Menero Med

Leaflet attached to the packaging: patient information

Menero MED, 5 mg, film-coated tablets

Tadalafil

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

• Keep this leaflet, you may need to read it again.
• In case of 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 Menero MED and what is it used for
• 2. Important information before taking Menero MED
• 3. How to take Menero MED
• 4. Possible side effects
• 5. How to store Menero MED
• 6. Package contents and other information

1. What is Menero MED and what is it used for

The active substance of Menero MED is tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Menero MED 5 mg is intended for use in the treatment of 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. After sexual stimulation, Menero MED helps to widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, the erection improves. Menero MED does not help patients who do not have erectile dysfunction. It is important to be aware that Menero MED does not work without sexual stimulation. The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication;
• with symptoms of benign prostatic hyperplasia (BPH). This is a condition where the prostate gland enlarges with age. Symptoms include: difficulty starting to urinate, a feeling of incomplete emptying of the bladder, and the need to urinate more frequently, even at night. Menero MED improves blood flow and causes relaxation of the prostate and bladder muscles, which can alleviate the symptoms of BPH. It has been shown that tadalafil alleviates these urinary symptoms within 1-2 weeks of starting treatment.

2. Important information before taking Menero MED

When not to take Menero MED:

• 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 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 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, irregular heartbeat, or uncontrolled high blood pressure;
• if the patient has ever had a loss of vision 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 phosphodiesterase type 5 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 take Menero MED, the patient should discuss it with their doctor.
It should be remembered that sexual activity is associated with a certain risk for patients with heart disease, as it puts an additional strain on the heart. If there are problems with the heart, the patient should inform their doctor.
Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so the doctor will perform an examination to rule out prostate cancer before starting treatment with Menero MED for symptoms of BPH.
Menero MED is not used to treat prostate cancer.
Before taking the medicine, the patient should inform their doctor if they have any of the following:

• 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 whether tadalafil is effective in patients:

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

If the patient experiences sudden vision loss or sudden loss of vision or distorted vision while taking tadalafil, they should stop taking Menero MED and contact their doctor immediately.
In some patients taking tadalafil, a decrease in hearing or sudden hearing loss has been observed. Although it is not known whether this event is directly related to the use of tadalafil, if a decrease in hearing or sudden hearing loss occurs, the patient should stop taking Menero MED and contact their doctor immediately.
Menero MED 5 mg is not intended for use in women.

Children and adolescents

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

Menero MED and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
It is not recommended to take Menero MED if the patient is taking nitrates.
Menero MED may affect the action of some medicines or other medicines may affect the action of Menero MED. The patient should tell their doctor or pharmacist if they are taking:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or symptoms of BPH);
• other medicines used to treat high blood pressure;
• riociguat;
• 5-alpha-reductase inhibitors (used to treat symptoms of BPH);
• medicines 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 medicines);
• ritonavir, saquinavir, rifampicin, erythromycin, clarithromycin, or itraconazole;
• other medicines used to treat erectile dysfunction.

Menero MED with food and alcohol

Information on the effect of alcohol is given in section 3.
Grapefruit juice may affect the efficacy of Menero MED, and therefore, it should be consumed with caution. For more information, the patient should consult their doctor.

Pregnancy, breastfeeding, and fertility

Menero MED, 5 mg, is not intended for use in women.
When administered to dogs, a decrease in sperm production in the testes was observed. A decrease in sperm concentration has been observed in some men. It is unlikely to lead to infertility.

Driving and using machines

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

Menero MED contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Menero MED

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
Menero MED tablets are intended for 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.
Consuming alcohol may cause a temporary decrease in blood pressure. If the patient has taken Menero MED 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.
Treatment of erectile dysfunction
Recommended doseis one 5 mg tablet, taken once a day, approximately at the same time every day. The doctor may change the dose to 2.5 mg, depending on the patient's reaction to Menero MED. In this case, the patient should take a 2.5 mg tablet.
The patient should not take Menero MED more than once a day.
Taking Menero MED once a day allows for an erection to be achieved after sexual stimulation at any time during the 24 hours. Taking Menero MED once a day may be beneficial for men who intend to engage in sexual activity twice a week or more often.
It is essential to be aware that Menero MED 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.
Treatment of symptoms of benign prostatic hyperplasia
Doseis one 5 mg tablet, taken once a day, approximately at the same time every day. If the patient has both BPH and erectile dysfunction, the dose of one 5 mg tablet per day remains unchanged. The patient should not take Menero MED more than once a day.

• one 5 mg tablet per day - remains unchanged. The patient should not take Menero MED more than once a day.

Taking a higher dose of Menero MED than recommended

In case of taking a higher dose than recommended, the patient should inform their doctor. Side effects described in section 4 may occur.

Missing a dose of Menero MED

As soon as the patient remembers, they should take the dose, but they should not take a double dose to make up for the missed tablet. The patient should not take Menero MED more than once a day.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Menero MED 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 taking the medicine and contact their doctor immediately:

stop taking the medicine and contact their doctor immediately:

• allergic reactions, including rash (not very common);
• chest pain - the patient should not take nitrates, but contact their doctor immediately (not very common);
• priapism, prolonged and possibly painful erection after taking Menero MED (rare). If such an erection occurs and lasts continuously for more than 4 hours, the patient should contact their doctor immediately;
• sudden vision loss (rare), distorted, blurred, or unclear vision, or sudden worsening of vision (frequency not known).

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

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

Uncommon(observed in 1 to 10 out of 1000 patients):

• dizziness, abdominal pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, 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 out of 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 to take this medicine.
There are rare reports of cases of partial, transient, or permanent loss of vision 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, eye disorders, irregular heartbeat, and angina pectoris, as well as sudden cardiac deaths;
• distorted, blurred, or unclear vision, or sudden worsening of vision (frequency not known).

Dizziness has been reported more frequently in men over 75 years old taking tadalafil. Diarrhea has been 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 tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw,
phone: +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 MED

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage of the medicinal product.
Do not use this medicine 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. Package contents and other information

What Menero MED contains

• The active substance of Menero MED is tadalafil. One tablet contains 5 mg of tadalafil.
• Other ingredients (excipients) are: tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate. Opadry II Blue 85F30605 coating: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol 3350 and 4000, talc, indigo carmine, aluminum lake (E132).

What Menero MED 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 7 mm, with a single-sided engraving of the symbol "C".
One pack of Menero MED contains 1, 2, 4, 8, 10, 12, or 28 film-coated tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
Żmigrodzka Street 242 E, 51-131 Wrocław

Information about the medicine

phone: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl
Date of last revision of the leaflet:11/2023