TADALAFIL TARBIS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Tarbis 5 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Tadalafil Tarbis and what is it used for
2. What you need to know before you take Tadalafil Tarbis
3. How to take Tadalafil Tarbis
4. Possible side effects
5. Storage of Tadalafil Tarbis
6. Contents of the pack and other information

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

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

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

• erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

After sexual stimulation, tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into the penis. The result is an improvement in erectile function. Tadalafil Tarbis will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil 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 condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty starting to urinate, feeling like the bladder is not completely empty, needing to urinate more often, even at night. Tadalafil Tarbis improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms in as little as 1-2 weeks after starting treatment.

2. What you need to know before you take Tadalafil Tarbis

Do not take Tadalafil Tarbis if:

• you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that tadalafil increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.

• you have a severe heart condition or have had a heart attack in the last 90 days.

• you have had a stroke in the last 6 months.

• you have low blood pressure or uncontrolled high blood pressure.

• you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "eye stroke".

• 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). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown that they 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 taking Tadalafil Tarbis

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, tell your doctor.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will check you for prostate cancer before you start taking Tadalafil Tarbis for benign prostatic hyperplasia. Tadalafil Tarbis does not treat prostate cancer.

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

• sickle cell anemia (a condition that affects red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukemia (cancer of the blood cells).
• any deformation of the penis.
• a severe liver problem.
• a severe kidney problem.

It is not known if Tadalafil Tarbis is effective in patients who have:

• had pelvic surgery.
• had an operation to remove the prostate gland (prostatectomy) in which the nerves to the prostate were cut (radical prostatectomy without nerve-sparing).

If you experience sudden loss of vision or your vision is distorted or blurred while taking Tadalafil Tarbis, stop taking this medicine and contact your doctor immediately.

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

Tadalafil Tarbis is not intended for use in women.

Children and adolescents

Tadalafil Tarbis should not be used in children and adolescents under 18 years.

Using Tadalafil Tarbis with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Some medicines may be affected by Tadalafil Tarbis or may affect how well Tadalafil Tarbis works. Tell 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 medicines for high blood pressure.
• riociguat.
• a 5-alpha-reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Tarbis with drinks and alcohol

Information about the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil Tarbis works and should be taken with caution. Talk to your doctor for more information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will affect fertility.

Driving and using machines

Some men who took tadalafil during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Tarbis contains lactose:

If you have an intolerance to certain sugars, talk to your doctor before taking this medicine.

3. How to take Tadalafil Tarbis

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, talk to your doctor or pharmacist.

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

Consuming large amounts of alcohol may temporarily reduce 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

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

Do not take Tadalafil Tarbis more than once a day.

Tadalafil Tarbis taken daily allows you to get an erection at any time during the 24 hours of the day, provided that you are sexually stimulated. Tadalafil Tarbis taken daily may be useful in men who anticipate having sexual activity twice or more per week.

It is important to note that Tadalafil 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.

Consuming large amounts of alcohol can affect your ability to get an erection.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet per day, taken at approximately the same time.

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

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, talk to your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. You may experience side 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are usually mild to moderate.

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

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

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, 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 heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

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

• fainting, seizures, and temporary memory loss, swelling of the eyelids, red eyes, sudden or temporary loss of hearing, hives (red itchy patches on the skin), bleeding from the penis, blood in the semen, and increased sweating.

Myocardial infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart conditions.

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

Additional rare side effectshave been reported in men taking tadalafil that were not seen in clinical trials, including:

• migraine, facial swelling, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• Distorted, blurred, or sudden loss of vision (frequency not known).

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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at www.notificaRAM.es. By reporting side 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 stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients are:

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

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

Appearance and packaging of the product

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

Tadalafil Tarbis 2.5 mg film-coated tablets are available in aluminum/PVC/PVDC blisters in packs of 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

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 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 last revision of this package leaflet:October 2023

Other sources of information

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