VIMTRILE 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vimtrile 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

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. Storing Vimtrile
6. Contents of the pack and other 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.
• Adult men with symptoms of benign prostatic hyperplasia (enlarged prostate). This is when the prostate gland gets bigger with age. Symptoms include difficulty starting to pass urine, a feeling of not completely emptying the bladder, needing to pass urine more often, or more often during the night. Tadalafil improves blood flow to the prostate and relaxes the muscles in the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms in a short period of time, such as 1-2 weeks after starting treatment.

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 for the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.
• if you have a severe heart or liver problem.
• if you have recently had a heart attack (within the last 3 months) or stroke (within the last 6 months).
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION).
• 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 due to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the effects of this medicine.

Warnings and precautions

Before taking Vimtrile, talk to your doctor if you:

• have sickle cell anemia (a disease of the red blood cells).
• have multiple myeloma (a cancer of the bone marrow).
• have leukemia (a cancer of the blood cells).
• have any deformation of the penis.
• have a serious liver or kidney problem.
• have heart problems.
• have high or low blood pressure.
• have any inherited eye disease.

Because 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.

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

• undergone pelvic surgery.
• had a radical prostatectomy (removal of the prostate gland).

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

Vimtrile should not be used in women, especially those who are pregnant or breastfeeding.

Children and adolescents

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

Other medicines and Vimtrile

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

Some medicines may be affected by Vimtrile or may affect how well Vimtrile works.

• 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 inhibitors (used to treat benign prostatic hyperplasia).
• protease inhibitors for the treatment of HIV or AIDS (such as ritonavir).
• phenobarbital, phenytoin, and carbamazepine (medicines for epilepsy).
• rifampicin, erythromycin, clarithromycin (for bacterial infections).
• ketoconazole or itraconazole (for fungal infections).
• other treatments for erectile dysfunction (PDE5 inhibitors).

Taking Vimtrile with drinks and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take tadalafil during pregnancy, unless it is strictly necessary and you have discussed this with your doctor.

Do not breastfeed while taking this medicine, as it is not known if the medicine passes into breast milk. Talk to your doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding.

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

Driving and using machines

Some men taking 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, talk to them before taking this medicine.

3. How to take Vimtrile

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

The tablets can be taken with or without food.

Do not take Vimtrile more than once a day.

For the treatment of erectile dysfunction

Flexible dose, taken as needed:

Tadalafil 10 mg and 20 mgshould be taken at least 30 minutes before sexual activity. The recommended 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.

Vimtrile can remain effective for up to 36 hours after taking the tablet.

Daily dosing:

Tadalafil 5 mgshould be taken once daily, approximately at the same time every day. Do not take more than one 5 mg tablet per day.

When taken once daily, Vimtrile 5 mg allows you to obtain an erection, when sexually stimulated, at any time during the 24-hour period. The daily dose of Vimtrile may be useful for men who anticipate having sexual activity twice or more per week.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet, taken once daily, approximately at the same time every day.

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

If you take more Vimtrile than you should

If you or anyone else has taken more tablets than they should, talk to a doctor or go to a hospital immediately. You may experience the side effects listed in section 4.

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 a forgotten dose. Do not take more than one dose per day.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and seek medical help immediately

• allergic reactions, including rashes (uncommon).
• chest pain (uncommon).
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare). If you have an erection that lasts more than 4 hours, contact a doctor immediately.
• sudden loss of vision (rare), distorted vision, blurred vision, or sudden decrease in vision (frequency not known).

Other side effects have been reported, and these are listed below, grouped by the body system:

Common side effects (may affect up to 1 in 10 people)

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

Uncommon side effects (may affect up to 1 in 100 people)

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

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

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

Additional rare side effects have been reported, including:

• migraine, swelling of the face, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina, and sudden cardiac death.

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 Agency's website: https://www.notificaram.es.

5. Storing 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 carton and blister after EXP. The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What Vimtrile contains

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

Appearance and packaging

The 5 mg tablets are film-coated, round, convex, reddish-brown, with a diameter of 6 mm.

The 5 mg tablets are packaged in PVC/PE/PVDC-Alu or oPa-Al-PVC/Al blisters in cartons 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

Further information about this medicinal product can be obtained 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 medicinal product is authorized in the EEA Member States under the following names:

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

Czech Republic: Zenavil 5mg and 20mg potahované tablety

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 tabletes

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

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

Slovak Republic: Zenavil 5mg and 20mg Filmom obalené tablety

Date of last revision of this leaflet: January 2024.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)