Prospect: Information for the user

Tadalafilo Aurovitas 5 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

TadalafiloAurovitascontains the active ingredient tadalafilo, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

TadalafiloAurovitas5 mg is used to treat adult men with:

-Impotence. This is when a man cannot get or keep an erection firm enough for satisfying sexual activity. Tadalafilo has shown a significant improvement in the ability to get a lasting erection of the penis suitable for sexual activity.

After sexual stimulation, tadalafilo acts by helping to relax the blood vessels in your penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafilo will not help if you do not have impotence. 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 as you would without taking a medicine for impotence.

-Urinary symptoms associated with a common disease calledbenign prostatic hyperplasia. This is when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate, feeling that the bladder is not fully emptied, needing to urinate more frequently, even at night. Tadalafilo improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo has shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

Do not takeTadalafilo Aurovitas

-If you are allergic totadalafiloor any of the other components 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 recent heart attack, within the last 90 days.

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

-If you have low or uncontrolled high blood pressure.

-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). PDE5 inhibitors, such as tadalafilo, have 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 may pose a risk to patients with heart problems, due to the additional strain it puts on the heart. If you have a heart problem, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer review before starting treatment with tadalafilo for benign prostatic hyperplasia. Tadalafilo does not treat prostate cancer.

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 problems.

-Severe kidney problems.

Tadalafilo is not known to be effective in patients who have undergone:

-Pelvic surgery.

-Surgery in which the prostate has been completely or partially removed and the prostate nerves 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 old.

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.

-Other medications for treating 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 machinery

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

Tadalafilo Aurovitascontains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them 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 of 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. Tablets can be taken with or without food.

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take tadalafilo, 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 once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafilo, by taking one 2.5 mg tablet.

Do not take tadalafilomore than once a day.

Daily tadalafiloadministration allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation.Tadalafilodaily administration may be useful for men who anticipate maintaining sexual activity two or more times a week.

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

Alcohol consumption may affect your ability to have an erection.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet once a day, approximately at the same time.

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

Do not take tadalafilomore than once a day.

If you take moreTadalafilo Aurovitasthan 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 forgot to useTadalafilo Aurovitas

Take your dose as soon as you remember, but do not take a double dose to compensate for the missed doses. Do not take Tadalafilo Aurovitas more than once a day.

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 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 reported 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 blister, carton or bottle after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of packaging and unused medications. This will help protect the environment.

Composition ofTadalafilo Aurovitas

-The active ingredient is tadalafilo. Each film-coated tablet contains 5 mg of tadalafilo.

-The other components are:

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

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

Appearance of the product and contents of the package

Film-coated tablets of a light yellow color, oval-shaped, with the mark “56” on one face and “L” on the other.

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

Blister pack sizes:: 4, 8, 12, 14, 28, 56, 84 and 90 film-coated tablets.

Bottle sizes:: 100 and 250 film-coated tablets.

Only some package 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/).