TADALAFIL TECNIMEDE 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Tecnimede 20 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 Tadalafil Tecnimede is and what it is 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 Tadalafil Tecnimede is and what it is used for

This medicine 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 has been shown to significantly improve the ability to get 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 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 this medicine will only work if you are sexually stimulated. 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 for the treatment of angina pectoris (“chest pain”). It has been shown that this medicine 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 “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). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown an increase in the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before taking this medicine.

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 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 your penis.
• have a severe liver problem.
• have a severe kidney problem.

It is not known if tadalafil is effective in patients who have undergone:

• surgery in the pelvic area.
• a surgical procedure in which the prostate has been partially or totally removed and the nerves of the prostate have been cut (radical prostatectomy without preservation of neurovascular bundles).

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

A sudden decrease or 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 decrease or loss of hearing, stop taking this medicine 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.

Using Tadalafil Tecnimede with other medicines

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

Do not take this medicine if you are already using nitrates.

Some medicines may be affected by tadalafil or may affect the good functioning of tadalafil. Tell your doctor or pharmacist if you are using:

• 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 functioning of tadalafil 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. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

Some men who took 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 (1mmol) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Tadalafil Tecnimede

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The tablets of this medicine 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 recommended initial doseis one 10 mg tablet before sexual activity. However, you have been given the dose of one 20 mg tablet because your doctor has decided that the recommended dose of 10 mg is too weak.

When you take tadalafil, you can initiate sexual activity at least 30 minutes after taking it.

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

Do not take tadalafil more than once a day. Tadalafil 10 and 20 mg will be used before anticipated sexual activity and are not recommended for continuous daily use.

It is important to note that tadalafil will not work if you are not sexually stimulated. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Consuming large amounts of alcohol may affect 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 consumption of alcohol (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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to carry the packaging with you. You may experience side effects described in section 4.

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 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 for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, central 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 heartbeat, 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 eyelids, red eyes, sudden or loss of hearing, hives (red itchy patches on the skin), bleeding from the penis, blood in 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 before taking this medicine.

Rarely, cases of decreased or loss of vision, partial, transient, or permanent 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, and sudden cardiac death.
• distorted, blurred, central 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 effect was dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported adverse effect 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. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil Tecnimede

The active substanceis tadalafil. Each tablet contains 20 mg of tadalafil.

The other ingredientsare: Core of the tablet: lactose monohydrate (see the end of section 2), corn starch, pregelatinized corn starch, crospovidone, lauryl sulfate, and magnesium stearate. Coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the pack

Tadalafil Tecnimede 20 mg are film-coated tablets, oblong, and yellow in color.

Tadalafil Tecnimede 20 mg is available in blister packs of 2, 4, 8, or 12 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid) Spain

Manufacturer:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, 2710-089 Abrunheira, Sintra

Portugal

Date of last revision of this leaflet:December 2023

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/