Victogon 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Victogón 20 mg film-coated tablets EFG

Tadalafil

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

• Keep this leaflet, as 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Victogón is and what it is used for
2. What you need to know before taking Victogón
3. How to take Victogón
4. Possible adverse effects
5. How to store Victogón
6. Contents of the pack and other information

1. What Victogón is and what it is used for

Victogón 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. Victogón has demonstrated a significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

Victogón contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Victogón works by helping to relax the blood vessels in your penis, allowing blood to flow into the penis. The result is improved erectile function. Victogón will not help you if you do not have erectile dysfunction.

It is important to inform you that Victogón is not effective in the absence of 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.

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

Do not take Victogón:

• if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• if 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 pectoris (“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.
• if you have severe heart disease or have recently had a heart attack (within the last 90 days).
• if you have recently had a stroke (within the last 6 months).
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever experienced vision loss 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 been shown to increase 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 starting to take Victogón.

Be aware that sexual activity involves a potential risk in patients with heart problems, due to the additional strain it places 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 the red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of blood cells).
• any penile deformity.
• severe liver problems.
• severe kidney problems.

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

• pelvic surgery.
• a surgical procedure involving total or partial removal of the prostate with damage to the nerves supplying the prostate (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking Victogón, stop taking this medicine immediately and contact your doctor without delay.

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 Victogón and contact your doctor immediately.

Victogón is not intended for use in women.

Children and adolescents

Victogón must not be used in children and adolescents under 18 years of age.

Other medicines and Victogón

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

Do not take Victogón if you are already using nitrates.

Some medicines may be affected by Victogón or may affect how well Victogón works. 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 medicines to treat high blood pressure.

• riociguat.

• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).

• medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.

• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).

• rifampicin, erythromycin, clarithromycin, or itraconazole.

• other treatments for erectile dysfunction.

Taking Victogón with food and alcohol

Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Victogón and should be used with caution. Consult your doctor for further information.

Fertility

In treated dogs, a decrease in sperm production by the testes has been observed. A reduction in sperm has been observed in some men. It is unlikely that these effects lead to infertility.

Driving and operating machinery

Some men who took Victogón during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Victogón contains lactose and sodium:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him 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 Victogón

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The recommended starting dose is one 10 mg tablet taken before sexual activity. However, you have been prescribed a dose of one 20 mg tablet because your doctor has determined that the recommended 10 mg dose would be too weak for you.

After taking Victogón, you may begin sexual activity at least 30 minutes later.

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

You must not take Victogón more than once a day. Victogón 10 mg and 20 mg are to be taken prior to anticipated sexual activity and are not recommended for continuous daily use.

It is important to warn you that Victogón is not effective without sexual stimulation. Therefore, you and your partner must 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 Victogón, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

If you take more Victogón than you should

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, Victogón may cause adverse effects, although not everyone will experience 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 medical help immediately:

• allergic reactions including rashes (uncommon).
• chest pain – do not use nitrates, but seek immediate medical help (uncommon).
• priapism, a 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, diminished, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse effects that have been reported:

Frequent (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 erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (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 transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy welts on the skin), bleeding from the penis, blood in semen, and increased sweating.

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.

Rare 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 heartbeat, angina, and sudden cardiac death.
• Distorted, diminished, blurred central 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 reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products http://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Victogón

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Victogón

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other components are:
• Tablet core: monohydrate lactose (see end of section 2), spray-dried lactose, hydroxypropylcellulose, sodium croscarmellose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.
• Coating: monohydrate lactose, hypromellose 606, triacetin, titanium dioxide, yellow iron oxide, talc.

Appearance of the medicinal product and contents of the container

Victogón 20 mg are yellow, elliptical, biconvex film-coated tablets marked with “T20” on one side.

Victogón 20 mg is available in blister packs containing 2, 4, 8, 10 or 12 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

LABORATORIOS NORMON, S.A.

C/Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid (Spain)

Date of the most recent review of this leaflet: October 2023

Other sources of information:

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

You can access detailed information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83614/P_83614.html