Tadilecto

Patient Information Leaflet

Tadilecto, 2.5 mg, coated tablets
Tadalafilum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• 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. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

1. What Tadilecto is and what it is used for
2. What you need to know 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 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 is unable to 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 blood
to flow into the penis. This leads to improved erection. Tadilecto does not benefit men who do
not have erectile dysfunction.
It is important to be aware that Tadilecto does not work without sexual stimulation.
The patient should engage in foreplay, just as when not taking medication for erectile dysfunction.

2. 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), 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 to take 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 their 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 deformity of the penis,
• 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 nerve cutting (non-nerve-sparing radical prostatectomy).
If there is sudden worsening of vision or sudden vision loss, or if vision becomes distorted or dimmed, stop taking Tadilecto 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 tadalafil use, if hearing worsens 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 your doctor about all medicines currently taken or recently taken, as well as any medicines you plan to take.
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 your 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 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 with alcohol consumption
Information regarding the effect of alcohol is provided in section 3.
Grapefruit juice may affect the effectiveness of Tadilecto, so caution should be exercised when consuming it. For further information, consult your 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 directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Tadilecto tablets are intended for oral use only in men. Swallow the tablet whole with a small amount of water. Tadilecto tablets may be taken with or without food.
Recommended dose: 1 tablet of 5 mg 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, use the 2.5 mg tablet.
Do not take Tadilecto more often than once a day.
Taking Tadilecto once daily may be beneficial for men who plan to engage in sexual activity two or more times per week.
Taking Tadilecto once daily allows the ability to achieve an erection following sexual stimulation at any time within 24 hours.
It is important to understand that Tadilecto will not work in the absence of sexual stimulation.
The patient should engage in foreplay, just as when not using medications 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.
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 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 rash (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, seek immediate medical advice,
• sudden loss of vision (rare), distorted, blurred, or dim central vision, or sudden decrease in 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 dyspepsia.

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 tired.

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

• fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin welts), increased sweating, rectal 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 vision impairment or
vision loss in one or both eyes.
In men taking tadalafil, several additional rare adverse reactions have been reported
that 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, angina pectoris, and sudden cardiac death.
• distorted, blurred, dim central vision or sudden decrease in vision (frequency not known).

The adverse reaction of 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 not listed in this leaflet, inform your doctor or pharmacist. 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 authorization 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 instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Tadilecto contains

• The active substance is tadalafil. Each coated tablet contains 2.5 mg of tadalafil.
• The other ingredients are: hypromellose phthalate, mannitol, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate in the tablet core; lactose monohydrate, hypromellose 6 cP, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red 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 2.5 mg, coated tablets (tablets): light orange, round, slightly biconvex
coated tablets with bevelled edges; tablet diameter: approximately 5 mm.
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 trade 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
02-235 Warsaw, Poland
Tel. 22 57 37 500