VIRVIRILO 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Virvirilo 5 mg film-coated tablets EFG

Tadalafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Virvirilo and what is it used for
2. What you need to know before you take Virvirilo
3. How to take Virvirilo
4. Possible side effects
5. Storing Virvirilo
6. Contents of the pack and further information

1. What is Virvirilo and what is it used for

Virvirilo contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Virvirilo 5 mg is used for the treatment of adult men with:

• erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Virvirilo has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity. After sexual stimulation, Virvirilo works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is an improvement in erectile function. Virvirilo will not help you if you do not have erectile dysfunction. It is important to note that Virvirilo is not effective in the treatment of erectile dysfunction if there is no sexual stimulation.Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty starting to urinate, feeling like the bladder is not completely empty, needing to urinate more often, even at night. Virvirilo improves blood flow and relaxes the muscles in the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia. Virvirilo has been shown to improve these urinary symptoms in as little as 1-2 weeks after starting treatment.

2. What you need to know before you take Virvirilo

Do not takeVirvirilo if:

• you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

• you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). It has been shown that tadalafil increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor (see section “Using Virvirilo with other medicines”).

• you have a severe heart condition or have had a recent heart attack within the last 90 days.

• you have had a recent stroke within the last 6 months.

• you have low blood pressure or uncontrolled high blood pressure.

• you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.

• 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). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown that they 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 Virvirilo

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain 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 check you for prostate cancer before you start taking tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.

Before taking the tablets, tell your doctor if you have:

• sickle cell anemia (a condition that affects red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukemia (cancer of the blood cells).
• any deformation of the penis.
• a severe liver problem.
• a severe kidney problem.

It is not known if tadalafil is effective in patients who have been surgically treated:

• in the pelvic area.
• with a surgical procedure in which the prostate was partially or completely removed and the nerves of the prostate were cut (radical prostatectomy without preservation of neurovascular bundles).

If you experience sudden loss or decrease of vision or your vision is distorted, blurred, or dimmed while taking Virvirilo, stop taking Virvirilo and contact your doctor immediately.

A sudden decrease or loss of hearing has been observed in patients taking tadalafil. Although it is not known if these cases are directly related to tadalafil, if you experience a sudden decrease or loss of hearing, stop taking tadalafil and contact your doctor immediately.

Virvirilo is not intended for use in women.

Children and adolescents

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

Using Virvirilo with other medicines

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

Do not take Virvirilo if you are already taking nitrates (see “Do not take Virvirilo”).

Some medicines may be affected by Virvirilo or may affect the way tadalafil works. Tell 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 for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Virvirilo with drinks and alcohol

Information about the effect of alcohol is in section 3. Grapefruit juice may affect the way tadalafil works and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

Some men who took tadalafil during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

Virvirilo contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Virvirilo contains sodium

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

3. How to take Virvirilo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Virvirilo tablets are for oral use only in men. Swallow the tablet whole with some water. The 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 tadalafil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet per day, taken at approximately 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 a 2.5 mg tablet.

Do not take more than one dose of Virvirilo per day.

Virvirilo taken daily may be useful in men who anticipate having sexual activity at least twice a week. Virvirilo taken daily allows you to get an erection at any time during the 24 hours of the day, provided that you are sexually stimulated.

It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Consuming alcohol may affect your ability to get an erection.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet per day, taken at approximately the same time.

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

Do not take more than one dose of Virvirilo per day.

If you take more Virvirilo than you should

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

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 medicine and the amount taken.

If you forget to take Virvirilo

Take your dose as soon as you remember, but do not take a double dose to make up for forgotten doses. Do not take more than one dose of tadalafil per day.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are usually mild to moderate.

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

• allergic reactions including rash (uncommon).
• chest pain - do not use nitrates but seek medical help immediately (uncommon).
• priapism, a prolonged and possibly painful erection after taking Virvirilo (rare). If you experience this type of erection, which can last for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, or diminished vision (frequency not known).

Other side effects that have been reported:

Common(seen in 1 to 10 in every 100 patients)

• headache
• back pain
• muscle pain
• pain in arms and legs
• flushing
• nasal congestion
• indigestion

Uncommon(seen in 1 to 10 in every 1,000 patients)

• 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 and ringing in the ears
• swelling of hands, feet, or ankles and feeling tired

Rare(seen in 1 to 10 in every 10,000 patients)

• fainting
• seizures
• temporary memory loss
• swelling of the eyelids, red eyes, sudden decrease or loss of hearing, and hives (red itchy patches on the skin)
• bleeding from the penis
• blood in the semen
• increased sweating

Myocardial infarction and stroke have also been reported rarely in men taking Virvirilo. Most of these men had pre-existing heart conditions.

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

Some additional rare side effectshave been reported in men taking tadalafil that were not seen in clinical trials, including:

• migraine
• swelling of the face
• severe allergic reaction that causes swelling of the face or throat
• severe skin rashes
• certain disorders that affect blood flow to the eyes
• irregular heartbeat
• angina pectoris
• sudden cardiac death
• distorted, blurred, or diminished vision (frequency not known)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Virvirilo

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Virvirilo

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients are:

Core of the tablet: Lactose monohydrate, sodium lauryl sulfate, povidone, crospovidone type B, and sodium stearyl fumarate.

Coating of the tablet: Polyvinyl alcohol, macrogol, titanium dioxide (E171), talc, and yellow iron oxide (E172).

Appearance and packaging

Virvirilo 5 mg is a yellow-orange, oval, film-coated tablet, 8.1 mm x 4.1 mm in size, marked with “5” on one side and smooth on the other.

Virvirilo 5 mg is available in packs of 28 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

Date of last revision of this leaflet: November 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es