Menero

BEFORE USING THE MEDICINAL PRODUCT, PLEASE USE THE PATIENT QUESTIONNAIRE PROVIDED!

Package leaflet: Information for the patient

MENERO, 10 mg, film-coated tablets
Tadalafilum
Please read carefully all the information in this leaflet before using the medicinal product, as it contains
important information for the patient.
This medicinal product should always be used exactly as described in this patient leaflet or as directed by
a doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after using this medicinal product, or if you feel worse, contact your doctor.

Contents of the leaflet

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

1. What Menero is and what it is used for

Menero 10 mg is a medicinal product intended for adult men with erectile dysfunction. This is a
condition in which a man is unable to achieve or maintain an erection sufficient for sexual intercourse.
It has been demonstrated that tadalafil significantly improves the ability to obtain an erection adequate
for sexual intercourse.
Menero contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. Following sexual stimulation, Menero helps widen the
blood vessels in the penis, allowing increased blood flow into the penis. As a result, erectile function
improves. Menero does not benefit patients who do not have erectile dysfunction.
It is important to understand that Menero does not work in the absence of sexual stimulation. The
patient and his partner should engage in foreplay, just as they would if the patient were not taking
medication for erectile dysfunction.

2. Important information before using Menero

When not to use Menero:

• if the patient is allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking organic nitrates in any form or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina (chest pain). It has been shown that tadalafil enhances the effects of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor;
• if the doctor has advised the patient to avoid sexual activity;
• if the patient has severe heart disease or has had a myocardial infarction (heart attack) within the last 90 days;
• if the patient has had a stroke within the last 6 months;
• if the patient has low blood pressure or uncontrolled high blood pressure, or uncontrolled heart rhythm disorders;
• if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "eye stroke";
• 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 tadalafil enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting treatment with Menero, please use the questionnaire included in the packaging. If any doubts arise, discuss them with your doctor or pharmacist.
Please remember that sexual activity involves some risk in patients with heart disease, as it places additional strain on the heart. If the patient has heart problems (including those indicated by the questionnaire as contraindications to using Menero due to heart conditions), they should inform their doctor.
Before taking the medicine, the patient should inform the doctor if any of the following conditions apply:

• sickle cell anemia (abnormal shape of red blood cells);
• multiple myeloma (a bone marrow cancer);
• leukemia (a blood cell cancer);
• any deformity of the penis;
• severe liver disease;
• severe kidney disease.

It is not known whether Menero is effective in patients:

• after pelvic surgery;
• after complete or partial removal of the prostate gland with nerve cutting (non-nerve-sparing radical prostatectomy).

If sudden vision deterioration or sudden vision loss occurs while taking tadalafil, or if vision becomes distorted or blurred, the use of Menero should be stopped immediately and the patient should contact a doctor without delay.
In some patients taking tadalafil, hearing deterioration or sudden hearing loss has been observed. Although it is not known whether this event is directly related to tadalafil use, if hearing deterioration or sudden hearing loss occurs, the use of Menero should be stopped immediately and the patient should contact a doctor without delay.
Menero should not be used concomitantly with other oral or topical medicines used to treat erectile dysfunction.
Menero should not be used simultaneously with arterial pulmonary hypertension (PAH) therapies using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Menero, medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension must not be taken.
Menero should not be taken if erectile dysfunction has not been diagnosed.
Menero 10 mg is not intended for use in women.

Children and adolescents
Menero is not intended for use in children and adolescents under 18 years of age.

Menero and other medicines
Before using Menero, please use the questionnaire included in the packaging. If in doubt, inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.
Do not take Menero if you are taking nitrates.
Menero may affect the action of certain medicines or other medicines may affect the action of Menero. Inform your doctor or pharmacist if the patient is taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or urinary symptoms caused by benign prostatic hyperplasia);
• other medicines used to treat high blood pressure;
• riociguat;
• 5-alpha-reductase inhibitors (used to treat symptoms of benign prostatic hyperplasia);
• such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);
• rifampicin, erythromycin, clarithromycin (antibiotics), or itraconazole (antifungal medicine);
• other medicines used to treat erectile dysfunction.

