ERVASIL MAX

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Package leaflet: Information for the patient

Ervasil Max, 50 mg, film-coated tablets
Sildenafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after taking the medicine, or if the patient feels worse, contact a doctor.

Table of contents of the leaflet:

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

Ervasil Max 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.
Ervasil Max helps achieve an erection only if preceded by sexual stimulation.
Ervasil Max is used to treat erectile dysfunction in adult men, i.e. impotence defined as the
inability to achieve or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using Ervasil Max

When not to use 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, because their concomitant use may lead to a dangerous decrease in blood pressure. The doctor should be informed if the patient is taking any medicines from this group – these medicines are often used to relieve symptoms of angina (chest pain). If in doubt, consult a 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 is taking riociguat. This is a medicine used in the treatment of 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). PDE5 inhibitors, such as Ervasil Max, have been shown to 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, or has low blood pressure.
• If the patient has hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions
Before starting to take Ervasil Max, discuss this with a doctor or pharmacist if:

• The patient has sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• The patient has been diagnosed with anatomical deformity of the penis or Peyronie's disease.
• The patient has heart problems. In such cases, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity.
• The patient has peptic ulcers or bleeding disorders (such as hemophilia).
• If sudden worsening of vision or sudden vision loss occurs, the use of Ervasil Max should be stopped immediately and the patient should contact a doctor without delay.

Ervasil Max should not be used simultaneously with other oral or topical treatments for erectile dysfunction.
Ervasil Max should not be used simultaneously with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Ervasil Max should not be taken if erectile dysfunction has not been diagnosed.
Ervasil Max is not a medicine intended for use by women.

Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor.
Patients with impaired kidney or liver function should not take a dose of sildenafil higher than 25 mg (they should not use Ervasil Max 50 mg).

Children and adolescents
Ervasil Max should not be used in individuals under 18 years of age.

Ervasil Max and other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Ervasil Max may interact with certain medicines, especially those used to treat chest pain. In case of worsening health requiring immediate medical attention, inform the doctor, pharmacist, or nurse about taking Ervasil Max and the time of its ingestion. Do not take Ervasil Max together with other medicines without a doctor's recommendation.
Do not take Ervasil Max if the patient is using nitrates, because their concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor or pharmacist if the patient is taking nitrates, which are used to treat angina (chest pain).
Do not take Ervasil Max if the patient is using drugs that release nitric oxide (such as amyl nitrite), because their concomitant use may also cause a dangerous drop in blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
If the patient is taking protease inhibitors used in the treatment of HIV infection, consult a doctor before taking Ervasil Max; in such cases, treatment should begin with a lower dose (25 mg) of sildenafil.
In some patients taking alpha-blockers for high blood pressure or prostate enlargement, 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 up. Such symptoms have been observed in some patients taking Ervasil Max together with alpha-blockers. These symptoms are most likely to occur within 4 hours after taking Ervasil Max. To reduce the likelihood of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting Ervasil Max. The doctor may decide to start treatment with a lower initial dose (25 mg) of Ervasil Max.
If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit until symptoms subside. Drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help. Rapid standing or sitting should be avoided.
If the patient is taking ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), consult a doctor before taking Ervasil Max.
If the patient is using medicines containing sacubitril with valsartan (used in the treatment of 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. However, taking Ervasil Max with a heavy meal may delay the onset of the medicine's effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of Ervasil Max, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding, and fertility
Ervasil Max is not intended for use by women.

Driving and operating machinery
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 certain sugars, they should consult a doctor before taking this medicine.

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

3. How to use Ervasil Max

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
If the patient has previously used 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 used if the patient did not achieve the desired effect (i.e. did not obtain an erection sufficient for sexual intercourse) after taking sildenafil at a dose of 25 mg.
If treatment with a lower dose of sildenafil (25 mg) enabled an erection sufficient for sexual intercourse, a dose of 50 mg should not be used.
Ervasil Max must not be taken more than once a day.
Do not take Ervasil Max coated tablets together with other medicines containing sildenafil (e.g. Viagra).
Ervasil Max should be taken approximately one hour before planned sexual activity.
Swallow the tablet whole with a glass of water.
If you feel that the effect of Ervasil Max is too strong or too weak, consult your doctor or pharmacist.
Ervasil Max enables an erection only in the presence of sexual stimulation.
The time to onset of effect of Ervasil Max 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.
Contact your doctor if no erection occurs after taking Ervasil Max, or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Ervasil Max
Adverse effects may occur more frequently and may be more severe.
Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than indicated in the patient information leaflet.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts regarding 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 the use of Ervasil Max are usually mild or moderate in intensity and transient.
If any of the following adverse reactions occur, discontinue taking Ervasil Max immediately
and seek medical help at once:

• Allergic reaction – occurs not very often (may occur in 1 out of 100 patients). Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs not very often. If chest pain occurs during or after sexual activity:
  • sit in a semi-upright position and try to relax,
  • do not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occur rarely (may occur in 1 out of 1000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden decrease or loss of vision – occurs rarely
• Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, genital area 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 1 in 10 patients):

• Nausea
• Sudden flushing of the face
• Hot flushes (symptoms include a feeling of warmth in the upper body)
• Indigestion
• Seeing coloured halos, blurred vision, visual disturbances
• Stuffy nose
• Dizziness.

Not very common (may affect 1 in 100 patients):

• Vomiting
• Skin rash
• Eye irritation
• Eye redness
• Eye pain
• Seeing flashes of light
• Bright vision
• Light sensitivity
• Watery eyes
• Palpitations
• Rapid heartbeat
• High blood pressure
• Low blood pressure
• Muscle pain
• Drowsiness
• Reduced sense of touch
• Dizziness
• Ringing in the ears
• Dryness in the mouth
• Blocked or stuffy sinuses
• Nasal mucositis (symptoms include runny nose, sneezing and blocked nose)
• Upper abdominal pain
• Gastroesophageal reflux disease (symptoms include heartburn)
• Blood in urine
• Pain in hands or feet
• Nosebleeds
• Feeling of warmth
• Feeling of fatigue.

Rare (may affect 1 in 1000 patients):

• Fainting
• Stroke
• Heart attack
• Irregular heartbeat
• Transient reduction in blood flow to part of the brain
• Throat tightness
• Numbness of the lips
• Bleeding into the back of the eye
• Double vision
• Reduced 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 of the eye
• Bleeding from the rectum
• Blood in semen
• Dry nose
• Nasal swelling
• Feeling of irritability
• Sudden weakness or loss of hearing.

After marketing authorization, cases of unstable angina (heart disease) and sudden death have been reported rarely. It is important to note that in most, but not all, men who experienced these adverse reactions, pre-existing heart conditions were present before taking Ervasil Max. It is not possible to determine whether these adverse reactions were related to the use of Ervasil Max.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
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 Ervasil Max

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer cardboard
package following EXP.
The expiry date refers to the last day of the indicated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ervasil Max contains

• The active substance in Ervasil Max is sildenafil. Each tablet contains 50 mg of sildenafil (as sildenafil citrate).
• The other ingredients 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 blue, round, biconvex tablets with a diameter of 10 mm, marked with the number "50" on one side.
Ervasil Max is available in cardboard boxes containing 2 or 4 tablets in PVC/PVDC/Aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Promedo Pharma Products GmbH
Anklamer Strasse 28
10115 Berlin
Germany
[email protected]

Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Poland

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