Tadalafil mensil med

Package leaflet: Information for the patient

Tadalafil MENSIL MED, 20 mg, coated tablets
Tadalafilum
Please read the entire 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 doubts, please consult 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 another person, 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.

Table of contents of the leaflet

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

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

The active substance of the medicine is tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil MENSIL MED is intended for use:

• In the treatment of erectile dysfunction in adult men. This is a condition in which a man cannot 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. Following sexual stimulation, Tadalafil MENSIL MED helps widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, erectile function improves. Tadalafil MENSIL MED does not benefit patients who do not have erectile dysfunction. It is important to be aware that Tadalafil MENSIL MED 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.
• In the treatment of pulmonary arterial hypertension in adults. The medicine helps widen the blood vessels in the lungs, thereby improving blood flow to the lungs. This results in improved exercise capacity.

2. Important information before using Tadalafil MENSIL MED

When not to use Tadalafil MENSIL 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 drugs ("nitrates") used in the treatment of angina pectoris ("chest pain"). It has been shown that tadalafil enhances the effects of these drugs. 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 myocardial infarction 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 ischemic optic neuropathy (NAION), also 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 MED, discuss this with your doctor.
Please bear in mind that sexual activity involves some risk in 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 the medicine, the patient should inform their doctor if any of the following apply:

• heart diseases other than pulmonary hypertension;
• abnormal blood pressure;
• sickle cell anemia (abnormal shape of red blood cells);
• multiple myeloma (a bone marrow cancer);
• leukemia (a blood cell cancer);
• 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, during which nerves to the prostate are severed (non-nerve-sparing radical prostatectomy).

If sudden worsening of vision, sudden vision loss, or blurred or dimmed vision occurs during treatment with tadalafil, treatment with Tadalafil MENSIL MED should be stopped immediately and the patient should contact their doctor without delay.
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 loss or sudden hearing deterioration occurs, treatment with Tadalafil MENSIL MED should be stopped immediately and the patient should contact their doctor without delay.
Tadalafil MENSIL MED for the indication "treatment of erectile dysfunction" is not intended for use in women, as erectile dysfunction affects men.

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

Tadalafil MENSIL MED and other medicines
Tell your doctor about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Tadalafil MENSIL MED if the patient is using nitrates.
Tadalafil MENSIL MED may affect the action of certain medicines or other medicines may affect the action of Tadalafil MENSIL MED. Tell your doctor or pharmacist if the patient is taking any of the following medicines:

• bosentan (another medicine used to treat pulmonary arterial hypertension);
• nitrates (used in the treatment of chest pain);
• alpha-blockers (used to treat high blood pressure or urinary symptoms caused by 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.

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

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not take Tadalafil MENSIL MED during pregnancy unless absolutely necessary and agreed upon with the attending physician.
Do not breastfeed while taking the tablets, as it is not known whether this medicine passes into human milk. Consult your doctor or pharmacist before using any medicine during pregnancy or breastfeeding.
When the medicine was administered to dogs, a reduction in sperm production in the testes occurred.
Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.

Driving and operating machinery
In some patients taking tadalafil during clinical trials, dizziness was reported. Therefore, patients should assess their response to the medicine before deciding to drive or operate machinery.

