TADALAFIL TARBIS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Tarbis 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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 10 mg is indicated for the treatment of erectile dysfunction in adult men. 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.

Tadalafil Tarbis contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is improved 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 will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

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

Do not take Tadalafil Tarbis if:

• you are allergic to tadalafil 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 in the treatment of angina pectoris ("chest pain"). Tadalafil has been shown to increase the effects of these medicines.

• you have a severe heart or liver problem.

• you have recently had a stroke or heart attack within the last 90 days.

• 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 "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 effects of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult 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 your heart. If you have a heart problem, tell your doctor.

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

• sickle cell anaemia (a disorder of the red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukaemia (cancer of the blood cells).
• any deformation of your penis.
• a severe liver problem.
• a severe kidney problem.

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

• undergone pelvic surgery.
• had a radical prostatectomy (removal of the prostate gland).

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

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

Tadalafil Tarbis is not intended for use by women.

Children and adolescents

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

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. Consult your doctor for more information.

Fertility

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

Driving and using machines

Some men taking 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, consult your doctor before taking this medicine.

3. How to take Tadalafil Tarbis

Take this medicine exactly as your doctor has told you. If you are not sure, check with 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.

The recommended doseis one 10 mg tablet taken 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 for oral use.

When taking Tadalafil Tarbis, you can start sexual activity at any time between 30 minutes to 36 hours after taking the tablet.

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

Do not take Tadalafil Tarbis more than once a day. Tadalafil Tarbis 10 and 20 mg will be used before anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that Tadalafil Tarbis is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Consuming large amounts of alcohol may affect your ability to get 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 it may increase the risk of dizziness when standing up.

The score line is not intended for breaking the tablet.

If you take more Tadalafil Tarbis than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the national poison control center, phone: 91 562 04 20, indicating the medicine and the amount taken. You may experience side effects described in section 4.

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 normally mild to moderate.

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

• allergic reactions including skin 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 vision, blurred vision, 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 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 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 decrease or loss of hearing, hives (red itchy patches on the skin that sting), bleeding from the penis, blood in the semen, and increased sweating.

Additionally, the following rare side effects have been reported in men taking tadalafil that were not seen in clinical trials:

• migraine, swelling of the face, 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 vision, blurred vision, or sudden loss of vision (frequency not known).

In men over 75 years of age treated with tadalafil, the most commonly reported side effect was dizziness. In men over 65 years of age treated with tadalafil, the most commonly reported side effect was diarrhea.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE Collection Point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. 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 10 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

Tadalafil Tarbis 10 mg are white or almost white, round, biconvex film-coated tablets, approximately 10 mm in diameter.

Tadalafil Tarbis 10 mg film-coated tablets are available in aluminum/PVC/PVDC blisters in packs of 4, 8, 10, 12, 16, 20, 24, 28, 30, 32, 36, 40, 48, 50, 60, 90, 100, 120, 180, 200, 250, 300, 360, 500, and 1000 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 authorised in the Member States of the European Economic Area under the following names:

UK Tadalafil Farmaprojects 10 mg film-coated tablets

DK Tadalafil Farmaprojects

IT Tadalafil Pensa

EL Tadalafil Ariti 10 mg film-coated tablets

Date of last revision of this 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/)