Tadalafil Krka 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafil Krka 5 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the 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. How to store Tadalafil Krka
6. Contents of the pack and other information

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

Tadalafilo Krka contains the active substance tadalafil, 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 occurs when a man cannot achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to achieve a durable penile erection suitable for sexual activity.

After sexual stimulation, Tadalafilo Krka works by helping to relax the blood vessels in the penis, allowing blood to flow into it. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that Tadalafilo Krka is not effective without sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate, a sensation that the bladder has not emptied completely, and a need to urinate more frequently, even during the night. Tadalafilo Krka improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within as little as 1–2 weeks after starting treatment.

2. What you need to know before taking Tadalafilo Krka

Do not take Tadalafilo Krka if

• you are allergic to tadalafil or to 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 pectoris ("chest pain"). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.
• you have a severe heart disease 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 experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• 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 blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

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

Be aware that sexual activity involves a possible risk for patients with heart problems, due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform a prostate cancer evaluation 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:

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

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

• pelvic surgery.
• a surgical procedure in which the prostate has been partially or completely removed and the nerves to the prostate have been severed (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or dimmed 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 whether this 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 of age.

Other medicines and Tadalafilo Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Some medicines may be affected by tadalafil or may affect how well tadalafil works. 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 certain forms of pulmonary hypertension).
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole or itraconazol (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection (e.g., ritonavir).
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, or clarithromycin (for treating bacterial infections).
• other treatments for erectile dysfunction.

Taking Tadalafilo Krka with food and alcohol

Information about the effect of alcohol is provided in section 3.

Grapefruit juice may affect how well tadalafil works and should be taken with caution. Consult your doctor for further information.

Fertility

In treated dogs, a decrease in sperm production by the testes was observed. In some men, reduced sperm has been observed. It is unlikely that these effects would lead to infertility.

Driving and use of machines

Some men who took tadalafil during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafilo Krka contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Tadalafil Krka

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Alcohol consumption may affect your ability to get 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 upon standing.

For the treatment of erectile dysfunction

The recommended dose is one 5 mg tablet once daily, taken at approximately the same time each day. Your doctor may adjust your dose to 2.5 mg depending on your response to tadalafil. This may be achieved by taking a 2.5 mg tablet. Alternatively, the 2.5 mg dose may be obtained by dividing the 5 mg tablet into two equal halves.

Do not take Tadalafil Krka more than once a day.

Tadalafil Krka taken daily allows you to achieve an erection at any time during the 24-hour day, provided that sexual stimulation is present. Daily administration of Tadalafil Krka may be beneficial for men who anticipate having sexual activity two or more times per week.

It is important to note that Tadalafil Krka is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to get an erection.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet once daily, taken at approximately the same time each day.

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

You must not take Tadalafil Krka more than once a day.

If you take more Tadalafil Krka than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet 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 forgotten doses. You must not take Tadalafil Krka more than once a day.

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

4. Possible adverse effects

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

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

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

Other adverse effects that have been reported:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• dizziness, stomach pain, reflux, feeling unwell, being sick (vomiting), blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (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 eyelids, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy skin rash), increased sweating, bleeding in the penis and presence of blood in semen.

Myocardial infarction and stroke have also been rarely reported in men taking tadalafil. Most of these men had pre-existing heart conditions before taking this medicine.

Rare cases of decreased or lost vision, partial, temporary or permanent in one or both eyes, have also been reported.

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

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death,
• distorted, diminished, blurred central vision or sudden decrease in vision (frequency not known).

In men over 75 years of age receiving tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse effect was diarrhea.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Krka

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

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil Krka

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other components are hypromellose phthalate, mannitol, sodium croscarmellose, sodium lauryl sulfate, and magnesium stearate (E470b) in the tablet core, and monohydrate lactose, 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 pack

Tadalafil 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 in length and 6 mm in width.

The tablet can be divided into equal doses.

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

Only certain pack 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 further information about this medicinal product 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 EEA member states under the following names:

Date of the last review of this leaflet: 11/2024

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