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

3. How to use Tadalafil MENSIL MED

This medicine should always be taken as prescribed by a doctor. In case of any doubts, consult your
doctor or pharmacist.
The tablets should be swallowed whole with a small amount of water. The tablets may be taken
regardless of meals.
Treatment of erectile dysfunction
The recommended starting dose is one 10 mg tablet taken prior to planned sexual activity. If this dose is
not sufficient, the doctor may increase the dose to 20 mg. Tadalafil MENSIL MED may be taken at least
30 minutes before planned sexual activity. Tadalafil MENSIL MED may still be effective up to 36 hours
after taking the tablet.
Do not take Tadalafil MENSIL MED more than once a day. Tadalafil MENSIL MED 10 mg and 20 mg is
intended for use prior to planned sexual activity. Regular, daily use is not recommended.
It is important to be aware that Tadalafil MENSIL MED does not work in the absence of sexual
stimulation. The patient and his partner should engage in foreplay, just as when the patient is not taking
medicines for erectile dysfunction.
Alcohol consumption may affect the patient's ability to achieve an erection and may cause transiently
lowered blood pressure. If the patient has taken or plans to take Tadalafil MENSIL MED, 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.
Treatment of pulmonary arterial hypertension
The usual dose is two 20 mg tablets taken once daily. Both tablets should be taken at the same time, one after the other. In cases of mild or moderate hepatic or renal impairment, the doctor may recommend taking only one 20 mg tablet once daily.
Use of a higher than recommended dose of Tadalafil MENSIL MED
If the patient takes more tablets than recommended, inform a doctor immediately or go to hospital, taking the medicine or its packaging with you. Adverse effects described in section 4 may occur.
Missed dose of Tadalafil MENSIL MED
Do not take a double dose to make up for a missed dose. In the treatment of pulmonary arterial hypertension, the patient should take the missed dose as soon as he remembers, provided that less than 8 hours have passed since the time the dose should have been taken.
Stopping Tadalafil MENSIL MED treatment
In the treatment of pulmonary arterial hypertension, do not stop taking this medicine without consulting
your treating doctor.
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below occur, stop taking
the medicine and contact a doctor immediately:

• allergic reactions, including rashes (not common);
• chest pain – do not take nitrates, seek immediate medical help (not common);
• priapism – prolonged and possibly painful erection after taking Tadalafil MENSIL MED (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately;
• sudden loss of vision (rare), distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency not known).

Other adverse effects have also been reported, listed below by indication.
Adverse effects in the treatment of erectile dysfunction:
Common (observed in 1 to 10 of 100 patients):

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

Not common (observed in 1 to 10 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, 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 of 10,000 patients):

• fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), bleeding from the penis, 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 problems before starting treatment with this medicine.
There are rare reports of cases involving partial, transient or permanent
visual impairment or vision loss in one or both eyes.
In men taking tadalafil, several additional rare adverse 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 rush to the eyes, irregular heartbeat and angina pectoris, as well as sudden cardiac death,
• distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known).

Adverse effect: 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.
Adverse effects in the treatment of pulmonary hypertension:
Very common (may occur in more than 1 in 10 patients):

• headache, facial flushing, nasal and sinus mucosa congestion (stuffy nose), nausea, dyspepsia (including abdominal pain or gastrointestinal discomfort), muscle pain, back pain, and limb pain (including limb discomfort).

Common (may occur in 1 in 10 patients):

• blurred vision, low blood pressure, nosebleeds, vomiting, increased or abnormal uterine bleeding, facial swelling, regurgitation of stomach contents into the oesophagus, migraine headache, irregular heartbeat, and fainting.

Not common (may occur in 1 in 100 patients):

• seizures, transient memory loss, urticaria, increased sweating, bleeding from the penis,
  presence of blood in semen and (or) in urine, high blood pressure, rapid heartbeat, sudden
  cardiac death, and tinnitus.
  Some adverse effects were reported in men taking tadalafil for the treatment of erectile dysfunction. These 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. Several rare additional adverse effects have been reported in men taking tadalafil, which were not observed during clinical trials. These include:

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

In most men who experienced symptoms such as rapid heartbeat, irregular heartbeat,
myocardial infarction, stroke, or sudden cardiac death, pre-existing heart conditions were present before starting tadalafil treatment. It cannot be definitively determined whether these cases were directly related to the use of tadalafil.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects
not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects
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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Tadalafil MENSIL MED

Keep this medicine out of sight and reach of children.
There are no special requirements for the 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Tadalafil MENSIL MED contains

• The active substance is tadalafil. One tablet contains 20 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 hydrolyzed, titanium dioxide (E171), macrogol 3350 and 4000, talc, indigo carmine, aluminium lake of indigo carmine (E132).

What Tadalafil MENSIL MED looks like and contents of the pack
Tadalafil MENSIL MED is a light blue, round, biconvex coated tablet with a diameter of 12 mm.
One pack contains 2, 4, 8, 10, 12, 16, 24, 28 or 60 coated tablets in 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
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]