TADALAFIL KRKA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Krka 20 mg Film-Coated Tablets EFG

Read all of this 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 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 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.

Tadalafil Krka contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is improved erectile function. Tadalafil 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.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 to treat angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.
• you have a severe heart or liver problem.
• you have recently had a stroke or heart attack (within the last 90 days).
• 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 Krka, have been shown to increase the hypotensive effects of this medicine.

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 disorder of the red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukemia (cancer of the blood cells).
• any deformation of the penis.
• a severe liver problem.
• a severe kidney problem.

It is not known if tadalafil is effective in patients who have been surgically treated for erectile dysfunction.

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

A 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 decrease or loss of hearing, stop taking this medicine and contact your doctor immediately.

Tadalafil Krka is not intended for use by women.

Children and adolescents

Tadalafil is not recommended for individuals 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 taking:

• 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 an enlarged prostate).
• medicines such as ketoconazole (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• phenobarbital, phenytoin, and carbamazepine (medicines for epilepsy).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Krka with food and drink

Information on 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. These effects are unlikely to produce 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 sodium (23 mg) per tablet, which is essentially “sodium-free”.

3. How to take Tadalafil Krka

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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

The recommended dose isone 10 mg tablet taken before sexual activity. This dose may be taken as one 10 mg tablet or divided into two 5 mg doses. However, you have been given the dose of one 20 mg tablet, as your doctor has decided that the recommended dose of 10 mg is too weak.

You may take a tadalafil tablet at least 30 minutes before sexual activity.

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 and 20 mg are intended for use before anticipated sexual activity and are not recommended for continuous daily use.

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 your doctor or pharmacist immediately, or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally 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 and possibly painful erections after taking Tadalafil Krka (rare). If you have an erection that lasts for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), 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, flushing, nasal congestion, and indigestion.

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach pain, reflux, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, heart 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 decrease or loss of hearing, hives (red itchy patches on the skin), increased sweating, bleeding from the penis, and blood in the semen.

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

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

Additional rare side effects have been reportedin men taking tadalafil that were not seen in clinical trials, including:

• migraine, swelling of the face, 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 adverse reaction was dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported adverse reaction was diarrhea.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. 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: http://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 20 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 and packaging

Tadalafil Krka 20 mg film-coated tablets are yellow-brown, biconvex, oval, film-coated tablets, scored on one side and marked with a 20 on the other side. The tablet can be divided into equal doses. Tablet dimensions: approximately 14 mm long and 9.5 mm wide.

Tadalafil Krka is available in packs containing 2, 4, 8, 12, 14, 24, 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 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/