Tadilecto

Leaflet accompanying the packaging: patient information

Tadilecto, 10 mg, film-coated tablets

Tadalafil

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

• 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 any not listed in this leaflet, please tell your 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 is a medicine 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 widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, 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. The patient should arrange foreplay, just as when the patient is not taking erectile dysfunction medication.

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 "eye stroke",
• if you are 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). Phosphodiesterase type 5 inhibitors, such as tadalafil, have been shown to 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 anaemia (abnormal shape of red blood cells),
• multiple myeloma (bone marrow cancer),
• leukaemia (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,
• had their prostate removed (prostatectomy) and the nerves in the prostate area are cut (radical prostatectomy without nerve sparing).

If you experience sudden loss of vision or sudden loss of hearing, or blurred vision, 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 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 by women.

Children and adolescents

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

Tadilecto and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You must not take Tadilecto if you are taking nitrates. Tadilecto may affect the way some medicines work, and 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 (anti-epileptic medicines),
• rifampicin, erythromycin, clarithromycin, or itraconazole,
• other medicines used to treat erectile dysfunction.

Tadilecto with food and drink

Information on 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, it caused a decrease in sperm production in the testes. 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 using machines.

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 is essentially "sodium-free".

3. How to take Tadilecto

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist. Tadilecto film-coated 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. The recommended doseis 10 mg, taken before planned sexual activity. If this dose is not effective, your doctor may increase the dose to 20 mg. Tadilecto can be taken at least 30 minutes before planned sexual activity. Tadilecto may still be effective up to 36 hours after taking the tablet. You should not take Tadilecto more than once a day. Tadilecto 10 mg and 20 mg is intended for use before planned sexual activity. It is not recommended to take the medicine on a continuous, daily basis. It is important to note that Tadilecto does not work without sexual stimulation. The patient should arrange foreplay, just as when the patient is not taking erectile dysfunction medication. Consuming alcohol may affect your ability to achieve an erection and may cause a temporary decrease in blood pressure. If you have taken Tadilecto or plan to take it, you should not consume large amounts of alcohol (blood alcohol level 0.08% or higher), as this may increase the risk of dizziness when standing up.

Taking more Tadilecto than you should

You should inform your doctor. Side effects may occur, as described in section 4. 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. These effects are usually mild or moderate.

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

• allergic reactions, including 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 for more than 4 hours, you should contact your doctor immediately,
• sudden loss of vision (rare), blurred vision, or sudden loss of hearing (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. In men taking tadalafil, several additional rare side effectshave 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 characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• blurred vision, or sudden loss of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years old taking tadalafil. Diarrhoea was reported more frequently in men over 65 years old taking tadalafil.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported 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. Side effects can also be reported to the marketing authorisation 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. There are no special precautions for storage. 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 10 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, 10 mg, film-coated tablets (tablets): yellow, oval, biconvex tablets with the marking "10" on one side. The dimensions of the tablet are: length approximately 12 mm and width approximately 7.5 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 authorisation holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia. For more information on the names of the medicines in other EU member states, you should contact the representative of the marketing authorisation 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