Virvirilo 10 mg film-coated tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Virvirilo 10 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 other people, even if they have the same symptoms as you, because it may 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:
- What Virvirilo is and what it is used for
- What you need to know before taking Virvirilo
- How to take Virvirilo
- Possible adverse effects
- How to store Virvirilo
- Contents of the pack and other information
1. What Virvirilo is and what it is used for
Virvirilo 10 mg is used to treat 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. Virvirilo has demonstrated significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.
Virvirilo contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Virvirilo works by helping to relax the blood vessels in your penis, allowing blood to flow into the penis. The result is improved erectile function. Virvirilo will not help you if you do not have erectile dysfunction.
It is important to warn you that Virvirilo 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 taking Virvirilo
Do not take Virvirilo if:
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you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
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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 (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 (see section "Taking Virvirilo with other medicines").
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you have severe heart disease or have recently had a heart attack (within the last 90 days).
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you have recently had a stroke (within the last 6 months).
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you have low blood pressure or uncontrolled high blood pressure.
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you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
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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 effects of this medicine. If you are taking riociguat or are unsure, consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Virvirilo.
Be aware that sexual activity carries a potential risk for 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 red blood cells).
- multiple myeloma (a cancer of the bone marrow).
- leukemia (a cancer of blood cells).
- any deformity of the penis.
- severe liver problems.
- severe kidney problems.
It is not known whether tadalafil is effective in patients who have undergone:
- pelvic surgery.
- a surgical procedure in which the prostate has been partially or completely removed and the nerves to the prostate have been severed (radical prostatectomy without neurovascular bundle preservation).
If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or dim while taking Virvirilo, stop taking the medicine immediately and contact your doctor.
Sudden decrease or loss of hearing has been observed in patients taking tadalafil. Although it is unknown whether these cases are directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking Virvirilo and contact your doctor immediately.
Virvirilo is not intended for use in women.
Children and adolescents
Virvirilo must not be used in children or adolescents under 18 years of age.
Taking Virvirilo with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not take Virvirilo if you are already using nitrates (see "Do not take Virvirilo").
Some medicines may be affected by Virvirilo or may affect how well tadalafil 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 (for treatment of fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
- phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
- rifampicin, erythromycin, clarithromycin, or itraconazole.
- other treatments for erectile dysfunction.
Taking Virvirilo with food and alcohol
Information about the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of tadalafil cinfamed and should be taken with caution. Consult your doctor for further information.
Fertility
In treated dogs, a decrease in sperm production by the testes was observed. Some men have shown reduced sperm count. It is unlikely that these effects would lead to infertility.
Driving and using machines
Some men who took tadalafil during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.
Virvirilo contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
Virvirilo cinfamed contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially "sodium-free".
3. How to take Virvirilo
Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Virvirilo tablets are for oral use only in men. Swallow the tablet whole with a little water. The tablets may be taken with or without food.
The recommended starting dose is one 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. Virvirilo tablets are administered orally.
After taking Virvirilo, you may initiate sexual activity at least 30 minutes after dosing.
Virvirilo may remain effective up to 36 hours after taking the tablet.
Do not take Virvirilo more than once a day.
Virvirilo 10 mg and 20 mg are to be used prior to anticipated sexual activity and are not recommended for daily continuous use.
It is important to warn you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in sexual stimulation as you normally would if you were not taking a medicine for erectile dysfunction.
Alcohol consumption may affect your ability to achieve an erection and may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness upon standing.
If you take more Virvirilo than you should
Consult your doctor. You may experience adverse effects described in section 4.
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 medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine 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 effects, stop using the medicine 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 Virvirilo (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, dimmed, blurred central vision, or sudden decrease in vision (frequency not known).
Other adverse effects that have been reported:
Common (observed in 1 to 10 out of every 100 patients)
- headache
- back pain
- muscle pain
- pain in arms and legs
- facial flushing
- nasal congestion
- indigestion.
Uncommon (observed in 1 to 10 out of every 1,000 patients)
- 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 and tinnitus (ringing in the ears)
- swelling of the hands, feet or ankles
- feeling of fatigue.
Rare (observed in 1 to 10 out of every 10,000 patients)
- fainting
- seizures
- transient memory loss
- eyelid swelling, red eyes, sudden decrease or loss of hearing, and urticaria (red, itchy welts on the skin surface)
- penile bleeding
- blood in the semen
- increased sweating.
Rare cases of myocardial infarction (heart attack) and stroke have also been reported in men taking Virvirilo. Most of these men had pre-existing heart conditions before taking this medicine.
Rare cases of decreased or lost vision, partial, transient or permanent, in one or both eyes have also 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 pectoris
- sudden cardiac death
- distorted, dimmed, blurred central vision or sudden decrease in vision (frequency not known).
In men over 75 years of age treated with Virvirilo, the most frequently reported adverse effect was dizziness. In men over 65 years of age treated with Virvirilo, the most frequently reported adverse effect was diarrhea.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Virvirilo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Virvirilo
- The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
- The other components are:
Tablet core: Lactose monohydrate, sodium lauryl sulfate, povidone, crospovidone type B and sodium stearyl fumarate.
Tablet coating: Polyvinyl alcohol, macrogol, titanium dioxide (E171), talc and yellow iron oxide (E172).
Nature of the product and pack contents
Virvirilo 10 mg is a yellowish-ochre, oval, film-coated tablet, marked with "10" on one side and smooth on the other. Size: 11.1 mm x 6.4 mm.
Virvirilo 10 mg is available in blister packs containing 4 film-coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/ Laguna 66-68-70. Polígono Industrial Urtinsa II.
28923 Alcorcón (Madrid)
Spain
Manufacturer
TEVA Pharmaceutical Industries, 18 Eli Hurvitz Street, Industrial Zone, Kfar-Saba 44102, ISRAEL
TEVA PHARMA, S.L.U. Polígono Industrial Malpica, C/C, nº4
50016, Zaragoza, SPAIN
Biomo Pharma GmbH
Josef-Dietzgen-Straße 3
53773 Hennef
Deutschland
Date of the most recent revision of this leaflet: November 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es