Sildenafil Sinoptis

Package Leaflet: Information for the Patient

Sildenafil Synoptis, 100 mg, Film-Coated Tablets

Sildenafil

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

Sildenafil Synoptis contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medication works by supporting the relaxation of blood vessels in the penis, increasing blood flow to the penis during sexual arousal. Sildenafil Synoptis helps achieve an erection only if there is prior sexual stimulation. Sildenafil Synoptis 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 Sildenafil Synoptis

When not to take Sildenafil Synoptis

If the patient is allergic to sildenafil or any of the other ingredients of this medication (listed in section 6).

• If the patient is taking 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 medications from this group; they are often used to alleviate symptoms of angina pectoris (or "chest pain"). In case of doubt, consult a doctor or pharmacist.
• If the patient is taking medications 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 medication 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 Sildenafil Synoptis, enhance the blood pressure-lowering effect of this medication. 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 changes in the retina, 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 to take Sildenafil Synoptis, 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), or multiple myeloma (a cancer of the bone marrow).
• If the patient has an 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 Sildenafil Synoptis and immediately consult a doctor.

Sildenafil Synoptis should not be used concurrently with other oral or topical treatments for erectile dysfunction. Sildenafil Synoptis should not be used concurrently with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. Sildenafil Synoptis should not be taken if erectile dysfunction has not been diagnosed. Sildenafil Synoptis is not intended for women. Special considerations for patients with kidney or liver function disordersPatients with kidney or liver function disorders should inform their doctor. The doctor may decide to use a lower dose of Sildenafil Synoptis.

Children and adolescents

Sildenafil Synoptis should not be used in persons under 18 years of age.

Sildenafil Synoptis and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. Sildenafil Synoptis may interact with some medications, especially those used to treat chest pain. If the patient's condition worsens, requiring immediate medical attention, they should inform their doctor, pharmacist, or nurse about taking Sildenafil Synoptis and the time of its administration. The patient should not take Sildenafil Synoptis concurrently with other medications without their doctor's recommendation. The patient should not use Sildenafil Synoptis if they are taking nitrates, 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 use Sildenafil Synoptis if they are taking medications that release nitric oxide, such as amyl nitrite, 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 protease inhibitors used to treat HIV infections, it is recommended to start treatment with a lower dose (25 mg) of sildenafil. In some patients who are 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 when standing up or sitting down quickly. Such symptoms occurred in some patients taking sildenafil and alpha-adrenergic blockers concurrently. Their occurrence is most likely within 4 hours after taking Sildenafil Synoptis. To minimize the possibility of these symptoms, the patient should regularly take their fixed doses of alpha-adrenergic blockers before starting to take Sildenafil Synoptis. The doctor may decide to use a lower initial dose (25 mg) of sildenafil. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling of impending faint), 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 medications containing sacubitril with valsartan, used to treat heart failure, they should inform their doctor or pharmacist.

Sildenafil Synoptis with food, drink, and alcohol

Sildenafil Synoptis can be taken with or without food. Although taking Sildenafil Synoptis during a heavy meal may prolong the time needed for the medication to start working. The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic effects of Sildenafil Synoptis, the patient should not consume significant amounts of alcohol before taking the medication.

Pregnancy, breastfeeding, and fertility

Sildenafil Synoptis is not intended for use by women.

Driving and using machines

Sildenafil Synoptis may cause dizziness and vision disturbances. Patients should be aware of how they react to Sildenafil Synoptis before driving or operating machinery. The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free).

3. How to take Sildenafil Synoptis

This medication should always be taken exactly as advised by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist. The recommended initial dose is 50 mg. Sildenafil Synoptis should 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 patient feels that the effect of Sildenafil Synoptis is too strong or too weak, they should consult a doctor or pharmacist. Sildenafil Synoptis enables an erection only if there is prior sexual stimulation. The time it takes for Sildenafil Synoptis to work varies from person to person, usually ranging from half an hour to one hour. The effect may occur later if the medication is taken after a heavy meal. The patient should consult a doctor if, after taking Sildenafil Synoptis, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Sildenafil Synoptis 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 mean increased efficacy of the medication. The patient should not take more tablets than prescribed by the doctor.The patient should consult a doctor if they have taken more tablets than recommended. In case of any further doubts about the use of this medication, the patient should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Sildenafil Synoptis can cause side effects, although not everybody gets them. Side effects reported in connection with the use of Sildenafil Synoptis are usually mild or moderate and short-lived.

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

• 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-up and try to relax, should not take nitratesto alleviate chest pain.
• should sit half-up and try to relax,
• should not take nitratesto alleviate chest pain.
• Prolonged and sometimes painful erections - occur rarely(may affect up to 1 in 1,000 people) If the erection lasts more than 4 hours, the patient should immediately consult a doctor.
• Sudden vision loss or blindness - occur rarely
• Severe skin reactions - occur rarely

Symptoms may include severe peeling and swelling of the skin, 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, visual disturbances, 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, nausea, dry mouth, stuffy or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing, and stuffy nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in 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, temporary reduction of 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, decreased sharpness of vision, abnormal sensations in the eye, swelling of the eyes or eyelids, small particles or spots in the visual field, seeing halos around light sources, dilated pupils, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden loss of hearing.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product 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 medication.

5. How to store Sildenafil Synoptis

The medication should be stored out of sight and reach of children. There are no special precautions for storing the medication. Do not use this medication after the expiry date stated on the carton and blister after the abbreviation: EXP. The expiry date refers to the last day of that month. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Synoptis contains

• The active substance of the medication is sildenafil. Each tablet contains 100 mg of sildenafil (in the form of citrate).
• Other ingredients of the medication 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 (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, with "100" 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 packed 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 the last revision of the leaflet: