Leaflet: information for the user

Tadalafilo Tarbis Farma 10 mg film-coated tablets EFG

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

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

1. What isTadalafilo Tarbis Farmaand what it is used for

2. What you need to know before starting to takeTadalafilo Tarbis Farma

3. How to takeTadalafilo Tarbis Farma

4. Possible side effects

5. Storage ofTadalafilo Tarbis Farma

6. Contents of the pack and additional information

Tadalafilo 10 mg is used for the treatment of adult men witherectile dysfunction. This occurs when a man is unable to obtain or maintain a firm, adequate erection for satisfactory sexual activity. Tadalafilo has demonstrated a significant improvement in the ability to obtain a lasting, adequate penis erection suitable for sexual activity.

Tadalafilo Tarbis Farma contains the active ingredient tadalafilo, which belongs to a group of medications known as phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafilo acts by helping to relax the blood vessels in your penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo will not be effective if you do not have erectile dysfunction.

It is essential to inform you that tadalafilo is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way you would without taking a medication for erectile dysfunction.

Do not take Tadalafilo Tarbis Farma if:

• You are allergic to tadalafilo or any of the other components of this medication (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 medications (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafilo has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor.
• You have a serious heart disease or have had a heart attack recently, within the last 90 days.
• You have had a recent stroke, within the last 6 months.
• You have low or uncontrolled high blood pressure.
• You have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarction”.
• You are taking riociguat. This medication 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 tadalafilo, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before starting to take this medication.

Be aware that sexual intercourse carries a possible risk for patients with heart problems, due to the additional effort it imposes on the heart. If you have a heart problem, consult your doctor.

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

• Thalassemia (a blood disorder).
• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cancer).
• Any penile deformity.
• A serious liver problem.
• A serious kidney problem.

The effectiveness of tadalafilo in patients who have undergone:

• Pelvic surgery.
• A surgical intervention in which the prostate has been completely or partially removed and the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

A decrease or sudden loss of hearing has been observed in some patients taking tadalafilo. Although it is not known if the event is directly related to tadalafilo, if you experience a decrease or sudden loss of hearing, stop taking this medication and immediately contact your doctor.

Tadalafilo is not intended for use in women.

Children and adolescents

Tadalafilo should not be used in children or adolescents under 18 years old.

Other medications and Tadalafilo Tarbis Farma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take tadalafilo if you are already using nitrates.

Some medications may be affected by tadalafilo or may affect the proper functioning of tadalafilo. Inform 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 medications to treat high blood pressure.
• Riociguat.
• A 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• Medications such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV/AIDS or HIV infection.
• Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
• Rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other treatments for erectile dysfunction.

Taking Tadalafilo Tarbis Farma with beverages and alcohol

The information about the effect of alcohol is found in section 3. Grapefruit juice may affect the proper functioning of tadalafilo and should be taken with caution. Consult your doctor for more information.

Fertility

In treated dogs, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machinery

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

Tadalafilo Tarbis Farma contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult him before taking this medication.

Tadalafilo Tarbis Farma contains sodium

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

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

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

Recommended starting doseis 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. The tablets of this medication are administered orally.

You can initiate sexual activity at least 30 minutes after taking tadalafilo.

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

You should not take tadalafilo more than once a day. Tadalafilo Tarbis Farma 10 and 20 mg will be used before expected sexual activity and are not recommended for continuous daily use.

It is essential to inform you that tadalafilo is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to have an erection. Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take tadalafilo, 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 Tadalafilo Tarbis Farma than you should

Consult your doctor. You may experience adverse 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 medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These side effects are generally mild to moderate in intensity.

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

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

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion, and indigestion.

Infrequent(may affect up to 1 in 100 people):

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

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

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

Infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had some pre-existing heart condition before taking this medicine.

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

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

• migraine, facial swelling, severe allergic reaction causing facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac death.
• distorted, blurred, or decreased central vision, or sudden vision loss (unknown frequency).

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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the vial after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tadalafilo Tarbis Farma

The active ingredient is tadalafil.

Each film-coated tablet contains 10 mg of tadalafil.

The other components are:

Core of the tablet:lactose monohydrate, copovidone, anhydrous colloidal silica, hydroxyestearate of macrogolglycerol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate,

Coating:hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b).

Appearance of the product and content of the container

Film-coated tablets, biconvex, elongated, white in color, engraved with “T16” on one face and “H” on the other.

Blister containing 4, 8, 12, 20, 24, 28, 30, and 50 film-coated tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Tadalafil Amarox 10 mg Filmtabletten

Netherlands:Tadalafil Amarox 10 mg filmomhulde tabletten

Spain:Tadalafilo Tarbis Farma 10 mg film-coated tablets EFG

Date of the last review of this leaflet: March 2024

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/