Leaflet: information for the user

Tadalafil Krka 5 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 contains the active ingredient tadalafilo, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafilo Krka 5 mg is used to treat adult men with:

• erectile dysfunction. This is when a man cannot get or keep an erection firm enough for satisfying sexual activity. Tadalafilo has shown a significant improvement in the ability to get a lasting erection of the penis suitable for sexual activity.

After sexual stimulation, Tadalafilo Krka 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 help if you do not have erectile dysfunction. It is essential to inform you that Tadalafilo Krka is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medicine for erectile dysfunction.

• urinary symptoms associated with a common disease calledbenign prostatic hyperplasia. This is when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate, feeling that the bladder is not fully emptied, needing to urinate more frequently, even at night. Tadalafilo Krka improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo has shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

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 condition or have had a heart attack recently, within the last 3 months.
• you have had a recent stroke, within the last 6 months.
• you have low or high blood pressure that is not controlled.
• you have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye infarction”.
• you are taking riociguat. This medicine is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as tadalafil, have shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warning and precautions

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

Be aware that sexual activity may pose 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.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer check before starting treatment with tadalafil for benign prostatic hyperplasia.

Tadalafilo Krka does not treat prostate cancer.

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

• thalassemia (a blood disorder).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cancer).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

It is not known if tadalafil is effective in patients who have undergone:

• pelvic surgery.
• surgeries in which the prostate has been completely or partially removed and the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

Tadalafilo Krka 5 mg 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 taking:

• 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 like ketoconazole or itraconazole (to treat fungal infections) and protease inhibitors for the treatment of HIV/AIDS (e.g. ritonavir).
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, or clarithromycin (to treat bacterial infections).
• other treatments for erectile dysfunction.

Taking Tadalafilo Krka with beverages and alcohol

Information about the effect of alcohol can be found in section 3.

Orange 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 a certain sugar intolerance, consult with them 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 of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Tadalafilo Krka 5 mg tablets are for oral administration only in men. Swallow the tablet whole with a little water. Tablets can be taken with or without food.

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

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafilo. This will be done by taking one 2.5 mg tablet. Alternatively, the 2.5 mg dose can be obtained by dividing the 5 mg tablet in half.

Do not take Tadalafilo Krka more than once a day.

Tadalafilo Krka taken daily allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Tadalafilo Krka taken daily may be useful for men who expect to engage in sexual activity two or more times a week.

It is essential to inform you that Tadalafilo Krka is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to have an erection.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet once a day, approximately at the same time.

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once a day.

Do not take Tadalafilo Krka more than once a day.

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 the Toxicological Information Service, Tel. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Tadalafilo Krka

Take your dose as soon as you remember, but do not take a double dose to compensate for the missed doses. Do not take Tadalafilo Krka more than once a day.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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).
• prolonged and possibly painful erection after taking Tadalafilo Krka (rare frequency). If you experience 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 people)

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

Infrequent(may affect up to 1 in 100 people)

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

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

• loss of consciousness, seizures and temporary 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 blood in the semen.

Infarction and stroke have also been reported rarely in men taking tadalafilo. Most of these men had some heart problem before taking this medicine.

Rarely reported 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 reported 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 effects were 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, 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:https://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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Tadalafilo Krka

• The active ingredient is tadalafilo. Each tablet contains 5 mg of tadalafilo.
• The other components are hypromelosa ftalato, manitol, croscarmelosa de sodio, laurilsulfato de sodio, and estearato de magnesio (E470b) in the tablet core and lactosa monohidrato, hypromelosa, talco (E553b), dióxido de titanio (E171), óxido de hierro amarillo (E172), and triacetina (E1518) in the coating.

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

Appearance of the product and contents of the package

Tadalafilo Krka 5 mg film-coated tablets are: light yellow, biconvex, oval, film-coated tablets, scored on one side, and marked with a 5 on the other side, tablet dimensions: approximately 9 mm in length and 6 mm in width.

The tablet can be divided into equal doses.

Tadalafilo Krka is available in packages containing 2, 4, 8, 12, 14, 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

Manufacturer

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

You can request more information about this medication by contacting 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 Member States of the EEA under the following names:

Last review date of this leaflet: 11/2024

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