Patient Information Leaflet

Sildenafil Espefa, 100 mg, film-coated tablets
Sildenafilum
Please read carefully the entire leaflet before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions 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 the penis during sexual stimulation. Sildenafil Espefa helps achieve an erection only if sexual stimulation is present.
Sildenafil Espefa is used to treat erectile dysfunction in adult men, defined as the inability to achieve or maintain a penile erection sufficient for sexual intercourse.

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. You should inform your doctor if you are taking any medicines from this group – these medicines are often used to relieve symptoms of angina (chest pain). If in doubt, consult your 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 decrease in blood pressure;
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 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 cancer of the bone marrow);
if the patient has anatomical deformity of the penis or Peyronie's disease (characterized by penile curvature, sometimes painful erections);
if the patient has heart problems; in such cases, the doctor should assess whether the cardiac condition allows for the additional strain associated with sexual activity;
if the patient has peptic ulcer disease;
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 your doctor without delay.
Sildenafil Espefa must not be used concomitantly with other oral or topical treatments for erectile dysfunction.
Sildenafil Espefa must not be used concomitantly with arterial pulmonary hypertension (PAH) therapies containing 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.
The doctor may decide to prescribe a lower dose of Sildenafil Espefa.

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 you are currently taking, have recently taken, or plan to take.

Sildenafil Espefa may interact with certain medicines, especially those used to treat chest pain. If your health deteriorates and you require immediate medical assistance, inform your doctor, pharmacist, or nurse that you have taken Sildenafil Espefa and when it was taken. Do not take Sildenafil Espefa with other medicines unless advised by your doctor.
Do not take Sildenafil Espefa if you are taking nitrates because their concomitant use may cause a dangerous drop in blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking nitrates, which are commonly used in the treatment of angina (chest pain).
Do not take Sildenafil Espefa if you are taking drugs that release nitric oxide (such as amyl nitrite), because their concomitant use may also cause a dangerous decrease in blood pressure.
If you are taking protease inhibitors used in the treatment of HIV infection, a lower starting dose (25 mg) of sildenafil is recommended.
In some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia, 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. Such symptoms have been observed in some patients taking sildenafil together with alpha-blockers. These are most likely to occur within 4 hours after taking Sildenafil Espefa. To minimize the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting Sildenafil Espefa. The doctor may decide to initiate treatment with a lower dose of sildenafil (25 mg).

Taking 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 onset of the drug's effect.
The ability to achieve an erection may be temporarily impaired by alcohol consumption. To maximize the therapeutic benefit of Sildenafil Espefa, significant alcohol intake should be avoided before taking the medicine.

Pregnancy, breastfeeding, and fertility
Sildenafil Espefa is not intended for use in women.

Driving and operating machinery
Sildenafil Espefa may cause dizziness and visual disturbances. Patients should assess how they react to Sildenafil Espefa before driving or operating machinery.

3. How to use Sildenafil Espefa

This medicine should always be taken as directed by the physician.
If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally. The recommended starting dose is 50 mg (½ of a 100 mg tablet).
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 if accompanied by sexual stimulation.
The time it takes for the medicine to work 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.
Consult your doctor if, after taking Sildenafil Espefa, an erection does not occur, or if the duration of erection is insufficient for sexual intercourse.
The tablet may be divided into equal doses (each containing 50 mg of sildenafil).
Sildenafil Espefa must not be used when a 25 mg dose of sildenafil is indicated for the patient.
In such a case, the doctor will prescribe another medicine containing sildenafil in the appropriate dose.
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 prescribed by your doctor.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts about 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 are usually mild or
moderate in intensity and transient.
If any of the following adverse reactions occur, discontinue taking Sildenafil Espefa and seek immediate medical help:

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 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 in 1000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.
Sudden worsening 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 organs 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 (feeling of warmth in the upper body);
indigestion;
coloured vision;
blurred vision;
visual disturbances;
stuffy nose;
dizziness.

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

vomiting;
skin rash;
eye irritation;
eye congestion;
eye pain;
seeing flashes of light;
bright vision;
sensitivity to light;
watery eyes;
palpitations;
rapid heartbeat;
high blood pressure;
low blood pressure (significant drop in blood pressure);
muscle pain;
drowsiness;
reduced sense of touch;
dizziness;
ringing in the ears;
dry mouth;
blocked or stuffy sinuses;
nasal mucositis (symptoms include runny nose, sneezing, blocked nose);
upper abdominal pain;
gastro-oesophageal 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 patients):

fainting;
stroke;
heart attack;
irregular heartbeat;
transient reduction in blood flow to part of the brain;
sensation of tightness in the throat;
numbness of the lips;
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 field of vision;
seeing halos around light sources;
pupil dilation;
abnormal discoloration of the white part of the eye;
bleeding from the rectum;
presence of blood in semen;
dry nose;
nasal swelling;
feeling of irritability;
sudden hearing loss or decreased hearing.

Since sildenafil has 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 present before taking sildenafil-containing medication. It is not possible to determine whether these adverse reactions were related to the use of sildenafil-containing medicines.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your 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 181 C, 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 to provide more information on the safety of this medicine.

5. How to store Sildenafil Espefa

Keep this medicine out of the sight and reach of children.
There are no special requirements for the storage of 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Sildenafil Espefa contains
The active substance is sildenafil.
Each coated tablet contains 100 mg of sildenafil (as sildenafil citrate).
The other ingredients are:

tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate;
tablet coating: Opadry II blue 85F505164 (partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, indigo carmine (E132), lac) and Opadry clear 02K19253/Instacoat Universal Clear A05G15189 (hypromellose 5cp, triacetin).

What Sildenafil Espefa looks like and contents of the pack
Sildenafil Espefa coated tablets are blue, round, biconvex, with "126" debossed on one side and "J" on the other, and a division line.
The pack contains 4 coated tablets.
Marketing Authorisation Holder
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
Juliusza Lea 208
30–133 Kraków, Poland
Tel.: +48 12 639 27 27
Importer responsible for batch release
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola
PLA 3000
Malta
Information for blind and partially sighted people: 800-007-777