Patient Information Leaflet

Mensil MED MAX, 100 mg, chewable tablets
Sildenafilum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Mensil MED MAX is and what it is used for
What you need to know before taking Mensil MED MAX
How to take Mensil MED MAX
Possible side effects
How to store Mensil MED MAX
Contents of the pack and other information

1. What Mensil MED MAX is and what it is used for

Mensil MED 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 to the penis during sexual stimulation. Sildenafil helps achieve an erection only if sexual stimulation is present.
Mensil MED MAX is used to treat 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 MED MAX

When not to use Mensil MED 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, because their concomitant 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 (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 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). It has been shown that PDE5 inhibitors, such as Mensil MED MAX, 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 MED 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 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 vision deterioration or sudden vision loss occurs, the patient should stop taking Mensil MED MAX and contact a doctor immediately.

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

Special considerations for patients with kidney or liver impairment
Patients with impaired kidney or liver function should inform their doctor. The doctor may decide to prescribe a lower dose.

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

Mensil MED MAX and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Mensil MED MAX may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and immediate medical assistance is required, inform the doctor, pharmacist, or nurse that Mensil MED MAX was taken and when it was taken. Do not take Mensil MED MAX together with other medicines without medical advice.

Do not take Mensil MED 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 MED 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 upon rapid standing or sitting. Such symptoms have been observed in some patients taking Mensil MED MAX and alpha-blockers. They are most likely to occur within 4 hours after taking Mensil MED MAX. To reduce the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting treatment with Mensil MED MAX. The doctor may decide to initiate treatment with a lower starting dose (25 mg).

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

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

Driving and operating machinery
Mensil MED MAX may cause dizziness and visual disturbances. Patients should understand how they react to Mensil MED MAX before driving or operating machinery.

Mensil MED MAX contains aspartame, a source of phenylalanine. The medicine may be harmful to patients with phenylketonuria.
Mensil MED MAX contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, such as lactose, they should consult their doctor before taking the medicine.

3. How to use Mensil MED MAX

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This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist. The recommended starting dose is 50 mg.
Mensil MED MAX should not be taken more than once a day.
Do not take Mensil MED MAX together with other medicines containing sildenafil.
Take Mensil MED MAX approximately one hour before planned sexual activity.
The tablet should be bitten and chewed.
If the effect of Mensil MED MAX seems too strong or too weak, consult a
doctor or pharmacist.
Mensil MED MAX enables an erection only in the presence of sexual stimulation. The time
required for Mensil MED MAX to take effect varies between patients, usually ranging from
half an hour to one hour. The effect of Mensil MED MAX may occur later if the medicine
is taken after a heavy meal.
Contact a doctor if, after taking Mensil MED MAX, an erection does not occur or if the duration of
erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Mensil MED MAX
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 prescribed by a doctor.
Contact a doctor if more tablets have been taken than recommended.
If there are any further doubts regarding the use of this medicine, consult a
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 MED MAX are usually mild
or moderately severe and transient.
If any of the following adverse reactions occur, discontinue taking Mensil MED MAX and
seek immediate medical help:

Allergic reaction – occurs not very commonly (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 not very 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 in 1000 patients). 4/6

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 organs and around the eyes, fever.
Seizures or convulsions – occur rarely.

Other adverse reactions:
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 flushes
(symptoms include a feeling of warmth in the upper body), indigestion, seeing coloured halos,
blurred vision, visual disturbances, stuffy nose, dizziness.
Not very common (may occur in 1 in 100 patients): vomiting, skin rash, eye irritation,
eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity,
tearing of the eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain,
drowsiness, reduced sense of touch, dizziness, ringing in the ears, dry mouth, blocked
or stuffy sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and blocked nose), pain
in the upper abdomen, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain
in hands or feet, nosebleeds, feeling of warmth 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 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 particles or spots in the visual field, seeing halos around light sources,
pupil dilation, abnormal discoloration of the white part of the eye, rectal bleeding, presence of 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 is important to note that in most, but not all, men who experienced these adverse reactions, cardiac disorders were present before taking the medicine containing sildenafil. It is not possible to determine whether these adverse reactions were related to the use of medicines 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 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
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
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5. How to store Mensil MED MAX

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

6. Contents of the packaging and other information

What the medicine contains Mensil MED MAX

The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).
The other ingredients (excipients) are: potassium polyacrylate, anhydrous colloidal silicon dioxide, lactose monohydrate, povidone K-30, aspartame (E 951), sodium croscarmellose, peppermint flavor, magnesium stearate, potassium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).

What Mensil MED MAX looks like and contents of the pack
Mensil MED MAX is white, triangular, biconvex tablets, marked on one side with the number "100".
Each pack contains 2, 4, 8 or 12 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. + 48 (22) 742 00 22
email: [email protected]
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