In some patients taking medicines that lower blood pressure, a drop in blood pressure may occur, especially when standing up or sitting down quickly. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit and wait until symptoms subside. Drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help. Rapid standing or sitting should be avoided.

Menero with food, drink, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Menero and therefore caution should be exercised when consuming it. For further information, please consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility
Menero 10 mg is not intended for use in women.
Fertility
When administered to dogs, the medicine caused a reduction in sperm production in the testes. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.

Driving and operating machinery
Dizziness has been reported in some men taking tadalafil during clinical trials; therefore, patients should understand their individual response to the medicine before deciding to drive or operate machinery.

Menero contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Menero

This medicine should always be used exactly as described in this patient information leaflet or as
advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor,
pharmacist, or nurse.
Menero tablets are intended for oral use only in men. The tablets should be swallowed whole with a small amount of water. Menero tablets may be taken with or without food.
The recommended dose is one 10 mg tablet taken prior to planned sexual activity.
Your doctor may recommend a different dosing regimen after consultation. The medicine should be taken at least 30 minutes before planned sexual activity.
Menero may remain effective for up to 36 hours after taking the tablet.
This is an on-demand medicine, taken as needed.
Do not use more than once a week. Do not take more than one tablet.
Menero should not be used concomitantly with other oral or topical medicines used in the treatment of erectile dysfunction.
Menero should not be used simultaneously with pulmonary arterial hypertension (PAH) therapy using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Menero, do not take any medicines containing sildenafil used for the treatment of erectile dysfunction or pulmonary hypertension.
Menero should not be taken if erectile dysfunction has not been diagnosed.
It is important to be aware that Menero does not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.
Alcohol consumption may affect the patient's ability to achieve an erection and may cause transient lowering of blood pressure. If the patient has taken or plans to take Menero, he should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Use of a higher than recommended dose of Menero
If a higher than recommended dose is taken, inform your doctor. Adverse effects described in section 4 may occur.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the medicine immediately
and seek medical advice right away:

• allergic reactions, including rashes (observed in 1 to 10 out of 1,000 patients – uncommon);
• chest pain – do not take nitrates, but seek immediate medical help (observed uncommonly);
• priapism, a prolonged and possibly painful erection after taking Menero (observed in no more than 1 out of 1,000 patients – rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately;
• sudden loss of vision (rare), distorted, dimmed, blurred central vision, or sudden decrease in vision (frequency not known).

Other reported adverse reactions:
Common (observed in 1 to 10 out of 100 patients)

• headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal mucosal congestion, and indigestion.

Uncommon (observed in 1 to 10 out of 1,000 patients)

• dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, breathing difficulties, blood in urine, prolonged erection, sensation of heart palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling tired.

Rare (observed in 1 to 10 out of 10,000 patients)

• fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), bleeding from penis, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these men had
pre-existing heart conditions before starting tadalafil treatment.
There are rare reports of cases of partial, transient or permanent visual impairment or vision loss in one or both eyes.
In men taking tadalafil, several additional adverse reactions have been rarely reported,
which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders characterized by blood rush to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death;
• distorted, dimmed, blurred central vision or sudden decrease in vision (frequency not known).

Adverse reaction: dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea was reported more frequently in men over 65 years of age taking tadalafil.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Menero

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the packaging. 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 in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Menero contains

• The active substance is tadalafil. One tablet contains 10 mg of tadalafil.
• The other components (excipients) are: Tablet core: monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate. Coating Opadry II Blue 85F30605: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), polyethylene glycol 3350 and 4000, talc, indigo carmine, aluminium lake of indigo carmine (E 132).

What Menero looks like and contents of the pack
Menero is a light blue, round, biconvex film-coated tablet with a diameter of 9 mm, embossed with the letter "E" on one side.
One pack contains 1 or 2 film-coated tablets in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław
Product information
tel.: 22 742 00 22
e-mail: [email protected]