Menero Med

Package Leaflet: Information for the Patient

Menero MED, 20 mg, Film-Coated Tablets

Tadalafil

Before Taking the Medication, Carefully Read the Contents of This Leaflet, as it Contains Important Information for the Patient.

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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. Contents of the pack and other information

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

The active substance of the medication is tadalafil, which belongs to a group of medications called phosphodiesterase type 5 inhibitors.
Menero MED is intended for use:

• In the treatment of erectile dysfunction in adult men. 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 their partner should arrange foreplay, just as if the patient were not taking medication for erectile dysfunction.
• In the treatment of pulmonary arterial hypertension in adults. The medication helps to widen the blood vessels in the lungs, improving blood flow to the lungs. This results in improved exercise ability.

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 medication (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 medications (nitrates) used to treat angina pectoris (chest pain). It has been shown that tadalafil enhances the effect of these medications. 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 medication 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 medication. 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 the patient has heart problems, they should inform their doctor.
Before taking the medication, the patient should inform their doctor if they have any of the following conditions:

• heart disease other than pulmonary hypertension;
• abnormal blood pressure;
• 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 total or partial removal of the prostate gland, during which the nerves of the prostate gland are cut (radical prostatectomy without nerve sparing).

If, during the use of tadalafil, the patient experiences sudden worsening of vision or sudden loss of vision or distorted vision, they should stop taking Menero MED 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 whether this event is directly related to the use of tadalafil. If the patient experiences a worsening or sudden loss of hearing, they should stop taking Menero MED and immediately contact their doctor.
Menero MED, in the indication "treatment of erectile dysfunction", is not intended for women, as erectile dysfunction affects men.

Children and adolescents

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

Menero MED and other medications

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

• bosentan (another medication used to treat pulmonary arterial hypertension);
• nitrates (taken for chest pain);
• alpha-adrenergic receptor blockers (used to treat high blood pressure or symptoms of benign prostatic hyperplasia);
• other medications used to treat high blood pressure;
• riociguat;
• 5-alpha-reductase inhibitors (used to treat symptoms of benign prostatic hyperplasia);
• medications 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 medications);
• ritonavir, saquinavir, rifampicin, erythromycin, clarithromycin, or itraconazole;
• other medications used to treat erectile dysfunction.

Menero MED with food and alcohol

Information about 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

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Menero MED should not be taken during pregnancy, unless it is absolutely necessary and has been agreed upon with the treating doctor.
The patient should not breastfeed while taking the tablets, as it is not known whether this medication passes into human milk. Before taking any medication during pregnancy or breastfeeding, the patient should consult their doctor or pharmacist.
When tadalafil was 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

In some patients taking tadalafil during clinical trials, dizziness was reported, so the patient should be aware of their reaction to the medication before driving a car or operating machinery.

Menero MED contains lactose

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

3. How to take Menero MED

This medication should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The tablets should be swallowed whole, with a small amount of water. The tablets can be taken with or without food.
Treatment of erectile dysfunction
The recommended starting dose is one 10 mg tablet, taken before planned sexual activity. If this dose is not sufficient, the doctor may increase the dose to 20 mg. Menero MED can be taken at least 30 minutes before planned sexual activity. Menero MED may still be effective up to 36 hours after taking the tablet.
Menero MED should not be taken more than once a day. Menero MED 10 mg and 20 mg is intended for use before planned sexual activity. It is not recommended to take the medication continuously, on a daily basis.
It is important to be aware that Menero MED does not work without sexual stimulation.
The patient and their partner should arrange foreplay, just as if the patient were not taking medication for erectile dysfunction.
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 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 pulmonary arterial hypertension
The usual dose is two 20 mg tablets, taken once a day. Both tablets should be taken at the same time, one after the other. In cases of mild or moderate liver or kidney impairment, the doctor may recommend taking only one 20 mg tablet once a day.

Taking a higher dose of Menero MED than recommended

If the patient takes more tablets than recommended, they should inform their doctor or immediately go to the hospital, taking the medication or packaging with them. Adverse reactions described in section 4 may occur.

Missing a dose of Menero MED

A double dose should not be taken to make up for a missed dose. In the treatment of pulmonary arterial hypertension, the patient should take the dose as soon as they remember, unless it is less than 8 hours before the time the dose was due to be taken.

Stopping treatment with Menero MED

In the treatment of pulmonary arterial hypertension, the patient should not stop taking the medication without consulting their doctor.
In case of any further doubts about the use of this medication, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Menero MED can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should stop taking the medication and immediately consult their doctor:

• allergic reactions, including skin rash (not very common);
• chest pain - the patient should not take nitrates, but immediately seek medical help (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 immediately contact their doctor;
• sudden loss of vision (rare), distorted, blurred, or unclear vision (frequency not known).

Other side effects have also been reported, which are listed below by indication.

Side effects in the treatment of erectile dysfunction:

Common(observed in 1 to 10 out of 100 patients):

• headache, back pain, muscle pain, pain in arms and legs, sudden reddening of the face, nasal congestion, and indigestion.

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), bleeding from the penis, blood in semen, and increased sweating.

Myocardial infarction and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before starting to take this medication.
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 rare side effects have been 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 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.

Side effects in the treatment of pulmonary arterial hypertension:

Very common(may occur in more than 1 out of 10 patients):

• headache, reddening of the face, nasal congestion, nausea, indigestion (including abdominal pain or discomfort), muscle pain, back pain, and limb pain (including pain in limbs).

Common(may occur in 1 out of 10 patients):

• blurred vision, low blood pressure, nosebleeds, vomiting, excessive or abnormal vaginal bleeding, facial swelling, reflux, migraine, irregular heartbeat, and fainting.

Uncommon(may occur in 1 out of 100 patients):

• seizures, transient memory loss, hives, increased sweating, bleeding from the penis, blood in semen or urine, high blood pressure, rapid heartbeat, sudden cardiac death, and ringing in the ears.

Some side effects were reported in men taking tadalafil for erectile dysfunction. These side effects were not observed during clinical trials for the treatment of pulmonary arterial hypertension, and therefore, their frequency is not known:

• eyelid swelling, eye pain, eye redness, myocardial infarction, and stroke.

In men taking tadalafil, several additional rare side effects have been reported, which were not observed during clinical trials. These include:

• distorted, blurred, or unclear vision or sudden worsening of vision (frequency not known).

Most men who reported symptoms such as rapid heartbeat, irregular heartbeat, myocardial infarction, stroke, and sudden cardiac death had heart problems before starting to take tadalafil. It cannot be determined with certainty whether these cases were directly related to the use of tadalafil.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 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 medication.

5. How to store Menero MED

The medication should be stored out of sight and reach of children.
There are no special recommendations for the storage of the medicinal product.
The medication should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Menero MED contains

• The active substance of the medication is tadalafil. One tablet contains 20 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 medication is in the form of light blue, round, and biconvex film-coated tablets with a diameter of 12 mm.
One pack of the medication contains 2, 4, 8, 10, 12, 16, 24, 28, or 60 film-coated tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

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

Information about the medication

phone: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: