Prospect: Information for the user

Tadalafilo Aurovitas 20 mg film-coated tablets EFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Tadalafilo Aurovitas

4.Possible adverse effects

5.Storage of Tadalafilo Aurovitas

6.Contents of the package and additional information

Tadalafilo is indicated for the treatment of erectile dysfunction in adult men. This condition occurs when a man is unable to obtain or maintain a firm erection, adequate for a satisfactory sexual activity. Tadalafilo has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis, adequate for sexual activity.

TadalafiloAurovitascontains the active ingredient tadalafilo, which belongs to a group of medications called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafilo acts by helping to relax the blood vessels of the penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo will not be effective if you do not have erectile dysfunction.

It is essential to inform you that tadalafilo is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way you would without taking a medication for erectile dysfunction.

Do not takeTadalafilo Aurovitas

-If you are allergic totadalafiloor any of the other ingredients of this medication (listed in section 6).

-If 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 pectoris (“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.

-If you have a serious heart condition or have had a heart attack recently, within the last 90 days.

-If you have had a recent stroke, within the last 6 months.

-If you have low or high blood pressure that is not controlled.

-If you have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye infarction”.

-If you are taking riociguat. This medication 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 clots). Phosphodiesterase type 5 inhibitors, such as tadalafilo, have been 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 or pharmacist before starting to take Tadalafilo Aurovitas.

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 problem, consult your doctor.

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

-Sickle cell anemia (a red blood cell abnormality).

-Multiple myeloma (bone marrow cancer).

-Leukemia (blood cell cancer).

-Any penile deformity.

-Severe liver disease.

-Severe kidney disease.

It is not known if tadalafilo is 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, stop taking tadalafilo 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 and contact your doctor immediately.

Tadalafilo is not intended for use in women.

Children and adolescents

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

Other medications andTadalafilo Aurovitas

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Do not taketadalafiloif you are already using nitrates.

Some medications may be affected bytadalafiloor may affect the proper functioning oftadalafilo. 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.

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

-Medications 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 medications).

-Rifampicin, erythromycin, clarithromycin, or itraconazole.

-Other treatments for erectile dysfunction.

TakingTadalafilo Aurovitaswith beverages and alcohol

The information on the effect of alcohol is found in section 3. Grapefruit juice may affect the proper functioning of tadalafilo 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. In some men, a reduction in sperm count has been observed. It is unlikely that these effects will cause infertility.

Driving and operating machines

Some men who took tadalafilo during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machines.

Tadalafilo Aurovitascontains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Tadalafilo Aurovitascontains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Tadalafilo Aurovitas 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.

Recommended initial doseis one 10 mg tablet before sexual activity. However, you have been given a dose of one 20 mg tablet because your doctor has decided that the recommended dose of 10 mg is too weak.

You can take the Tadalafilo Aurovitas tablet at least 30 minutes before sexual activity.

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

You should not take Tadalafilo Aurovitas more than once a day. Tadalafilo Aurovitas 10 mg and 20 mg will be used before expected sexual activity and are not recommended for continuous daily use.

It is essential to inform you thattadalafilois 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 medication for erectile dysfunction.

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to taketadalafilo, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

If you take moreTadalafiloAurovitasthan you should

Consult your doctor. You may experience adverse effects described in section 4.

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 taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can 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 tadalafil (rare frequency). If you experience this type of erection, which can last for more than 4 hours, you must contact a doctor immediately.

-Sudden loss of vision (rare frequency), distorted, blurred, central vision blurred or sudden decrease in 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, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nasal bleeding, tinnitus, swelling of the hands, feet or ankles and feeling tired.

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

-Loss of consciousness, seizures and temporary loss of memory, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red itchy patches on the skin's surface), bleeding in the penis, blood in the semen and increased sweating.

Also, rare cases of heart attack and stroke have been reported in men taking tadalafil. Most of these men had some heart problem before taking this medicine.

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

Some rare additional side effects have been reported in men taking tadalafil that were not notified during clinical trials. These include:

-Migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.

-Distorted, blurred, central vision blurred or sudden decrease in 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 the Spanish 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.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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 at the pharmacy.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.

Composition ofTadalafilo Aurovitas

-The active ingredient is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.

-The other components are:

Core of the tablet:Copovidone, hydroxyestearate of macrogolglycerol, lactose monohydrate, anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Coating of the tablet:Hydroxypropyl methylcellulose, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), triacetin.

Appearance of the product and contents of the package

Film-coated tablets of yellow color, oval shape, with the mark “58” on one side and “L” on the other.

Tadalafilo Aurovitas is available in PVC/PVdC transparent-Aluminium blisters.

Blister pack sizes: 2, 4, 8, 12, 24, 28 and 56 film-coated tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

O

Orion Corporation Orion Pharma

Orionintie 1, Espoo

FI-02200

Finland

O

Orion Corporation Orion Pharma

Joensuunkatu 7, Salo

FI-24100

Finland

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: December 2023

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