Sildenafil Espefa

Package Leaflet: Information for the Patient

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Sildenafil ESPEFA, 50 mg, Film-Coated Tablets

Sildenafil

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This medication should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.
• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Sildenafil ESPEFA and What is it Used For
• 2. Important Information Before Taking Sildenafil ESPEFA
• 3. How to Take Sildenafil ESPEFA
• 4. Possible Side Effects
• 5. How to Store Sildenafil ESPEFA
• 6. Package Contents and Other Information

1. What is Sildenafil ESPEFA and What is it Used For

Sildenafil ESPEFA contains the active substance sildenafil, which belongs to a group of phosphodiesterase type 5 (PDE5) inhibitors. The medication works by supporting the relaxation of blood vessels in the penis, increasing blood flow to the penis during sexual arousal. Sildenafil ESPEFA helps achieve an erection only if there is prior sexual stimulation. Sildenafil ESPEFA is used to treat erectile dysfunction in adult men, defined as the inability to achieve or maintain an erection sufficient for sexual intercourse. The medication should not be taken if there are no erectile dysfunction issues.

2. Important Information Before Taking Sildenafil ESPEFA

When Not to Take Sildenafil ESPEFA

• If the patient is allergic to sildenafil or any other component of this medication (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 medications from this group - these medications are often used to alleviate symptoms of angina pectoris ("chest pain"). In case of doubts, consult a doctor or pharmacist.
• If the patient is taking medications that release nitric oxide (such as amyl nitrite, also known as "poppers"), as their concurrent use may also lead to a dangerous decrease in blood pressure.
• If the patient is taking riociguat. This medication 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 Sildenafil ESPEFA, enhance the blood pressure-lowering effect of this medication. 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 experienced a stroke or heart attack.
• If the patient has low blood pressure.
• If the patient has inherited degenerative changes in the retina, such as retinitis pigmentosa.
• If the patient has ever experienced vision loss due to non-inflammatory anterior ischemic optic neuropathy (NAION).

Warnings and Precautions

Before starting to take Sildenafil ESPEFA, the patient should discuss it with their doctor or pharmacist:

• if the patient has sickle cell anemia (a disorder 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 deformation of the penis or Peyronie's disease (characterized by curvature of the penis, sometimes painful erection),
• if the patient has heart problems; in this case, the doctor should assess whether the patient's heart condition allows for the additional effort associated with sexual activity,
• if the patient has stomach ulcers,
• if the patient has blood clotting disorders (such as hemophilia).

If sudden vision loss or sudden vision deterioration occurs, the patient should stop taking Sildenafil ESPEFA and immediately consult a doctor. Sildenafil ESPEFA should not be taken concurrently with other oral or topical medications used to treat erectile dysfunction. Sildenafil ESPEFA should not be taken concurrently with pulmonary arterial hypertension (PAH) therapies using sildenafil or other PDE5 inhibitors. Sildenafil ESPEFA should not be taken if there are no erectile dysfunction issues. Sildenafil ESPEFA is not intended for women. Special considerations for patients with kidney or liver function disorders.Patients with kidney or liver function disorders should inform their doctor. Patients with kidney or liver function disorders should not take a sildenafil dose higher than 25 mg.

Children and Adolescents

Sildenafil ESPEFA should not be taken by individuals under the age of 18.

Sildenafil ESPEFA and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

• Sildenafil ESPEFA may interact with certain medications, especially those used to treat chest pain.In case of a medical emergency, the patient should inform their doctor about taking Sildenafil ESPEFA. The patient should not take Sildenafil ESPEFA concurrently with other medications without their doctor's advice.
• The patient should not take Sildenafil ESPEFA if they are taking nitrate medications, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should always inform their doctor or pharmacist if they are taking nitrates, which are often used to treat angina pectoris ("chest pain").
• The patient should not take Sildenafil ESPEFA if they are taking medications that release nitric oxide (such as amyl nitrite), as their concurrent use may also lead to a dangerous decrease in blood pressure.
• If the patient is already taking riociguat, they should inform their doctor or pharmacist.
• In case of taking protease inhibitors used to treat HIV infections, the patient should consult their doctor before taking Sildenafil ESPEFA. In such cases, it is recommended to start treatment with the lowest dose (25 mg) of Sildenafil ESPEFA.
• In some patients taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of low blood pressure caused by a drop in blood pressure when standing up or sitting down quickly (orthostatic hypotension). Such symptoms have occurred in some patients taking sildenafil and alpha-adrenergic blockers concurrently. Their occurrence is most likely within 4 hours of taking the medication. To minimize the risk of these symptoms, the patient should regularly take their alpha-adrenergic blocker medication before starting Sildenafil ESPEFA. The doctor may decide to use a lower initial dose of sildenafil (25mg). If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling of impending faint), the patient should first lie down or sit and wait for the symptoms to pass; drinking water, taking fresh air, tensing abdominal muscles, or crossing legs may also help. The patient should avoid standing up or sitting down quickly.
• If the patient is taking ketoconazole (an antifungal medication), erythromycin (an antibiotic), or cimetidine (a medication for heartburn), they should consult their doctor before taking Sildenafil ESPEFA.
• The patient should inform their doctor or pharmacist about taking medications containing sacubitril with valsartan, used to treat heart failure.

