Package leaflet: Information for the patient

Before taking the medicine, use the diagnostic tool provided!
Sildenafil ESPEFA, 50 mg, coated tablets
Sildenafilum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician or pharmacist.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Sildenafil ESPEFA is and what it is used for
Important information before taking Sildenafil ESPEFA
How to take Sildenafil ESPEFA
Possible side effects
How to store Sildenafil ESPEFA
Contents of the package and other information

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

Sildenafil ESPEFA 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. Sildenafil ESPEFA helps achieve an erection only if sexual stimulation occurs beforehand.
Sildenafil ESPEFA is used in the treatment of erectile dysfunction in adult men, i.e. impotence defined as the inability to achieve or maintain a penile erection sufficient for sexual intercourse.
Do not take this medicine if you do not have erectile dysfunction.

2. Important information before using Sildenafil ESPEFA

When not to use Sildenafil ESPEFA

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 concomitant use may lead to a dangerous decrease in blood pressure. The doctor should be informed if the patient is taking any medicines from this group – these medicines are often used to relieve symptoms of angina (chest pain). If in doubt, consult a doctor or pharmacist.
If the patent is taking nitric oxide-releasing drugs (such as amyl nitrite, so-called "poppers"), because their concomitant use may also lead to dangerous lowering of 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 Sildenafil ESPEFA have been shown to enhance the blood pressure-lowering effect of this drug. 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.
If the patient has low blood pressure.
If the patient has inherited degenerative retinal disorders, such as retinitis pigmentosa.
If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with Sildenafil ESPEFA, discuss with a doctor or pharmacist:

if the patient has sickle cell anemia (an abnormality affecting red blood cells),
if the patient has leukemia (a blood cancer),
if the patient has multiple myeloma (a cancer of the bone marrow),
if the patient has anatomical deformity of the penis or Peyronie's disease (characterized by penile curvature and sometimes painful erections),
if the patient has heart problems; in such cases, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity,
if the patient has a stomach ulcer,
if the patient has blood clotting disorders (such as hemophilia).

If sudden vision deterioration or sudden vision loss occurs, treatment with Sildenafil ESPEFA must be stopped and the patient should contact a doctor immediately.
Sildenafil ESPEFA should not be used concomitantly with other oral or topical medicines used to treat erectile dysfunction.
Sildenafil ESPEFA should not be used concomitantly with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Sildenafil ESPEFA should not be used if erectile dysfunction has not been diagnosed.
Sildenafil ESPEFA is not a medicine intended for women.
Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. Patients with impaired kidney or liver function should not take a dose of sildenafil higher than 25 mg.
Children and adolescents
Sildenafil ESPEFA should not be used in individuals under 18 years of age.
Sildenafil ESPEFA and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Sildenafil ESPEFA may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and requires immediate medical attention, the doctor must be informed about taking Sildenafil ESPEFA. Do not take Sildenafil ESPEFA together with other medicines without medical advice.
Do not take Sildenafil ESPEFA if the patient is taking nitrates, because their concomitant use may lead to dangerous lowering of blood pressure. Always inform the doctor or pharmacist if the patient is taking nitrates, which are used to treat angina (chest pain).
Do not take Sildenafil ESPEFA if the patient is taking nitric oxide-releasing drugs (such as amyl nitrite), because their concomitant use may also cause dangerous lowering of blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
If the patient is taking protease inhibitors used in the treatment of HIV infection, consult a doctor before taking Sildenafil ESPEFA. In such cases, the doctor may consider initiating treatment with sildenafil, starting with the lowest dose (25 mg).
In some patients taking α-adrenolytic drugs 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 upon rapid standing or sitting (orthostatic hypotension). Such symptoms have occurred in some patients taking sildenafil-containing medicines together with α-adrenolytic drugs. These symptoms are most likely to occur within 4 hours after taking sildenafil. To reduce the likelihood of such symptoms, the patient should be on a stable dose regimen of their α-adrenolytic medicine before starting Sildenafil ESPEFA. The doctor may decide to start with a lower initial dose of sildenafil (25 mg). If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit until symptoms subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. Rapid standing or sitting should be avoided.
If the patient is taking ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), consult a doctor before taking Sildenafil ESPEFA.
Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Sildenafil ESPEFA with food, drink and alcohol
Sildenafil ESPEFA can be taken with or without food.
Taking Sildenafil ESPEFA with a heavy meal may delay 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 Sildenafil ESPEFA, significant alcohol consumption should be avoided before taking the medicine.
Pregnancy, breastfeeding and fertility
Sildenafil ESPEFA is not intended for use by women.
Driving and operating machinery
Sildenafil ESPEFA may cause dizziness and visual disturbances. Patients should understand how they react to Sildenafil ESPEFA before driving or operating machinery.

