Silderos Max

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

Leaflet included in the packaging: patient information

SILDEROS MAX, 50 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, pharmacist, or nurse.
• 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.
• If the patient's condition does not improve or if they feel worse after taking the medicine, they should contact their doctor.

Table of contents of the leaflet

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

1. What is SILDEROS MAX and what is it used for

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

2. Important information before taking SILDEROS MAX

When not to take SILDEROS 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 medicines containing nitrates, as their concurrent 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 concurrent 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). It has been shown that PDE5 inhibitors, such as SILDEROS MAX, 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, such as 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 treatment with SILDEROS MAX, 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 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.
• Ulcers or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden blindness, they should stop taking SILDEROS MAX and immediately consult their doctor.

SILDEROS MAX should not be taken concurrently with other oral or topical treatments for erectile dysfunction. SILDEROS MAX should not be taken concurrently with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. SILDEROS MAX should not be taken if the patient has not been diagnosed with erectile dysfunction. SILDEROS MAX is not intended for women. Special considerations for patients with renal or hepatic impairmentPatients with renal or hepatic impairment should inform their doctor. The doctor may decide to use a lower dose of sildenafil - 25 mg.

Children and adolescents

SILDEROS MAX should not be taken by individuals under the age of 18.

SILDEROS MAX 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 MAX may interact with certain 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 MAX and the time of its administration. The patient should not take SILDEROS MAX concurrently with other medicines without their doctor's recommendation. The patient should not take SILDEROS MAX if they are taking medicines from the nitrate group, as their concurrent 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"). The patient should not take SILDEROS MAX if they are taking medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"), as their concurrent 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 medicines from the protease inhibitor group, used to treat HIV infections, the patient should inform their doctor before taking SILDEROS MAX; in such cases, it is recommended to start treatment with a lower dose (25 mg) of sildenafil. In some patients taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of low blood pressure caused by a drop in blood pressure during rapid standing or sitting. Such symptoms occurred in some patients taking sildenafil and alpha-adrenergic blockers concurrently. Their occurrence is most likely within 4 hours of taking SILDEROS MAX. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting treatment with SILDEROS MAX. The doctor may decide to use a lower initial dose (25 mg) of sildenafil. If the patient experiences symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending fainting), they 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 rapid standing or sitting. If the patient is taking ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), they should consult their doctor before taking SILDEROS MAX. If the patient is taking medicines containing sacubitril with valsartan, used to treat heart failure, they should inform their doctor or pharmacist.

SILDEROS MAX with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

SILDEROS MAX is not intended for use by women.

Driving and using machines

SILDEROS MAX may cause dizziness and vision disturbances. Before driving or operating machines, patients should find out how they react to SILDEROS MAX. 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 MAX

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. If the patient has previously taken medicines containing sildenafil in a dose of 50 mg or higher, the recommended dose is 50 mg (1 tablet) taken approximately 1 hour before planned sexual activity. Otherwise, SILDEROS MAX in a dose of 50 mg should only be used if the patient did not experience a satisfactory therapeutic effect after taking sildenafil in a dose of 25 mg (i.e., they did not achieve an erection sufficient for sexual intercourse). If the use of a medicine containing sildenafil in a lower dose (25 mg) allowed the patient to achieve an erection enabling sexual intercourse, they should not take a dose of 50 mg. The patient should not take SILDEROS MAX concurrently with other medicines containing sildenafil. SILDEROS MAX should not be taken more than once a day.SILDEROS MAX should be taken approximately 1 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 MAX is too strong or too weak, they should consult their doctor or pharmacist. SILDEROS MAX enables an erection only if there is prior sexual stimulation. The time after which the effect of SILDEROS MAX occurs varies among patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a large 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 MAX.

Taking a higher dose of SILDEROS MAX 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 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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, SILDEROS MAX can cause side effects, although not everybody gets them. Side effects reported in connection with the use of SILDEROS MAX are usually mild or moderate and short-term.

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

• An 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 up and try to relax, should not take nitratesto relieve chest pain.
• should sit up and try to relax,
• should not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may affect up to 1 in 1,000 people) If the erection lasts for more than 4 hours, the patient should contact their doctor immediately.
• Sudden vision loss or blindness - occur rarely
• Severe skin reactions - occur rarelySymptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur 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, hot flashes (symptoms include a feeling of heat in the upper body), indigestion, seeing a blue tint, blurred vision, disturbances in 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 sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation, dizziness, ringing in the ears, dry mouth, stuffy or runny nose, sinusitis (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 affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to a part of the brain, feeling of constriction in the throat, numbness of the lips, bleeding in the back of the eye, double vision, reduced 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, blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden hearing loss or 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, patients who experienced these side effects, heart problems existed before taking the medicine containing sildenafil. It is not possible to determine whether these side effects were related to the use of SILDEROS MAX.

Reporting side effects

If the patient experiences any side effects, including any possible 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, more information can be collected on the safety of the medicine.

5. How to store SILDEROS MAX

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 "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 SILDEROS MAX contains

• The active substance of the medicine is sildenafil. Each tablet contains 50 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 MAX looks like and contents of the pack

SILDEROS MAX, 50 mg, film-coated tablets are blue, round, biconvex with a diameter of 9.2 mm, with "50" embossed on one side of the tablet and "H" and "J" on the other side, with a dividing line for breaking the tablet. The tablet can be divided into equal doses. The tablets are packaged in PVC/Aluminum blisters containing 2 or 4 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 Synoptis Industrial Sp. z o.o., ul. Rabowicka 15, Swarzędz, 62-020, Poland

Date of last revision of the leaflet: 04.2024