Sildenafil promedo

Package leaflet: Information for the patient

SILDENAFILUM PROMEDO, 100 mg, film-coated tablets
Sildenafilum
Please read carefully the entire leaflet before taking this 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 questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for a particular individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What SILDENAFILUM PROMEDO is and what it is 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 SILDENAFILUM PROMEDO is and what it is 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 blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation.
SILDENAFILUM PROMEDO helps achieve an erection only if sexual stimulation is present.
SILDENAFILUM PROMEDO is used in the treatment of erectile dysfunction in adult men, that is, impotence defined as the inability to obtain or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using the medicine SILDENAFILUM PROMEDO

When not to use 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, because their concomitant use may lead to a dangerous decrease in blood pressure. The patient should inform the doctor if they are taking any medicines from this group – these medicines are often used to relieve symptoms of angina (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 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). PDE5 inhibitors such as SILDENAFILUM PROMEDO 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 inherited degenerative retinal disorders, such as retinitis pigmentosa (retinitis pigmentosa).
• If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions
Before starting treatment with SILDENAFILUM PROMEDO, discuss this with a doctor,
pharmacist, or nurse if:

• The patient has sickle cell anemia (an abnormality affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• The patient has been diagnosed with anatomical penile deformity or Peyronie's disease.
• The patient has heart problems. In such cases, the doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity.
• The patient has peptic ulcer disease or bleeding disorders (such as hemophilia).
• If sudden worsening of vision or sudden vision loss occurs, the patient should stop using SILDENAFILUM PROMEDO and contact a doctor immediately.

SILDENAFILUM PROMEDO must not be used concomitantly with other oral or topical treatments for erectile dysfunction.
SILDENAFILUM PROMEDO must not be used concomitantly with arterial pulmonary hypertension (APH) therapies containing sildenafil or other PDE5 inhibitors.
SILDENAFILUM PROMEDO must not be taken if erectile dysfunction has not been diagnosed.
SILDENAFILUM PROMEDO 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 SILDENAFILUM PROMEDO.

Children and adolescents
SILDENAFILUM PROMEDO must not be used in individuals under 18 years of age.

SILDENAFILUM PROMEDO and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
SILDENAFILUM PROMEDO may interact with certain medicines, especially those used to treat chest pain. In case of worsening health requiring immediate medical attention, inform the doctor, pharmacist, or nurse about taking SILDENAFILUM PROMEDO and the time of administration.
Do not take SILDENAFILUM PROMEDO together with other medicines without a doctor's recommendation.
Do not take SILDENAFILUM PROMEDO if the patient is taking nitrates, 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 (chest pain).
Do not take SILDENAFILUM PROMEDO if the patient is taking medicines that release nitric oxide (such as amyl nitrite), because their concomitant use may also cause a dangerous decrease in blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
For patients taking protease inhibitors used in the treatment of HIV infection, initiation of therapy with a lower dose (25 mg) of SILDENAFILUM PROMEDO is recommended.
Some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness, which may be symptoms of low blood pressure caused by a drop in blood pressure upon rapid standing or sitting up. Such symptoms have occurred in some patients taking sildenafil and alpha-blockers concomitantly. These symptoms are most likely to occur within 4 hours after taking SILDENAFILUM PROMEDO. To reduce the possibility of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting SILDENAFILUM PROMEDO. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of sildenafil.
If the patient is taking medicines containing sacubitril with valsartan (used in the treatment of heart failure), they should inform the doctor or pharmacist.

SILDENAFILUM PROMEDO with food, drink, and alcohol
SILDENAFILUM PROMEDO can be taken with or without food. However, taking SILDENAFILUM PROMEDO with a heavy meal may prolong the time required for the medicine to take effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of SILDENAFILUM PROMEDO, significant alcohol intake should be avoided before taking the medicine.

Pregnancy, breastfeeding, and fertility
SILDENAFILUM PROMEDO is not intended for use in women.

