Victogon 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Victogón 10 mg film-coated tablets EFG

Tadalafil

Read the entire 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 personally and must not be given 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 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 side 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. Erectile dysfunction occurs when a man is unable to achieve or maintain a firm erection adequate for satisfactory sexual activity. Victogón has demonstrated 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 the penis, allowing blood 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 warn you that Victogón is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in stimulation 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).
• you are taking any type of organic nitrates 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. If you are taking any type of nitrate or are unsure, tell your doctor.
• you have severe heart disease or have recently had a heart attack within the last 90 days.
• you have recently had a stroke within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have ever experienced vision loss 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). 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 placed 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 the blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

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

• surgery in the pelvic area.
• a surgical procedure involving total or partial removal of the prostate with cutting of the nerves to the prostate (radical prostatectomy without preservation of neurovascular bundles).

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 and contact your doctor immediately.

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 medicine.

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 taking:

• an alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).

• other medicines for treating 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 drinks and alcohol

Information regarding the effect of alcohol is located in section 3. Grapefruit juice may affect the way Victogón works and should be taken with caution. Consult your doctor for further information.

Fertility

In treated dogs, a decrease in sperm production by the testes has been observed. In some men, a reduction in sperm has been observed. 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 of 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 use of this medicine provided 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 a little water. Victogón tablets may be taken with or without food.

The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Victogón tablets are administered orally.

After taking Victogón, you may initiate sexual activity at least 30 minutes after taking the tablet.

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 used prior to anticipated sexual activity and are not recommended for continuous daily use.

It is important to warn 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.

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 it 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, immediately consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

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

If you experience any of the following adverse reactions, stop using the medication and seek immediate medical help:

• 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 vision loss (rare frequency), distorted vision, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse reactions 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 the urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (ringing in the ears), swelling of the hands, feet or ankles, and feeling tired.

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

• fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy welts on the skin), penile bleeding, blood in the 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 conditions before taking the medication.

Rare cases of decreased or sudden vision loss, partial, transient or permanent, in one or both eyes have also been reported.

Some additional rare adverse reactions 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 pectoris, 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 reaction was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse reaction 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 at 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 the 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. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and their containers. 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 10 mg of tadalafil.
• The other components are:
• Tablet core: monohydrate lactose (see the end of section 2), spray-dried lactose, hydroxypropylcellulose, sodium croscarmellose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.
• Coating: monohydrate lactose, hydroxypropyl methylcellulose 606, triacetin, titanium dioxide, yellow iron oxide, talc.

Appearance of the product and contents of the container

Victogón 10 mg are yellow, elongated, biconvex, film-coated tablets marked with "T10" on one side.

Victogón 10 mg is available in blister packs containing 4 tablets.

Marketing Authorization Holder and Manufacturing Responsible

LABORATORIOS NORMON, S.A.

C/Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid (Spain)

Date of the latest revision of this leaflet: October 2023

Other sources of information:

Detailed information about this medicine 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 medicine 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/83613/P_83613.html