TADALAFIL TECNIMEDE 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Tecnimede 5 mg film-coated tablets EFG

Tadalafil

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

• Keep this package 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 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 Tadalafil Tecnimede and what is it used for
2. What you need to know before taking Tadalafil Tecnimede
3. How to take Tadalafil Tecnimede
4. Possible side effects
5. Storage of Tadalafil Tecnimede
6. Contents of the pack and further information

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

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

Tadalafil is used for the treatment of 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, tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into the 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 is not effective if there is no sexual stimulation.

• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty starting to pass urine, a feeling that the bladder is not completely empty, needing to pass urine more often, even at night. Tadalafil improves blood flow 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 as little as 1-2 weeks after starting treatment.

2. What you need to know before taking 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 condition or have had a heart attack in the last 90 days.
• you have had a stroke in 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 ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• 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 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 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, tell your doctor.

Since 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.

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

• sickle cell anemia (a disorder of the red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukemia (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.
• had prostate surgery (prostatectomy) in which 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, or diminished while taking tadalafil, stop taking tadalafil 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 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 by women.

Children and adolescents

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

Use of 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 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 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 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 has been observed in some men. It is unlikely that these effects will 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 (1mmol) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Tadalafil Tecnimede

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Tadalafil tablets are for oral use only in men. Swallow the tablet whole with a little 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 this medicine, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet taken once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This will be done by taking a 2.5 mg tablet.

Do not take tadalafil more than once a day.

Tadalafil taken daily allows you to achieve an erection at any time during the 24 hours of the day, provided that you are sexually stimulated. Tadalafil taken daily may be useful for men who anticipate having sexual activity twice or more per week.

It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medicine for erectile dysfunction.

Consuming alcohol may affect your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet taken once a day, approximately at the same time.

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day.

Do not take this medicine more than once a day.

If you take more Tadalafil Tecnimede than you should

In case of overdose or accidental intake, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 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 forget to take Tadalafil Tecnimede

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

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, or diminished 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, 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 temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (red itchy patches on the skin that sting), bleeding from the penis, blood in the semen, and increased sweating.

Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart conditions.

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

Some additional rare side effectshave been reported in men taking tadalafil that were not seen in clinical trials, including:

• migraine, swelling of the face, 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, or diminished vision (frequency not known).

In men over 75 years old taking tadalafil, the most frequently reported side effect was dizziness. In men over 65 years old taking 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 and Healthcare Products Agency (AEMPS) via the website: 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 stated on the carton and blister after “EXP”. The expiry date refers to the last day of the month stated.

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 further information

Composition of Tadalafil Tecnimede

The active substanceis tadalafil. Each tablet contains 5 mg of tadalafil.

The other ingredientsare: tablet core: lactose monohydrate (see the end of section 2), corn starch, pregelatinized corn starch, crospovidone, laurilsulfate sodium, 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 pack contents

Tadalafil Tecnimede 5 mg are film-coated, oblong tablets, yellow to cream in color.

Tadalafil Tecnimede 5 mg is available in blister packs containing 28 film-coated tablets.

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 package leaflet:December 2023

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