Menero

Before using the medicine, use the attached PATIENT QUESTIONNAIRE!

Leaflet attached to the packaging: patient information

MENERO, 10 mg, coated tablets

Tadalafil

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 leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If the patient's condition does not improve or worsens after taking the medicine, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Menero and what is it used for

Menero, 10 mg, is a medicine for adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for sexual intercourse.
Menero contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). After sexual stimulation, Menero helps to widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, there is an improvement in erection. Menero does not help patients who do not have erectile dysfunction.
It is essential to be aware that Menero does not work without sexual stimulation. The patient and their partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.

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 donors of nitric oxide, such as amyl nitrite. This is a group of medicines (nitrates) used to treat angina pectoris (chest pain). It has been shown that tadalafil enhances the effect 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 heart attack in the last 90 days;
• if the patient has had a stroke in 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 had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to 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 to use Menero, the patient should use the questionnaire attached to the packaging. In case of any doubts, the patient should discuss this with their doctor or pharmacist.
The patient should remember that sexual activity is associated with a certain risk for patients with heart disease, as it puts an additional strain on the heart. If the patient has heart problems (including those resulting from the questionnaire that indicate Menero should not be used due to heart problems), they should inform their doctor.
Before taking the medicine, the patient should inform their doctor if they have any of the following conditions:

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

It is not known if Menero is effective in patients:

• after surgical procedures in the pelvic area;
• after total or partial removal of the prostate gland, during which the nerves of the prostate gland are cut (radical prostatectomy without nerve sparing).

If the patient experiences sudden worsening of vision or sudden loss of vision or distorted vision during tadalafil use, they should stop using Menero and immediately contact their doctor.
In some patients taking tadalafil, a worsening or sudden loss of hearing has been observed. Although it is not known if this event is directly related to tadalafil use, if the patient experiences a worsening or sudden loss of hearing, they should stop using Menero and immediately contact their doctor.
Menero should not be used at the same time as other oral or topical medicines used to treat erectile dysfunction.
Menero should not be used at the same time as pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Menero, the patient should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Menero should not be taken if the patient does not have erectile dysfunction.
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, the patient should use the questionnaire attached to the packaging. In case of any doubts, the patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Menero should not be taken if the patient is taking nitrates.
Menero may affect the action of some medicines or other medicines may affect the action of Menero. The patient should inform their doctor or pharmacist if they are taking:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or symptoms of 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 in tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (antiepileptic drugs);
• rifampicin, erythromycin, clarithromycin (antibiotics) or itraconazole (antifungal medicine);
• other medicines used to treat erectile dysfunction.

In some patients who take blood pressure-lowering medicines, there may be a decrease in blood pressure, especially when standing up or sitting down quickly. If the patient experiences symptoms of low blood pressure (dizziness, fainting, feeling of impending faint), they should first lie down or sit down and wait for the symptoms to pass; drinking water, taking fresh air, tensing abdominal muscles, or crossing legs may also help. The patient should avoid standing up or sitting down quickly.

Menero with food, drink, and alcohol

Information about the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Menero, and the patient should be cautious when consuming it. For more information, the patient should consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

Menero, 10 mg, is not intended for use in women.
Fertility
When tadalafil was administered to dogs, there was a decrease in sperm production in the testes. A decrease in sperm concentration was observed in some men. It is unlikely to lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness; therefore, the patient should be aware of their reaction to the medicine before driving a car or operating machines.

Menero contains lactose and sodium

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

3. How to use Menero

This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor, pharmacist, or nurse. In case of doubts, the patient should consult their 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. The tablets can be taken with or without food.
Recommended doseof the medicine is one 10 mg tablet, taken before planned sexual activity. The doctor may recommend a different dosing regimen after consultation. The medicine should be taken at least 30 minutes before planned sexual activity.
Menero may still be effective up to 36 hours after taking the tablet.
The medicine is for occasional use as needed.

Do not use more than once a week. Do not take more than one tablet.

Menero should not be used at the same time as other oral or topical medicines used to treat erectile dysfunction.
Menero should not be used at the same time as pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Menero, the patient should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Menero should not be taken if the patient does not have erectile dysfunction.
It is essential to be aware that Menero does not work without sexual stimulation. The patient and their partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.
Consuming alcohol may affect the patient's ability to achieve an erection and may cause a temporary decrease in blood pressure. If the patient has taken Menero or plans to take it, they should not consume large amounts of alcohol (blood alcohol concentration 0.08% or higher), as this may increase the risk of dizziness when standing up.

Using more than the recommended dose of Menero

In case of taking a dose higher than recommended, the patient should inform their doctor. Side effects described in section 4 may occur.
In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are usually mild or moderate.

If any of the following side effects occur, the patient should stop using the medicine and immediately consult their doctor:

Stop using the medicine and immediately consult a doctor:

• allergic reactions, including skin rash (observed in 1 to 10 per 1,000 patients - uncommon);
• chest pain - the patient should not take nitrates, but should immediately seek medical help (observed uncommonly);
• priapism, prolonged and possibly painful erection after taking Menero (observed in less than 1 in 1,000 patients - rare). If such an erection occurs and lasts continuously for more than 4 hours, the patient should immediately contact their doctor;
• sudden loss of vision (rare), distorted, blurred, or unclear vision, or sudden worsening of vision (frequency not known).

Other reported side effects:
Common(observed in 1 to 10 per 100 patients)

• headache, back pain, muscle pain, pain in arms and legs, flushing, nasal congestion, and nausea.

Uncommon(observed in 1 to 10 per 1,000 patients)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, breathing difficulties, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(observed in 1 to 10 per 10,000 patients)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, hives (itchy, red swellings on the skin surface), penile bleeding, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before starting tadalafil use.
There are rare reports of cases of partial, transient, or permanent vision loss or blindness in one or both eyes.
In men taking tadalafil, several additional side effects have been rarely reported, which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, disorders characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac deaths;
• distorted, blurred, or unclear vision, or sudden worsening of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years old taking tadalafil. Diarrhea was reported more frequently in men over 65 years old taking tadalafil.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Menero

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The medicine should not be used after the expiry date stated on the packaging. 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. Contents of the pack and other information

What Menero contains

• The active substance of the medicine is tadalafil. One tablet contains 10 mg of tadalafil.
• Other ingredients (excipients) are: tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate. Opadry II Blue 85F30605 coating: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 3350 and 4000, talc, indigo carmine, aluminum lake (E 132).

What Menero looks like and contents of the pack

The medicine is in the form of light blue, round, biconvex, film-coated tablets with a diameter of 9 mm, with a single-sided embossing of the symbol "E".
One pack of the medicine contains 1 or 2 film-coated tablets in PVC/PVDC/Aluminum 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 revision of the leaflet:11/2023