Leaflet: information for the user

Tadalafil Krka 20 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Tadalafilo Krka is indicated for the treatment of erectile dysfunction in adult men.

This condition occurs when a man is unable to obtain or maintain a firm, adequate erection for sexual activity. Tadalafilo has demonstrated a significant improvement in the ability to obtain a lasting, adequate erection of the penis suitable for sexual activity.

Tadalafilo Krka contains the active ingredient tadalafilo, which belongs to a group of medications known as phosphodiesterase type 5 inhibitors.After sexual stimulation, tadalafilo acts by helping to relax the blood vessels in your penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo will not be effective if you do not have erectile dysfunction.

It is essential to inform you that Tadalafilo Krka is not effective without sexual stimulation.Therefore, you and your partner should stimulate yourselves in the same way you would without taking a medication for erectile dysfunction.

Do not take Tadalafilo Krka if

• you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• you are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina (chest pain). Tadalafil has been seen to increase the effects of these medicines. If you are taking any type of nitrates or are unsure, tell your doctor.
• you have a serious heart disease or have had a heart attack recently, in the last 90 days.
• you have had a recent stroke, in the last 6 months.
• you have low or uncontrolled high blood pressure.
• you have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarction”.
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as Tadalafilo Krka, have shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tadalafilo Krka.

Be aware that sexual intercourse carries a possible risk for patients with heart problems, due to the additional strain it puts on the heart. If you have a heart problem, consult your doctor.

Before taking the tablets, inform your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any deformity of the penis.
• serious liver disease.
• serious kidney disease.

Tadalafil is not known to be effective in patients who have undergone:

- pelvic surgery.

- a surgical intervention in which the prostate has been completely or partially removed and the nerves of the prostate have been cut (radical prostatectomy without preservation of neurovascular bundles).

If you experience a decrease or sudden loss of vision, or your vision is distorted or weakened while taking tadalafil, stop taking this medicine and contact your doctor immediately.

Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience a decrease or loss of hearing, stop taking this medicine and contact your doctor immediately.

Tadalafilo Krka is not intended for use in women.

Children and adolescents

Tadalafil is not recommended for children or adolescents under 18 years.

Other medicines and Tadalafilo Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Do not take Tadalafilo Krka if you are already using nitrates.

Some medicines may be affected by tadalafil or may affect the proper functioning of tadalafil. Inform your doctor or pharmacist if you are using:

• an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medicines to treat high blood pressure.
• riociguat (used to treat some forms of pulmonary hypertension).
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole (for fungal infections) and protease inhibitors for the treatment of HIV/AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafilo Krka with beverages and alcohol

The information about the effect of alcohol is found in section 3. Grapefruit juice may affect the proper functioning of tadalafil and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machines

Some men who took tadalafil during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machines.

Tadalafilo Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor.If you are unsure, consult your doctor or pharmacist again.

Tadalafilo Krka tablets are for oral administration only in men. Swallow the tablet whole with a little water. Tablets can be taken with or without food.

The recommended initial doseis one 10 mg tablet before sexual activity. This dose can be taken as one 10 mg tablet or by dividing a 20 mg tablet into equal parts. However,you have been given a 20 mg dose, as your doctor has decided that the recommended 10 mg dose is too weak.

You can take a tadalafilo tablet at least 30 minutes before sexual activity.

Tadalafilo may be effective up to 36 hours after taking the tablet.

Do not take Tadalafilo Krka more than once a day.

Tadalafilo Krka 10 mg and 20 mg are intended for your use before anticipated sexual activity andare not recommended for continuous daily use.

It is essential to inform you that tadalafilo is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to achieve an erection and may temporarily lower your blood pressure. If you have taken or are planning to take tadalafilo, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

If you take more Tadalafilo Krka than you should

Consult your doctor. You may experience adverse effects described in section 4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.These side effects are generally mild to moderate in intensity.

If you experience any of the following side effects, stop using the medicine and seek medical help immediately:

• allergic reactions including rashes (infrequent).
• chest pain - do not use nitrates but seek medical help immediately (infrequent).
• priapism, a prolonged and possibly painful erection after taking Tadalafilo Krka (rare frequency). If you suffer from this type of erection, which can last for more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency),distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 patients)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion and indigestion.

Infrequent(may affect up to 1 in 100 patients)

• dizziness, stomach pain,reflux, feeling sick, being sick (vomiting), reflux,blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nasal bleeding, ringing in the ears, swelling of hands, feet or ankles and feeling tired.

Rare(may affect up to 1 in 1,000 patients)

• syncope, seizures and transient loss of memory, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red itchy patches on the skin's surface), increased sweating, bleeding in the penis and presence of blood in semen.

Also, rare cases of heart attack and stroke have been reported in men taking tadalafilo. Most of these men had some heart problem before taking this medicine.

Rarely, cases of partial or permanent loss of vision, temporary or permanent, in one or both eyes have been reported.

Some rare additional side effects have been reported in men taking tadalafilo that were not notified during clinical trials. These include:

• migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death,
• distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

In men over 75 years old taking tadalafilo, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafilo, the most frequently reported side effect was diarrhea.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Tadalafil Krka Composition

• The active ingredient is tadalafil. Each tablet contains 20 mg of tadalafil.

• The other components are hypromellose phthalate, mannitol, sodium croscarmellose, sodium lauryl sulfate, and magnesium stearate (E470b) in the tablet core and lactose monohydrate, hypromellose, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), and triacetin (E1518) in the coating.

See section 2 “Tadalafil Krka contains lactose and sodium”.

Appearance of the product and contents of the package

Tadalafil Krka 20 mg film-coated tablets are: yellow-brown, biconvex, oval, film-coated tablets, scored on one side and marked with a 20 on the other side. The tablet can be divided into equal doses. Tablet dimensions: approximately 14 mm in length and 9.5 mm in width.

Tadalafil Krka is available in packages containing 2, 4, 8, 12, 14, 24, 28, 56, and 84 film-coated tablets in blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the EEA member states under the following names:

Last revision date of this leaflet:11/2024

Further information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/