Sildenafil Simphar

Leaflet attached to the packaging: information for the user

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

important information for the patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 to 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 the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking nitrates, as their simultaneous intake 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 medicines are often used to relieve symptoms of angina pectoris ("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 simultaneous intake may also lead to a dangerous decrease in blood pressure.

If the patient is 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 the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions

Before starting to take Sildenafil SymPhar, 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 Peyronie's disease.
• Heart problems. In this case, the doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity.
• Ulcer disease or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden loss of vision, they should stop taking Sildenafil SymPhar and immediately contact their doctor.

Sildenafil SymPhar should not be taken simultaneously with other orally or topically administered types of erectile dysfunction therapy.

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

Sildenafil SymPhar should not be taken if the patient has not been diagnosed with erectile dysfunction.

Sildenafil SymPhar is not intended for women.

Special considerations for patients with renal or hepatic impairment

Patients with renal or hepatic impairment 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

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.

Sildenafil SymPhar may interact with some medicines, especially those used to treat chest pain. If the patient's condition worsens and requires immediate medical attention, they should inform their doctor, pharmacist, or nurse about taking Sildenafil SymPhar and the time of intake. The patient should not take Sildenafil SymPhar with other medicines without their doctor's recommendation.

The patient should not take Sildenafil SymPhar if they are taking nitrate medicines, as their simultaneous 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 ("chest pain").

The patient should not take Sildenafil SymPhar if they 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 the patient is already taking riociguat, they should inform their 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 of 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.

The patient should tell their doctor or pharmacist if they 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, the patient should not consume significant 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 means that the product is considered "sodium-free".

3. How to take Sildenafil SymPhar

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended starting dose is 50 mg.

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

The patient should not take Sildenafil SymPhar at the same time as other medicines containing sildenafil.

Sildenafil SymPhar should be taken about an 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 SymPhar is too strong or too weak, they should consult their doctor or pharmacist.

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

The time it takes for Sildenafil SymPhar to work 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.

The patient should contact their doctor if, after taking Sildenafil SymPhar, 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 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 effectiveness of the medicine.

The patient should not take more tablets than prescribed by their doctor.

The patient should contact their doctor if they have taken 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, 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, the patient 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:
• the patient should sit half-up and try to relax,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may occur in 1 in 1000 patients) If the erection lasts for more than 4 hours, the patient should contact their doctor immediately.
• Sudden vision loss or blindness - occurs rarely
• Severe skin reactions - occurs rarelySymptoms may include severe peeling and swelling of the skin, 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 of the face, 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, stuffy or congested sinuses, 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, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of constriction in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased visual acuity, 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, pupil dilation, abnormal discoloration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, nasal congestion, feeling of irritation, and sudden hearing loss or loss of hearing.

After the medicine has been 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 problems 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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, 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 Sildenafil SymPhar

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

There are no special precautions for storage.

The medicine should not be used after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the stated 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 Sildenafil SymPhar contains

• The active substance of the medicine is sildenafil. Each tablet contains 100 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 what the pack contains

The medicine is in the form of blue, film-coated, elliptical tablets with a "+" sign embossed on one side. The tablets are packaged in blisters of 1, 2, 4, 8, or 12 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

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