TADALAFIL TECNIMEDE 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Tecnimede 10 mg film-coated tablets EFG

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 symptoms 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 Tadalafil Tecnimede and what is it used for
2. What you need to know before you take Tadalafil Tecnimede
3. How to take Tadalafil Tecnimede
4. Possible side effects
5. Storage of Tadalafil Tecnimede
6. Contents of the pack and other information

1. What is Tadalafil Tecnimede and what is it used for

Tadalafil Tecnimede is indicated for the treatment of erectile dysfunction in adult men. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil Tecnimede has been shown to significantly improve the ability to obtain a hard erect penis suitable for sexual activity.

This medicine contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Tecnimede acts by helping to relax the blood vessels in your penis, allowing the flow of blood into the penis. The result is an improvement in erectile function. Tadalafil will not help if you do not have erectile dysfunction.

It is important to note that Tadalafil Tecnimede is not effective if there is no sexual stimulation. Therefore, 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 Tadalafil Tecnimede

Do not take Tadalafil Tecnimede if:

• 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 to treat angina pectoris (“chest pain”). It has been shown that tadalafil increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• you have a severe heart or liver problem.
• you have recently had a stroke or heart attack (within the last 90 days).
• you have low blood pressure or uncontrolled high blood pressure.
• 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 or pharmacist before taking Tadalafil Tecnimede.

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 anemia (a disorder of the red blood cells).
• have multiple myeloma (cancer of the bone marrow).
• have leukemia (cancer of the blood cells).
• have any deformation of the penis.
• have a severe liver problem.
• have a severe kidney problem.

It is not known if Tadalafil Tecnimede is effective in patients who have:

• undergone pelvic surgery.
• had a radical prostatectomy (removal of the prostate gland) without preserving the nerve endings.

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

Tadalafil is not intended for use in women.

Children and adolescents

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

Other medicines and Tadalafil Tecnimede

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

Do not take Tadalafil Tecnimede if you are already taking nitrates.

Some medicines may affect the way Tadalafil Tecnimede works or Tadalafil Tecnimede may affect the way other medicines work. Tell your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat an enlarged prostate).
• medicines such as ketoconazole tablets (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 Tadalafil Tecnimede with drinks and alcohol

Information about the effect of alcohol is in section 3. Grapefruit juice may affect the way Tadalafil Tecnimede 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 has been observed in some men. These effects are unlikely to produce a lack of fertility.

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.

Tadalafil Tecnimede contains lactose

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

Tadalafil Tecnimede contains sodium

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

3. How to take Tadalafil Tecnimede

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

Tadalafil Tecnimede 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. Tadalafil Tecnimede tablets are taken by mouth.

When you take tadalafil, you can start sexual activity at any time between 30 minutes to 36 hours after taking the tablet.

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

Do not take Tadalafil Tecnimede more than once a day. Tadalafil will be used before anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that Tadalafil Tecnimede is not effective if there is no sexual stimulation. Therefore, 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 alcohol consumption (blood alcohol level of 0.08 % or higher), as it may increase the risk of dizziness when standing up.

If you take more Tadalafil Tecnimede 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, phone 91 562 04 20, indicating the medicine and the amount taken.

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 skin 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 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, facial flushing, nasal congestion, and 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 erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(seen in 1 to 10 in every 10,000 patients)

• fainting, seizures, and transient loss of memory, 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.

Myocardial infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart problems.

Rarely, cases of partial, transient, or permanent loss of vision in one or both eyes have been reported.

Additional rare side effectshave been reported in men taking tadalafil that were not seen in clinical trials. These include:

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

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

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Tecnimede

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 the month shown.

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

Composition of Tadalafil Tecnimede

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredients are:

Core of the tablet:lactose monohydrate, corn starch, pregelatinized starch (corn), crospovidone, sodium lauryl sulfate, and magnesium stearate.

Tablet coating (Opadry II 32K32328 yellow):lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, and yellow iron oxide (E172).

Appearance and packaging

Yellow, film-coated, oblong tablets, 10.0 mm long and 5.5 mm wide.

Available in PVC/PCTFE/PVC-Aluminum blisters in packs of 4 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América.

Polígono Arroyo de la Vega, 28108 Alcobendas (Madrid) Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, nº 2, Abrunheira, 2710 – 228 Sintra, Portugal

Date of last revision of this leaflet: July 2025

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