Tadalafil Krka 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafil Krka 10 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. 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 others, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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 10 mg is indicated for the treatment of erectile dysfunction in adult men. This condition occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil has demonstrated significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

Following 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. Tadalafilo Krka will not help you if you do not have erectile dysfunction.

It is important to warn you that Tadalafilo Krka is not effective without sexual stimulation. Therefore, you and your partner should engage in stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Tadalafil Krka

Do not take Tadalafil 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 group of medicines ("nitrates") is used to treat angina (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 taking Tadalafil Krka.

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

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 preservation of neurovascular bundles).

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.

Tadalafil Krka 10 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 Tadalafil Krka

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

Do not take Tadalafil 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 for 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 itraconazole (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 treatment of bacterial infections).
• other treatments for erectile dysfunction.

Taking Tadalafil Krka with drinks 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

A reduction in sperm production by the testes was observed in treated dogs. A reduction in sperm has been observed in some men. These effects are unlikely to result in 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.

Tadalafil Krka contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him 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 administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Tadalafil Krka 10 mg tablets are for oral use only in men. Swallow the tablet whole with a little water. The tablets can be taken with or without food.

The recommended starting dose is 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 tadalafil. Tadalafil Krka is for oral use.

When you take tadalafil, you may begin sexual activity at least 30 minutes after taking it.

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

You must not take Tadalafil Krka more than once a day. Tadalafil Krka 10 mg is intended to be used before anticipated sexual activity and daily continuous use is not recommended.

It is important to inform you that Tadalafil 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.

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, 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 Tadalafil Krka than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at phone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine package and leaflet to the healthcare professional.

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 may cause adverse effects, although not everyone experiences 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 and possibly painful erection after taking tadalafil (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, dimmed, central blurred 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, nausea (vomiting), blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (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, urticaria (red, itchy welts on the skin), increased sweating, bleeding from the penis, and presence of blood in semen.

Rare cases of heart attack and stroke have also been reported in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medicine.

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

Some additional rare adverse effects have been reported in men taking tadalafil that were not observed 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 heartbeats, angina, and sudden cardiac death,
• distorted, dimmed, central blurred 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, consult 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 Medicines: 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 sight and reach of children.

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

This medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to 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 container and additional information

Composition of Tadalafilo Krka

• The active substance is tadalafil. Each tablet contains 10 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 “Tadalafilo Krka contains lactose and sodium”.

Appearance of the Product and Contents of the Pack

Tadalafilo Krka 10 mg film-coated tablets (tablets) are yellow, biconvex, oval, film-coated tablets marked with "10" on one side. Tablet dimensions: approximately 12 mm long and 7.5 mm wide.

Tadalafilo Krka is available in packaging 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

For further information regarding 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:

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

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