Package leaflet: Information for the patient

Tadilecto, 20 mg, coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, because 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 consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Tadilecto is and what it is used for
What you need to know 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 is a medicine intended for adult men with erectile dysfunction. This is a condition
in which a man cannot achieve or maintain an erection sufficient for sexual intercourse.
Tadilecto has been shown to significantly improve the ability to achieve an erection suitable for
sexual intercourse.
Tadilecto contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
During sexual stimulation, Tadilecto helps widen the blood vessels in the penis, allowing increased blood flow into the penis. This results in improved erection. Tadilecto does not help patients who do not have erectile dysfunction.
It is important to understand that Tadilecto does not work in the absence of sexual stimulation.
The patient should engage in foreplay, just as when not taking medication for erectile dysfunction.

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, e.g. amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris (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), 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). 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 treatment with Tadilecto, consult a doctor or pharmacist.
Please remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If there are any heart problems, inform the doctor.
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 radical prostatectomy without nerve sparing, i.e. complete or partial removal of the prostate gland with cutting of the nerves supplying the prostate.

If sudden vision deterioration or sudden vision loss occurs, or if vision becomes distorted or blurred, discontinue use of Tadilecto and contact a doctor immediately.
In some patients taking tadalafil, hearing loss 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, discontinue use of Tadilecto and contact a doctor immediately.
Tadilecto is not intended for use in women.
Children and adolescents
Tadilecto is not indicated for use in children and adolescents under 18 years of age.
Tadilecto and other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
DO NOT take Tadilecto if taking nitrates.
Tadilecto may affect the action of certain medicines or other medicines may affect the action of Tadilecto. Inform the doctor or pharmacist if taking any of the following medicines:

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 (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 ketoconazole tablets (used to treat fungal infections) and protease inhibitors used in the treatment of AIDS or HIV infection,
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines),
rifampicin, erythromycin, clarithromycin, or itraconazole,
other medicines used to treat erectile dysfunction.

Tadilecto, food, and alcohol
Information regarding the effect of alcohol is provided in section 3.
Grapefruit juice may affect the efficacy of Tadilecto, and therefore caution should 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 was observed. 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 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; therefore, 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 use in men only. Swallow the tablet whole with a small amount of water.
Tadilecto tablets may be taken with or without food.
The recommended starting dose is 10 mg, taken prior to planned sexual activity.
This dose can be achieved by taking one 10 mg tablet or by splitting a 20 mg tablet into equal doses. If your doctor has determined that the recommended 10 mg dose is insufficient, then one 20 mg tablet should be taken as directed by your doctor.
Tadilecto may be taken at least 30 minutes before planned sexual activity.
Tadilecto may remain effective for up to 36 hours after taking the tablet.
Do not take Tadilecto more than once a day. The 10 mg and 20 mg Tadilecto tablets are intended to be used as needed prior to planned sexual activity. Regular, daily use of this medicine is not recommended.
It is important to understand that Tadilecto does not work in the absence of sexual stimulation.
The patient should engage in foreplay, just as when not using medicines for erectile dysfunction.
Alcohol consumption 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 Tadilecto, large amounts of alcohol (blood alcohol concentration of 0.08% or higher) should be avoided, as this may increase the risk of dizziness upon standing.
Use of a higher than recommended dose of Tadilecto
Inform your doctor if this occurs. Adverse effects described in section 4 may occur.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
These effects are usually mild or moderate.
If any of the adverse effects 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 loss of vision (rare), distorted, blurred, or impaired central vision, or sudden decrease in vision (frequency not known).

Other reported adverse effects:
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, 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 (may occur in up to 1 in 1,000 patients):

fainting, convulsions and 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 problems 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 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 manifesting as ocular hyperaemia, irregular heartbeat, angina pectoris, and sudden cardiac death.
distorted, blurred, or impaired central vision or sudden decrease in vision (frequency not known).

The 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.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 this 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 are required 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 pack and other information

What Tadilecto contains

The active substance is tadalafil. Each coated tablet contains 20 mg of tadalafil.
The other ingredients are: phthalate hypromellose, mannitol, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate in the tablet core; monohydrate lactose, 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 20 mg, coated tablets (tablets): brownish-yellow, oval, biconvex coated tablets with a division line on one side and the marking "20" on the other side; tablet dimensions: approximately 14 mm in length and 9.5 mm in width. The tablet can be divided into equal doses.
Packaging: Blister packs containing 2, 4, 8, 12, 14, 28, 56 and 84 coated tablets 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
Tel. 22 57 37 500