Package leaflet: Information for the patient

Before taking the medicine, use the diagnostic tool provided!
Sildenafil ESPEFA, 25 mg, film-coated tablets
Sildenafil
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 prescribed by the doctor or pharmacist.
Keep this leaflet so that you can read it again if necessary.
If you have any questions, consult your doctor or pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 pack 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 this organ during sexual stimulation. Sildenafil ESPEFA helps achieve an erection only if there is prior sexual stimulation.
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 drop in blood pressure. The patient should inform the doctor if they are taking any medicines from this group – these drugs are often used to relieve symptoms of angina (chest pain). If in doubt, consult a doctor or pharmacist.
If the patient is taking drugs that release nitric oxide (such as amyl nitrite, so-called "poppers"), because their concomitant use may also lead to a dangerous drop 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 lung pressure 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 the following with your 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 bone marrow cancer),
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 bleeding disorders (such as hemophilia).

If sudden worsening of vision or sudden vision loss occurs, stop taking Sildenafil ESPEFA immediately and contact a doctor without delay.
Sildenafil ESPEFA must not be used concurrently with other oral or topical medicines used to treat erectile dysfunction.
Sildenafil ESPEFA must not be used concurrently with arterial pulmonary hypertension (PAH) therapies involving sildenafil or other PDE5 inhibitors.
Sildenafil ESPEFA must not be used if erectile dysfunction has not been diagnosed.
Sildenafil ESPEFA is not a medicine intended for use in 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 ESPEFA higher than 25 mg.

Children and adolescents
Sildenafil ESPEFA must not be used in individuals under 18 years of age.

Sildenafil ESPEFA and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.

Sildenafil ESPEFA may interact with certain medicines, particularly those used to treat chest pain. If the patient's health deteriorates and requires immediate medical attention, they must inform the doctor about having taken Sildenafil ESPEFA. Do not take Sildenafil ESPEFA together with other medicines unless advised by a doctor.
Do not take Sildenafil ESPEFA if the patient is taking nitrates, as their concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor or pharmacist if the patient is taking nitrates used to treat angina (chest pain).
Do not take Sildenafil ESPEFA if the patient is taking drugs that release nitric oxide (such as amyl nitrite), as their concomitant use may also cause a dangerous drop in 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, they should consult their doctor before taking Sildenafil ESPEFA. In such cases, treatment should be initiated with the lowest dose (25 mg) of Sildenafil ESPEFA.
Some patients taking α-adrenergic blockers (α-blockers) for high blood pressure or prostate enlargement 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 (orthostatic hypotension). Such symptoms have occurred in some patients taking sildenafil-containing medicines together with α-blockers. 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-blocker before starting Sildenafil ESPEFA. The doctor may decide to initiate treatment with a lower starting 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. Avoid rapid standing or sitting.
If the patient is taking ketoconazole (a medicine for fungal infections), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), consult a doctor before taking Sildenafil ESPEFA.
Inform the doctor or pharmacist if 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 start working.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of Sildenafil ESPEFA, significant amounts of alcohol should not be consumed 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 determine 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 this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 25 mg.
This medicine should be taken orally. The recommended initial dose is 25 mg (1 tablet).
Sildenafil ESPEFA should not be used 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 to occur only in the presence of sexual stimulation.
The time until the medicine takes effect varies between patients, but usually ranges from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal.
You should contact 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 reactions may occur more frequently and may be more severe.
Taking a dose higher than 100 mg does not result in increased effectiveness of the medicine.
Do not take more tablets than indicated in the patient information leaflet.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts concerning 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 experiences 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 it 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 peeling and swelling of the skin, blistering in the mouth, genital area 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 1 in 10 patients):

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

Uncommon (may affect 1 in 100 patients):

Vomiting,
Skin rash,
Eye irritation,
Eye congestion,
Eye pain,
Seeing flashes of light,
Bright vision,
Light sensitivity,
Watery eyes,
Palpitations,
Rapid heartbeat,
Hypertension,
Hypotension (significant drop in blood pressure),
Muscle pain,
Drowsiness,
Reduced sense of touch,
Dizziness,
Tinnitus,
Dry mouth,
Blocked or stuffy sinuses,
Nasal mucosal inflammation (manifesting as catarrh, sneezing, blocked 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 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 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,
Swelling inside the nose,
Irritability,
Sudden weakness or hearing loss.

After sildenafil-containing medicines were introduced to 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 existed prior to taking sildenafil-containing medicines. It is not possible to determine whether these adverse reactions were related to the use of Sildenafil ESPEFA.

Reporting adverse reactions
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 the medicine out of sight and reach of children.
No special storage instructions apply.
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 no longer in use. Such measures 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 25 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), macrogol 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 "25" debossed on one side and "HJ" on the other.
PVC/Aluminium blister in a cardboard box. The pack contains 2 or 4 or 8 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