Leaflet: information for the user

Virvirilo 10 mg film-coated tablets EFG

Tadalafil

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 Virvirilo is and what it is used for

2.What you need to knowbefore you start takingVirvirilo

3.How to takeVirvirilo

4.Possible side effects

5. Storage ofVirvirilo

6.Contents of the pack and additional information

Virvirilo 10 mg is used for the treatment of erectile dysfunction in adult men. This condition occurs when a man is unable to obtain or maintain a firm, adequate erection for satisfactory sexual activity. Virvirilo has demonstrated a significant improvement in the ability to obtain a lasting, penile erection suitable for sexual activity.

Virvirilo contains the active ingredient tadalafilo, which belongs to a group of medications known as phosphodiesterase type 5 inhibitors. After sexual stimulation, Virvirilo acts by helping to relax the blood vessels in the penis, allowing blood to flow into the penis. This results in improved erectile function.Virvirilo will not be effective if you do not have erectile dysfunction.

It is essential to note that Virvirilo is not effective without sexual stimulation.Therefore, you and your partner should stimulate yourselves in the same way you would without taking a medication for erectile dysfunction.

Do not takeVirviriloif:

• You are allergic to tadalafil or any of the other components of this medication (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 medications (“nitrates”) used to treat angina pectoris (“chest pain”). It has been seen that tadalafil increases the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor (see section “Use of Virvirilo with other medications”).

• You have a serious heart condition or have had a heart attack recently, within the last 90 days.

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

• You have low or uncontrolled high blood pressure.

• You have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarction”.

• You are taking riociguat. This medication is used to treat pulmonary 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 Virvirilo.

Be aware that sexual activity poses a possible risk for patients with heart problems, due to the additional strain it puts on the heart. If you have a heart problem, consult your doctor.

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

• Anemia falciforme (a red blood cell abnormality).
• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cell cancer).
• Any penile deformity.
• A severe liver problem.
• A severe kidney problem.

Tadalafil is not known to be effective in patients who have undergone:

• Pelvic surgery.
• A surgical intervention in which the prostate has been completely or partially removed and the prostate nerves have been cut (radical prostatectomy without neurovascular bundle preservation).

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

A sudden decrease or loss of hearing has been observed in patients taking tadalafil. Although it is unknown if these cases are directly related to tadalafil, if you experience a sudden decrease or loss of hearing, stop taking Virvirilo and immediately contact your doctor.

Virvirilo is not intended for use in women.

Children and adolescents

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

Use of Virvirilo with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to use any other medication.

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

Some medications may be affected by Virvirilo or may affect the proper functioning of tadalafil.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.
• A 5-alpha reductase inhibitor (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.

Taking Virvirilo with beverages and alcohol

The information about the effect of alcohol is found in section 3. Orange juice may affect the proper functioning of tadalafil cinfamed and should be taken with caution. Consult your doctor for more information.

Fertility

In treated dogs, 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 tadalafil during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machinery.

Virvirilo contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Virvirilo cinfamed contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

TheVirvirilotablets are for oral administration only in men. Swallow the tablet whole with a little water. The tablets can be taken with or without food.

The recommended initial doseis 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.Virvirilotablets are administered orally.

You can start sexual activity at least 30 minutes after takingVirvirilo.

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

Do not takeVirvirilomore than once a day.

Virvirilo10 mg and 20 mg are used before expected sexual activity and are not recommended for continuous daily use.

It is essential to inform you that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way you would without taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to have an erectionandmay 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.

If you take moreVirvirilothan you should

Consult your doctor. You may experience adverse effects 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 medication and the amount ingested.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These side effects are generally mild to moderate in intensity.

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

• allergic reactions including rashes (rare).
• chest pain - do not use nitrates but seek medical help immediately (rare).
• prolonged and possibly painful erection after takingVirvirilo(very rare). If you experience this type of erection, which can last for more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (very rare), distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

Other side effects that have been reported:

Common(observed in 1 to 10 of every 100 patients)

• headache
• back pain
• muscle pain
• pain in the arms and legs
• flushing of the face
• nasal congestion
• indigestion.

Rare(observed in 1 to 10 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 heartbeat, high blood pressure, low blood pressure
• nasal bleeding and ringing in the ears
• swelling of the hands, feet or ankles
• feeling of fatigue.

Very rare(observed in 1 to 10 of every 10,000 patients)

• syncope
• seizures
• transient loss of memory
• swelling of the eyelids, red eyes, sudden decrease or loss of hearing and urticaria (red itchy patches on the skin)
• bleeding in the penis
• blood in the semen
• increased sweating.

Infarction and stroke have also been reported rarely in men takingVirvirilo. Most of these men had some heart problems before taking this medicine.

Very rarely, cases of partial or permanent loss of vision 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
• swelling in 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, central vision blurred or sudden decrease in vision (unknown frequency).

In men over 75 years old takingVirvirilo, the most frequently reported side effect was dizziness. In men over 65 years old takingVirvirilo, 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appearson the packaging and the blisterafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special preservation conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat 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.

Composition of Virvirilo

• The active ingredient is tadalafilo. Each tablet contains 10 mg of tadalafilo.
• The other components are:

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

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

Appearance of the product and content of the container

Virvirilo 10 mg is a yellow ochre-coated tablet with a film coating, oval in shape, marked with “10” on one face and smooth on the other face of the tablet. Size 11.1 mm x 6.4 mm.

Virvirilo 10 mg is available in containers with blisters of 4 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70. Industrial Park Urtinsa II.

28923 Alcorcón (Madrid)

Spain

Responsible for manufacturing

TEVA Pharmaceutical Industries, 18 Eli Hurvitz Street, Industrial Zone, Kfar-Saba 44102, ISRAEL

TEVA PHARMA, S.L.U. Industrial Park Malpica, C/C, nº4

50016, Zaragoza, SPAIN

Biomo Pharma GmbH

Josef-Dietzgen-Straße 3

53773 Hennef

Germany

Last review date of this leaflet: November 2023

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http:// www.aemps.gob.es