Menero Med

Package Leaflet: Information for the Patient

Menero MED, 2.5 mg, Film-Coated Tablets

Tadalafil

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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. Contents of the pack and other information

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

Menero MED 2.5 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 satisfactory sexual performance. It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for satisfactory sexual performance.
Menero MED contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Menero MED helps to widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, it helps to improve erectile function. Menero MED does not help patients who do not have erectile dysfunction.
It is important to note that Menero MED does not work without sexual stimulation.

2. Important information before taking Menero MED

When not to take Menero MED:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6);
• if you are taking organic nitrates 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 effects of these medicines. If you are taking nitrates in any form, or if you are unsure, you should inform your doctor;
• if you have severe heart disease or have had a heart attack in the last 90 days;
• if you have had a stroke in the last 6 months;
• if you have low blood pressure, irregular heartbeat, or uncontrolled high blood pressure;
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "eye stroke";
• if you are 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 you are taking riociguat or are unsure, you should inform your doctor.

Warnings and precautions

Before taking Menero MED, you should discuss it with your doctor.
It should be remembered that sexual activity carries a certain risk for patients with heart disease, as it puts an additional strain on the heart. If you have heart problems, you should inform your doctor.
Before taking the medicine, you should tell your doctor if you 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 deformity of the penis;
• severe liver disease;
• severe kidney disease.

It is not known whether tadalafil is effective in patients who have:

• undergone pelvic surgery;
• had their prostate removed (radical prostatectomy without nerve sparing).

If you experience sudden worsening of vision or sudden loss of vision, or if your vision is blurred or distorted, you should stop taking Menero MED and contact your doctor immediately.
In some patients taking tadalafil, a decrease in hearing or sudden loss of hearing has been observed. Although it is not known whether this event is directly related to the use of tadalafil, if you experience a decrease in hearing or sudden loss of hearing, you should stop taking Menero MED and contact your doctor immediately.
Menero MED, 2.5 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

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You must not take Menero MED if you are taking nitrates.
Menero MED may affect the way some other medicines work, or other medicines may affect the way Menero MED works. You should tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or symptoms of an enlarged prostate);
• other medicines used to treat high blood pressure;
• riociguat;
• 5-alpha-reductase inhibitors (used to treat symptoms of an enlarged prostate);
• 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 (anti-epileptic 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, caution should be exercised when consuming it. For more information, you should consult your doctor.

Pregnancy, breastfeeding, and fertility

Menero MED, 2.5 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 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, so you should be aware of how you react to the medicine before driving or operating machinery.

Menero MED contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Menero MED

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Menero MED tablets are for use in men only. The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food.
Recommended doseis one 5 mg tablet, taken once daily, at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg, depending on your response to Menero MED. You should then take a 2.5 mg tablet.
You should not take Menero MED more than once a day.
Taking Menero MED once daily may be beneficial for men who intend to have sexual activity twice a week or more frequently.
Taking Menero MED once daily allows for the achievement of an erection after sexual stimulation at any time point during the 24-hour period.
It is essential to remember that Menero MED does not work without sexual stimulation.

Use of a higher than recommended dose of Menero MED

If you take more than the recommended dose, you should inform your doctor. You may experience side effects described in section 4.

Missed dose of Menero MED

As soon as you remember, you should take the dose, but you should not take a double dose to make up for the missed tablet. You should not take Menero MED more than once a day.
If you have any further questions on the use of this medicine, you should ask your 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 you experience any of the following side effects, stop taking the medicine and contact your doctor immediately:

stop taking the medicine and contact your doctor immediately:

• allergic reactions, including rash (not very common);
• chest pain - do not take nitrates, but seek medical help immediately (not very common);
• priapism - prolonged and possibly painful erections after taking Menero MED (rare). If you experience such an erection and it lasts for more than 4 hours, you should contact your doctor immediately;
• sudden loss of vision (rare), blurred vision, or sudden loss of vision (frequency not known).

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

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

Uncommon(seen in 1 to 10 in 1,000 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(seen in 1 to 10 in 10,000 patients):

• fainting, seizures, and transient memory loss, swelling of the eyelids, redness of the eyes, sudden worsening or loss of hearing, hives (itchy, red bumps on the skin), bleeding from the penis, 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 taking the medicine.
There have been rare reports of partial, transient, or permanent loss of vision or loss of vision in one or both eyes.
In men taking tadalafil, several additional side effects have been 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 flow to the eyes, irregular heartbeat, and angina pectoris, as well as sudden cardiac deaths;

• blurred vision, or sudden loss of vision (frequency not known).

Dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Menero MED

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
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. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Menero MED contains

• The active substance is tadalafil. One tablet contains 2.5 mg of tadalafil.
• The other ingredients (excipients) are: 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 (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 6 mm, with a single-sided engraving of the symbol "B".
One pack of the medicine contains 1, 2, 4, 8, 10, or 12 film-coated tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

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

Information about the medicine

phone: 22 742 00 22
e-mail: [email protected]
Date of last revision of the leaflet:11/2023