Tadalafil Tarbis 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafilo Tarbis 5 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 Tadalafilo Tarbis is and what it is used for
2. What you need to know before taking Tadalafilo Tarbis
3. How to take Tadalafilo Tarbis
4. Possible adverse effects
5. How to store Tadalafilo Tarbis
6. Contents of the pack and other information

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

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

Tadalafilo Tarbis 5 mg is used for the treatment of adult men with:

• erectile dysfunction. This occurs when a man cannot achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil has demonstrated significant improvement in the ability to obtain a durable penile erection suitable for sexual activity.

After sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing blood to flow into it. The result is improved erectile function. Tadalafilo Tarbis will not help you if you do not have erectile dysfunction. It is important to note that Tadalafilo Tarbis is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland increases in size over time. Symptoms include difficulty starting urination, a sensation that the bladder has not emptied completely, and the need 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. Tadalafil has been shown to improve these urinary symptoms within as little as 1–2 weeks after starting treatment.

2. What you need to know before taking Tadalafilo Tarbis

Do not take Tadalafilo Tarbis if:

• you are allergic to the active substance or to any of the other ingredients 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"). Tadalafil 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 disease 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

Talk to your doctor before starting Tadalafilo Tarbis.

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

Since benign prostatic hyperplasia and prostate cancer may have similar symptoms, your doctor will perform a prostate cancer evaluation 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:

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

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

• pelvic surgery.
• a surgical procedure in which the prostate has been partially or completely removed and the nerves to the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

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

Tadalafilo Tarbis is not intended for use in women.

Children and adolescents

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

Use of Tadalafilo Tarbis with other medicines

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

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

Some medicines may be affected by Tadalafilo Tarbis or may affect how well Tadalafilo Tarbis 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 (for treatment of fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafilo Tarbis with food and alcohol

Information about the effect of alcohol is found in section 3. Grapefruit juice may affect the effectiveness of Tadalafilo Tarbis and should be taken with caution. Consult your doctor for further information.

Fertility

In treated dogs, a decrease in sperm production by the testes was observed. A reduction in sperm has been observed in some men. These effects are unlikely to cause infertility.

Driving and use of machines

Some men who took tadalafil during clinical trials experienced dizziness. Carefully assess 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 medicine.

3. How to take Tadalafil Tarbis

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Alcohol consumption may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil 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

Recommended dose: One 5 mg tablet once daily, taken at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Tarbis. This will be achieved by taking a 2.5 mg tablet.

Do not take Tadalafil Tarbis more than once a day.

Tadalafil Tarbis taken daily allows you to achieve an erection at any time during the 24-hour day, provided sexual stimulation occurs. Daily administration of Tadalafil Tarbis may be beneficial for men who expect to have sexual activity two or more times per week.

It is important to inform you that Tadalafil Tarbis is not effective in the absence of sexual stimulation. Therefore, you and your partner should 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.

For the treatment of benign prostatic hyperplasia

Dose: One 5 mg tablet once daily, taken at approximately the same time each day.

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

Do not take Tadalafil Tarbis more than once a day.

If you take more Tadalafil Tarbis than you should

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

If you forget to take Tadalafil Tarbis

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 Tarbis more than once a day.

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 cause adverse effects, although not everyone experiences 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 immediate medical help:

• 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 this medicine (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 loss of vision (rare frequency), distorted central vision, dimness, blurred vision, or sudden decrease in vision (frequency unknown).

Other adverse effects that have been reported:

Frequent (may affect up to 1 in 10 people)

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

Uncommon (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, nosebleeds, tinnitus (ringing in the ears), swelling of the hands, feet or ankles, and feeling tired.

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

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

Rare cases of heart attack and stroke have also been reported in men taking tadalafil. Most of these men had existing heart problems before taking this medicine.

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

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 heartbeats, angina, and sudden cardiac death.
• Distorted, dimmed, blurred central vision or sudden decrease in vision (frequency unknown).

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 diarrhoea.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Tarbis

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 is the last day of the month indicated.

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 a SIGRE point. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafilo Tarbis

• The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• The other components are:

Tablet core: lactose monohydrate (see end of section 2), microcrystalline cellulose, povidone, poloxamer, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica,
magnesium stearate.

Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171).

Appearance of the product and contents of the pack

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.
Gran Vía Carlos III, 94
08028 Barcelona (Spain)

Manufacturers

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 European Economic Area member states under the following names:

UK Tadalafil Farmaprojects 2.5 mg film-coated tablets
DK Tadalafil Farmaprojects
IT Tadalafil Pensa
EL Tadalafil Ariti 2.5 mg δισκ?α επικαλυμμ?να με λεπτ? υμ?νιο

Date of the latest revision of this package leaflet: October 2023

Other sources of information

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