Leaflet: information for the user

Tadalafil Krka 10 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 10 mg 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 erection, adequate for a satisfactory sexual activity. Tadalafilo has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis, adequate for sexual activity.

After sexual stimulation, Tadalafilo Krka acts by helping to relax the blood vessels of your penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo Krka will not help 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 as 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 condition or have had a heart attack recently, in the last 3 months.
• you have had a recent stroke, in 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 stroke”.
• you are taking riociguat. This medicine is used to treat pulmonary arterial 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.

Warnings and precautions

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

Be aware that sexual activity can pose a possible risk to 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:

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

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

• pelvic surgery.
• surgery 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 or blurred 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 sudden decrease or loss of hearing, stop taking this medicine and contact your doctor immediately.

Tadalafilo Krka 10 mg is not intended for use in women.

Children and adolescents

Tadalafil is not recommended in 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 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 drinks 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 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 in doubt, consult your doctor or pharmacist again.

Tadalafilo Krka 10 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.

The recommended initial doseis one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg of tadalafilo. Tadalafilo Krka is for oral use.

You can initiate sexual activity at least 30 minutes after taking tadalafilo.

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

You should not take Tadalafilo Krka more than once a day. Tadalafilo Krka 10 mg will be used before expected sexual activity andis not recommended for continuous daily use.

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 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 the Toxicological Information Service, Tfno. 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 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).
• priapism, prolonged and possibly painful erection after taking tadalafil (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, nausea, 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), increased sweating, bleeding in the penis and blood in the semen.

It has also been reported that infarction and stroke can occur in men taking tadalafil. 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 tadalafil 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 tadalafil, the most frequently reported side effects were dizziness. In men over 65 years old taking tadalafil, 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 after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition of Tadalafilo Krka

• The active ingredient is tadalafilo. Each tablet contains 10 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 10 mg film-coated tablets are: yellow film-coated, biconvex, oval, marked with a 10 on one face. D Dimensions of the tablet: approximately 12 mm long and 7.5 mm wide.

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 EEA member states 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/