Tadilecto

Leaflet accompanying the packaging: patient information

Tadilecto, 5 mg, film-coated tablets

Tadalafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Tadilecto and what is it used for

Tadilecto contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadilecto 5 mg is used to treat adult men:

• with erectile dysfunction.This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual activity. It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for satisfactory sexual activity. After sexual stimulation, Tadilecto helps to widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, the erection improves. Tadilecto does not help patients who do not have erectile dysfunction. It is important to be aware that Tadilecto does not work in the absence of sexual stimulation. The patient should arrange foreplay, just as if the patient were not taking erectile dysfunction medication.
• with symptoms of benign prostatic hyperplasia (a non-cancerous enlargement of the prostate gland). This is a condition where the prostate gland enlarges with age. Symptoms include: difficulty starting to urinate, a feeling of not emptying the bladder completely, and a need to urinate more frequently, even at night. Tadilecto improves blood flow and causes relaxation of the prostate and bladder muscles, which can alleviate the symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates urinary symptoms after 1-2 weeks of treatment.

2. Important information before taking Tadilecto

When not to take Tadilecto

• 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 nitrates in any form or other donors of nitric oxide, 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 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 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 medicine used to treat certain types of 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 medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions

Before taking Tadilecto, the patient should consult a doctor or pharmacist.
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 there are problems with the heart, the patient should inform their doctor.
Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so the doctor will perform an examination to rule out prostate cancer before starting treatment with Tadilecto for symptoms of benign prostatic hyperplasia. Tadilecto is not used to treat prostate cancer.
The patient should inform their doctor if they have any of the following conditions:

• 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 whether Tadilecto is effective in patients:

• who have had pelvic surgery,
• who have had their prostate removed (radical prostatectomy without nerve sparing).

If the patient experiences sudden vision loss or sudden vision disturbance, or if their vision is blurred, they should stop taking Tadilecto and consult their doctor immediately.
In some patients taking tadalafil, a decrease in hearing or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if the patient experiences a decrease in hearing or sudden hearing loss, they should stop taking Tadilecto and consult their doctor immediately.

Tadilecto is not intended for use in women.

Children and adolescents

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

Tadilecto 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.
Tadilecto must not be taken if the patient is taking nitrates.
Tadilecto may affect the action of some medicines or other medicines may affect the action of Tadilecto. The patient should tell their doctor or pharmacist if they 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 (a medicine used to treat certain types of pulmonary hypertension),
• 5-alpha-reductase inhibitors (medicines used to treat benign prostatic hyperplasia),
• medicines 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 medicines),
• rifampicin, erythromycin, clarithromycin, or itraconazole,
• other medicines used to treat erectile dysfunction.

Tadilecto with food and alcohol

Information about the effect of alcohol is given in section 3.
Grapefruit juice may affect the efficacy of Tadilecto, and therefore, it should be consumed with caution. For more information, the patient should consult their doctor.

Fertility

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

Some men taking tadalafil during clinical trials reported dizziness, so the patient should be aware of their reaction to the medicine before driving or operating machinery.

Tadilecto contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Tadilecto

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.
Tadilecto tablets are 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.
Consuming alcohol may cause a temporary decrease in blood pressure. If the patient has taken Tadilecto 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 erectile dysfunction

Recommended doseis one 5 mg tablet, taken once a day, at approximately the same time every day. The doctor may change the dose to 2.5 mg, depending on the patient's response to Tadilecto. The patient should then take a 2.5 mg tablet or a 2.5 mg dose of tadalafil can be obtained by dividing a 5 mg tablet into equal doses.
Tadilecto should not be taken more than once a day.
Taking Tadilecto once a day allows the patient to achieve an erection after sexual stimulation at any time during the 24 hours. Taking Tadilecto once a day may be beneficial for men who intend to engage in sexual activity twice a week or more often.
It is important to be aware that Tadilecto does not work in the absence of sexual stimulation. The patient should arrange foreplay, just as if they were not taking erectile dysfunction medication.
Consuming alcohol may affect the patient's ability to achieve an erection.

Treatment of benign prostatic hyperplasia

Recommended doseis one 5 mg tablet, taken once a day, at approximately the same time every day. If the patient has benign prostatic hyperplasia and erectile dysfunction, the dose of one 5 mg tablet per day remains unchanged.
Tadilecto should not be taken more than once a day.

Use of higher than recommended dose of Tadilecto

The patient should inform their doctor. Adverse reactions described in section 4 may occur.

Missed dose of Tadilecto

The patient should take the dose as soon as they remember, but they should not take a double dose to make up for the missed tablet. Tadilecto should not be taken more than once a day.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tadilecto can cause side effects, although not everybody gets them.
These effects are usually mild or moderate.

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

• allergic reactions, including skin rash (uncommon),
• chest pain - the patient should not take nitrates, but should seek medical help immediately (uncommon),
• priapism: prolonged and possibly painful erections after taking Tadilecto (rare). If the patient experiences such an erection and it lasts for more than 4 hours, they should seek medical help immediately,
• sudden vision loss (rare), blurred vision, or sudden disturbance of vision (frequency not known).

Other reported side effects:
Common(may affect up to 1 in 10 patients):

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

Uncommon(may affect up to 1 in 100 patients):

• dizziness, stomach pain, reflux, nausea, vomiting, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(may affect up to 1 in 1000 patients):

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden hearing loss, hives (itchy, red swellings on the skin), increased sweating, bleeding from the penis, and blood in semen.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before taking tadalafil.
There have been reports of rare cases of partial, transient, or permanent vision loss or blindness in one or both eyes.
In men taking tadalafil, several additional rare side effectshave been reported, which were not observed during clinical trials. These include:
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migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac death.
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blurred vision, or sudden disturbance 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration 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 Tadilecto

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Tadilecto contains

• The active substance of Tadilecto is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other ingredients are: hypromellose phthalate, mannitol, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate in the tablet core, lactose monohydrate, hypromellose 6 cP, talc, titanium dioxide (E 171), yellow iron oxide (E 172), and triacetin in the tablet coating. See section 2 "Tadilecto contains lactose and sodium".

What Tadilecto looks like and contents of the pack

Tadilecto, 5 mg, film-coated tablets (tablets): light yellow, oval, biconvex film-coated tablets with a score line on one side and the marking "5" on the other side; tablet dimensions: length approximately 9 mm and width approximately 6 mm. The tablet can be divided into equal doses.
Packaging:2, 4, 8, 12, 14, 28, 56, and 84 film-coated tablets in blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on the names of the medicines in other EU member states, the patient should contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:03.11.2024