VIRVIRILO 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Virvirilo 10 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 Package Leaflet:

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. Storage of Virvirilo
6. Contents of the pack and other information

1. What is Virvirilo and what is it used for

Virvirilo 10 mg is used to treat erectile dysfunction in adult men. 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.

Virvirilo contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. 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 improved erectile function. Virvirilo will not help you if you do not have erectile dysfunction.

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

2. What you need to know before you take Virvirilo

Do not takeVirviriloif:

• 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 for the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor (see section “Taking Virvirilo with other medicines”).

• you have a severe heart or liver problem.

• you have recently had a heart attack (within the last 90 days).

• you have had a stroke (including a ‘mini-stroke’ or transient ischaemic attack) 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 ischaemic optic neuropathy (NAION), a condition described as “stroke of the eye”.

• 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 due to 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

Consult your doctor or pharmacist before taking 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, tell your doctor.

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

• sickle cell anaemia (a disease of the red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukaemia (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 had:

• pelvic surgery.
• removal of the prostate gland or other surgeries that have affected the nerves that control erections.

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

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

Virvirilo is not intended for use by women.

Children and adolescents

Virvirilo should not be used in children and adolescents under 18 years of age.

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 how well 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 (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 food and drink

Information about the effect of alcohol is in section 3. Grapefruit juice may affect how well 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 count has been observed in some men. These effects are unlikely to lead to infertility.

Driving and using machines

Some men taking 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 them before taking this medicine.

Virvirilo contains sodium

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

3. How to take Virvirilo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The tablets are for oral use only in men. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended doseis 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. The tablets are to be taken orally.

When you take Virvirilo, you may be able to have sexual activity at any time between 30 minutes and 36 hours after taking the tablet.

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

Do not take Virvirilo more than once a day.

Virvirilo 10 mg and 20 mg will be used before anticipated sexual activity and is not recommended for continuous daily use.

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

Drinking too much alcohol can reduce your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive drinking of alcohol (blood alcohol level of 0.08 % or greater), as this may increase the risk of dizziness when standing up.

If you take more Virvirilo than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

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 normally mild to moderate in nature.

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

• allergic reactions including skin rash (uncommon).
• chest pain - do not use nitrates, but seek medical help immediately (uncommon).
• prolonged and possibly painful erections 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 vision, blurred vision, or sudden loss of 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 aches
• 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 erections
• palpitations, rapid heartbeat, high blood pressure, low blood pressure
• nosebleeds and ringing in the ears
• swelling of the hands, feet or ankles
• 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 (itchy red welts on the surface of the skin)
• bleeding from the penis
• presence of blood in the semen
• increased sweating

Additionally, the following rare side effects have been reported in men taking tadalafil that were not seen in clinical trials:

• migraine
• swelling of 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 heartbeats
• angina pectoris
• sudden cardiac death
• distorted vision, blurred vision, or sudden loss of vision (frequency not known)

In men over 75 years of age, the most frequently reported side effect was dizziness. In men over 65 years of age, the most frequently reported side effect was diarrhoea.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

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 other information

What Virvirilo contains

• The active substance is tadalafil. Each tablet contains 10 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 of the product and contents of the pack

Virvirilo 10 mg is a yellow-orange, oval, film-coated tablet 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 packs with blisters of 4 film-coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

Germany

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 Healthcare Products (AEMPS) http://www.aemps.gob.es