Sildenafil Simphar

Package Leaflet: Information for the User

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

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

Sildenafil SymPhar 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. Sildenafil SymPhar helps achieve an erection only if there is prior sexual stimulation.

Sildenafil SymPhar is used to treat erectile dysfunction in adult men, which is defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Sildenafil SymPhar

When not to take Sildenafil SymPhar

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates, as their simultaneous intake may lead to a dangerous decrease in blood pressure. You should inform your doctor if you are taking any medicines from this group - these medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, consult your doctor or pharmacist.
• If you are taking medicines that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their simultaneous intake may also lead to a dangerous decrease in blood pressure.

• If you are 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 sildenafil, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.
• Severe heart or liver disease.
• Recent stroke or heart attack, as well as in cases of low blood pressure.
• Hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If you have ever experienced vision loss due to non-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Sildenafil SymPhar, you should discuss it with your 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 bone marrow cancer).
• If you have anatomical deformation of the penis or Peyronie's disease.
• Heart problems. In this case, your doctor should assess whether your heart condition allows for the additional strain associated with sexual activity.
• Ulcers or bleeding disorders (such as hemophilia).
• If you experience sudden vision loss or sudden vision impairment, you should stop taking Sildenafil SymPhar and immediately consult your doctor.

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

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

Sildenafil SymPhar should not be taken if you have not been diagnosed with erectile dysfunction.

Sildenafil SymPhar 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. The doctor may decide to use a lower dose of Sildenafil SymPhar.

Children and adolescents

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

Sildenafil SymPhar and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Sildenafil SymPhar may interact with some medicines, especially those used to treat chest pain. In case of a worsening of your health condition requiring immediate medical attention, you should inform your doctor, pharmacist, or nurse about taking Sildenafil SymPhar and the time of its intake. You should not take Sildenafil SymPhar simultaneously with other medicines without your doctor's recommendation.

You should not take Sildenafil SymPhar if you are taking medicines from the nitrate group, as their simultaneous use may lead to a dangerous decrease in blood pressure.

You should always inform your doctor, pharmacist, or nurse if you are taking nitrates, which are used to treat angina pectoris ("chest pain").

You should not take Sildenafil SymPhar if you are taking medicines that release nitric oxide (such as amyl nitrite), as their simultaneous use may also cause a dangerous decrease in blood pressure.

If you are already taking riociguat, you should inform your doctor or pharmacist.

In the case of taking protease inhibitors used to treat HIV infections, it is recommended to start treatment with a lower dose (25 mg) of Sildenafil SymPhar.

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 during rapid standing or sitting. Such symptoms occurred in some patients taking a medicine containing sildenafil and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours after taking sildenafil. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Sildenafil SymPhar. The doctor may decide to use a lower initial dose (25 mg) of Sildenafil SymPhar.

You should tell your doctor or pharmacist if you are taking medicines containing sacubitril with valsartan (used to treat heart failure), as combination therapy with this medicine may lead to a decrease in blood pressure.

Sildenafil SymPhar with food, drink, and alcohol

Sildenafil SymPhar can be taken with or without food.

Taking Sildenafil SymPhar during a large meal may prolong the time it takes 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 Sildenafil SymPhar, you should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Sildenafil SymPhar is not intended for use by women.

Driving and using machines

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

Sildenafil SymPhar contains sodium

This medicinal product contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is considered to be "sodium-free".

3. How to take Sildenafil SymPhar

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

The recommended starting dose is 50 mg.

Sildenafil SymPhar should not be taken more than once a day.

You should not take Sildenafil SymPhar simultaneously with other medicines containing sildenafil.

Sildenafil SymPhar should be taken approximately one hour before planned sexual activity.

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

If you feel that the effect of Sildenafil SymPhar is too strong or too weak, you should consult your doctor or pharmacist.

Sildenafil SymPhar allows for an erection only if there is prior sexual stimulation.

The time it takes for Sildenafil SymPhar to start working varies from person to person, usually between half an hour and one hour. The effect may occur later if the medicine is taken after a large meal.

You should consult your doctor if, after taking Sildenafil SymPhar, you do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Sildenafil SymPhar 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.

You should not take more tablets than prescribed by your doctor.

You should consult your doctor if you have taken more tablets than recommended.

If you have any further doubts about the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

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

In case of any of the following serious side effects, you should stop taking Sildenafil SymPhar and seek immediate medical attention:

• Allergic reaction - occurs uncommonly(may occur in 1 in 100 patients) 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:
• you should sit half-up and try to relax,
• do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may occur in 1 in 1000 patients)

If an erection lasts for more than 4 hours, you should immediately consult your doctor.

• Sudden vision loss or vision impairment - 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 occur in more than 1 in 10 patients): headache.

Common(may occur in 1 in 10 patients): nausea, sudden flushing, hot flushes (symptoms include a feeling of heat in the upper body), indigestion, seeing a blue tint on objects, blurred vision, disturbance in color perception, stuffy nose, dizziness.

Uncommon(may occur in 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctival hyperemia, eye pain, seeing flashes of light, increased sensitivity to light, lacrimation, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, somnolence, decreased tactile sensitivity, dizziness, tinnitus, dry mouth, nasal congestion, rhinitis (symptoms include runny nose, sneezing, and stuffy nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), hematuria, pain in arms or legs, epistaxis, feeling of heat, and feeling of fatigue.

Rare(may occur in 1 in 1000 patients): fainting, stroke, myocardial infarction, irregular heartbeat, transient ischemic attack, feeling of compression in the throat, numbness of the lips, retinal hemorrhage, double vision, decreased visual acuity, abnormal sensations in 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 of the eye, penile hemorrhage, presence of blood in semen, dry nose, nasal swelling, feeling of irritation, and sudden hearing loss or hearing impairment.

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, men who experienced these side effects, heart function disorders existed before taking the medicine. It is not possible to determine whether these side effects were related to the use of sildenafil.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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

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, you can help provide more information on the safety of this medicine.

5. How to store Sildenafil SymPhar

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

There are no special precautions for storing the medicine.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Sildenafil SymPhar contains

• The active substance of the medicine is sildenafil. Each tablet contains 50 mg of sildenafil (in the form of citrate).
• The other ingredients are: tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate. coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, indigo carmine (E 132), lac.

What Sildenafil SymPhar looks like and contents of the pack

The medicine is in the form of blue, film-coated, elliptical tablets. The tablets are packed in blisters of 1, 2, or 4 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Symphar Sp. z o.o.

ul. Koszykowa 65

00-667 Warsaw

Rua da Tapada Grande, nº 2, Abrunheira, 2710 – 089 Sintra, Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Sildenafil SymPhar

Portugal: Sildenafil Tecnimede

Date of last revision of the leaflet:August 2023