Silderos max

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

Package leaflet: information for the patient

SILDEROS MAX, 50 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 this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet for future reference.
• If you have any further questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If you do not notice improvement after using the medicine, or if you feel worse, contact your doctor.

Table of contents

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

SILDEROS MAX 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 MAX helps achieve an erection only if the patient is sexually stimulated.
SILDEROS MAX 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 satisfactory 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 concomitant 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; these 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 simultaneous use may also lead to a dangerous drop 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 MAX have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they must 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 hereditary degenerative retinal disorders, i.e. retinitis pigmentosa.
• If the patient has ever experienced vision loss due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with SILDEROS MAX, discuss this with your doctor, pharmacist, or nurse if:

• The patient has sickle cell anaemia (an abnormality affecting red blood cells), leukaemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• The patient has been diagnosed with anatomical deformity of the penis or Peyronie's disease.
• The patient has heart problems. The doctor should assess whether the patient's cardiac condition allows for the additional strain associated with sexual activity.
• The patient has peptic ulcer disease or bleeding disorders (such as haemophilia).
• If sudden worsening of vision or sudden vision loss occurs, stop taking SILDEROS MAX immediately and contact a doctor without delay.

SILDEROS MAX must not be used concomitantly with other oral or locally applied treatments for erectile dysfunction.
SILDEROS MAX must not be used together with arterial pulmonary hypertension (APH) therapies containing sildenafil or other PDE5 inhibitors.
SILDEROS MAX should not be taken if erectile dysfunction has not been diagnosed.
SILDEROS MAX is not a medicine intended for use by women.

Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. The doctor may decide to prescribe a lower dose of sildenafil – 25 mg.

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

SILDEROS MAX and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.

SILDEROS MAX may interact with certain medicines, particularly those used to treat chest pain. If the patient's health deteriorates and immediate medical attention is required, the doctor, pharmacist, or nurse must be informed about the intake of SILDEROS MAX and the time it was taken. Do not take SILDEROS MAX with other medicines without medical advice.

Do not take SILDEROS MAX if the patient is using nitrate-containing medicines, as 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 (or "chest pain").

Do not take SILDEROS MAX if the patient is using nitric oxide-releasing drugs such as amyl nitrite (so-called "poppers"), as their simultaneous 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, they should inform their doctor before taking SILDEROS MAX; in such cases, treatment should start with a lower dose (25 mg) of sildenafil.

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 drop in blood pressure upon rapid standing or sitting. 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 MAX. To reduce the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting SILDEROS MAX. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of sildenafil.

If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit and wait for symptoms to subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help.

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 in the treatment of 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. However, taking SILDEROS MAX with a heavy meal may delay the onset of its effect.

The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximise the therapeutic effect of SILDEROS MAX, significant amounts of alcohol should not be consumed before taking the medicine.

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

Driving and operating machinery
SILDEROS MAX may cause dizziness and visual disturbances. Patients should assess how they react to SILDEROS MAX before driving or operating machinery.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. 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. If in doubt, consult the doctor or pharmacist.

If the patient has previously used sildenafil-containing medicines at a dose of 50 mg or higher, the recommended dose is 50 mg (1 tablet) taken as needed approximately one hour before planned sexual activity. Otherwise, SILDEROS MAX 50 mg should only be used if the patient did not achieve a satisfactory therapeutic effect (i.e. an erection sufficient for intercourse) after taking 25 mg of sildenafil.

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

Do not take SILDEROS MAX together with other medicines containing sildenafil.

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

SILDEROS MAX 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 MAX seems too strong or too weak, consult the doctor or pharmacist.

SILDEROS MAX enables an erection only in the presence of sexual stimulation. The time to onset of effect of SILDEROS MAX varies between patients, usually ranging from 30 minutes to one hour. The effect may be delayed if the medicine is taken after a heavy meal.

Contact the doctor if, after taking SILDEROS MAX, no erection occurs or if the duration of erection is insufficient for sexual intercourse.

Taking more than the recommended dose of SILDEROS MAX
Adverse reactions may occur more frequently and be more severe.

Taking a dose exceeding 100 mg does not increase the medicine's effectiveness.

Do not take more tablets than indicated in the patient leaflet.

Contact a doctor if more tablets have been taken than recommended.

If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported with SILDEROS MAX are usually mild or moderate in intensity and transient.
If any of the following adverse reactions occur, stop taking SILDEROS MAX and seek immediate medical help:

• Hypersensitivity reaction – occurs uncommonly (may affect up to 1 in 100 patients). Symptoms: sudden wheezing, difficulty in 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 assume a semi-sitting position and try to relax,
  • must 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 longer than 4 hours, contact a doctor immediately.
• Sudden worsening or loss of vision – occurs 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 fits – occur rarely

Other adverse reactions:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, sudden flushing, hot flushes (symptoms include a feeling of warmth in the upper body), dyspepsia, coloured vision, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity, tearing of the eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, somnolence, reduced sense of touch, dizziness, tinnitus, nausea, dryness of the 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 up to 1 in 1,000 people): fainting, stroke, myocardial infarction, irregular heartbeat, transient reduction in blood flow to part of the brain, 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 part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden weakness or hearing loss.

Since the medicine has been marketed, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that most, but not all, of these patients who experienced such adverse reactions had pre-existing heart conditions before taking the medicine containing sildenafil. It is not possible to determine whether these adverse reactions were related to the use of SILDEROS MAX.

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

5. How to store SILDEROS MAX

Keep this medicine out of 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What SILDEROS MAX contains

• The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
• Other components of the medicine 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, 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, marked with "50" on one side and "H" and "J" on the other side, with a break line to allow splitting into equal doses. The tablet can be divided into equal doses.
The tablets are contained in PVC/Aluminium blisters containing: 2 or 4 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
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.,
Rabowicka 15,
Swarzędz, 62-020, Poland