TADALAFIL Zentiva 10 mg FILM-COATED TABLETS

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

Tadalafil Zentiva 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 Zentiva has been shown to significantly improve the ability to obtain a hard erect penis suitable for sexual activity.

Tadalafil Zentiva contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Zentiva 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 Zentiva will not help you if you do not have erectile dysfunction.

It is important to note that Tadalafil Zentiva 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 Zentiva

Do not take Tadalafil Zentiva:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if 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”). Tadalafil has been shown to increase the effects of these medicines.
• if you have a severe heart or liver problem.
• if you have recently had a stroke or heart attack within the last 90 days.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
• if 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 shown an increase in the hypotensive effect of this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on your 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 your penis.
• severe kidney or liver disease.

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

• pelvic surgery.
• removal of the prostate gland (prostatectomy) in which the nerves of the prostate are cut (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision or hearing, stop taking tadalafil 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 this 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 is not intended for use by women.

Children and adolescents

Tadalafil should not be used in children and adolescents under 18 years of age.

Other medicines and Tadalafil Zentiva

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Do not take tadalafil 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.
• a 5-alpha reductase inhibitor (used to treat an enlarged prostate).

• medicines such as ketoconazole tablets (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 Zentiva with food, drinks, and alcohol

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 Zentiva 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 Zentiva

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

The 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 dose isone 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. Tadalafil tablets are taken by mouth.

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 more than once a day. Tadalafil 10 and 20 mg is intended for use before anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that tadalafil 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 affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or plan 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 Zentiva 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.

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 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 Zentiva (rare). If you experience this type of erection, which can last 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, facial flushing, nasal congestion, and indigestion.

Uncommon (may affect up to 1 in 100 people)

• dizziness, stomach pain, nausea, vomiting, reflux, 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 decrease or loss of hearing, hives (red itchy patches on the skin), bleeding from the penis, blood in the semen, and increased sweating.

Heart attack and stroke have also been reported rarely 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.

Additional rare side effects have been reportedin men taking tadalafil that were not seen in clinical trials. These include:

• 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, and sudden cardiac death.
• distorted vision, blurred vision, or sudden loss of vision (frequency not known).

In men over 75 years old taking tadalafil, the most commonly reported side effect was dizziness. In men over 65 years old taking tadalafil, the most commonly reported side effect was diarrhea.

Reporting of side effects

If you get 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Zentiva

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 after “EXP”. The expiry date refers to the last day of that month.

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 Zentiva

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredients are:
• Core of the tablet: lactose monohydrate, pregelatinized starch, colloidal anhydrous silica, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
• Coating: hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Appearance and packaging of the product

Tadalafil Zentiva 10 mg is a film-coated tablet (tablet), oval, pale yellow, engraved with “10” on one side and smooth on the other. The tablet is 11 mm x 6.6 mm in diameter and 3.9 – 4.5 mm in thickness.

Pack sizes

Tadalafil Zentiva 10 mg is available in blister packs containing 4 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Zentiva k.s.

U kabelovny 130

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Manufacturer

Actavis Ltd

BLB016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Street

Dupnitsa, 2600

Bulgaria

Special Products’s Line S.P.A.

Via Fratta Rotonda Vado Largo 1

03012 Anagni (FR)

Italy

For further information about this medicine, please contact the local representative of the marketing authorisation holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:January 2024

Other sources of information:

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