Tadalafil Tarbis 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafilo Tarbis 10 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 10 mg 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 demonstrated significant improvement in the ability to obtain a durable penile erection suitable for sexual activity.

Tadalafilo Tarbis contains the active substance tadalafil, which belongs to a group of medicines known as 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. Tadalafilo Tarbis will not help you if you do not have erectile dysfunction.

It is important to warn you that Tadalafilo Tarbis is not effective in the absence of sexual stimulation. Therefore, you and your partner must engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

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 for the treatment of 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 to take Tadalafilo Tarbis.

Be aware that sexual activity carries a potential risk for 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 red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of blood cells).
• any penile deformity.
• a severe liver problem.
• a severe kidney problem.

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 severed (radical prostatectomy without preservation of neurovascular bundles).

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 treating 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 provided in section 3. Grapefruit juice may affect the way Tadalafilo Tarbis works and should be taken with caution. Consult your doctor for further information.

Fertility

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

Driving and using 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 for use of this medicine given by your doctor. 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.

The recommended starting dose is 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. Tadalafil Tarbis tablets are administered orally.

When you take Tadalafil Tarbis, you may begin sexual activity at least 30 minutes after taking the tablet.

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

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

It is important to note that Tadalafil Tarbis is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in the same level of sexual stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to obtain an erection and 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 this may increase the risk of dizziness upon standing.

The tablet score line should not be used to split the tablet.

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 telephone number: 91 562 04 20, indicating the medicine and the amount ingested. 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 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). 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), distorted central vision, dimness, blurred vision, or sudden decrease in vision (frequency unknown).

Other adverse effects that have been reported:

Common (may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in arms and legs, 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 urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (ringing in the ears), swelling of hands, feet or ankles, and feeling tired.

Rare (may affect up to 1 in 1000 people)

• fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy welts on the skin), penile bleeding, blood in 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 decreased or lost vision, partial, transient or permanent, 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 pectoris, and sudden cardiac death.
• distorted central vision, dimness, blurred 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 diarrhea.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 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 refers to 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 empty containers and unused medicines at a SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil 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, anhydrous colloidal silica,
magnesium stearate.

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

Appearance of the product and contents of the pack

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

Tadalafil 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 most recent review of this 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/)