3. How to use Sildenafil ESPEFA

This medicine should always be taken exactly as described in the patient leaflet or as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine should be taken orally.
If the patient has previously used medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, Sildenafil ESPEFA at a dose of 50 mg should only be used if the patient did not achieve the desired effect (i.e. an erection sufficient for sexual intercourse) after taking sildenafil at a dose of 25 mg.
If taking a lower dose of sildenafil (25 mg) enabled the patient to achieve an erection sufficient for sexual intercourse, a 50 mg dose should not be used.
Sildenafil ESPEFA must not be taken more than once a day.
Sildenafil ESPEFA should be taken approximately one hour before planned sexual activity.
The tablet should be swallowed whole with a glass of water.
Sildenafil ESPEFA enables an erection only in the presence of sexual stimulation.
The time it takes for the medicine to work varies between patients, usually between half an hour and one hour. The effect may occur later if the medicine is taken after a heavy meal.
Consult your doctor if, after taking Sildenafil ESPEFA, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Sildenafil ESPEFA
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 indicated in the patient leaflet.
Consult your doctor if you have taken more tablets than recommended.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported with Sildenafil ESPEFA are usually mild or moderate in intensity and transient.
If any of the following adverse reactions occur, stop taking Sildenafil ESPEFA and seek immediate medical help:

Allergic reaction – occurs uncommonly (may occur in 1 out of 100 patients). Symptoms: sudden wheezing, difficulty 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 decrease or loss of vision – occur rarely
Severe skin reactions – occur rarely. Symptoms may include severe skin peeling and swelling, formation of blisters in the mouth, genital organs and around the eyes, fever.
Seizures or convulsions – occur rarely

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

Headache.

Common (may affect up to 1 in 10 people):

Nausea,
Sudden flushing,
Hot flushes (symptoms include feeling of warmth in the upper body),
Indigestion,
Visual disturbances, seeing colored halos, blurred vision,
Stuffy nose,
Dizziness.

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

Vomiting,
Skin rash,
Eye irritation,
Conjunctival congestion,
Eye pain,
Seeing flashes of light,
Bright vision,
Light sensitivity,
Eye tearing,
Palpitations,
Rapid heartbeat,
Hypertension,
Hypotension (significant drop in blood pressure),
Muscle pain,
Drowsiness,
Reduced sense of touch,
Dizziness,
Ringing in the ears,
Dryness of the mouth,
Blocked or stuffy sinuses,
Nasal mucositis (symptoms include runny nose, sneezing, stuffy nose),
Upper abdominal pain,
Gastroesophageal reflux disease (including heartburn),
Blood in urine,
Pain in hands or feet,
Nosebleeds,
Feeling of warmth,
Feeling of fatigue.

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

Fainting,
Stroke,
Heart attack,
Irregular heartbeat,
Transient reduction in blood flow to part of the brain,
Throat tightness,
Lip numbness,
Bleeding into the back of the eye,
Double vision,
Decreased visual acuity,
Abnormal sensations inside 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 sclera,
Bleeding from the penis,
Blood in semen,
Dry nose,
Nasal swelling,
Feeling of irritability,
Sudden weakness or loss of hearing.

Since sildenafil-containing medicines have been marketed, 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 sildenafil-containing medicines. It is not possible to determine whether these adverse reactions were related to the use of Sildenafil ESPEFA.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 provide more information on the safety of this medicine.

5. How to store Sildenafil ESPEFA

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sildenafil ESPEFA contains
The active substance is sildenafil.
Each coated tablet contains 50 mg of sildenafil (as sildenafil citrate).
The other ingredients are:

tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate;
tablet coating: Opadry II blue 85F505164 (partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol 3350, talc, indigo carmine (E 132), aluminium lake) and Opadry clear 02K19253 (hypromellose 5cp (2910), triacetin).

What Sildenafil ESPEFA looks like and contents of the pack
Sildenafil ESPEFA coated tablets are blue, round, biconvex, with "50" embossed on one side and "H" and "J" on the other side, with a division line.
PVC/Aluminium blister in a cardboard box. The pack contains 2 or 4 coated tablets.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208
30 – 133 Kraków, Poland
Tel. +48 12 639 27 27
Fax +48 12 637 96 45
Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Information for the blind and visually impaired: 800-007-777