Victogon 10 mg comprimidos recubiertos con pelicula efg
Introduction
Leaflet: information for the user
Tadalafil 10 mg film-coated tablets EFG
Tadalafilo
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 isVictogónand for what it is used
2. What you need to know before starting to takeVictogón
3. How to takeVictogón
4. Possible side effects
5. Storage ofVictogón
6. Contents of the pack and additional information.
1. What is Victogón and how is it used
Victogón is indicated for the treatment of erectile dysfunction in adult men. This occurs when a man is unable to obtain or maintain a firm erection, adequate for a satisfactory sexual activity. Victogón has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis, adequate for sexual activity.
Victogón contains the active ingredient tadalafilo, which belongs to a group of medications called phosphodiesterase type 5 inhibitors. After sexual stimulation, Victogón acts by helping to relax the blood vessels of your penis, allowing blood to flow to 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 you would if you were not taking a medication 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 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 heart attack recently, 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 activity poses a possible risk for patients with heart problems, due to the additional effort it requires. If you have a heart problem, consult your doctor.
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.
- surgery 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 or blurred while taking Victogón, stop taking this medication and contact your doctor immediately.
Sudden 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 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 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.
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 machinery
Some men who took Victogón during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machinery.
Victogón contains lactose and sodium:
This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult him before taking this medication.
This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.
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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 tadalafil (rare frequency). If you experience this type of erection, which may 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 the urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nasal bleeding, ringing in the ears, swelling of the 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, hives (red itchy patches on the skin), bleeding in the penis, blood in the semen, and increased sweating.
Also, rare cases of heart attack and stroke have been reported in men taking tadalafil. 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 tadalafil 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 tadalafil, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafil, 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 not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Victogón Storage
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.
6. Contents of the packaging and additional information
Composition of Victogón
- The active principle is tadalafilo. Each tablet contains 10 mg of tadalafilo.
- The other components are:
- Tablet core : lactose monohydrate (see the end of section 2), lactose (spray-dried), hydroxypropylcellulose, croscarmellose sodium, 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 10 mg are yellow-coated, elongated, biconvex tablets marked with “T10” on one face.
Victogón 10 mg is available in blister packs containing 4 tablets.
Marketing authorization holder and manufacturer responsible
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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob. es/
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