Mensil

Before using the medicine, please read the attached PATIENT INFORMATION LEAFLET!

Leaflet attached to the packaging: patient information

Mensil, 25 mg, chewable tablets

Sildenafil

Please read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient information leaflet or as advised by a doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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 Mensil and what is it used for
• 2. Important information before taking Mensil
• 3. How to take Mensil
• 4. Possible side effects
• 5. How to store Mensil
• 6. Package contents and other information

1. What is Mensil and what is it 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 the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil helps achieve an erection only if there is prior sexual stimulation.

Mensil 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 Mensil

When not to take 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, 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, also known as "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 Mensil, 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, 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 a sudden loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting to take Mensil, the patient should discuss the following with their doctor, pharmacist, or nurse:

• 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 hearing loss, they should stop taking Mensil and immediately consult their doctor.

Mensil should not be taken at the same time as other oral or topical treatments for erectile dysfunction.

Mensil should not be taken at the same time as treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

Mensil should not be taken if the patient has not been diagnosed with erectile dysfunction.

Mensil is not intended for women.

Special considerations for patients with kidney or liver function disorders

Patients with kidney or liver function disorders should inform their doctor. Such patients should not take a dose of Mensil higher than 25 mg.

Children and adolescents

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

Mensil 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.

Mensil may interact with some medicines, especially those used to treat chest pain. In case of a worsening condition requiring immediate medical attention, the patient should inform their doctor, pharmacist, or nurse about taking Mensil and the time of intake. Mensil should not be taken with other medicines without a doctor's recommendation.

Mensil 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, pharmacist, or nurse if they are taking nitrates, which are often used to treat angina pectoris (chest pain).

Mensil should not be taken if the patient is taking medicines that release nitric oxide (such as amyl nitrite), as their concurrent use may also lead to 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 Mensil.

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 or sitting down quickly. Such symptoms have occurred in some patients taking Mensil and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking Mensil. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Mensil. The doctor may decide to use a lower initial dose (25 mg) of Mensil. 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.

The patient should tell their doctor or pharmacist if they are taking medicines containing sacubitril with valsartan, used to treat heart failure.

Mensil with food, drink, and alcohol

Mensil can be taken with or without food. However, taking Mensil while eating a large meal may prolong the time it takes 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 Mensil, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Mensil is not intended for use by women.

Driving and using machines

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

Mensil contains 2.15 mg of aspartame (E 951) in one tablet

Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

Mensil contains lactose

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

3. How to take Mensil

This medicine should always be used exactly as described in the patient information leaflet or as advised by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.

The recommended dose of Mensil is 25 mg. The doctor may recommend a different dosing regimen after consultation.

Mensil should not be taken more than once a day.

Mensil should not be taken with other medicines containing sildenafil.

Mensil should be taken about an hour before planned sexual activity. The tablet should be chewed and sucked. The tablets do not require drinking.

If the patient feels that the effect of Mensil is too strong or too weak, they should consult their doctor or pharmacist.

Mensil allows for an erection only if there is prior sexual stimulation. The time it takes for Mensil to start working varies from patient to patient, usually ranging from half an hour to one hour. The effect of Mensil may occur later if the medicine is taken after a large meal.

The patient should consult their doctor if they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse after taking Mensil.

Taking a higher dose of Mensil than recommended

The patient may experience more frequent or more severe side effects.

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 information 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, Mensil can cause side effects, although not everybody gets them.

Side effects reported in connection with the use of Mensil are usually mild or moderate and short-lived.

In case of the following side effects, the patient should stop taking Mensil and seek immediate medical attention:

• 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,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in 1 in 1000 patients). If the erection lasts for more than 4 hours, the patient should immediately consult their doctor.
• Sudden vision loss or hearing loss - occur rarely.
• Severe skin reactions - occur rarely. Symptoms 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, hot flushes (symptoms include a feeling of heat in the upper body), indigestion, seeing a colored glow, blurred vision, visual disturbances, stuffy nose, dizziness.

Uncommon(may occur in 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctival hyperemia, eye pain, seeing flashes of light, bright vision, sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, somnolence, decreased tactile sensitivity, dizziness, ringing in the ears, dry mouth, stuffy or blocked sinuses, nasal congestion (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 of heat, and 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 in the back of the eye, double vision, reduced visual acuity, abnormal sensations in 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 penis, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritability, and sudden loss of hearing.

After the medicine has been 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 function disorders existed before taking the medicine containing sildenafil. It is not possible to determine whether these side effects were related to the use of the medicine containing sildenafil.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 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.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Mensil

The medicine should be stored out of sight and reach of children.

Store in the original packaging to protect from light.

No special precautions for storage temperature are necessary.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP".

The expiry date refers to the last day of the month stated.

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. Package contents and other information

What Mensil contains

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

What Mensil looks like and what the pack contains

Mensil is a white, triangular, biconvex tablet with the number "25" engraved on one side.

One pack of Mensil contains 2, 4, or 8 chewable tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.

ul. Żmigrodzka 242 E, 51-131 Wrocław

Information about the medicine

tel.: (22) 742 00 22

e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet:02/2023