Mensil Med Max

Leaflet attached to the packaging: patient information

Mensil MED MAX, 100 mg, chewable tablets

Sildenafil

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Mensil MED MAX and what is it used for
• 2. Important information before taking Mensil MED MAX
• 3. How to take Mensil MED MAX
• 4. Possible side effects
• 5. How to store Mensil MED MAX
• 6. Package contents and other information

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

When not to take 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, 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, consult a 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 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, 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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting to take Mensil MED MAX, the patient should discuss it with their doctor, pharmacist, or nurse in the following cases:

• 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 vision deterioration, they should stop taking Mensil MED MAX and contact their doctor immediately.

Mensil MED MAX should not be taken concurrently with other oral or topical treatments for erectile dysfunction.
Mensil MED MAX should not be taken concurrently with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.
Mensil MED MAX should not be taken if erectile dysfunction has not been diagnosed.
Mensil MED MAX is not intended for women.
Special considerations for patients with renal or hepatic impairment
Patients with renal or hepatic impairment should inform their doctor. The doctor may decide to use a lower dose of the medicine.

Children and adolescents

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

Mensil MED MAX 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 MED MAX 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 MED MAX and the time of its administration. The patient should not take Mensil MED MAX with other medicines without their doctor's recommendation.
The patient should not take Mensil MED MAX if they are taking nitrate medicines, 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 used to treat angina pectoris (chest pain).
The patient should not take Mensil MED MAX if they are taking medicines that release nitric oxide (such as amyl nitrite), as their concurrent use may also cause a dangerous decrease in blood pressure.
If the patient is already taking riociguat, they should inform their doctor or pharmacist.
In the case of taking protease inhibitors used to treat HIV infections, it is recommended to start treatment with a lower dose (25 mg) of Mensil MED MAX.
In some patients taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which may be symptoms of low blood pressure caused by a drop in blood pressure when standing up or sitting down quickly. Such symptoms occurred in some patients taking Mensil MED MAX and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking Mensil MED MAX. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Mensil MED MAX. The doctor may decide to use a lower initial dose (25 mg) of the medicine.

Mensil MED MAX with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

Mensil MED MAX is not intended for use by women.

Driving and using machines

Mensil MED MAX may cause dizziness and vision disturbances. Patients should find out 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 been diagnosed with intolerance to some sugars, such as lactose, they should contact their doctor before taking the medicine.

3. How to take Mensil MED MAX

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. The recommended initial dose is 50 mg.
Mensil MED MAX should not be taken more than once a day.
The patient should not take Mensil MED MAX with other medicines containing sildenafil.
Mensil MED MAX should be taken about an hour before planned sexual activity.
The tablet should be chewed and swallowed.
If the patient feels that the effect of Mensil MED MAX is too strong or too weak, they should consult their doctor or pharmacist.
Mensil MED MAX allows for an erection only if there is prior sexual stimulation. The time it takes for Mensil MED MAX to start working varies from person to person, usually between half an hour and one hour. The effect of Mensil MED MAX may occur later if the medicine is taken after a heavy meal.
The patient should contact their doctor if, after taking Mensil MED MAX, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Mensil MED 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 increase the efficacy of the medicine.
The patient should not take more tablets than prescribed by the doctor.
The patient should contact their doctor if they have taken more tablets than recommended.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Mensil MED MAX can cause side effects, although not everybody gets them.
The side effects reported in connection with the use of Mensil MED MAX are usually mild or moderate and short-lived.

In case of any of the following side effects, the patient should stop taking Mensil MED 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:
• the patient should sit half-up and try to relax,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may occur in 1 in 1000 patients).

If the erection lasts more than 4 hours, the patient should contact their doctor immediately.

• Sudden vision loss or deterioration - occurs rarely.
• Severe skin reactions - occurs rarely. Symptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occurs 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, disturbances in vision, 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, hypertension, hypotension, muscle pain, somnolence, decreased tactile sensitivity, dizziness, tinnitus, dry mouth, blocked or stuffy sinuses, rhinitis (symptoms include runny nose, sneezing, and stuffy nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), hematuria, pain in arms or legs, epistaxis, feeling hot, and feeling tired.
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 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, dilated pupils, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden hearing loss or hearing impairment.
After the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is essential to note that in most, but not all, men who experienced these side effects, heart problems 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 side effects not listed in the leaflet, they should tell 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Mensil MED MAX

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light.
No special storage temperature instructions.
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.
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 MED MAX contains

• The active substance of the medicine is sildenafil. One tablet of the medicine contains 100 mg of sildenafil (in the form of 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 MED MAX looks like and what the pack contains

Mensil MED MAX is a white, triangular, biconvex tablet, marked with the number "100" on one side.
One pack of the medicine contains 2, 4, 8, or 12 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.
+48 (22) 742 00 22
email: informacjaoleku@hasco-lek.pl

Date of last update of the leaflet: 08.2016

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