Tadalafil Tecnimede 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafil Tecnimede 20 mg film-coated tablets EFG

Tadalafil

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Tadalafil Tecnimede is and what it is used for
2. What you need to know before taking Tadalafil Tecnimede
3. How to take Tadalafil Tecnimede
4. Possible adverse effects
5. How to store Tadalafil Tecnimede
6. Package contents and additional information

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

This medicine is indicated for the treatment of erectile dysfunction in adult men. Erectile dysfunction occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to achieve a durable penile erection suitable for sexual activity.

This medicine contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing blood to flow 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 warn you that this medicine is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in sexual stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before starting to take Tadalafil Tecnimede

Do not take Tadalafil Tecnimede if:

• you are allergic to tadalafil or to any of the other components of this medicine (listed in section 6).
• you are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). This medicine has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.
• you have a severe heart condition or have recently had a heart attack, within the last 90 days.
• you have recently had a stroke, within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have ever experienced vision loss 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 caused by blood clots). PDE5 inhibitors, such as tadalafil, have been shown to 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 to take this medicine.

Be aware that sexual activity carries a potential risk in patients with heart problems, due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

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

• sickle cell anemia (an abnormality of the red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of the blood cells).
• any deformity of the penis.
• severe liver problems.
• severe kidney problems.

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

• surgery in the pelvic area.
• a surgical procedure involving total or partial removal of the prostate in which the nerves to the prostate have been severed (radical prostatectomy without neurovascular bundle preservation).

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

Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known if this event is directly related to tadalafil, if you experience 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 must not be used in children or adolescents under 18 years of age.

Use of Tadalafil Tecnimede with other medicines

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

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

Some medicines may interact with tadalafil or affect how well tadalafil works. Inform your doctor or pharmacist if you are taking:

• 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 (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Tecnimede with food and alcohol

Information regarding the effect of alcohol is located in section 3. Grapefruit juice may affect the effectiveness of tadalafil and should be consumed with caution. Consult your doctor for further information.

Fertility

In treated dogs, a decrease in sperm production by the testes has been observed. A reduction in sperm has been observed in some men. It is unlikely that these effects would result in infertility.

Driving and operating machinery

Some men who took tadalafil during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafil Tecnimede contains lactose:

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Tadalafil Tecnimede contains sodium:

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is, essentially "sodium-free".

3. How to take Tadalafil Tecnimede

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The tablets of this medicine are for oral use only in men. Swallow the tablet whole with a little water. The tablets may be taken with or without food.

The recommended starting dose is one 10 mg tablet prior to sexual activity. However, you have been prescribed a dose of one 20 mg tablet because your doctor has determined that the recommended 10 mg dose is too weak for you.

When you take tadalafil, you may begin sexual activity at least 30 minutes after taking it.

Tadalafil may remain effective for up to 36 hours after taking the tablet.

You must not take tadalafil more than once a day. Tadalafil 10 mg and 20 mg are to be used prior to anticipated sexual activity and are not recommended for continuous daily use.

It is important to warn you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner must stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to achieve 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 this may increase the risk of dizziness upon standing.

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 at telephone number 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the container with you. You may experience adverse effects described in section 4.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them. These effects are generally mild to moderate in intensity.

If you experience any of the following adverse effects, stop using the medicine and seek medical help immediately:

• allergic reactions including rashes (uncommon).
• chest pain – do not use nitrates, but seek immediate medical help (uncommon).
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you experience this type of erection, which may last continuously for more than 4 hours, you must contact a doctor immediately.
• sudden vision loss (rare frequency), distorted vision, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse effects that have been reported:

Frequent (observed in 1 to 10 out of 100 patients)

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

Uncommon (observed in 1 to 10 out of 1,000 patients)

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

Rare (observed in 1 to 10 out of 10,000 patients)

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

Myocardial infarction (heart attack) and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medicine.

Cases of decreased or sudden, partial, temporary or permanent vision loss in one or both eyes have been reported rarely.

Some additional rare adverse effects have been reported in men taking tadalafil that were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac death.
• distorted vision, dimmed vision, blurred central vision, or sudden decrease in vision (frequency not known).

In men over 75 years of age receiving tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse effect was diarrhea.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Tecnimede

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack after “EXP”. The expiry date refers to the last day of the stated month.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This 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 20 mg of tadalafil.

The other components are: Tablet core: monohydrate lactose (see end of section 2), corn starch, pregelatinized corn starch, crospovidone, sodium lauryl sulfate, and magnesium stearate. Coating: monohydrate lactose, 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 yellowish, oval, film-coated tablets.

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

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid), Spain

Manufacturing Responsible Party:

Atlantic Pharma - Produções Farmacêuticas, S.A.

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

Portugal

Date of most recent review of this leaflet: December 2023

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