VIMTRILE 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vimtrile 20 mg film-coated tablets EFG

tadalafil

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Vimtrile and what is it used for
2. What you need to know before you take Vimtrile
3. How to take Vimtrile
4. Possible side effects
5. Storage of Vimtrile
6. Package contents and further information

1. What is Vimtrile and what is it used for

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

Vimtrile is used to treat:

• Adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity. After sexual stimulation, Vimtrile 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. Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that Vimtrile is not effective if there is no sexual stimulation.
• Adults with pulmonary arterial hypertension. It works by helping to relax the blood vessels around the lungs, which improves blood flow to the lungs. The result is improved ability to exercise.

2. What you need to know before you take Vimtrile

Do not take Vimtrile:

• If you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• If 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 Vimtrile increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• If you have had a severe heart attack or stroke in the last 3 or 6 months.
• If you have low blood pressure or uncontrolled high blood pressure.
• If you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "eye stroke".
• If 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 before starting treatment with Vimtrile.

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.

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

• sickle cell anemia (a condition that affects red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any deformation of the penis, or unwanted or prolonged erections lasting more than 4 hours.
• a severe liver problem.
• a severe kidney problem.
• any heart problem.
• blood pressure problems.
• any inherited eye disease.

Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.

It is not known if Vimtrile is effective in patients who have:

• had surgery in the pelvic area.
• had an operation in which the prostate was completely or partially removed and the nerves of the prostate were cut (radical prostatectomy without preservation of neurovascular bundles).

If you experience sudden loss of vision or your vision is distorted, blurred, or diminished while taking tadalafil, stop taking Vimtrile and contact your doctor immediately.

A sudden loss of hearing has been observed in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience sudden loss of hearing, stop taking Vimtrile and contact your doctor immediately.

Vimtrile should not be used as treatment for erectile dysfunction or benign prostatic hyperplasia in women because these are male-specific health issues.

Children and adolescents

Vimtrile should not be used in children or adolescents under 18 years of age.

Other medicines and Vimtrile

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not take Vimtrile if you are already using nitrates.

Some medicines may be affected by Vimtrile or may affect the way Vimtrile works. Tell your doctor or pharmacist if you are using:

• nitrates (for chest pain),
• alpha-blockers (used to treat high blood pressure or symptoms of benign prostatic hyperplasia).
• other medicines for high blood pressure.
• riociguat,
• 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• protease inhibitors for the treatment of HIV/AIDS or HIV infection (ritonavir).
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin (for bacterial infections).
• medicines such as ketoconazole or itraconazole (for fungal infections).
• other treatments for erectile dysfunction (phosphodiesterase type 5 inhibitors).

Taking Vimtrile with drinks and alcohol

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take tadalafil during pregnancy, unless it is strictly necessary and you have discussed it with your doctor.

Do not breast-feed while taking these tablets, as it is not known if the medicine passes into breast milk. Consult your doctor or pharmacist before taking any medicine if you are pregnant or breast-feeding.

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

Driving and using machines

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

Vimtrile contains lactose

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

3. How to take Vimtrile

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

The tablets of Vimtrile are for oral use. 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 or above 5 units of alcohol), as it may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

Flexible dose, on demand:

Tadalafil 10 mg and 20 mg should be used; the recommended initial dose is 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.

You can take one tadalafil tablet at least 30 minutes before sexual activity.

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

Do not take Vimtrile more than once a day.

Tadalafil 10 mg and 20 mg is intended for use before anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that Vimtrile is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way 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 pulmonary arterial hypertension

The usual doseis two 20 mg tablets once a day. You should take both tablets at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may recommend that you take only 20 mg per day.

If you take more Vimtrile than you should

If you or anyone else takes more tablets than they should, contact your doctor or go to a hospital immediately, taking the medicine or the package with you. You may experience the side effects described in section 4.

If you have taken more tadalafil than you should, contact your doctor, pharmacist, or call the Toxicological Information Service, Phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Vimtrile

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

If you stop taking Vimtrile

For the treatment of pulmonary arterial hypertension, do not stop taking your tablets unless your doctor tells you to.

If you have any further questions about 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 tadalafil (rare). If you experience this type of erection, which can last continuously 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 have been reported, and these are listed below, separated by indication:

Side effects in erectile dysfunction or benign prostatic hyperplasia:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, indigestion.

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, sensation of strong heartbeat, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(may affect up to 1 in 1,000 people)

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

Rarely, heart attacks and strokes have been reported in men taking tadalafil. Most of these men had known heart problems before taking this medicine.

Rarely, a partial, temporary, or permanent decrease or loss of vision in one or both eyes has been reported.

Some additional rare side effectshave been reported in men taking tadalafil that were not observed in clinical trials. These include:

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

In men over 75 years of age treated with tadalafil, the most frequently reported side effect was dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported side effect was diarrhea.

Reporting of side effects

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

5. Storage of Vimtrile

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and further information

Composition of Vimtrile

• The active substanceis tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredientsare:
• • Core of the tablet: lactose monohydrate, hydroxypropylcellulose, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate,
  • Coating: hypromellose, lactose monohydrate, triacetin, titanium dioxide (E171), talc, red iron oxide (E172)

Appearance of the product and package contents

The 5 mg tablets are film-coated, round, convex, and red-brick colored, with a core diameter of 6 mm.

The 5 mg tablets are packaged in PVC/PE/PVDC-Alu or Pa-Al-PVC/Al blisters in cardboard boxes of 2, 4, 10, 14, 28, and 84 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Ltd,

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

Manufacturer

Medochemie Ltd (Central Factory),

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

You can obtain further information about this medicine from the local representative of the marketing authorization holder:

Local representative:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

This medicine is authorized in the EEA member states with the following names:

Bulgaria: Zenavil 20mg ????????? ????????

Czech Republic: Zenavil 5mg and 20mg film-coated tablets

Cyprus: Zenavil 5 mg, 10 mg, and 20 mg

Croatia: Zenavil 10 mg and 20 mg film-coated tablets

Greece: Zenavil 5 mg, 10 mg, and 20 mg

Estonia: Zenavil

Lithuania: Zenavil 5mg, 20mg Plevele dengtos tabletės

Malta: Zenavil 5 mg, 10 mg, and 20 mg film-coated tablets

Netherlands: Zenavil 5 mg, 10 mg, and 20 mg filmomhulde tabletten

Slovakia: Zenavil 5mg and 20mg filmom obalené tablety

Date of last revision of this package leaflet: January 2024.

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/)