Sildenafil synoptis

Package leaflet: Information for the patient

Sildenafil Synoptis, 100 mg, film-coated tablets
Sildenafilum
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Sildenafil Synoptis is and what it is used for

Sildenafil Synoptis contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by promoting relaxation of blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation. Sildenafil Synoptis helps achieve an erection only if sexual stimulation occurs beforehand.
Sildenafil Synoptis 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 Sildenafil Synoptis

When not to take Sildenafil Synoptis
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, because 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"). In case of doubt, consult a doctor or pharmacist.
• If the patient is taking medicines 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 in the treatment of 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 Sildenafil Synoptis, 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 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 Sildenafil Synoptis, discuss this with a doctor, pharmacist, or
nurse if:

• The patient has sickle cell anaemia (a disorder affecting red blood cells), leukaemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• The patient has been diagnosed with penile anatomical deformity or Peyronie's disease.
• The patient has heart problems. The doctor should assess whether the condition of the heart muscle 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, treatment with Sildenafil Synoptis should be stopped immediately and the patient should contact a doctor without delay.

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

Special considerations for patients with kidney or liver impairment
Patients with impaired kidney or liver function should inform their doctor. The doctor
may decide to prescribe a lower dose of Sildenafil Synoptis.

Children and adolescents
Sildenafil Synoptis must not be used in individuals under 18 years of age.

Sildenafil Synoptis and other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Sildenafil Synoptis may interact with certain medicines, especially 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 Sildenafil Synoptis and the time it was taken. Do not take Sildenafil Synoptis together with other medicines without a doctor's recommendation.
Do not take Sildenafil Synoptis if the patient is taking medicines from the nitrate group, because 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, which are used to treat angina (or "chest pain").
Do not take Sildenafil Synoptis if the patient is taking medicines 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, initiation of treatment with a lower dose (25 mg) of sildenafil is recommended.
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 observed in some patients taking sildenafil and alpha-blockers concomitantly. These symptoms are most likely to occur within 4 hours after taking Sildenafil Synoptis. To reduce the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting Sildenafil Synoptis. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of sildenafil.
If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), 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 medicines containing sacubitril with valsartan, used in the treatment of heart failure, inform the doctor or pharmacist.

Sildenafil Synoptis with food, drink, and alcohol
Sildenafil Synoptis can be taken with or without food. However, taking Sildenafil Synoptis 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 effect of Sildenafil Synoptis, significant amounts of alcohol should be avoided before taking the medicine.

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

Driving and operating machinery
Sildenafil Synoptis may cause dizziness and visual disturbances. Patients should assess how they react to the medicine before driving or operating machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Sildenafil Synoptis
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of
doubt, consult the doctor or pharmacist. The recommended starting dose is 50 mg.
Sildenafil Synoptis must not be taken more than once a day.
Sildenafil Synoptis 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 Sildenafil Synoptis seems too strong or too weak, consult the doctor or pharmacist.
Sildenafil Synoptis enables an erection only in the presence of sexual stimulation. The time to onset of effect 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 Sildenafil Synoptis, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.

Taking more than the recommended dose of Sildenafil Synoptis
Adverse reactions may occur more frequently and 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 prescribed by the doctor.
Contact the doctor if more tablets have been taken than recommended.
In case of any further doubts regarding the use of this medicine, consult the 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 the use of Sildenafil Synoptis are usually mild or moderate in intensity and short-lived.
If any of the following adverse reactions occur, stop taking Sildenafil Synoptis 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,
  • must not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1000 patients). If an erection lasts more 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, formation of blisters in the mouth, on the genitals and around the eyes, fever.

• Seizures or fits – occur rarely

Other adverse reactions:
Very commonly (may affect more than 1 in 10 people): headache.
Commonly (may affect up to 1 in 10 patients): nausea, sudden flushing of the face, hot flushes (symptoms include feeling of warmth in the upper body), indigestion, coloured vision, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommonly (may affect up to 1 in 100 patients): vomiting, skin rash, eye irritation, eye hyperaemia, eye pain, seeing flashes of light, bright vision, light sensitivity, watery eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, somnolence, reduced sense of touch, dizziness, tinnitus, nausea, dryness of the mouth, stuffy or blocked sinuses, inflammation of the nasal mucosa (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.
Rarely (may affect up to 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of tightness in the throat, numbness of the lips, 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 field of vision, seeing halos around light sources, pupil dilation, abnormal discoloration of the white part of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden weakness 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 adverse reactions, heart problems were present before taking the sildenafil-containing medicine. It is not possible to determine whether these adverse reactions were related to the use of Sildenafil Synoptis.

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 for 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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sildenafil Synoptis

Keep this medicine out of sight and reach of children.
There are no special storage instructions for 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 that month.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Synoptis contains

• The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).
• Other components of the medicinal product 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, lacquer (E132), hypromellose 5 cP (type 2910), triacetin.

What Sildenafil Synoptis looks like and contents of the pack
Sildenafil Synoptis 100 mg film-coated tablets are blue, round, biconvex, with a diameter of 12.2 mm, embossed with "100" on one side and "H" and "J" on the other side, with a break line to allow division of the tablet into equal doses.
The tablets are contained in PVC/Aluminium 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

For more detailed information, please contact the representative of the responsible entity.