Driving and using machines
SILDENAFILUM PROMEDO may cause dizziness and visual disturbances. Patients should determine how they react to the medicine before driving or operating machinery.

SILDENAFILUM PROMEDO contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

SILDENAFILUM PROMEDO contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free."

3. How to use SILDENAFILUM PROMEDO
This medicine should always be used as directed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. The recommended starting dose is 50 mg.
SILDENAFILUM PROMEDO must not be taken more than once a day.
Do not take SILDENAFILUM PROMEDO coated tablets together with Viagra or other medicines containing sildenafil.
SILDENAFILUM PROMEDO 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 SILDENAFILUM PROMEDO seems too strong or too weak, consult a doctor or pharmacist.
SILDENAFILUM PROMEDO enables an erection only in the presence of sexual stimulation. The time to onset of effect of SILDENAFILUM PROMEDO varies between patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal.
Contact a doctor if, after taking SILDENAFILUM PROMEDO, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.

Taking more than the recommended dose of SILDENAFILUM PROMEDO
Adverse effects may occur more frequently and may be more severe. Taking a dose higher than 100 mg does not increase the medicine's effectiveness.
Do not take more tablets than prescribed by the doctor.
Contact a doctor if more tablets have been taken than recommended.
For any further questions regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions reported with the use of SILDENAFILUM PROMEDO are usually mild or moderately severe and transient.
If any of the following adverse reactions occur, stop taking SILDENAFILUM PROMEDO and seek
immediate medical help:

• Allergic reaction – occurs uncommonly (may occur in 1 out of 100 patients)
  Symptoms: sudden wheezing, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs uncommonly
  If chest pain occurs during or after sexual intercourse:
  • adopt a semi-sitting position and try to relax,
  • do not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occur rarely (may occur in 1 out of 1000 patients)

If an erection lasts longer than 4 hours, contact a doctor immediately.

• Sudden loss of vision or blurred 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 convulsions – occur rarely

Other adverse reactions:
Very common (may affect more than 1 in 10 patients):

• Headache.

Common (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
• Seeing coloured halos, blurred vision, visual disturbances
• Stuffy nose
• Dizziness.

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

• Vomiting
• Skin rash
• Eye irritation
• Eye redness
• Eye pain
• Seeing flashes of light
• Bright vision
• Light sensitivity
• Watery eyes
• Palpitations
• Rapid heartbeat
• High blood pressure
• Low blood pressure
• Muscle pain
• Drowsiness
• Reduced sense of touch
• Dizziness
• Ringing in the ears
• Nausea
• Dryness of the mouth
• Blocked or stuffy sinuses
• Nasal mucositis (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
• Feeling of fatigue.

Rare (may affect up to 1 in 1000 patients):

• Fainting
• Stroke
• Heart attack
• Irregular heartbeat
• Transient reduction in blood flow to part of the brain
• Throat tightness
• Numbness of the lips
• Bleeding into the back of the eye
• Double vision
• Reduced visual acuity
• Abnormal sensations inside the eye
• Swelling of eyes or eyelids
• Small particles or spots in the field of vision
• Seeing halos around light sources
• Dilated pupils
• Abnormal discoloration of the white part of the eye
• Bleeding from the penis
• Blood in semen
• Dry nose
• Swelling inside the nose
• Irritability
• Sudden hearing loss or deafness.

Since the medicine has been 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 adverse reactions, heart problems were already present before taking SILDENAFILUM PROMEDO. It is not possible to determine whether these adverse reactions were related to the use of SILDENAFILUM PROMEDO.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store SILDENAFILUM PROMEDO

Keep the medicine out of the sight and reach of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What SILDENAFILUM PROMEDO contains

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

What SILDENAFILUM PROMEDO looks like and contents of the pack
SILDENAFILUM PROMEDO coated tablets are blue, elongated, biconvex, with the number "100" marked on one side.
The tablets are packed in cardboard boxes containing 2, 4 or 8 tablets in PVC/PVDC/Aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation 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