Package leaflet: information for the patient

Mensil, 25 mg, chewable tablets
Sildenafilum
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician, pharmacist, or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your physician, pharmacist, or nurse. See section 4.
If there is no improvement after taking the medicine, or if you feel worse, contact your physician.

Contents of the leaflet

What Mensil is and what it is used for
Important information before taking Mensil
How to take Mensil
Possible side effects
How to store Mensil
Contents of the pack and other information

1. What Mensil is and what it is used for

Mensil 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. Sildenafil helps
achieve an erection only if the patient is sexually stimulated beforehand.
Mensil is used in the treatment of 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 Mensil

When not to use Mensil:

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 patient should inform the doctor if they are taking any medicines from this group – these medicines are often used to relieve symptoms of angina (i.e. "chest pain"). If in doubt, consult a doctor or pharmacist.

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If the patient is taking drugs that release nitric oxide (such as amyl nitrite, so-called "poppers"), because their simultaneous 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 Mensil, 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.
In cases of severe heart or liver disease.
After a recent stroke or heart attack, and in cases of 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 Mensil, discuss this with a doctor, pharmacist, or nurse if:

The patient has sickle cell anemia (an abnormality affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
The patient has been diagnosed with anatomical penile deformity 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 patient should stop taking Mensil and contact a doctor immediately.

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

Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. Such patients should not take a dose of Mensil higher than 25 mg.

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

Mensil and other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Mensil may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and requires immediate medical attention, inform the doctor, pharmacist, or nurse that Mensil has been taken and when it was taken. Do not take Mensil with other medicines without medical advice.
Do not take Mensil if the patient is using nitrates, because their concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates, which are used to treat angina ("chest pain").
Do not take Mensil if the patient is taking drugs that release nitric oxide (such as amyl nitrate), because their simultaneous use may also cause a dangerous drop in blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
For patients taking protease inhibitors used in the treatment of HIV infection, treatment with a lower starting dose (25 mg) of Mensil 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 Mensil and alpha-blockers. They are most likely to occur within 4 hours after taking Mensil. To reduce the likelihood of these symptoms, the patient should be on a stable dose regimen of their alpha-blocker before starting Mensil. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of Mensil. If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit and wait until symptoms subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. Avoid rapid standing or sitting.
Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Mensil with food, drink, and alcohol
Mensil can be taken with or without food. However, taking Mensil 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 effect of Mensil, significant alcohol intake should be avoided before taking the medicine.

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

Driving and using machines
Mensil may cause dizziness and visual disturbances. Patients should understand how they react to Mensil before driving or operating machinery.
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Mensil contains 2.15 mg of aspartame (E 951) per tablet
Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.

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

3. How to take Mensil

This medicine should always be taken exactly as described in the patient leaflet or as directed by your
doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse.
The recommended dose of Mensil is 25 mg. Your doctor may, after consultation, recommend a different dosing regimen.
Mensil must not be taken more than once a day.
Do not take Mensil together with other medicines containing sildenafil.
Mensil should be taken approximately one hour before planned sexual activity. The tablet should be bitten and chewed. Tablets do not need to be swallowed with liquid.
If you feel the effect of Mensil is too strong or too weak, consult your doctor or pharmacist.
Mensil enables an erection to occur only in the presence of sexual stimulation. The time to onset of effect of Mensil varies between patients, but is usually between half an hour and one hour. The effect of Mensil may occur later if the medicine is taken after a heavy meal.
Contact your doctor if, after taking Mensil, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking more Mensil than recommended
Adverse effects may occur more frequently and may be more severe.
Taking a dose higher than 100 mg does not result in increased effectiveness of the medicine.
Do not take more tablets than indicated in the patient leaflet.
Contact your doctor if you have taken more tablets than recommended.
If you have any further questions about 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 Mensil are usually mild or
moderate in intensity and transient.
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If any of the following adverse reactions occur,
discontinue taking Mensil 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 skin peeling and swelling, blistering in the mouth, genital area or 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 up to 1 in 10 patients): nausea, sudden flushing, hot flushes (symptoms include a feeling of warmth in the upper body), indigestion, seeing coloured halos, blurred vision, visual disturbances, stuffy nose, 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, excessive tearing, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, drowsiness, reduced sense of touch, dizziness, tinnitus, dry 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 and 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, lip numbness, bleeding into the back of the eye, double vision, reduced visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids, small specks or dots in the visual field, seeing halos around light sources, pupil dilation, abnormal discoloration of the white part of the eye, bleeding from the penis, blood in semen, dry nose, nasal swelling, feeling of irritation, and sudden hearing loss or hearing impairment.

Since the medicine has been marketed, 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 reactions, cardiac disorders were present prior to taking the medicine containing sildenafil.
It is not possible to determine whether these adverse reactions were related to the use of the medicine containing sildenafil.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
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Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +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 the medicine.

5. How to store the medicine Mensil

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
No special temperature storage conditions are required.
Do not use this medicine after the expiry date stated on the carton and blister pack after "Tw."
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine contains Mensil

The active substance is sildenafil. One tablet contains 25 mg of sildenafil formed in situ from 35.12 mg of sildenafil citrate.
The other ingredients (excipients) are: potassium polycrylinate, colloidal anhydrous silica, lactose monohydrate, povidone K-30, aspartame (E 951), sodium croscarmellose, mint flavor, magnesium stearate, potassium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).

What Mensil looks like and contents of the pack
Mensil is white, triangular, biconvex tablets marked on one side with the number "25".
One pack contains 2, 4 or 8 orodispersible and chewable tablets in blisters within a cardboard box.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław

Medicinal Product Information
tel.: (22) 742 00 22
e-mail: [email protected]
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