before taking SILDEROS.
In some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of low blood pressure caused by a sudden drop in blood pressure upon standing up or sitting down quickly. Such symptoms have been reported in some patients taking sildenafil and alpha-blockers concomitantly. These are most likely to occur within 4 hours after taking SILDEROS. To reduce the possibility of these symptoms, the patient should be on a stable dose regimen of their alpha-blocker before starting SILDEROS. The patient should consult their doctor before taking SILDEROS.
If symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending fainting) occur, the patient should lie down or sit down and wait until symptoms subside. Drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help.
Avoid standing up or sitting down quickly.
If the patient is taking medicines containing sacubitril with valsartan, used to treat heart failure, inform the doctor or pharmacist.

SILDEROS with food, drink, and alcohol
SILDEROS may be taken with or without food. However, taking SILDEROS with a heavy meal may delay the onset of its action.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic benefit of SILDEROS, significant amounts of alcohol should not be consumed before taking the medicine.

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

Driving and operating machinery
SILDEROS may cause dizziness and visual disturbances. Patients should be aware of how they react to SILDEROS before driving or operating machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free."

3. How to take SILDEROS
This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.
The recommended dose is 25 mg (1 SILDEROS tablet). After consultation, the doctor may recommend a different dosing regimen.
SILDEROS should not be taken more than once a day.
Do not take SILDEROS coated tablets together with other medicines containing sildenafil.
SILDEROS should be taken approximately one hour before planned sexual activity.
The tablet should be swallowed whole with a glass of water.
If the effect of SILDEROS seems too strong or too weak, consult a doctor or pharmacist.
SILDEROS enables an erection only in the presence of sexual stimulation. The time to onset of action of SILDEROS 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 a doctor if, after taking SILDEROS, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.

Taking more SILDEROS than recommended
Adverse effects may occur more frequently and be more severe.
Taking a dose greater than 100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than indicated in the patient leaflet.
Contact a doctor if more tablets have been taken than recommended.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions reported with the use of SILDEROS are usually mild or
moderately severe and short-lived.
If any of the following adverse reactions occur, stop taking SILDEROS and seek immediate medical help:

Allergic reaction – occurs uncommonly (may affect up to 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, the patient:
- should adopt a semi-sitting position and try to relax,
- should not take nitrates to relieve chest pain.
Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1,000 patients). If an erection lasts more 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, 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 people):

headache.

Common (may affect up to 1 in 10 patients):

nausea,
sudden flushing,
hot flushes (symptoms include a feeling of warmth in the upper body),
indigestion,
coloured vision, blurred vision, visual disturbances,
stuffy nose,
dizziness.

Uncommon (may affect up to 1 in 100 patients):

vomiting,
skin rash,
eye irritation, eye redness,
eye pain, seeing flashes of light, bright vision,
light sensitivity, watery eyes,
palpitations, rapid heartbeat,
hypertension, hypotension,
muscle pain,
drowsiness,
reduced sense of touch,
dizziness,
ringing in the ears,
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,
feeling of fatigue.

Rare (may affect up to 1 in 1,000 patients):

fainting,
stroke,
heart attack,
irregular heartbeat,
transient reduction in blood flow to part of the brain,
sensation of throat tightness,
numbness of the lips,
bleeding into the back of the eye or eyelids,
double vision,
reduced visual acuity,
abnormal sensations inside the eye,
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,
presence of blood in semen,
dry nose,
swelling inside the nose,
feeling of irritability,
sudden hearing loss or decreased 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 patients who experienced these adverse reactions, pre-existing heart conditions were present before taking the medicine containing sildenafil. It is not possible to determine whether these adverse reactions were related to the use of SILDEROS.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store SILDEROS

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What SILDEROS contains

The active substance is sildenafil. Each coated tablet contains 25 mg of sildenafil (as citrate).
Other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
Coating: polyvinyl alcohol - partially hydrolysed, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine, lac (E 132), hypromellose 5 cP (type 2910), triacetin.

What SILDEROS looks like and contents of the pack
SILDEROS 25 mg, film-coated tablets are blue, round, biconvex, with a diameter of 7.4 mm, embossed with "25" on one side and "HJ" on the other side of the tablet.
The tablets are packed in PVC/aluminum blisters containing: 2, 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Tel. 607 696 231
e-mail: [email protected]

Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

Synoptis Industrial Sp. z o.o.	,
Rabowicka Street 15,
Swarzędz, 62-020, Poland

For more detailed information, please contact the representative of the marketing authorization holder.