ERVASIL 50 mg Tablets

Contents of the leaflet

1. Before taking the medicine, use the attached diagnostic tool (questionnaire)!
2. Leaflet attached to the packaging: patient information
3. Ervasil Max, 50 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 Max and what is it used for
5. Important information before taking Ervasil Max
   1. When not to take Ervasil Max
   2. Warnings and precautions
   3. Children and adolescents
   4. Ervasil Max and other medicines
   5. Ervasil Max with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Ervasil Max contains lactose
   9. Ervasil Max contains sodium
6. How to take Ervasil Max
   1. Taking a higher dose of Ervasil Max than recommended
7. Possible side effects
   1. In case of the following side effects, the patient should stop taking Ervasil Max and immediately seek medical attention:
   2. Other side effects: Very common (may affect more than 1 in 10 people):
   3. Reporting side effects
8. How to store Ervasil Max
9. Contents of the pack and other information
   1. What Ervasil Max contains
   2. What Ervasil Max 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 (questionnaire)!

Leaflet attached to the packaging: patient information

Ervasil Max, 50 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 your 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 Max and what is it used for
• 2. Important information before taking Ervasil Max
• 3. How to take Ervasil Max
• 4. Possible side effects
• 5. How to store Ervasil Max
• 6. Contents of the pack and other information

1. What is Ervasil Max and what is it used for

Ervasil Max contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Ervasil Max helps achieve an erection only if there is prior sexual stimulation. Ervasil Max 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 Ervasil Max

When not to take Ervasil Max

• 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 medicine 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 Ervasil Max, 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 experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Ervasil Max, 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), 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 effort associated with sexual activity.
• Peptic ulcer or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden blindness, they should stop taking Ervasil Max and immediately consult their doctor.

Ervasil Max should not be taken concurrently with other oral or topical treatments for erectile dysfunction. Ervasil Max should not be taken concurrently with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. Ervasil Max should not be taken if the patient has not been diagnosed with erectile dysfunction. Ervasil Max 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 higher dose of sildenafil than 25 mg (they should not take Ervasil Max 50 mg).

Children and adolescents

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

Ervasil Max 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 Max 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 Max and the time of its administration. The patient should not take Ervasil Max concurrently with other medicines without their doctor's recommendation. The patient should not take Ervasil Max 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 or pharmacist if they are taking nitrates, which are used to treat angina pectoris (chest pain). The patient should not take Ervasil Max 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. If the patient is already taking riociguat, they should inform their doctor or pharmacist. When taking medicines from the protease inhibitor group, used to treat HIV infections, the patient should consult their doctor before taking Ervasil Max; in such cases, it is recommended to start treatment with a lower dose (25 mg) of sildenafil. 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 quickly or sitting down. Such symptoms occurred in some patients taking Ervasil Max and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours after taking Ervasil Max. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Ervasil Max. The doctor may decide to use a lower initial dose (25 mg) of Ervasil Max. If the patient experiences symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint), they 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 quickly or sitting down. If the patient is taking ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), they should consult their doctor before taking Ervasil Max. If the patient is taking medicines containing sacubitril with valsartan (used to treat heart failure), they should inform their doctor or pharmacist.

Ervasil Max with food, drink, and alcohol

Ervasil Max can be taken with or without food. Although taking Ervasil Max while eating a large 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 Max, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Ervasil Max is not intended for use by women.

Driving and using machines

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

Ervasil Max contains lactose

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

Ervasil Max contains sodium

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

3. How to take Ervasil Max

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. If the patient has previously taken medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, Ervasil Max at a dose of 50 mg should only be taken if the patient did not experience the desired effect after taking sildenafil at a dose of 25 mg (i.e., they did not achieve an erection sufficient for sexual intercourse). If taking a lower dose of sildenafil (25 mg) allowed the patient to achieve an erection sufficient for sexual intercourse, they should not take a dose of 50 mg. Ervasil Max should not be taken more than once a day.The patient should not take Ervasil Max tablets concurrently with other medicines containing sildenafil (e.g., Viagra). Ervasil Max should be taken approximately one 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 Max is too strong or too weak, they should consult their doctor or pharmacist. Ervasil Max allows for an erection only if there is prior sexual stimulation. The time after which the effect of Ervasil Max occurs varies among patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a large meal. The patient should contact their doctor if they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse after taking Ervasil Max.

Taking a higher dose of Ervasil Max 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 efficacy of the medicine. The patient should not take more tablets than indicated in the patient leaflet.The patient should contact their doctor if they have taken more tablets than recommended. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

In case of the following side effects, the patient should stop taking Ervasil Max and immediately seek medical attention:

• Allergic reaction - occurs uncommonly(may affect up to 1 in 100 people) Symptoms: sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - occurs uncommonlyIf 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 - occurs rarely(may affect up to 1 in 1,000 people) If the erection lasts more than 4 hours, the patient should immediately contact their doctor.
• Sudden vision loss or blindness - occurs rarely
• Severe skin reactions - occurs rarelySymptoms 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 affect more than 1 in 10 people):

• Headache.

Common(may affect up to 1 in 10 people):

• Nausea
• Facial flushing
• Hot flushes (symptoms include a feeling of heat in the upper body)
• Indigestion
• Visual disturbances, blurred vision, color tinge to vision
• Nasal congestion
• Dizziness.

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

• Vomiting
• Rash
• Eye irritation
• Conjunctivitis
• Eye pain
• Flashes of light
• Increased light sensitivity
• Eye discomfort
• Increased tearing
• Pounding heart
• Fast heartbeat
• Hypertension
• Hypotension
• Muscle pain
• Somnolence
• Decreased sensation of touch
• Dizziness
• Ringing in the ears
• Dry mouth
• Blocked or stuffy nose
• Rhinitis (symptoms include runny nose, sneezing, and stuffy nose)
• Upper abdominal pain
• Gastroesophageal reflux disease (symptoms include heartburn)
• Blood in urine
• Pain in arms or legs
• Nosebleeds
• Feeling hot
• Feeling tired.

Rare(may affect up to 1 in 1,000 people):

• 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
• Reduced visual acuity
• Abnormal sensations in the eye
• Eye swelling or eyelid swelling
• 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
• Blood in semen
• Nasal dryness
• Nasal swelling
• Feeling irritable
• Sudden hearing loss.

After the medicine was placed on 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 Ervasil Max. It is not possible to determine whether these side effects were related to the use of Ervasil Max.

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 Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 gathered on the safety of the medicine.

5. How to store Ervasil Max

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 Max contains

• The active substance of Ervasil Max is sildenafil. Each tablet contains 50 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 Max looks like and contents of the pack

Ervasil Max 50 mg is a blue, round, biconvex tablet, 10 mm in diameter, with the number "50" on one side. Ervasil Max is available in cartons containing 2 or 4 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