TADILECTO 2.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Tadilecto, 2.5 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet
3. What is Tadilecto and what is it used for
4. Important information before taking Tadilecto
   1. When not to take Tadilecto
   2. Warnings and precautions
   3. Tadilecto is not intended for use in women.
   4. Children and adolescents
   5. Tadilecto and other medicines
   6. Tadilecto with food and drink
   7. Fertility
   8. Driving and using machines
   9. Tadilecto contains lactose and sodium
5. How to take Tadilecto
   1. If you take more Tadilecto than you should
   2. If you forget to take Tadilecto
6. Possible side effects
   1. If you experience any of the following side effects, stop taking Tadilecto and contact your doctor immediately:
   2. Reporting side effects
7. How to store Tadilecto
8. Contents of the pack and other information
   1. What Tadilecto contains
   2. What Tadilecto looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

Package Leaflet: Information for the Patient

Tadilecto, 2.5 mg, Film-Coated Tablets

Tadalafil

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package 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 is a medicine used for adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual performance. Tadilecto has been shown to significantly improve the ability to achieve an erection sufficient for satisfactory sexual performance. Tadilecto contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadilecto helps to relax the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection is improved. Tadilecto does not help patients who do not have erectile dysfunction. It is important to note that Tadilecto does not work without sexual stimulation.

2. Important information before taking Tadilecto

When not to take Tadilecto

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6),
• if you are taking organic nitrates or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris (chest pain). Tadalafil has been shown to increase the effects of these medicines. If you are taking nitrates in any form or are unsure, you should tell your doctor.
• if you have severe heart disease or have had a heart attack in the last 90 days,
• if you have had a stroke in the last 6 months,
• if you have low blood pressure or uncontrolled high blood pressure,
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "stroke of the eye",
• if you are 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 phosphodiesterase type 5 inhibitors, such as tadalafil, increase the effects of this medicine. If you are taking riociguat or are unsure, you should tell your doctor.

Warnings and precautions

Before taking Tadilecto, you should tell your doctor or pharmacist. You should remember that sexual activity carries a risk for patients with heart disease, as it puts extra strain on the heart. If you have heart problems, you should tell your doctor. Before taking this medicine, you should tell your doctor if you have any of the following:

• sickle cell anemia (abnormal shape of red blood cells),
• multiple myeloma (bone marrow cancer),
• leukemia (blood cell cancer),
• any deformation of the penis,
• severe liver disease,
• severe kidney disease.

It is not known whether Tadilecto is effective in patients who have:

­undergone pelvic surgery,

­undergone radical prostatectomy (removal of the prostate gland) without nerve sparing.

If you experience sudden loss of vision or sudden hearing loss, or if your vision is blurred, distorted, or doubled, you should stop taking Tadilecto and contact your doctor immediately. Some patients taking tadalafil have reported a decrease in hearing or sudden hearing loss. Although it is not known whether this event is directly related to the use of tadalafil, if you experience a decrease in hearing or sudden hearing loss, you should stop taking Tadilecto and contact your 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

You should tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You should not take Tadilecto if you are taking nitrates. Tadilecto may affect the way some medicines work, or some medicines may affect the way Tadilecto works. You should tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or symptoms of an enlarged prostate),
• 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 an enlarged prostate),
• medicines such as ketoconazole (in tablet form, used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection,
• phenobarbital, phenytoin, and carbamazepine (medicines used to treat epilepsy),
• rifampicin, erythromycin, clarithromycin, or itraconazole,
• other medicines used to treat erectile dysfunction.

Tadilecto with food and drink

Information about the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadilecto, and therefore, caution should be exercised when consuming it. For more information, you should ask your doctor.

Fertility

When tadalafil was given 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 you should be aware of how you react to the medicine before driving or operating machinery.

Tadilecto contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Tadilecto

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist. Tadilecto tablets are for oral use only, for men. The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food.

Recommended doseis one 5 mg tablet, taken once a day, at approximately the same time of day. Your doctor may adjust the dose to 2.5 mg, depending on your response to Tadilecto. You should take one 2.5 mg tablet.

You should not take Tadilecto more than once a day.

Taking Tadilecto once a day may be beneficial for men who intend to have sexual activity twice a week or more frequently.

Taking Tadilecto once a day allows for the achievement of an erection after sexual stimulation at any time point during the 24-hour period.

It is important to note that Tadilecto does not work without sexual stimulation.

You should arrange foreplay, just as you would if you were not taking erectile dysfunction medicines.

Drinking alcohol may affect your ability to achieve an erection and may temporarily lower your blood pressure. If you have taken Tadilecto or plan to take it, you should not drink large amounts of alcohol (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

If you take more Tadilecto than you should

You should inform your doctor. You may experience side effects described in section 4.

If you forget to take Tadilecto

You should take the dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet.

You should not take Tadilecto more than once a day.

If you have any further questions on the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Tadilecto and contact your doctor immediately:

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

Other reported side effects:

Common(may affect up to 1 in 10 people):

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

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

• 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 1,000 people):

• fainting, seizures, and transient memory loss, swelling of the eyelids, redness of the eyes, sudden loss of hearing, hives (itchy, red bumps on the skin), increased sweating, bleeding from the penis, and blood in the 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 decrease in vision or loss of vision in one or both eyes.

Men taking tadalafil have reported several additional rare side effects, including:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac death.
• blurred vision, double vision, or sudden loss 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 you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring 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

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help 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 month stated.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tadilecto contains

• The active substance is tadalafil. Each film-coated tablet contains 2.5 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), 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, film-coated tablets (tablets): light orange, round, slightly biconvex film-coated tablets with beveled edges; tablet diameter: approximately 5 mm.

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, you should contact the representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

Tel. 22 57 37 500

Date of last revision of the leaflet:03.11.2024