Mensil Max

Before using the medicine, take advantage of the attached PATIENT INFORMATION LEAFLET!

Leaflet attached to the packaging: patient information

MENSIL MAX, 50 mg, chewable tablets

Sildenafil

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient information leaflet or as advised 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 more information, you should talk to a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

1. What is MENSIL MAX and what is it used for

MENSIL 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 the flow of blood to the penis during sexual stimulation. Sildenafil helps to achieve an erection only if there is prior sexual stimulation.

2. Important information before using MENSIL MAX

When not to use MENSIL MAX:

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates, as their simultaneous use may lead to a dangerous decrease in blood pressure. You should inform your doctor if you are taking any medicines from this group - these medicines are often used to relieve symptoms of angina pectoris (chest pain).
• If you are taking medicines that release nitric oxide (such as amyl nitrite, so-called poppers), as their simultaneous use may also lead to a dangerous decrease in blood pressure.

1/7

• If you are 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). It has been shown that PDE5 inhibitors, such as MENSIL MAX, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.
• In case of severe heart or liver disease.
• After a recent stroke or heart attack, as well as in cases of low blood pressure.
• If you have hereditary degenerative changes in the retina, such as retinitis pigmentosa.
• If you have ever experienced loss of vision due to non-inflammatory anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting to use MENSIL MAX, you should discuss it with your doctor, pharmacist, or nurse if:

• You have sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• You have been diagnosed with penile deformity or Peyronie's disease.
• You have heart problems. In this case, your doctor should assess whether your heart condition allows for the additional strain associated with sexual activity.
• You have stomach ulcers or bleeding disorders (such as hemophilia).
• If you experience sudden vision loss or sudden loss of vision, you should stop using MENSIL MAX and contact your doctor immediately.

MENSIL MAX should not be used in combination with other oral or topical treatments for erectile dysfunction.

MENSIL MAX should not be used in combination with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

MENSIL MAX should not be taken if you have not been diagnosed with erectile dysfunction.

MENSIL MAX 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. Patients with kidney or liver function disorders should not use a sildenafil dose higher than 25 mg.

Children and adolescents

MENSIL MAX should not be used in people under 18 years of age.

MENSIL MAX and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

MENSIL MAX may interact with some medicines, especially those used to treat chest pain. In case of a worsening condition requiring immediate medical attention, you should inform your doctor, pharmacist, or nurse about taking MENSIL MAX and the time of its administration. You should not take MENSIL MAX with other medicines without a doctor's recommendation.

2/7

MENSIL MAX with food, drink, and alcohol

MENSIL MAX can be taken with or without food. Although taking MENSIL MAX during a heavy 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 MENSIL MAX, you should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

MENSIL MAX is not intended for use by women.

Driving and using machines

MENSIL MAX may cause dizziness and vision disturbances. Before driving or operating machinery, patients should be aware of how they react to MENSIL MAX.

3/7

MENSIL MAX contains aspartame

The medicine contains 4.30 mg of aspartame in each 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 excretion.

MENSIL MAX contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to use MENSIL MAX

This medicine should always be used exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If you are unsure, you should talk to a doctor or pharmacist.

Recommended dose

If you have previously used medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg.

Otherwise, MENSIL MAX at a dose of 50 mg should only be used if you did not experience the desired effect (i.e., you did not achieve an erection sufficient for intercourse) after using sildenafil at a dose of 25 mg.

If using a medicine containing sildenafil at a lower dose (25 mg) allowed you to achieve an erection enabling you to have sexual intercourse, you should not use a dose of 50 mg.

MENSIL MAX should not be used more than once a day.

You should not take MENSIL MAX with other medicines containing sildenafil.

MENSIL MAX should be taken about an hour before planned sexual activity.

The tablet should be chewed.

If you feel that the effect of MENSIL MAX is too strong or too weak, you should talk to a doctor or pharmacist.

MENSIL MAX allows you to achieve an erection only if there is prior sexual stimulation. The time after which MENSIL MAX works varies from person to person, usually ranging from half an hour to one hour. The effect of MENSIL MAX may occur later if the medicine is taken after a heavy meal.

You should contact your doctor if, after using MENSIL MAX, you do not achieve an erection or if the duration of the erection is not sufficient for intercourse.

Taking a higher dose of MENSIL 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 mean increased efficacy of the medicine.

You should not use more tablets than indicated in the patient information leaflet.

You should contact your doctor if you have taken more tablets than recommended.

If you have any further doubts about using this medicine, you should talk to a doctor or pharmacist.

4/7

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects reported in connection with the use of MENSIL MAX are usually mild or moderate and short-term.

In case of any of the following side effects, you should stop using MENSIL MAX and seek medical attention immediately:

• 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:
• you should take a half-sitting position and try to relax,
• do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in 1 in 1000 patients). If an erection lasts for more than 4 hours, you should contact your doctor immediately.
• Sudden vision loss or vision 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 of the face, hot flashes (symptoms include a feeling of heat in the upper body), indigestion, seeing a colored glow, blurred vision, disturbances in vision, feeling of a blocked 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, drowsiness, decreased sensation, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, nasal congestion (symptoms include runny nose, sneezing, and stuffy nose), stomach 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, decreased sharpness of vision, 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, dilated pupils, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dryness of the nose, swelling inside the nose, feeling of irritability, and sudden hearing loss or loss of hearing.

5/7

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 function disorders occurred 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 you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.

By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store MENSIL MAX

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

There are no special recommendations for storage temperature.

Store in the original packaging to protect from light.

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. You should ask your 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 MENSIL MAX contains

• The active substance of the medicine is sildenafil. One tablet of the medicine contains 50 mg of sildenafil formed in situ from 70.24 mg of sildenafil citrate.
• 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 MAX looks like and contents of the pack

MENSIL MAX is a white, triangular, biconvex tablet, marked with the number "50" on one side.

One pack of the medicine contains 1, 2, or 4 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

Medicine information

tel.: (22) 742 00 22

e-mail: [email protected]

Date of last update of the leaflet:02/2023

6/7

7/7