Leaflet: information for the user

Tadalafil 5 mg film-coated tablets EFG

Tadalafil

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Tadalafil and for what it is used

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

3. How to take Tadalafil

4. Possible side effects

5. Storage of Tadalafil

6. Contents of the pack and additional information

Victogón contains the active ingredient tadalafilo, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Victogón 5 mg is used to treat adult men with:

• erectile dysfunction. This occurs when a man is unable to obtain or maintain a firm erection, adequate for satisfactory sexual activity. Victogón has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis, adequate for sexual activity.

After sexual stimulation, Victogón acts by helping to relax the blood vessels of the penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Victogón will not help if you do not have erectile dysfunction. It is essential to inform you that Victogón is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medicine for erectile dysfunction.

• urinary symptoms associated with a common disease calledbenign prostatic hyperplasia. This occurs when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate, feeling that the bladder has not been completely emptied, a need to urinate more frequently, even at night. Victogón improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Victogón has demonstrated an improvement in these urinary symptoms in as little as 1-2 weeks after starting treatment.

Do not take Victogón:

• if you are allergic to tadalafil or any of the other components of this medication (listed in section 6).
• if you are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medications (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor.
• if you have a serious heart disease or have had a recent heart attack, within the last 90 days.
• if you have had a recent stroke, within the last 6 months.
• if you have low or uncontrolled high blood pressure.
• if you have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarction”.
• if you are taking riociguat. This medication 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 clots). PDE5 inhibitors, such as tadalafil, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Victogón.

Be aware that sexual intercourse carries a possible risk for patients with heart problems, due to the additional effort it puts on the heart. If you have a heart problem, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer review before starting treatment with Victogón for benign prostatic hyperplasia. Victogón 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 (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformity.
• serious liver disease.
• serious kidney disease.

It is not known if Victogón is effective in patients who have undergone:

• pelvic surgery.
• surgeries in which the prostate has been completely or partially removed and the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision or your vision is distorted, blurred while taking Victogón, stop taking this medication and contact your doctor immediately.

A decrease or 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 a decrease or sudden loss of hearing, stop taking Victogón and contact your doctor immediately.

Victogón is not intended for use in women.

Children and adolescents

Victogón should not be used in children or adolescents under 18 years old.

Other medications and Victogón

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take Victogón if you are already using nitrates.

Some medications may be affected by Victogón or may affect the proper functioning of Victogón. Inform your doctor or pharmacist if you are using:

• an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medications to treat high blood pressure.
• riociguat.
• an inhibitor of 5-alpha reductase (used to treat benign prostatic hyperplasia).
• medications such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV/AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Victogón with beverages and alcohol

The information about the effect of alcohol is found in section 3. Grapefruit juice may affect the proper functioning of Victogón and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machines

Some men who took Victogón during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machines.

Victogón contains lactose and sodium:

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Victogón tablets are for oral administration only in men. Swallow the tablet whole with a little water. Tablets can be taken with or without food.

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Victogón, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

Treatment of erectile dysfunction

The recommended doseis one 5 mg tablet once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This will be done by taking one 2.5 mg tablet.

Do not take Victogón more than once a day.

Victogón taken daily allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Victogón taken daily may be useful for men who expect to engage in sexual activity two or more times a week.

It is essential to inform you that Victogón is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way you would if you were not taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to have an erection.

Treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet once a day, approximately at the same time.

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

Do not take Victogón more than once a day.

If you take more Victogón than you should

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

If you forgot to take Victogón

Take your dose as soon as you remember, but do not take a double dose to compensate for the missed doses. Do not take Victogón more than once a day.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines, Victogón may cause side effects, although not everyone will experience them. These side effects are generally mild to moderate in intensity.

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

• Allergic reactions including rashes (infrequent).
• Chest pain - do not use nitrates but seek medical help immediately (infrequent).
• Priapism, a prolonged and possibly painful erection after taking tadalafilo (rare frequency). If you experience this type of erection, which can last for more than 4 hours, you must contact a doctor immediately.
• Sudden loss of vision (rare frequency), distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 people)

-Headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion and indigestion.

Infrequent(may affect up to 1 in 100 people)

• Dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nasal bleeding, tinnitus, swelling of hands, feet or ankles and feeling tired.

Rare(may affect up to 1 in 1,000 people)

• Loss of consciousness, seizures and temporary loss of memory, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red itchy patches on the skin's surface), bleeding in the penis, blood in semen and increased sweating.

Also, rare cases of heart attack and stroke have been reported in men taking tadalafilo. Most of these men had some heart problem before taking this medicine.

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

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

• Migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.
• Distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Victogón

• Theactive ingredientis tadalafilo. Each tablet contains 5 mg of tadalafilo.
• Theother componentsare:

Tablet core: lactose monohydrate (see the end of section 2), lactose (spray-dried), hydroxypropylcellulose, sodium croscarmellose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

Capsule coating: lactose monohydrate, hydroxypropyl methylcellulose 606, triacetin, titanium dioxide, yellow iron oxide, talc.

Appearance of the product and contents of the packaging

Victogón 5 mg are yellow-coated, elongated, biconvex tablets marked with “T5” on one face.

Victogón 5 mg is available in blister packs containing 14, 28, or 84 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

C/Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid (Spain)

Last review date of this leaflet:October 2023

Other sources of information:

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