Sildenafil Espefa

Leaflet attached to the packaging: patient information

Sildenafil Espefa, 100 mg, film-coated tablets

Sildenafil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil Espefa helps achieve an erection only if there is prior sexual stimulation.

Sildenafil Espefa is used to treat erectile dysfunction in adult men, which is defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Sildenafil Espefa

When not to take Sildenafil Espefa

Warnings and precautions

Before starting treatment with Sildenafil Espefa, the patient should discuss it with their doctor or pharmacist:

If sudden vision loss or sudden loss of vision occurs, the patient should stop taking Sildenafil Espefa and contact their doctor immediately.

Sildenafil Espefa should not be taken at the same time as other oral or topical treatments for erectile dysfunction.

Sildenafil Espefa should not be taken at the same time as therapies for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

Sildenafil Espefa should not be taken if there are no erection disorders.

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.

The doctor may decide to use a lower dose of Sildenafil Espefa.

Children and adolescents

Sildenafil Espefa should not be taken by people under 18 years of age.

Sildenafil Espefa and other medicines

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

• Sildenafil Espefa may interact with some medicines, especially those used to treat chest pain. If the patient's condition worsens and requires immediate medical attention, they should inform their doctor, pharmacist, or nurse about the use of Sildenafil Espefa and the time it was taken. The patient should not take Sildenafil Espefa at the same time as other medicines without their doctor's advice.
• The patient should not take Sildenafil Espefa if they are taking nitrate medicines, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should always inform their doctor, pharmacist, or nurse if they are taking nitrates, which are used to treat angina pectoris ("chest pain").
• The patient should not take Sildenafil Espefa if they are taking medicines that release nitric oxide(such as amyl nitrite), as their concurrent use may also cause a dangerous decrease in blood pressure.
• In the case of protease inhibitor medicinesused to treat HIV infections, it is recommended to start treatment with a lower dose (25 mg) of sildenafil.
• In some patients taking alpha-adrenergic blocking agentsfor 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. Such symptoms have occurred in some patients taking sildenafil and alpha-adrenergic blocking agents at the same time. Their occurrence is most likely within 4 hours of taking Sildenafil Espefa. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocking agent before starting Sildenafil Espefa. The doctor may decide to use a lower initial 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 while eating a large meal may prolong the time it takes for the medicine 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 medicine.

Pregnancy, breastfeeding, and fertility

Sildenafil Espefa is not intended for use by women.

Driving and using machines

Sildenafil Espefa may cause dizziness and vision disturbances. Patients should be aware of how they react to Sildenafil Espefa before driving or operating machinery.

3. How to take Sildenafil Espefa

This medicine should always be taken as directed by the doctor.

In case of doubts, the patient should consult their doctor or pharmacist.

The medicine should be taken orally. The recommended initial dose is 50 mg (½ tablet of 100 mg).

Sildenafil Espefa should not be taken more than once a day.

Sildenafil Espefa should be taken about an hour before planned sexual activity.

The tablet should be swallowed whole, with a glass of water.

Sildenafil Espefa allows for an erection only if there is prior sexual stimulation.

The time it takes for the medicine to work varies from person to person, usually between half an hour and one hour. The effect may occur later if the medicine is taken after a large meal.

The patient should consult their doctor if they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse after taking Sildenafil Espefa.

The tablet can be divided into equal doses (50 mg of sildenafil).

Sildenafil Espefa should not be used if the patient requires a dose of 25 mg. In this case, the doctor will prescribe another sildenafil-containing medicine in the appropriate dose.

Taking a higher dose of Sildenafil Espefa than recommended

The patient may experience more frequent side effects, and they may be more severe.

Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.

The patient should not take more tablets than prescribed by their doctor.

The patient should consult their doctor if they have taken more tablets than recommended.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sildenafil Espefa can cause side effects, although not everybody gets them.

Side effects reported in connection with the use of sildenafil are usually mild or moderate and short-lived.

If any of the following side effects occur, the patient should stop taking Sildenafil Espefa and seek medical attention immediately:

• 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 it occurs during or after sexual intercourse:
• the patient should sit up and try to relax,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections- occurs rarely (may occur in 1 in 1000 patients). If an erection lasts more than 4 hours, the patient should seek medical attention immediately.
• Sudden vision loss or blindness- occurs rarely.
• Severe skin reactions- occurs rarely. Symptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions- occurs rarely.

Other side effects:

Very common(may occur in more than 1 in 10 patients):

• headache.

Common(may occur in 1 in 10 patients):

• nausea;
• sudden flushing of the face;
• flushing;
• indigestion;
• seeing a blue tint on objects;
• blurred vision;
• visual disturbances;
• stuffy nose;
• dizziness.

Uncommon(may occur in 1 in 100 patients):

• vomiting;
• skin rash;
• eye irritation;
• redness of the eyes;
• eye pain;
• seeing flashes of light;
• increased sensitivity to light;
• tearing;
• palpitations;
• rapid heartbeat;
• high blood pressure;
• low blood pressure;
• muscle pain;
• drowsiness;
• reduced sense of touch;
• dizziness;
• ringing in the ears;
• dry mouth;
• stuffy or congested sinuses;
• inflammation of the nasal mucosa (manifested by a runny nose, sneezing, stuffy nose);
• upper abdominal pain;
• gastroesophageal reflux disease (manifested by heartburn, among other symptoms);
• blood in the urine;
• pain in the arms or legs;
• nosebleeds;
• feeling hot;
• feeling tired.

Rare(may occur in 1 in 1000 patients):

• fainting;
• stroke;
• heart attack;
• irregular heartbeat;
• temporary reduction in blood flow to part of the brain;
• feeling of pressure in the throat;
• numbness of the lips;
• bleeding into the back of the eye;
• double vision;
• reduced visual acuity;
• abnormal sensations in 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 of the eye;
• bleeding from the penis;
• presence of blood in the semen;
• dry nose;
• swelling inside the nose;
• feeling irritable;
• sudden loss of hearing.

Rarely, after the introduction of sildenafil to the market, there have been reports of unstable angina (heart disease) and sudden death. It is important to note that in most, but not all, men who experienced these side effects, heart function disorders occurred before taking the sildenafil-containing medicine. It is not possible to determine whether these side effects were related to the use of the sildenafil-containing medicine.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181 C, 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 medicine.

5. How to store Sildenafil Espefa

The medicine should be stored out of sight and reach of children.

There are no special recommendations for storing the medicine.

Do not use this medicine after the expiry date stated on the packaging.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Sildenafil Espefa contains

The active substance of the medicine is sildenafil.

Each film-coated tablet contains 100 mg of sildenafil (as sildenafil citrate).

The other ingredients are:

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

What Sildenafil Espefa looks like and what the package contains

Sildenafil Espefa film-coated tablets are blue, round, and biconvex with "126" embossed on one side and "J" on the other side, with a dividing line.

The package contains 4 film-coated tablets.

Marketing authorization holder

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA

ul. Juliusza Lea 208

30-133 Kraków, Poland

Tel.: +48 12 639 27 27

Importer, which releases the series

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola

PLA 3000

Malta

Information for the blind and visually impaired:800-007-777

Date of the last update of the leaflet: