Mensil max

Before using the medicine, read the PATIENT INFORMATION LEAFLET included in the package!

Patient Information Leaflet

MENSIL MAX, 50 mg, chewable 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
physician or pharmacist.

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

Table of Contents

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

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

MENSIL 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 into the penis during sexual stimulation. Sildenafil helps achieve an
erection only when sexual stimulation is present.
MENSIL MAX is used for the treatment of erectile dysfunction in adult men, i.e. impotence defined as the
inability to obtain or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using MENSIL MAX

When not to use MENSIL 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, as 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.

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• 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 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.
• 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 MAX, discuss this with a doctor, pharmacist, or nurse if:

• The patient has sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• 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 patient's heart condition allows for the additional strain associated with sexual activity.
• The patient has peptic ulcers or bleeding disorders (such as hemophilia).
• If sudden vision loss or sudden decrease in vision occurs, the use of MENSIL MAX should be stopped immediately and the patient should contact a doctor without delay.

MENSIL MAX should not be used concurrently with other oral or topical treatments for erectile dysfunction.
MENSIL MAX should not be used concurrently with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
MENSIL MAX should not be taken if erectile dysfunction has not been diagnosed.
MENSIL 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 sildenafil dose higher than 25 mg.

Children and adolescents
MENSIL MAX should not be used in individuals under 18 years of age.

MENSIL MAX and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
MENSIL MAX may interact with certain medicines, especially those used to treat chest pain. If your health deteriorates and requires immediate medical attention, inform the doctor, pharmacist, or nurse that you have taken MENSIL MAX and when it was taken. Do not take MENSIL MAX together with other medicines without medical advice.
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Do not take MENSIL MAX if the patient is taking 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 MAX if the patient is taking 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.
When taking protease inhibitors used in the treatment of HIV infection, it is recommended to start treatment with a lower dose (25 mg) of the medicine.
In some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of low blood pressure caused by a drop in blood pressure during rapid standing or sitting up. Such symptoms have been observed in some patients taking MENSIL MAX and alpha-blockers. They are most likely to occur within 4 hours after taking MENSIL MAX. To reduce the risk of such symptoms, the patient should be on a stable dose regimen of their alpha-blocker before starting MENSIL MAX. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of the medicine.
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. Rapid standing or sitting should be avoided.
If the patient is taking ketoconazole, erythromycin, or cimetidine, they should consult a doctor before taking MENSIL MAX.
Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.

MENSIL MAX with food, drink, and alcohol
MENSIL MAX can be taken with or without food. However, taking MENSIL 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 benefit of MENSIL MAX, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding, and fertility
MENSIL MAX is not intended for use by women.

Driving and operating machinery
MENSIL MAX may cause dizziness and visual disturbances. Patients should understand how they react to MENSIL MAX before driving or operating machinery.
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MENSIL MAX contains aspartame
The medicine contains 4.30 mg of aspartame per 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 improper excretion.

MENSIL MAX 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 use MENSIL MAX

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose
If the patient has 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 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 taking a lower dose of sildenafil (25 mg) enabled an erection sufficient for sexual intercourse, a dose of 50 mg should not be used.

MENSIL MAX must not be taken more than once a day.

Do not take MENSIL MAX together with other medicines containing sildenafil.

MENSIL MAX should be taken approximately one hour before planned sexual activity.

The tablet should be chewed and swallowed.

If you feel that the effect of MENSIL MAX is too strong or too weak, consult your doctor or pharmacist.

MENSIL MAX enables an erection only in the presence of sexual stimulation. The time it takes for MENSIL MAX to take effect varies between patients, usually between half an hour and one hour. The effect of MENSIL MAX may occur later if the medicine is taken after a heavy meal.

Contact your doctor if, after taking MENSIL MAX, no erection occurs or if the duration of erection is insufficient for sexual intercourse.

Taking more MENSIL MAX than recommended

The patient may experience adverse reactions more frequently and they 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 more tablets have been taken than recommended.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

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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 MAX are usually mild or
moderately severe and short-lived.
If any of the following adverse reactions occur, stop taking MENSIL MAX and seek immediate medical help:

• Allergic reaction – occurs not commonly (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 commonly. 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 worsening or loss of vision – occurs rarely.
• Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, formation of blisters 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 people): headache.
Common (may affect 1 in 10 people): nausea, sudden flushing of the face, hot flushes (symptoms include feeling of warmth in the upper body), indigestion, seeing coloured tinge, blurred vision, visual disturbances, stuffy nose, dizziness.
Not common (may affect 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity, tearing eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, drowsiness, reduced sense of touch, dizziness, ringing in the ears, 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 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of tightness in the throat, numbness of the lips, bleeding into the back of the eye, double vision, decreased 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 discolouration of the white of the eye, rectal bleeding, blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden hearing loss.

After the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that most, but not all, men who experienced these adverse reactions already had underlying heart conditions before taking sildenafil-containing medicines.
It is not possible to determine whether these adverse reactions were related to the use of sildenafil-containing medicines.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store MENSIL MAX

Keep this medicine out of sight and reach of children.
There are no special requirements regarding 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 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 MAX

• The active substance is sildenafil. One tablet contains 50 mg of sildenafil formed in situ from 70.24 mg of sildenafil citrate.
• The other ingredients (excipients) are: potassium polycrylline, anhydrous colloidal silicon dioxide, lactose monohydrate, povidone K-30, aspartame (E 951), sodium croscarmellose, peppermint flavour, magnesium stearate, potassium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).

What MENSIL MAX looks like and contents of the pack
MENSIL MAX is white, triangular, biconvex tablets, marked on one side with the number "50".
One pack contains 1, 2 or 4 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

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