ERVASIL 25 mg Tablets

Contents of the leaflet

1. Before taking the medicine, use the attached diagnostic tool!
2. Leaflet attached to the packaging: patient information
3. Ervasil, 25 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Ervasil and what is it used for
5. Important information before taking Ervasil
   1. When not to take Ervasil
   2. Warnings and precautions
   3. Children and adolescents
   4. Ervasil and other medicines
   5. Ervasil with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Ervasil contains lactose
   9. Ervasil contains sodium
6. How to take Ervasil
   1. Taking a higher dose of Ervasil than recommended
7. Possible side effects
   1. If the patient experiences any of the following side effects, they should stop taking Ervasil and seek medical help immediately:
   2. Other side effects: Very common (may occur in more than 1 in 10 patients):
   3. Reporting side effects
8. How to store Ervasil
9. Contents of the pack and other information
   1. What Ervasil contains
   2. What Ervasil looks like and contents of the pack
   3. Marketing authorization holder
   4. Promedo Pharma Products GmbH
   5. Manufacturer

Before taking the medicine, use the attached diagnostic tool!

Leaflet attached to the packaging: patient information

Ervasil, 25 mg, film-coated tablets

Sildenafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If the patient's condition does not improve or worsens after taking the medicine, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Ervasil and what is it used for
• 2. Important information before taking Ervasil
• 3. How to take Ervasil
• 4. Possible side effects
• 5. How to store Ervasil
• 6. Contents of the pack and other information

1. What is Ervasil and what is it used for

Ervasil contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Ervasil helps achieve an erection only if there is prior sexual stimulation. Ervasil is used to treat erectile dysfunction in adult men, which is the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Ervasil

When not to take Ervasil

• 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 concurrent use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medicines from this group - these medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, the patient should consult their doctor or pharmacist.
• If the patient is taking medicines that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concurrent use may also lead to a dangerous decrease 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 blood pressure in the lungs caused by blood clots). It has been shown that PDE5 inhibitors, such as Ervasil, enhance the blood pressure-lowering effect of this medicine. 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, as well as in cases of low blood pressure.
• If the patient has hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If the patient has ever had a loss of vision due to non-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Ervasil, the patient should discuss it with their doctor or pharmacist in the following cases:

• Sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• If the patient has anatomical deformation of the penis or Peyronie's disease.
• Heart problems. In this case, the doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity.
• Ulcer or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden blindness, they should stop taking Ervasil and seek medical help immediately.

Ervasil should not be taken at the same time as other oral or topical treatments for erectile dysfunction. Ervasil should not be taken at the same time as treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. Ervasil should not be taken if erectile dysfunction has not been diagnosed. Ervasil is not intended for women. Special considerations for patients with renal or hepatic impairmentPatients with renal or hepatic impairment should inform their doctor. Patients with renal or hepatic impairment should not take a dose of Ervasil higher than 25 mg.

Children and adolescents

Ervasil should not be taken by persons under 18 years of age.

Ervasil 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. Ervasil may interact with some medicines, especially those used to treat chest pain. If the patient's condition worsens, requiring immediate medical attention, they should inform their doctor, pharmacist, or nurse about taking Ervasil and the time of its administration. Ervasil should not be taken with other medicines without a doctor's recommendation. Ervasil should not be taken if the patient is taking nitrates, 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 used to treat angina pectoris ("chest pain"). Ervasil should not be taken if the patient is taking medicines that release nitric oxide (such as amyl nitrite), as their concurrent use may also cause a dangerous decrease in blood pressure. If the patient is already taking riociguat, they should inform their doctor or pharmacist. When taking protease inhibitors used to treat HIV infections, it is recommended to start treatment with a lower dose (25 mg) of Ervasil. In some patients who take 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. Such symptoms occurred in some patients taking Ervasil and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking Ervasil. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Ervasil. The doctor may decide to use a lower initial dose (25 mg) of Ervasil. If symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint) occur, 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 medicines containing sacubitril with valsartan (used to treat heart failure), they should inform their doctor or pharmacist.

Ervasil with food, drink, and alcohol

Ervasil can be taken with or without food. Although taking Ervasil during a heavy meal may prolong the time needed 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 Ervasil, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Ervasil is not intended for use by women.

