TADALAFIL KRKA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Krka 5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What Tadalafil Krka is and what it is used for
2. What you need to know before taking Tadalafil Krka
3. How to take Tadalafil Krka
4. Possible side effects
5. Storage of Tadalafil Krka
6. Package contents and additional information

1. What Tadalafil Krka is and what it is used for

Tadalafil Krka contains the active substance tadalafil, which belongs to a group of medications called phosphodiesterase type 5 inhibitors.

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

• erectile dysfunction. This occurs when a man cannot obtain or maintain a firm erection sufficient for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to achieve a lasting erection of the penis suitable for sexual activity.

After sexual stimulation, Tadalafil Krka acts by helping to relax the blood vessels in the penis, allowing blood flow to the penis. The result is an improvement in erectile function. Tadalafil will not help if you do not have erectile dysfunction. It is essential to note that Tadalafil Krka is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medication for erectile dysfunction.

• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, feeling that the bladder has not been completely emptied, need to urinate more frequently, even at night. Tadalafil Krka improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within a short period, such as 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Krka

Do not take Tadalafil Krka if

• you are allergic to tadalafil or any of the other ingredients of this medication (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 medications ("nitrates") used to treat angina pectoris ("chest pain"). It has been seen that tadalafil increases the effects of these medications. If you are taking any type of nitrate or are unsure, tell your doctor.
• you have a severe heart condition or have recently had a heart attack, within the last 3 months.
• you have recently had a stroke, within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "eye infarction".
• you are taking riociguat. This medication 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 blood clots). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown that they increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

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

Be aware that sexual activity carries a possible risk in patients with heart problems, due to the additional effort it requires for 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 screening before starting treatment with tadalafil for benign prostatic hyperplasia.

Tadalafil Krka does not treat prostate cancer.

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

• sickle cell anemia (a red blood cell abnormality).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformation.
• a severe liver problem.
• a severe kidney problem.

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

• surgery in the pelvic area.
• a surgical procedure in which the prostate was completely or partially removed and the prostate nerves were cut (radical prostatectomy without preservation of neurovascular bundles).

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

A 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 medication and contact your doctor immediately.

Tadalafil Krka 5 mg is not intended for use in women.

Children and adolescents

Tadalafil is not recommended in children or adolescents under 18 years of age.

Other medications and Tadalafil Krka

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

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

Some medications 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 medications for treating high blood pressure.
• riociguat (used to treat some forms of pulmonary hypertension).
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medications such as ketoconazole or itraconazole (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection (e.g., ritonavir).
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
• rifampicin, erythromycin, or clarithromycin (for treating bacterial infections).
• other treatments for erectile dysfunction.

Taking Tadalafil Krka with beverages and alcohol

Information about the effect of alcohol can be 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 with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

Some men who took tadalafil during clinical trials experienced dizziness. Carefully check how you react when taking the tablets before driving or using machines.

Tadalafil Krka contains lactose and sodium

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

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

3. How to take Tadalafil Krka

Follow the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Tadalafil Krka 5 mg tablets are for oral administration only in men. Swallow the tablet whole with a little water. The 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 Tadalafil 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 tadalafil. This will be done by taking a 2.5 mg tablet. Alternatively, the 2.5 mg dose can be obtained by dividing the 5 mg tablet into two equal halves.

Do not take Tadalafil Krka more than once a day.

Tadalafil Krka administered daily allows you to achieve an erection at any time during the 24 hours of the day, provided there is sexual stimulation. Tadalafil Krka administered daily may be useful in men who anticipate having sexual activity two or more times a week.

It is essential to note that Tadalafil Krka is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other 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 Tadalafil Krka more than once a day.

If you take more Tadalafil Krka than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to take the packaging and the package leaflet of the medication to the healthcare professional.

If you forget to take Tadalafil Krka

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. These effects are generally mild to moderate.

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

• allergic reactions, including rash (uncommon).
• chest pain - do not use nitrates, but seek medical help immediately (uncommon).
• Priapism, prolonged and possibly painful erection after taking Tadalafil Krka (rare). If you experience this type of erection, which can last continuously for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, central blurred vision, or sudden decrease in vision (frequency not known).

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

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

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

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

Infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medication.

Rarely, cases of decreased or lost vision, partial, transient, or permanent in one or both eyes have been reported.

Some additional rare side effectshave been reported in men taking tadalafil that were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death,
• distorted, blurred, central blurred vision, or sudden decrease in vision (frequency not known).

In men over 75 years of age treated with tadalafil, the most frequently reported side effects were dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported side effect was diarrhea.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tadalafil Krka

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

Do not use this medication after the expiration date stated on the carton and blister after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

6. Package contents and additional information

Composition of Tadalafilo Krka

• The active ingredient is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients 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 "Tadalafilo Krka contains lactose and sodium".

Appearance and packaging of the product

Tadalafilo Krka 5 mg film-coated tablets (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 long and 6 mm wide.

The tablet can be divided into equal doses.

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

Only some pack sizes may be marketed.

Marketing authorisation 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 medicinal product by contacting the local representative of the marketing authorisation holder:

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

This pharmaceutical product is authorised in the EEA member states under the following names:

Date of last revision of this leaflet:11/2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/