Sildenafil ESPEFA with Food, Drink, and Alcohol

Sildenafil ESPEFA can be taken with or without food. Taking Sildenafil ESPEFA while consuming large meals may prolong the time needed for the medication to start working. The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of Sildenafil ESPEFA, the patient should not consume significant amounts of alcohol before taking the medication.

Pregnancy, Breastfeeding, and Fertility

Sildenafil ESPEFA is not intended for use by women.

Driving and Operating Machines

Sildenafil ESPEFA may cause dizziness and vision disturbances. Before driving or operating machines, patients should determine how they react to Sildenafil ESPEFA.

3. How to Take Sildenafil ESPEFA

This medication should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist. The medication should be taken orally. If the patient has previously taken sildenafil medications in a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, Sildenafil ESPEFA in a dose of 50 mg should only be taken if the patient did not experience the desired effect after taking sildenafil in a dose of 25 mg (i.e., they did not achieve an erection sufficient for sexual intercourse). If taking sildenafil in a lower dose (25 mg) allowed the patient to achieve an erection enabling sexual intercourse, they should not take a dose of 50 mg.

Sildenafil ESPEFA should 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 there is prior sexual stimulation. The time it takes for the medication to start working varies among patients, usually ranging from half an hour to one hour. The effect may occur later if taken after a large meal. The patient should consult their doctor if, after taking Sildenafil ESPEFA, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a Higher Than Recommended Dose of Sildenafil ESPEFA

The patient may experience more frequent or severe side effects. Taking a dose higher than 100 mg does not increase the medication's effectiveness. The patient should not take more tablets than indicated in the patient leaflet.The patient should consult their doctor if they have taken more tablets than recommended. In case of any further doubts about taking this medication, the patient should consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Sildenafil ESPEFA can cause side effects, although not everyone will experience them. Side effects reported in connection with taking Sildenafil ESPEFA are usually mild or moderate and short-term.

In Case of the Following Side Effects, the Patient Should Stop Taking Sildenafil ESPEFA and Immediately Seek Medical Attention:

• An 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 the following occur during or after sexual intercourse:

• the patient should assume a semi-sitting position and try to relax,
• not take nitratesto alleviate chest pain.
• Prolonged and sometimes painful erections occur rarely (may occur in 1 in 1000 patients).If an erection lasts more than 4 hours, the patient should immediately consult a doctor.
• Sudden vision loss or deterioration - occurs rarely
• Severe skin reactions - occur rarely.Symptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur 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,
• Flushing (symptoms include a feeling of heat in the upper body),
• Indigestion,
• Visual disturbances, seeing a colored glow, blurred vision,
• Stuffy nose,
• Dizziness.

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

• Vomiting,
• Skin rash,
• Eye irritation,
• Conjunctivitis,
• Eye pain,
• Seeing flashes of light,
• Increased sensitivity to light,
• Eye tearing,
• Palpitations,
• Rapid heartbeat,
• Hypertension,
• Hypotension (significant decrease in blood pressure),
• Muscle pain,
• Somnolence,
• Decreased sense of touch,
• Dizziness,
• Ringing in the ears,
• Dry mouth,
• Stuffy or congested sinuses,
• Rhinitis (characterized by a runny nose, sneezing, stuffy nose),
• Upper abdominal pain,
• Gastroesophageal reflux disease (characterized by 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 tightness in the throat,
• Numbness of the lips,
• Bleeding in the back of the eye,
• Double vision,
• Decreased visual acuity,
• Abnormal sensations in the eye,
• Eye or eyelid swelling,
• Small particles or dots 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,
• Nose dryness,
• Nasal congestion,
• Feeling of irritability,
• Sudden hearing loss or hearing impairment.

After the introduction of sildenafil-containing medications to the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is essential to note that in most, but not all, men who experienced these side effects, heart function disorders were present before taking the medication. It is not possible to determine whether these side effects were related to taking Sildenafil ESPEFA.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Sildenafil ESPEFA

The medication should be stored out of sight and reach of children. There are no special storage instructions for this medication. Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Sildenafil ESPEFA Contains

The active substance of the medication is sildenafil. Each film-coated tablet contains 50 mg of sildenafil (in the form of sildenafil citrate). The other ingredients are:

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

Appearance and Package Contents of Sildenafil ESPEFA

Sildenafil ESPEFA film-coated tablets are blue, round, and biconvex with "50" embossed on one side and "H" and "J" on the other side, with a dividing line. The medication comes in a PVC/Aluminum blister pack in a cardboard box. The package contains 2 or 4 film-coated tablets.

Marketing Authorization Holder and Importer

Marketing Authorization 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

Date of Last Revision of the Leaflet: