Silderos

Before taking the medicine, use the diagnostic test included in the packaging!

Leaflet included in the packaging: patient information

SILDEROS, 25 mg, film-coated tablets

Sildenafil

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If the patient's condition does not improve or worsens after taking the medicine, they should contact their doctor.

Table of contents of the leaflet

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

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

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 simultaneous use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medicines from this group; they are often used to relieve symptoms of angina pectoris (or "chest pain"). In case of doubt, the patient should consult their doctor or pharmacist.
• If the patient is taking medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"), as their simultaneous use may also lead to a dangerous decrease in blood pressure.
• If the patient is taking riociguat. This medicine is 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 SILDEROS, 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 hereditary degenerative retinal disorders, i.e., retinitis pigmentosa.
• If the patient has ever experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting to take SILDEROS, the patient should discuss this with their doctor or pharmacist 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 has been diagnosed with Peyronie's disease.
• Heart problems. The doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity.
• Ulcer or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden blindness, they should stop taking SILDEROS and seek medical attention immediately.

SILDEROS should not be taken simultaneously with other oral or topical treatments for erectile dysfunction.

SILDEROS should not be taken simultaneously with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

SILDEROS should not be taken if the patient has not been diagnosed with erectile dysfunction.

SILDEROS is not intended for women.

Special considerations for patients with kidney or liver function disorders

Patients with kidney or liver function disorders should inform their doctor. Patients with kidney or liver function disorders should not take a dose of SILDEROS higher than 25 mg.

Children and adolescents

SILDEROS should not be taken by persons under 18 years of age.

SILDEROS 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.

SILDEROS may interact with some medicines, especially those used to treat chest pain.

In case of a worsening condition requiring immediate medical attention, the patient should inform their doctor, pharmacist, or nurse about taking SILDEROS and the time of its administration.

SILDEROS should not be taken with other medicines without a doctor's recommendation.

SILDEROS should not be taken if the patient is taking medicines from the nitrate group, 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 used to treat angina pectoris (or "chest pain").

SILDEROS should not be taken if the patient is taking medicines that release nitric oxide, such as amyl nitrite, as their simultaneous use may cause a dangerous decrease in blood pressure.

If the patient is already taking riociguat, they should inform their doctor or pharmacist.

When taking protease inhibitors used to treat HIV infections, the patient should consult their doctor before taking SILDEROS.

In some patients taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which may be symptoms of low blood pressure caused by a drop in blood pressure when standing up or sitting down quickly. Such symptoms have occurred in some patients taking sildenafil and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours after taking SILDEROS. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take SILDEROS. Before taking SILDEROS, the patient should consult their doctor.

In case of symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending fainting), the patient should first lie down or sit and wait for the symptoms to pass; drinking water, taking fresh air, tensing abdominal muscles, or crossing legs may also help.

The patient should avoid standing up or sitting down quickly.

If the patient is taking medicines containing sacubitril with valsartan, used to treat heart failure, they should inform their doctor or pharmacist.

SILDEROS with food, drink, and alcohol

SILDEROS can be taken with or without food. Although taking SILDEROS during a heavy meal may prolong the time needed for the medicine to start working.

The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of SILDEROS, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

SILDEROS is not intended for use by women.

Driving and using machines

SILDEROS may cause dizziness and vision disturbances. Patients should be aware of how they react to SILDEROS before driving or operating machines.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means 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. In case of doubt, the patient should consult their doctor or pharmacist.

The recommended dose of SILDEROS is 25 mg (1 tablet). The doctor may recommend a different dosing regimen after consultation.

SILDEROS should not be taken more than once a day.

The patient should not take SILDEROS tablets simultaneously with other medicines containing sildenafil.

SILDEROS should be taken about an hour before planned sexual activity.

The tablet should be swallowed whole with a glass of water.

If the patient feels that the effect of SILDEROS is too strong or too weak, they should consult their doctor or pharmacist.

SILDEROS allows for an erection only if there is prior sexual stimulation. The time it takes for SILDEROS to work 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 contact their doctor if they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse after taking SILDEROS.

Taking a higher dose of SILDEROS 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 effectiveness of the medicine.

The patient should not take more tablets than indicated in the patient leaflet.

The patient should contact their doctor in case of taking more tablets than recommended.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, SILDEROS can cause side effects, although not everybody gets them.

Side effects reported in connection with the use of SILDEROS are usually mild or moderate and short-lived.

In case of any of the following side effects, the patient should stop taking SILDEROS and seek medical attention immediately:

• Allergic reaction - occurs uncommonly(may affect up to 1 in 100 people) Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - occurs uncommonlyIf it occurs during or after sexual intercourse, the patient:
• should sit half-upright and try to relax,
• should not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may affect up to 1 in 1,000 people) If the erection lasts more than 4 hours, the patient should seek medical attention immediately.
• Sudden vision loss or blindness - occurs rarely
• Severe skin reactions - occurs rarelySymptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occurs rarely

Other side effects:

Very common(may affect more than 1 in 10 people):

• headache.

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

• nausea,
• sudden flushing of the face,
• hot flushes (symptoms include a feeling of heat in the upper part of the body),
• indigestion,
• visual disturbances, including blurred vision,
• stuffy nose,
• dizziness.

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

• vomiting,
• skin rash,
• eye irritation, conjunctivitis,
• eye pain, seeing flashes of light, increased light sensitivity,
• light sensitivity, tearing of the eyes,
• palpitations, rapid heartbeat,
• high blood pressure, low blood pressure,
• muscle pain,
• drowsiness,
• reduced sense of touch,
• dizziness,
• ringing in the ears,
• dry mouth,
• stuffy or runny nose,
• nasal congestion (symptoms include a runny nose, sneezing, and a stuffy nose),
• upper abdominal pain,
• gastroesophageal reflux disease (symptoms include heartburn),
• blood in urine,
• arm or leg pain,
• nosebleeds,
• feeling hot,
• feeling tired.

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

• fainting,
• stroke,
• heart attack,
• irregular heartbeat,
• temporary reduction of blood flow to part of the brain,
• feeling of tightness in the throat,
• numbness of the lips,
• bleeding into the back of the eye or eyelids,
• double vision,
• reduced visual acuity,
• abnormal sensations in the eye,
• small particles or spots in the field of vision,
• 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 irritable,
• sudden hearing loss.

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 side effects, heart function disorders were present before taking the medicine containing sildenafil. It is not possible to determine whether these side effects were related to the use of SILDEROS.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store SILDEROS

The medicine should be stored out of sight and reach of children.

There are no special recommendations for storing the medicine.

The patient should not use this medicine after the expiry date stated on the carton and blister after the abbreviation: EXP. The expiry date refers to the last day of the given 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 SILDEROS contains

• The active substance of the medicine is sildenafil. Each film-coated tablet contains 25 mg of sildenafil (as citrate).
• The other ingredients of the medicine are:
• Core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate. Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine, lake (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, and biconvex with a diameter of 7.4 mm, with "25" embossed on one side of the tablet and "HJ" on the other side.

The tablets are packaged in PVC/Aluminum blisters containing 2, 4, or 8 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.

ul. Krakowiaków 65

02-255 Warsaw

Tel. 607 696 231

e-mail: [email protected]

Manufacturer/Importer:

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

To obtain more detailed information, the patient should contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: