Tadalafil mensil

Before using the medicine, please use the PATIENT QUESTIONNAIRE provided!

Package leaflet: Information for the patient

Tadalafil MENSIL, 10 mg, coated tablets
Tadalafilum
Please read carefully all the information in this 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 the
physician, pharmacist, or nurse.

• Keep this leaflet, so that it can be read again if necessary.
• If advice or further information is needed, please consult the pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the physician, pharmacist, or nurse. See section 4.
• If there is no improvement after using the medicine, or if the patient feels worse, contact the physician.

Contents of the leaflet

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

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

Tadalafil MENSIL 10 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. Tadalafil has been shown to significantly improve 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 (PDE5) inhibitors. Following sexual stimulation, Tadalafil MENSIL helps
dilate the blood vessels of the penis, allowing blood flow into the penis. As a result, erection is improved. Tadalafil MENSIL does not benefit patients who do not have erectile dysfunction.
It is important to be aware that Tadalafil MENSIL does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as they would when the patient is not taking medication for erectile dysfunction.

2. Important information before using Tadalafil MENSIL

When not to use Tadalafil MENSIL:

• 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 to treat 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 doctor has advised the patient to avoid sexual activity;
• if the patient has severe heart disease or has had a myocardial infarction (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 or uncontrolled high blood pressure, or uncontrolled cardiac arrhythmias;
• if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to 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 PDE5 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 treatment with Tadalafil MENSIL, patients should complete the questionnaire included in the package. If there are any doubts, patients should discuss them with their doctor or pharmacist.
It should be remembered that sexual activity involves some risk in patients with heart disease, as it places additional strain on the heart. If the patient has heart problems (including those indicated in the questionnaire as contraindicating the use of Tadalafil MENSIL due to heart conditions), they should inform their doctor.
Before taking the 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 cancer);
• leukaemia (a blood cell cancer);
• any penile deformity;
• severe liver disease;
• severe kidney disease.

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

• after pelvic surgery;
• after total or partial removal of the prostate gland with cutting of the nerves supplying the prostate (nerve-sparing radical prostatectomy).

If sudden worsening of vision, sudden vision loss, or distorted or blurred vision occurs during treatment with tadalafil, the patient should stop taking Tadalafil MENSIL and contact a doctor immediately.
In some patients taking tadalafil, worsening or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing deterioration or sudden hearing loss occurs, the patient should stop taking Tadalafil MENSIL and contact a doctor immediately.
Tadalafil MENSIL should not be used concomitantly with other oral or topical medicines used to treat erectile dysfunction.
Tadalafil MENSIL should not be used together with arterial pulmonary hypertension (PAH) therapies using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadalafil MENSIL, the patient must not take any medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Tadalafil MENSIL should not be taken if erectile dysfunction has not been diagnosed.
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 using Tadalafil MENSIL, patients should complete the questionnaire included in the package. If in doubt, patients should inform their doctor or pharmacist about all medicines currently or recently taken, as well as any medicines they plan to take.
Tadalafil MENSIL must not be taken if the patient is using nitrates.
Tadalafil MENSIL may affect the action of certain medicines or other medicines may affect the action of Tadalafil MENSIL. The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor 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);
• such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);
• rifampicin, erythromycin, clarithromycin (antibiotics), or itraconazole (antifungal medicine);
• other medicines used to treat erectile dysfunction.

In some patients taking medicines that lower blood pressure, a drop in blood pressure may occur, especially when standing up or sitting down quickly. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit and wait for symptoms to subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing the legs may also help. The patient should avoid standing up or sitting down quickly.

Tadalafil MENSIL with food, drink and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil MENSIL, and therefore caution should be exercised when consuming it. For further information, patients should consult their doctor or pharmacist.

Pregnancy, breastfeeding and fertility
Tadalafil MENSIL, 10 mg, is not intended for use in women.
Fertility
When administered to dogs, the medicine caused a reduction in sperm production in the testes. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.

Driving and using machines
In clinical trials, some men taking tadalafil reported dizziness. Therefore, patients should understand their individual response to the medicine before deciding to drive a car or operate machinery.

Tadalafil MENSIL contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Tadalafil MENSIL

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult 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. Tablets may be taken with or without food.
The recommended dose is one 10 mg tablet taken prior to anticipated sexual activity.
Your doctor may, after consultation, recommend a different dosing regimen. The medicine should be taken at least 30 minutes before anticipated sexual activity.
Tadalafil MENSIL may remain effective for up to 36 hours after taking the tablet.
This is an on-demand medicine, taken as needed.
Do not use more than once a week. Do not take more than one tablet.
Tadalafil MENSIL should not be used simultaneously with other oral or topical medicines used in the treatment of erectile dysfunction.
Tadalafil MENSIL should not be used concurrently with arterial pulmonary hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadalafil MENSIL, do not take any medicines containing sildenafil used for the treatment of erectile dysfunction or pulmonary hypertension.
Tadalafil MENSIL should not be taken if erectile dysfunction has not been diagnosed.
It is important to understand that Tadalafil MENSIL 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.
Drinking alcohol 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 Tadalafil MENSIL, he should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Taking a higher than recommended dose of Tadalafil MENSIL
If a dose higher than recommended is taken, inform your doctor immediately. Adverse effects described in section 4 may occur.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience 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 rashes (observed in 1 to 10 out of 1,000 patients - uncommon);
• chest pain - do not take nitrates, but seek immediate medical help (observed uncommonly);
• priapism, a prolonged and possibly painful erection after taking Tadalafil MENSIL (observed in no more than 1 out of 1,000 patients - rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately;
• sudden loss of vision (rare), distorted, blurred, or dim 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, facial flushing, nasal mucosa congestion, and indigestion.

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, difficulty breathing, presence of blood in urine, prolonged erection, sensation of 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), rectal 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 had
pre-existing heart conditions before starting tadalafil treatment.
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 flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death;
• distorted, blurred, dim central vision, or sudden worsening of vision (frequency unknown).

Adverse reaction: dizziness was reported more frequently in men over 75 years of age
taking tadalafil. Diarrhoea was reported more frequently in men over 65 years of age
taking tadalafil.
Reporting of adverse reactions
If any adverse effects occur, including any 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tadalafil MENSIL

Keep this medicine out of the sight and reach of children.
There are no special requirements for storage of this medicine.
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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Tadalafil MENSIL contains

• The active substance is tadalafil. One tablet contains 10 mg of tadalafil.
• The other ingredients (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 (E 171), macrogol 3350 and 4000, talc, indigo carmine, aluminium lake (E 132).

What Tadalafil MENSIL looks like and contents of the pack
The medicine is in the form of light blue, round, biconvex coated tablets with a diameter of 9 mm, embossed on one side with the symbol "E".
One pack contains 2 or 4 coated tablets in PVC/PVDC/Al blisters, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław, Poland

Medicine Information
tel.: (22) 742 00 22
e-mail: [email protected]