Package leaflet: Information for the patient

Tadilecto, 5 mg, coated tablets
Tadalafilum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Tadilecto is and what it is used for
Important information before taking Tadilecto
How to take Tadilecto
Possible side effects
How to store Tadilecto
Contents of the pack and other information

1. What Tadilecto is and what it is 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 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, Tadilecto helps widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, erectile function improves. Tadilecto does not help patients who do not have erectile dysfunction. It is important to understand that Tadilecto does not work without sexual stimulation. The patient should engage in foreplay, just as when not taking medication for erectile dysfunction.
with urinary symptoms caused by a common condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, feeling of incomplete bladder emptying, and the need to urinate more frequently, even at night. Tadilecto improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. Tadalafil has been shown to relieve urinary symptoms within 1–2 weeks of starting treatment.

2. Important information before using Tadilecto

When not to use 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 organic nitrates in any form or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of 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 patient has severe heart disease or has had a 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,
if the patient has ever experienced vision loss 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 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). PDE5 inhibitors such as tadalafil have been shown to 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 Tadilecto, consult a doctor or pharmacist.
Please remember that sexual activity involves some risk in patients with heart disease, as it places additional strain on the heart. If there are any heart problems, inform the doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms, therefore 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.
Before taking this medicine, the patient should inform the doctor if any of the following apply:

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

It is not known whether Tadilecto 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 vision deterioration or sudden vision loss occurs, or if vision becomes distorted or blurred, stop taking Tadilecto and contact a doctor immediately.
In some patients taking tadalafil, hearing loss or sudden hearing deterioration 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, stop taking Tadilecto and contact a 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
Tell the doctor about all medicines currently used, recently used, or planned for use.
DO NOT take Tadilecto if you are using nitrates.
Tadilecto may affect the action of certain medicines or other medicines may affect the action of Tadilecto. Tell the doctor or pharmacist if you are taking any of the following medicines:

alpha-blockers (used to treat high blood pressure or urinary symptoms due to benign prostatic hyperplasia),
other medicines used to treat high blood pressure,
riociguat (a medicine used to treat certain types of pulmonary arterial hypertension),
5-alpha-reductase inhibitors (medicines used to treat benign prostatic hyperplasia),
medicines such as oral ketoconazole (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection,
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines),
rifampicin, erythromycin, clarithromycin, or itraconazole,
other medicines used to treat erectile dysfunction.

Tadilecto, alcohol, and grapefruit juice
Information regarding the effect of alcohol is provided in section 3.
Grapefruit juice may affect the effectiveness of Tadilecto and caution should therefore be exercised when consuming it. For further information, consult a doctor.
Effect on fertility
When tadalafil 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
Some men using tadalafil in clinical trials reported dizziness. Therefore, patients should understand their individual response to the medicine before deciding to drive or operate machinery.
Tadilecto 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 Tadilecto

This medicine should always be taken as advised by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Tadilecto tablets are intended for oral administration only in men. The tablets should be
swallowed whole with a small amount of water. Tadilecto tablets may be taken with or without
food.
Consuming alcohol may cause a temporary decrease in blood pressure. If a patient has taken or
plans to take Tadilecto, they should not consume large amounts of alcohol (blood alcohol
concentration of 0.08% or higher), as this may increase the risk of experiencing dizziness upon
standing.

Treatment of erectile dysfunction
Recommended dose: One 5 mg tablet taken once daily, at approximately the same time each
day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadilecto. In such
cases, a 2.5 mg tablet should be used, or a 2.5 mg dose of tadalafil can be obtained by splitting a
5 mg tablet into equal halves.
Do not take Tadilecto more often than once a day.
Taking Tadilecto once daily allows the possibility of achieving an erection following sexual
stimulation at any time within 24 hours. Daily administration of Tadilecto may be beneficial for
men who plan to engage in sexual activity two or more times per week.
It is important to understand that Tadilecto does not work in the absence of sexual stimulation.
The patient should engage in foreplay, just as they would when not taking medications for erectile
dysfunction.
Alcohol consumption may affect the patient's ability to achieve an erection.

Treatment of benign prostatic hyperplasia
Recommended dose: One 5 mg tablet taken once daily, at approximately the same time each
day. If a patient has both benign prostatic hyperplasia and erectile dysfunction, the recommended
dose remains one 5 mg tablet once daily.
Do not take Tadilecto more often than once a day.

Overdose of Tadilecto
Inform your doctor immediately. Adverse effects described in section 4 may occur.

Missed dose of Tadilecto
Take the missed dose as soon as you remember, but do not take a double dose to make up for the
missed tablet. Do not take Tadilecto more often than once a day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 (uncommon),
chest pain – do not take nitrates, but seek immediate medical help (uncommon),
priapism: prolonged and possibly painful erection after taking Tadilecto (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately,
sudden vision loss (rare), distorted, blurred, or impaired central vision, or sudden worsening of vision (frequency not known).

Other reported adverse reactions:
Common (may occur in up to 1 in 10 patients):

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

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

dizziness, abdominal pain, regurgitation of stomach contents into the oesophagus, nausea, vomiting, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling tired.

Rare (may occur in up to 1 in 1,000 patients):

fainting, seizures, transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), increased sweating, penile bleeding, and presence of blood in semen.

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 have been reports of rare cases of partial, transient, or permanent
visual impairment or vision loss in one or both eyes.
In men taking tadalafil, a few additional rare adverse reactions have been reported
that 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 death.
distorted, blurred, or impaired central vision or sudden worsening of vision
(frequency not known).
The adverse reaction: dizziness has been reported more frequently in men over 75 years of age
taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age
taking tadalafil.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be
reported directly to the Department for 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 provide more information on the safety of the medicine.

5. How to store Tadilecto

Keep this medicine out of the sight and reach of children.
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.
No special storage conditions apply for this medicine.
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 package and other information

What Tadilecto contains

The active substance is tadalafil. Each coated tablet contains 5 mg of tadalafil.
The other ingredients are: hypromellose phthalate, mannitol, sodium croscarmellose, sodium lauryl sulphate, 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, coated tablets (tablets): light yellow, oval, biconvex coated tablets with a division line on one side and the imprint "5" on the other side; tablet dimensions: approximately 9 mm in length and 6 mm in width. The tablet can be divided into equal doses.
Pack sizes: 2, 4, 8, 12, 14, 28, 56 and 84 coated tablets in blister packs contained in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about the names of the medicinal product in other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
Tel. 22 57 37 500