Sildenafilum Promedo

Leaflet attached to the packaging: patient information

SILDENAFILUM PROMEDO, 100 mg, film-coated tablets

Sildenafilum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, 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 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 tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is SILDENAFILUM PROMEDO and what is it used for

SILDENAFILUM PROMEDO 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. SILDENAFILUM PROMEDO helps achieve an erection only if there is prior sexual stimulation. SILDENAFILUM PROMEDO is used to treat erectile dysfunction in adult men, defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking SILDENAFILUM PROMEDO

When not to take SILDENAFILUM PROMEDO

• 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 concurrent 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 medicines are often used to relieve symptoms of angina pectoris ("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), as their concurrent use 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 SILDENAFILUM PROMEDO, 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, and in cases of low blood pressure.
• If the patient has hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If the patient has ever had vision loss due to non-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before taking SILDENAFILUM PROMEDO, 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 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 effort associated with sexual activity.
• Ulcer or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden hearing loss, they should stop taking SILDENAFILUM PROMEDO and seek medical attention immediately.

SILDENAFILUM PROMEDO should not be taken with other oral or topical treatments for erectile dysfunction. SILDENAFILUM PROMEDO should not be taken with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. SILDENAFILUM PROMEDO should not be taken if erectile dysfunction has not been diagnosed. SILDENAFILUM PROMEDO is not intended for women. Special considerations for patients with renal or hepatic impairmentPatients with renal or hepatic impairment should inform their doctor. The doctor may decide to use a lower dose of SILDENAFILUM PROMEDO.

Children and adolescents

SILDENAFILUM PROMEDO should not be used in persons under 18 years of age.

SILDENAFILUM PROMEDO 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. SILDENAFILUM PROMEDO may interact with some medicines, 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 SILDENAFILUM PROMEDO and the time of its administration. The patient should not take SILDENAFILUM PROMEDO with other medicines without their doctor's advice. The patient should not take SILDENAFILUM PROMEDO 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 ("chest pain"). The patient should not take SILDENAFILUM PROMEDO if they are taking medicines that release nitric oxide (such as amyl nitrite), as their concurrent use may also 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 SILDENAFILUM PROMEDO. 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 when standing up or sitting down quickly. Such symptoms occurred in some patients taking sildenafil and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking SILDENAFILUM PROMEDO. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting SILDENAFILUM PROMEDO. The doctor may decide to use a lower initial dose (25 mg) of sildenafil. If the patient is taking medicines containing sacubitril with valsartan (used to treat heart failure), they should inform their doctor or pharmacist.

SILDENAFILUM PROMEDO with food, drink, and alcohol

SILDENAFILUM PROMEDO can be taken with or without food. Although taking SILDENAFILUM PROMEDO during a heavy meal may prolong the time needed 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 SILDENAFILUM PROMEDO, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

SILDENAFILUM PROMEDO is not intended for use by women.

Driving and using machines

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

SILDENAFILUM PROMEDO contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. SILDENAFILUM PROMEDO contains sodiumThe medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take SILDENAFILUM PROMEDO

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. The recommended starting dose is 50 mg. SILDENAFILUM PROMEDO should not be taken more than once a day.The patient should not take SILDENAFILUM PROMEDO tablets at the same time as Viagra or other medicines containing sildenafil. SILDENAFILUM PROMEDO 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 SILDENAFILUM PROMEDO is too strong or too weak, they should consult their doctor or pharmacist. SILDENAFILUM PROMEDO allows for an erection only if there is prior sexual stimulation. The time after which the effect of SILDENAFILUM PROMEDO occurs varies from patient to patient, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal. The patient should consult their doctor if, after taking SILDENAFILUM PROMEDO, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of SILDENAFILUM PROMEDO 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 medicine. The patient should not take more tablets than prescribed by their doctor.The patient should consult 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, SILDENAFILUM PROMEDO can cause side effects, although not everybody gets them. Side effects reported in connection with the use of SILDENAFILUM PROMEDO are usually mild or moderate and short-lived.

In case of any of the following side effects, the patient should stop taking SILDENAFILUM PROMEDO and seek medical attention immediately:

• 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-upright 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 seek medical attention immediately.

• Sudden vision loss or hearing loss - 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 up to 1 in 10 patients):

• Nausea
• Sudden flushing of the face
• Hot flashes (symptoms include a feeling of heat in the upper body)
• Indigestion
• Blurred vision, double vision, or changes in color vision
• Stuffy nose
• Dizziness.

Uncommon(may occur in up to 1 in 100 patients):

• Vomiting
• Rash
• Irritation of the eye
• Conjunctival hyperemia
• Eye pain
• Flashes of light
• Increased sensitivity to light
• Excessive tearing
• Pounding heart
• Fast heartbeat
• Hypertension
• Hypotension
• Muscle pain
• Somnolence
• Impaired sense of touch
• Dizziness
• Ringing in the ears
• Nausea
• Dry mouth
• Stuffy or runny nose
• Rhinitis (symptoms include runny nose, sneezing, and stuffy nose)
• Upper abdominal pain
• Gastroesophageal reflux disease (symptoms include heartburn)
• Blood in the urine
• Pain in the arms or legs
• Nosebleeds
• Feeling of heat
• Feeling of fatigue.

Rare(may occur in up to 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 visual field
• Seeing halos around light sources
• Pupil dilation
• Abnormal discoloration of the white of the eye
• Bleeding from the penis
• Blood in the semen
• Dry nose
• Swelling inside the nose
• Feeling of irritability
• Sudden loss of hearing.

Rarely, after the medicine was introduced to the market, 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 SILDENAFILUM PROMEDO. It is not possible to determine whether these side effects were related to the use of SILDENAFILUM PROMEDO.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 gathered on the safety of the medicine.

5. How to store SILDENAFILUM PROMEDO

How to store SILDENAFILUM PROMEDOThe medicine should be stored out of sight and reach of children. There are no special storage instructions for the medicine. Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the 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 SILDENAFILUM PROMEDO contains

• The active substance of SILDENAFILUM PROMEDO is sildenafil. Each tablet contains 100 mg of sildenafil (as sildenafil citrate).
• The other ingredients are: Tablet core: microcrystalline cellulose 102, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate. Coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), triacetin, indigo carmine (E 132).

What SILDENAFILUM PROMEDO looks like and contents of the pack

SILDENAFILUM PROMEDO film-coated tablets are blue, elongated, and convex on both sides, with the number "100" on one side. The tablets are packaged in a carton containing 2, 4, or 8 tablets in PVC/PVDC/Aluminum blisters. Not all pack sizes may be marketed.

Marketing authorization holder

Promedo Pharma Products GmbH

Anklamer Strasse 28, 10115 Berlin, Germany

Manufacturer

Adamed Pharma S.A., ul. Marszałka J. Piłsudskiego 5, 95-200 Pabianice, Poland Date of last revision of the leaflet:November 2022