Leaflet: information for the user

Tadalafilo Tarbis 20 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 Tarbisand what is it used for

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

3. How to takeTadalafilo Tarbis

4. Possible side effects

5. Storage ofTadalafilo Tarbis

6. Contents of the pack and additional information

Tadalafilo Tarbis 20 mg is indicated for the treatment of erectile dysfunction in adult men. This condition occurs when a man is unable to obtain or maintain a firm erection, suitable for a satisfactory sexual activity. Tadalafilo has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis suitable for sexual activity.

Tadalafilo Tarbis 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 of the penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo Tarbis will not help if you do not have erectile dysfunction.

It is essential to inform you that Tadalafilo Tarbis 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 if:

• You are allergic to the active ingredient or to 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 (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 condition 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 condition described as "eye infarction".

• You are taking riociguat. This medication is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by 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 Tadalafilo Tarbis.

Be aware that sexual activity can pose a possible risk for patients with heart problems, due to the additional strain it puts 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 (a blood disorder).

-Multiple myeloma (bone marrow cancer).

-Leukemia (blood cancer).

-Any penile deformity.

-Severe liver disease.

-Severe kidney disease.

Tadalafilo Tarbis is not known to be effective in patients who have undergone:

-Pelvic surgery.

-Prostatectomy (surgical removal of the prostate gland) with or without neurovascular bundle preservation.

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

Sudden hearing loss has been observed in some patients taking tadalafilo. Although it is not known if the event is directly related to tadalafilo, if you experience sudden hearing loss, stop taking Tadalafilo Tarbis and contact your doctor immediately.

Tadalafilo Tarbis is not intended for use in women.

Children and adolescents

Tadalafilo Tarbis should not be used in children or adolescents under 18 years of age.

Use of Tadalafilo Tarbis with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take Tadalafilo Tarbis if you are already taking nitrates.

Some medications may be affected by Tadalafilo Tarbis or may affect the proper functioning of Tadalafilo Tarbis. 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 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 Tarbis and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated with tadalafilo, 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. Check carefully how you react when taking the tablets before driving or operating machinery.

Tadalafilo Tarbis contains lactose:

If you have an intolerance to certain sugars, consult your doctor before taking this medication.

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

Tadalafilo Tarbis tablets 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 a dose of one 20 mg tablet because your doctor has decided that the recommended dose of 10 mg is too weak.

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

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

You should not take Tadalafilo Tarbis more than once a day. Tadalafilo Tarbis 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 Tarbis is not effective without 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 achieve an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafilo Tarbis, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

The notch should not be used to break the tablet.

If you take more Tadalafilo Tarbis than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. You may experience adverse effects described in section 4.

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

Like all medicines, this medicine may 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 this medicine (rare). If you experience this type of erection, which may last for more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (rare), 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 pulse, high blood pressure, low blood pressure, nasal bleeding, tinnitus, swelling of the hands, feet, or ankles, and feeling tired.

Rare(may affect up to 1 in 1000 people)

• syncope, seizures, and transient memory loss, eyelid swelling, red eyes, sudden hearing loss, 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 in men taking tadalafil. Most of these men had some pre-existing heart condition before taking this medicine.

Rarely, cases of partial or permanent vision loss, temporary or permanent, 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 or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and the blister packafter EXP. 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 packaging and unused medications at the SIGRE Collection Point. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Tadalafilo Tarbis Composition

• The active ingredient is tadalafilo. Each tablet contains 2.5 mg of tadalafilo.
• The other components are:

Tablet Core:monohydrate lactose (see the end of section 2), microcrystalline cellulose, povidone, poloxamer, sodium lauryl sulfate, sodium croscarmellose, anhydrous colloidal silica,

magnesium stearate.

Coating: polyvinyl alcohol, macrogol, talc, and titanium dioxide (E171).

Product Appearance and Packaging Contents

Tadalafilo Tarbis 2.5 mg are white or almost white, round, biconvex, film-coated tablets approximately 5 mm in diameter.

Tadalafilo Tarbis 2.5 mg film-coated tablets are available in aluminum/PVC/PVDC blisters in packs containing 28 film-coated tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible Manufacturers

Pharmacare Premium Ltd.

HHF003 Hal Far Industrial State,

Hal Far Birzebbugia,

BBG 3000

Malta

Pharmaceutical Works POLPHARMA SA

19, Pelplinska Street

83-200 Starogard Gdanski

Poland

Pharmaceutical Works POLPHARMA, S.A

1 Szypowskiego Street

39-460 Nowa Deba

Poland

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

UKTadalafil Farmaprojects 2.5 mg film-coated tablets

DKTadalafil Farmaprojects

ITTadalafil Pensa

ELTadalafil Ariti 2.5 mg δισκ?α επικαλυμμ?να με λεπτ? υμ?νιο

Last review date of thissummary of product characteristics:October 2023.

Other sources of information

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