Ervasil

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Package leaflet: Information for the patient

Ervasil, 25 mg, film-coated tablets
Sildenafilum
Please read this leaflet carefully before using the medicine, as 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 you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after using the medicine, or if you feel worse, contact your doctor.

Contents of the leaflet:

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

1. What Ervasil is and what it is 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 blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation.
Ervasil helps achieve an erection only if sexual stimulation occurs beforehand.
Ervasil is used in the treatment of erectile dysfunction in adult men, i.e. impotence. This refers to the inability to obtain or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using Ervasil

When not to use 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, because their concomitant use may lead to a dangerous drop in blood pressure. The patient should inform the doctor if they are 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 medicines that release nitric oxide (such as amyl nitrite, so-called "poppers"), because their concomitant use may also lead to a dangerous drop 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). PDE5 inhibitors such as Ervasil 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 (NAION).

Warnings and precautions
Before starting treatment with Ervasil, discuss 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).
• Sudden decrease or loss of vision occurs – treatment with Ervasil should be stopped immediately and the patient should contact a doctor without delay.

Ervasil should not be used concomitantly with other oral or topical therapies for erectile dysfunction.
Ervasil should not be used together with arterial pulmonary hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Ervasil should not be taken if erectile dysfunction has not been diagnosed.
Ervasil is not a medicine intended for use in 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 Ervasil higher than 25 mg.

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

Ervasil and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Ervasil may interact with certain medicines, particularly those used to treat chest pain. If your health deteriorates and you require immediate medical attention, inform the doctor, pharmacist, or nurse that you have taken Ervasil and when you took it. Do not take Ervasil with other medicines unless advised by a doctor.
Do not take Ervasil if you are taking nitrates, because their concomitant use may lead to a dangerous drop in blood pressure. Always inform your doctor or pharmacist if you are taking nitrates, which are used to treat angina (chest pain).
Do not take Ervasil if you are taking medicines that release nitric oxide (such as amyl nitrite), because their concomitant use may also cause a dangerous drop in blood pressure.
If you are already taking riociguat, inform your doctor or pharmacist.
If you are taking protease inhibitors used in the treatment of HIV infection, treatment with a lower starting dose (25 mg) of Ervasil is recommended.
Some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness, which may be symptoms of low blood pressure caused by a drop in blood pressure upon rapid standing or sitting. Such symptoms have occurred in some patients taking Ervasil together with alpha-blockers. These symptoms are most likely to occur within 4 hours after taking Ervasil. To reduce the risk of such symptoms, patients should be on a stable dose of their alpha-blocker before starting Ervasil. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of Ervasil. If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit until symptoms subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. Rapid standing or sitting should be avoided.
If you are taking medicines containing sacubitril with valsartan (used in the treatment of heart failure), inform your doctor or pharmacist.

Ervasil with food, drink, and alcohol
Ervasil can be taken with or without food. However, taking Ervasil with a heavy meal may delay the onset of its effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic benefit of Ervasil, significant alcohol intake should be avoided before taking the medicine.

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

Driving and operating machinery
Ervasil may cause dizziness and visual disturbances. Patients should assess how they react to Ervasil before driving or operating machinery.

Ervasil contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

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

3. How to use Ervasil

This medicine should always be taken exactly as described in the patient information leaflet or as
advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose of the medicine is 25 mg. Your doctor may, after consultation, recommend a different dosing regimen.
Ervasil must not be taken more than once a day.
Do not take Ervasil coated tablets at the same time as Viagra or other products
containing sildenafil.
Ervasil should be taken approximately one hour before planned sexual activity.
The tablet should be swallowed whole with a glass of water.
If you feel that the effect of Ervasil is too strong or too weak, consult your
doctor or pharmacist.
Ervasil enables an erection to be achieved only if there is sexual stimulation. The time it takes for Ervasil to take effect varies between patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal.
You should contact your doctor if, after taking Ervasil, an erection does not occur or if the duration of the erection is insufficient for sexual intercourse.
Use of a higher than recommended dose of Ervasil
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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects reported with the use of Ervasil are usually mild or
moderate in intensity and short-lived.
If any of the following adverse effects occur, stop taking Ervasil and seek immediate medical help:

• Allergic reaction – occurs uncommonly (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 uncommonly). If chest pain occurs during or after sexual intercourse:
  • adopt a semi-sitting 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, blisters in the mouth, on the genitals and around the eyes, fever.
• Seizures or fits – occur rarely

Other adverse effects:
Very common (may affect more than 1 in 10 patients):

• Headache.

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

• Nausea,
• Sudden flushing of the face,
• Hot flushes (symptoms include a feeling of warmth in the upper body),
• Indigestion,
• Visual disturbances (seeing coloured halos, light sensitivity, blurred vision or reduced visual acuity),
• Nasal congestion,
• Dizziness.

Uncommon (may affect up to 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,
• Hypertension,
• Hypotension,
• Muscle pain,
• Drowsiness,
• Reduced sense of touch,
• Dizziness,
• Tinnitus,
• Dryness of the mouth,
• Blocked or stuffy sinuses,
• Nasal mucosal inflammation (symptoms include runny nose, sneezing and nasal congestion),
• 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 up to 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 or eyelids,
• Small particles or spots in the field of vision,
• Seeing halos around light sources,
• Pupil dilation,
• Abnormal eye white discoloration,
• Penile bleeding,
• Blood in semen,
• Dry nose,
• Swelling inside the nose,
• Irritability,
• Sudden hearing loss or hearing impairment.

Since the introduction of sildenafil-containing medicines into 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 adverse effects, pre-existing heart conditions were present
before taking sildenafil-containing medicines. It is not possible to determine whether these adverse effects
were related to the use of Ervasil.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Ervasil

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer carton after EXP. The expiry date refers to the last day of the specified 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 will help protect the environment.

6. Contents of the packaging and other information

What Ervasil contains

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

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

What Ervasil looks like and contents of the pack
Ervasil coated tablets are blue, round, biconvex, with the number "25" marked on one side.
Ervasil is available in cardboard packages containing 2, 4 or 8 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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