Tadalafil Mensil

Before using the medicine, use the attached PATIENT QUESTIONNAIRE!

Leaflet attached to the packaging: patient information

Tadalafil MENSIL, 10 mg, coated tablets

Tadalafilum

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 more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If you do not improve or feel worse after taking the medicine, you should contact your doctor.

Table of contents of the leaflet

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

1. What is Tadalafil MENSIL and what is it used for

Tadalafil MENSIL 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.
Tadalafil MENSIL contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). After sexual stimulation, Tadalafil MENSIL 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. Tadalafil MENSIL does not help patients who do not have erectile dysfunction.
It is important to be aware that Tadalafil MENSIL 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.

2. Important information before taking Tadalafil MENSIL

When not to take Tadalafil MENSIL:

• 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 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 you are taking nitrates in any form or are unsure, you should inform your doctor;
• if your doctor has advised you to avoid sexual activity;
• 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 or uncontrolled high blood pressure, or uncontrolled heart rhythm disorders;
• if you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to 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 PDE5 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 starting to take Tadalafil MENSIL, you should use the questionnaire attached to the packaging. In case of any doubts, you should discuss them with your doctor or pharmacist.
You should remember that sexual activity is associated with a risk for patients with heart disease, as it puts an additional strain on the heart. If you have heart problems (including those resulting from the questionnaire that indicate you should not take Tadalafil MENSIL due to heart problems), you should inform your doctor.
Before taking the medicine, you should tell your doctor if you have any of the following:

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

It is not known if Tadalafil MENSIL is effective in patients:

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

If you experience sudden worsening of vision or sudden loss of vision or distorted vision while taking tadalafil, you should stop taking Tadalafil MENSIL and contact your doctor immediately.
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 the use of tadalafil, if you experience a worsening or sudden loss of hearing, you should stop taking Tadalafil MENSIL and contact your doctor immediately.
Tadalafil MENSIL should not be used with other oral or topical medicines used to treat erectile dysfunction.
Tadalafil MENSIL should not be used with pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadalafil MENSIL, you should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Tadalafil MENSIL should not be taken if you do not have erectile dysfunction.
Tadalafil MENSIL, 10 mg, is not intended for use in women.

Children and adolescents

Tadalafil MENSIL is not intended for use in children and adolescents under 18 years of age.

Tadalafil MENSIL and other medicines

Before taking Tadalafil MENSIL, you should use the questionnaire attached to the packaging. In case of doubts, you should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should not take Tadalafil MENSIL if you are taking nitrates.
Tadalafil MENSIL may affect the action of some medicines or other medicines may affect the action of Tadalafil MENSIL. 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 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 taking blood pressure-lowering medicines, there may be a decrease in blood pressure, especially when standing up or sitting down quickly. If you experience symptoms of low blood pressure (dizziness, fainting, feeling of impending faint), you should first lie down or sit down and wait for the symptoms to pass, drinking water may also help, as well as getting some fresh air, tensing abdominal muscles, or crossing your legs. You should avoid standing up or sitting down quickly.

Tadalafil MENSIL with food, drink, and alcohol

Information about the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil MENSIL, and therefore, you should be cautious when consuming it. For more information, you should ask your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

Tadalafil MENSIL, 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, so you should get to know your reaction to the medicine before driving a car or operating machines.

Tadalafil MENSIL contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your 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 take Tadalafil MENSIL

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. In case of doubts, you should ask your doctor, pharmacist, or nurse.
Tadalafil MENSIL 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.
Your doctor may recommend a different dosing regimen after consultation. The medicine should be taken at least 30 minutes before planned sexual activity.
Tadalafil MENSIL may still be effective up to 36 hours after taking the tablet.
The medicine is for occasional use, as needed.

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

Tadalafil MENSIL should not be used with other oral or topical medicines used to treat erectile dysfunction.
Tadalafil MENSIL should not be used with pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadalafil MENSIL, you should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Tadalafil MENSIL should not be taken if you do not have erectile dysfunction.
It is important to be aware that Tadalafil MENSIL 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.
Consuming alcohol may affect your ability to achieve an erection and may cause a temporary decrease in blood pressure. If you have taken Tadalafil MENSIL or plan to take it, you 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 a higher dose of Tadalafil MENSIL than recommended

If you have taken a higher dose than recommended, you should inform your doctor. You may experience side effects described in section 4.
In case of any further doubts about 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, you should stop taking the medicine and contact your doctor immediately:

Stop taking the medicine and contact your doctor immediately:

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

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

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

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

• dizziness, stomach 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 in 10,000 patients)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, hives (itchy, red bumps on the skin), 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 tadalafil.
There are rare reports of cases 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 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 impaired 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 Tadalafil MENSIL

The medicine should be stored out of 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil MENSIL contains

• The active substance of the medicine is tadalafil. One tablet contains 10 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 (E 171), macrogol 3350 and 4000, talc, indigo carmine, aluminum lake (E 132).

What Tadalafil MENSIL 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 engraving of the symbol "E".
One pack of the medicine contains 2 or 4 film-coated tablets in PVC/PVDC/Al 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: