Package leaflet: Information for the patient

Menero MED, 2.5 mg, coated tablets
Tadalafilum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

What Menero MED is and what it is used for
Important information before taking Menero MED
How to take Menero MED
Possible side effects
How to store Menero MED
Contents of the pack and other information

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

Menero MED 2.5 mg is a medicine 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 shown that tadalafil significantly improves the ability to obtain an erection suitable for sexual intercourse.
Menero MED contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Following sexual stimulation, Menero MED helps widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, 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 in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, as they would when the patient is not taking medication for erectile dysfunction.

2. Important information before using Menero MED

When not to use 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, e.g. amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of 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 patient has severe heart disease or has had a 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, irregular heartbeat, or uncontrolled high blood pressure;
if the patient has ever experienced vision loss due to non-arteritic anterior ischaemic 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). PDE5 inhibitors such as tadalafil have been shown to 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 MED, patients should discuss this with their doctor.
Patients should be aware that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Before taking this medicine, the patient should inform their doctor if any of the following apply:

sickle cell anaemia (abnormal shape of red blood cells);
multiple myeloma (a bone marrow tumour);
leukaemia (a blood cell tumour);
any deformity of the penis;
severe liver disease;
severe kidney disease.

It is not known whether tadalafil is effective in patients:

after pelvic surgery;
after total or partial removal of the prostate gland with nerve-sparing techniques (radical prostatectomy without nerve preservation).

If sudden worsening of vision or sudden vision loss occurs during treatment with tadalafil, or if vision becomes blurred or distorted, the patient should stop taking Menero MED immediately and contact their doctor without delay.
In some patients taking tadalafil, hearing loss or sudden decrease in hearing has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing loss or sudden decrease in hearing occurs, the patient should stop taking Menero MED and contact their 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
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.
Menero MED must not be taken if the patient is using nitrates.
Menero MED may affect the action of certain medicines, or other medicines may affect the action of Menero MED. The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

alpha-blockers (used to treat high blood pressure or urinary symptoms due to benign prostatic hyperplasia);
other medicines used to treat high blood pressure;
riociguat;
5-alpha-reductase inhibitors (used to treat symptoms of benign prostatic hyperplasia);
medicines such as oral ketoconazole (used to treat fungal infections) and protease inhibitors used in the treatment of AIDS or HIV infection;
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);
ritonavir, saquinavir, rifampicin, erythromycin, clarithromycin, or itraconazole;
other medicines used to treat erectile dysfunction.

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

Pregnancy, breastfeeding, and fertility
Menero MED 2.5 mg is not intended for use in women.
When the medicine was administered to dogs, a reduction in sperm production in the testes was observed.
Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.

Driving and operating machinery
In clinical trials, some men taking tadalafil reported dizziness. Therefore, patients should understand how they react to the medicine before deciding to drive or operate machinery.

Menero MED contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Menero MED

This medicine should always be used exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
Menero MED tablets are intended for use in men only. The tablets should be swallowed whole with a small amount of water. Menero MED tablets may be taken regardless of meals.
The recommended dose is 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. In such case, use the 2.5 mg tablet.
Do not take Menero MED more often than once a day.
Taking Menero MED once daily may be beneficial for men who plan to engage in sexual activity two or more times per week.
Taking Menero MED once daily allows the achievement of an erection following sexual stimulation at any time within 24 hours.
It is important to understand that Menero MED 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 MED, he should avoid consuming large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Taking more Menero MED than recommended
If you take more Menero MED than recommended, inform your doctor immediately. Adverse effects described in section 4 may occur.
If you forget to take Menero MED
As soon as you remember, take the missed dose, but do not take a double dose to make up for the forgotten tablet. Do not take Menero MED more often than once a day.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, 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 and seek immediate medical advice:

allergic reactions, including skin rashes (uncommon);
chest pain – do not take nitrates, but seek immediate medical help (uncommon);
priapism – prolonged and possibly painful erection after taking Menero MED (rare). If such an erection occurs and lasts continuously for more than 4 hours, seek immediate medical advice;
sudden loss of vision (rare), distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency unknown).

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

headache, back pain, muscle pain, pain in arms and legs, sudden facial flushing, nasal mucosa congestion, and dyspepsia.

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, presence of blood in urine, prolonged duration of erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

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

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

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these men
already had heart problems before starting treatment with this medicine.
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 congestion in the eyes, irregular heartbeat,
angina pectoris, and sudden cardiac death;

distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

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

5. How to store Menero MED

Keep the medicine out of the sight and reach of children.
There are no special requirements for storage of this 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 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 hydrolysed, titanium dioxide (E171), polyethylene glycol 3350 and 4000, talc, indigo carmine, aluminium lake (E132).

What Menero MED looks like and contents of the pack
Menero MED is in the form of light blue, round, biconvex film-coated tablets with a diameter of 6 mm, embossed with the letter "B" on one side.
One pack contains 1, 2, 4, 8, 10 or 12 film-coated tablets in blisters within a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław
Information line
tel.: 22 742 00 22
e-mail: [email protected]