Package Leaflet: Information for the User

Virvirilo 5 mg Film-Coated Tablets EFG

Tadalafil

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to 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 know before you start taking Virvirilo

3.How to take Virvirilo

4.Possible side effects

5. Storage of Virvirilo

6.Contents of the pack and additional information

Virvirilocontains the active ingredient tadalafilo, which belongs to a group of medications called phosphodiesterase type 5 inhibitors.

Virvirilo 5 mg is used to treat adult men with:

• erectile dysfunction. This is when a man cannot get or maintain a firm erection, which is suitable for a satisfying sexual activity.Virvirilohas shown a significant improvement in the ability to obtain a lasting erection of the penis suitable for sexual activity. After sexual stimulationVirviriloacts by helping to relax the blood vessels of the penis, allowing blood to flow into the penis. The result is an improvement in erectile function.Virvirilowill not help if you do not have erectile dysfunction.It is essential to inform you that Virvirilo is not effective in treating erectile dysfunction if there is no sexual stimulation.Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medication for erectile dysfunction.
• Urinary symptoms associated with a common disease calledbenign prostatic hyperplasia.This is when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate, feeling that the bladder has not been completely emptied, and the need to urinate more frequently, even at night.Virviriloimproves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia.Virvirilohas shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

Do not takeVirvirilo if:

• 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 disease 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 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). Inhibitors of phosphodiesterase type 5, such as tadalafil, have shown that they 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 effort it requires. If you have a heart problem, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer review before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil cinfamed does not treat prostate cancer.

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

• Thalassemia major (a blood disorder).
• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cancer).
• Any penile deformity.
• Severe liver disease.
• Severe kidney disease.

It is not known if tadalafil is 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 tadalafil cinfamed 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.
• 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.

Consumption of 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 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 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 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 of this medication indicated by your doctor or pharmacist. In case of 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 consumption of alcohol may temporarily decrease your blood pressure. If you have taken or are planning to take tadalafilo, 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 once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafilo. This will be done by taking one 2.5 mg tablet.

Do not takeVirvirilomore than once a day.

Virviriloadministered daily may be useful in men who anticipate engaging in sexual activity two or more times a week.Virviriloadministered daily allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation.

It is essential to inform you that tadalafilo 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.

Alcohol consumption may affect your ability to have an erection.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet once a day, approximately at the same time.

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

You must not takeVirvirilomore than once a day.

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 forgot to takeVirvirilo

Take your dose as soon as you remember, but do not take a double dose to compensate for the missed doses. Do not take tadalafilo cinfamed more than once a day.

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
• arm and leg pain
• 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 and 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 affecting 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 of 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 Vigilance 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 storage 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 ofVirvirilo

• The active ingredient is tadalafilo. Each tablet contains 5 mg of tadalafilo.
• The other components are:

Tablet core: Lactose monohydrate, sodium lauryl sulfate, povidone, crospovidone type B, and sodium stearate fumarate.

Tablet coating:Polyvinyl alcohol,macrogol, titanium dioxide (E171), talc, and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Virvirilo5 mg is a yellow ochre-coated, oval-shaped tablet, 8.1 mm x 4.1 mm in size, marked with “5” on one side and smooth on the other.

Virvirilo5 mg is available in blister packs containing 28 coated tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Responsible manufacturer

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

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

50016, Zaragoza, SPAIN

Last review date of this leaflet: November 2023

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