TADALAFIL KRKA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Krka 10 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tadalafil Krka and what is it used for
2. What you need to know before you take Tadalafil Krka
3. How to take Tadalafil Krka
4. Possible side effects
5. Storage of Tadalafil Krka
6. Contents of the pack and other information

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

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

Tadalafil Krka 10 mg is indicated for the treatment of erectile dysfunction in adult men. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

After sexual stimulation, Tadalafil Krka acts by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is an improvement in erectile function. Tadalafil Krka will not help you if you do not have erectile dysfunction.

It is important to note that Tadalafil Krka is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before you take Tadalafil Krka

Do not take Tadalafil Krka if

• you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used for the treatment of angina pectoris (“chest pain”). It has been shown that tadalafil increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• you have a severe heart or liver problem.
• you have recently had a stroke or heart attack within the last 3 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have ever had loss of vision 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). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown an increase in 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 taking Tadalafil Krka.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, tell your doctor.

Before taking the tablets, tell your doctor if you:

• have sickle cell anemia (a disease of the red blood cells).
• have multiple myeloma (cancer of the bone marrow).
• have leukemia (cancer of the blood cells).
• have any deformation of your penis.
• have a severe liver problem.
• have a severe kidney problem.

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

• pelvic surgery.
• removal of the prostate gland or other surgeries that have affected the nerves that control erection (prostatectomy).

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

A sudden 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 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 in children and 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 take any other medicines.

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

Some medicines may be affected by tadalafil or may affect how well tadalafil works. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines for 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 (for fungal infections) and protease inhibitors for the treatment of HIV or AIDS (e.g., ritonavir).
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, or clarithromycin (for bacterial infections).
• other treatments for erectile dysfunction.

Taking Tadalafil Krka with food and drink

Information about the effect of alcohol is in section 3.

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

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm count has been observed in some men. It is unlikely that these effects will lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Tadalafil Krka

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

The recommended doseis one 10 mg tablet taken 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 only.

When you take tadalafil, you may be able to have sexual activity at any time between 30 minutes and 36 hours after taking the tablet.

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

Do not take Tadalafil Krka more than once a day. Tadalafil Krka 10 mg should be taken before anticipated sexual activity and not for continuous daily use.

It is important to note that Tadalafil Krka is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Consuming large amounts of alcohol may decrease 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

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 medicine and the amount taken. It is recommended to bring the package and the package leaflet of the medicine to the healthcare professional.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are usually mild to moderate.

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

• allergic reactions including skin rash (uncommon).
• chest pain - do not use nitrates but seek medical help immediately (uncommon).
• prolonged erections, painful erections lasting more than 4 hours (rare). If you experience this type of erection, you should contact a doctor immediately.
• sudden loss of vision, distorted vision, blurred vision, or sudden loss of vision (frequency not known).

Other side 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 sick (vomiting), blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, 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 temporary memory loss, swelling of the eyelids, red eyes, sudden loss of hearing, hives (itchy red welts on the surface of the skin), increased sweating, bleeding from the penis, and blood in the semen.

Myocardial infarction and stroke have been reported in men taking tadalafil. Most of these men had pre-existing heart problems.

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

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

• migraine, facial swelling, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.

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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 10 mg of tadalafil.

• The other ingredients are hypromellose phthalate, mannitol, croscarmellose sodium, laurilsulfate sodium, 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 film coating.

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

Appearance of the product and contents of the pack

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

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

Not all 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 medicine from 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 medicinal product is authorised in the Member States of the EEA under the following names:

Date of last revision of this package leaflet:11/2024

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