Driving and using machines

Ervasil may cause dizziness and visual disturbances. Patients should be aware of how they react to Ervasil before driving vehicles or operating machines.

Ervasil contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Ervasil.

Ervasil contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Ervasil

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose of Ervasil is 25 mg. The doctor may recommend a different dosing regimen after consultation. Ervasil should not be taken more than once a day.The patient should not take Ervasil tablets at the same time as Viagra or other products containing sildenafil. Ervasil should be taken about an hour before planned sexual activity. The tablet should be swallowed whole with a glass of water. If the patient feels that the effect of Ervasil is too strong or too weak, they should consult their doctor or pharmacist. Ervasil allows for an erection only if there is prior sexual stimulation. The time it takes for Ervasil to start working varies from person to person, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal. The patient should consult their doctor if they do not achieve an erection after taking Ervasil or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Ervasil 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 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 the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ervasil can cause side effects, although not everybody gets them. Side effects reported in connection with the use of Ervasil are usually mild or moderate and short-lived.

If the patient experiences any of the following side effects, they should stop taking Ervasil and seek medical help immediately:

• 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 it occurs during or after sexual intercourse:
• the patient should sit half-up and try to relax,
• they should not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely (may occur in 1 in 1000 patients).

If the erection lasts more than 4 hours, the patient should seek medical help immediately.

• Sudden vision loss or blindness - occurs rarely
• Severe skin reactions - occur rarelySymptoms 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 1 in 10 patients) :

• Nausea,
• Sudden flushing of the face,
• Hot flushes (symptoms include a feeling of heat in the upper part of the body),
• Indigestion,
• Visual disturbances (seeing a colored glow, increased sensitivity to light, blurred vision, or decreased sharpness of vision),
• Feeling of a blocked nose,
• Dizziness.

Uncommon(may occur in 1 in 100 patients) :

• Vomiting,
• Skin rash,
• Eye irritation,
• Eye redness,
• Eye pain,
• Seeing flashes of light,
• Increased brightness of vision,
• Light sensitivity,
• Eye watering,
• Palpitations,
• Rapid heartbeat,
• Hypertension,
• Hypotension,
• Muscle pain,
• Somnolence,
• Decreased sense of touch,
• Dizziness,
• Ringing in the ears,
• Dry mouth,
• Blocked or stuffy sinuses,
• Nasal congestion (symptoms include runny nose, sneezing, and stuffy nose),
• Pain in the upper abdomen,
• Gastroesophageal reflux disease (symptoms include heartburn),
• Blood in the urine,
• Pain in the arms or legs,
• Nosebleeds,
• Feeling of heat,
• Feeling of fatigue.

Rare(may occur in 1 in 1000 patients) :

• Fainting,
• Stroke,
• Heart attack,
• Irregular heartbeat,
• Transient reduction in blood flow to part of the brain,
• Feeling of constriction in the throat,
• Numbness of the lips,
• Bleeding into the back of the eye or eyelids,
• Small particles or dots 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 of irritability,
• Sudden loss of hearing.

After the introduction of sildenafil-containing medicines 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 side effects, heart problems existed before taking the sildenafil-containing medicine. It is not possible to determine whether these side effects were related to the use of Ervasil.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, PL-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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ervasil

The medicine should be stored out of sight and reach of children. There are no special precautions for storing the medicine. The patient should not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month. 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. Contents of the pack and other information

What Ervasil contains

• The active substance of Ervasil is sildenafil. Each tablet contains 25 mg of sildenafil (as sildenafil citrate).
• The other ingredients of the medicine are: Tablet core: microcrystalline cellulose 102, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.

Coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), triacetin, indigo carmine (E 132).

What Ervasil looks like and contents of the pack

Ervasil film-coated tablets are blue, round, and biconvex, with the number "25" on one side. The medicine is available in cartons containing 2, 4, or 8 tablets in PVC/PVDC/Aluminum blisters. Not all pack sizes may be marketed.

Marketing authorization holder

Promedo Pharma Products GmbH

Anklamer Strasse 28, 10115 Berlin, Germany

Manufacturer

Adamed Pharma S.A., ul. Marszałka J. Piłsudskiego 5, 95-200 Pabianice, Poland Date of last revision of the leaflet:November 2022