Leaflet: information for the user

Tadalafilo Tarbis 5 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 is Tadalafilo Tarbis and what is it used for

2. What you need to know before starting to take Tadalafilo Tarbis

3. How to take Tadalafilo Tarbis

4. Possible side effects

5. Storage of Tadalafilo Tarbis

6. Contents of the pack and additional information

Tadalafilo Tarbis contains the active ingredient tadalafilo, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafilo Tarbis 5 mg is used to treat adult men with:

-erectile dysfunction. This is when a man cannot get or keep an erection firm enough for satisfying sexual activity. Tadalafilo has shown a significant improvement in the ability to get a lasting erection of the penis suitable for sexual activity.

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 Tarbis will not help if you do not have erectile dysfunction. It is essential to inform you that Tadalafilo Tarbis 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.

-urinary symptoms associated with a common disease calledbenign prostatic hyperplasia. This is when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate, feeling that the bladder is not fully emptied, needing to urinate more frequently, even at night. Tadalafilo Tarbis improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo has shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

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 arterial 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.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer review before starting treatment with Tadalafilo Tarbis for benign prostatic hyperplasia. Tadalafilo Tarbis does not treat prostate cancer.

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

-Anemia falciforme (a red blood cell abnormality).

-Multiple myeloma (bone marrow cancer).

-Leukemia (blood cell 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.

-Surgery 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 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 old.

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.

-5-alpha reductase inhibitors (used to treat benign prostatic hyperplasia).

-Medications such as ketoconazole tablets (for fungal infections) and protease inhibitors for HIV or AIDS treatment.

-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, 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 of 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 consumption of alcohol may temporarily decrease 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.

For the treatment of erectile dysfunction

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

Do not take Tadalafilo Tarbis more than once a day.

Tadalafilo Tarbis taken daily allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Tadalafilo Tarbis taken daily may be useful in men who plan to engage in sexual activity two or more times a week.

It is essential to inform you that Tadalafilo Tarbis 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.

Alcohol consumption may affect your ability to have an erection.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet once a day, approximately at the same time.

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

Do not take Tadalafilo Tarbis more than once a day.

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 Toxicological 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 forgot to take Tadalafilo Tarbis

Take your dose as soon as you remember, but do not take a double dose to compensate for the missed doses. Do not take Tadalafilo Tarbis more than once a day.

If you have any other questions about the use of this medication, 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 (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 1000 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 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 (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 that does not appear 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 medications you no longer need at the SIGRE Collection Point. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Tadalafil Tarbis Composition

• The active ingredient is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• 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).

Appearance of the product and contents of the package

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

Tadalafil Tarbis 2.5 mg tablets are available in aluminum/PVC/PVDC blisters in packages with 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 medicine 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 revision date of thisleaflet:October 2023

Other sources of information

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