Package Leaflet: Information for the User

Tadalafilo Aristo 5 mg Film-Coated Tablets EFG

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

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

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

Tadalafilo Aristo is used to treat adult men with:

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

After sexual stimulation, Tadalafilo Aristo 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 Aristo will not help if you do not have erectile dysfunction. It is essential to inform you that Tadalafilo Aristo 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 erectile dysfunction.

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

Do not take Tadalafilo Aristo if:

• You are allergic to tadalafilo or any of the other components of this medication

(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 medications (“nitrates”) used to treat angina pectoris (“chest pain”). It has been seen that Tadalafilo Aristo increases the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor;

• You have a serious heart disease or have had a heart attack recently, in the last 90 days;

• You have had a recent stroke, in the last 6 months;

• You have low or high blood pressure that is not controlled;

• You have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarction”;

• 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). The PDE5 inhibitors, such as Tadalafilo Aristo, have shown that they produce an increase in the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before starting to take Tadalafilo Aristo.

Be aware that sexual intercourse carries a possible risk for patients with heart problems, due to the additional effort it imposes on the same. 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 cancer of the prostate review before starting treatment with Tadalafilo Aristo for benign prostatic hyperplasia. Tadalafilo Aristo does not treat prostate cancer.

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

• Anemia falciforme (a red blood cell abnormality);
• Multiple myeloma (bone marrow cancer);
• Leukemia (blood cell cancer);
• Any penile deformity;
• A serious liver problem:
• A serious kidney problem.

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

• Surgery in the pelvic area;
• A surgical intervention in which the prostate has been completely or partially removed and in which the prostate nerves have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a decrease or sudden loss of vision or your vision is distorted, blurred while taking Tadalafilo Aristo, stop taking Tadalafilo Aristo and immediately contact your doctor.

A decrease or sudden loss of hearing has been observed in some patients taking tadalafilo. Although, it is not known if the event is directly related to tadalafilo, if you experience a decrease or sudden loss of hearing, stop taking Tadalafilo Aristo and immediately contact your doctor.

Tadalafilo Aristo is not intended for use in women.

Children and adolescents

Tadalafilo Aristo should not be used in children or adolescents under 18 years old.

Use of Tadalafilo Aristo with other medications

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

Do not take Tadalafilo Aristo if you are already using nitrates.

Some medications may be affected by Tadalafilo Aristo or may affect the proper functioning of Tadalafilo Aristo. 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;
• An inhibitor of 5-alpha reductase (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/AIDS or HIV infection;
• Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications);
• Rifampicin, erythromycin, clarithromycin, or itraconazole;
• Other treatments for erectile dysfunction.

Taking Tadalafilo Aristo with beverages and alcohol

The information about the effect of alcohol is found in section 3 “How to take Tadalafilo Aristo”. Orange juice may affect the proper functioning of Tadalafilo Aristo and should be taken with caution. Consult your doctor for more information.

Fertility

In treated dogs, a decrease in sperm production by the testicles was observed. A decrease in sperm has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machines

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

Tadalafilo Aristo contains lactose

Each film-coated tablet contains 63 mg of lactose (as monohydrate)

If you have an intolerance to certain sugars, consult your doctor before taking this

medication.

Tadalafilo Aristo contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is essentially sodium-free.

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

Tadalafilo Aristo tablets are for oral administration only in men. Swallow the tablet with a little water. The tablets can be taken with or without food.

The tablet can be divided into equal doses.

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafilo Aristo, 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 Aristo. This will be done by taking half of a 5 mg tablet.

Do not take Tadalafilo Aristo more than once a day.

Tadalafilo Aristo taken daily allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Tadalafilo Aristo taken daily may be useful for men who plan to engage in sexual activity two or more times a week.

It is essential to inform you that Tadalafilo Aristo is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to have an erection.

For the treatment of benign prostatic hyperplasia

The recommended 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 Tadalafilo Aristo more than once a day.

If you take more Tadalafilo Aristo than you should

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

If you forgot to take Tadalafilo Aristo

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 Aristo 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 (rare);
• chest pain - do not use nitrates but seek medical help immediately (rare);
• prolonged and possibly painful erection after taking Tadalafilo Aristo (rare). 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), distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

Other side effects that have been reported:

Frequent(observed in 1 to 10 of every 100 patients)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion and indigestion.

Rare(observed in 1 to 10 of every 1,000 patients)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nasal bleeding, tinnitus, swelling of the hands, feet or ankles and feeling tired.

Rare(observed in 1 to 10 of every 10,000 patients)

• 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.

Infarction and stroke have also been reported rarely in men taking Tadalafilo Aristo. Most of these men had some heart problems 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 Tadalafilo Aristo 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 tadalafilo, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafilo, the most frequently reported side effect was diarrhea.

Reporting side effects

If you experience any type of side effect, consult your doctor, 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 box and the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tadalafilo Aristo 5 mg

-Theactive ingredientis tadalafilo. Each tablet contains 5 mg of tadalafilo.

-Theother componentsare:

Core of the tablet:

lactose monohydrate (see the end of section 2 “What you need to know before taking Tadalafilo Aristo”), croscarmellose sodium, hydroxypropylcellulose of low substitution, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

Coating:

Opadry II yellow 32K220031: lactose monohydrate, hydroxypropylmethylcellulose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.

Appearance of the product and contents of the package

Tadalafilo Aristo 5 mg are yellow tablets, oval in shape, biconvex, scored on one face and engraved with “T 5” on the other face, of8.70 x 4.50 mm.

Tadalafilo Aristo 5 mg is available in blister packs with 10, 14, 20, 28, 30, 50, 60, 84, 90 or 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin

Germany

Responsible for manufacturing

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin

Germany

Or

Laboratorios Medicamentos Internacionales S.A.

Calle Solana, 26

28850 Torrejón De Ardoz (Madrid)

Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This medicine is authorized in the member states of the European Economic Area and the United Kingdom (Northern Ireland) with the following names:

Austria:Tadalafil Aristo 5 mg Filmtabletten

Republic of Czechia:Tadalafil Aristo

Germany:Tadalafil Aristo 5 mg Filmtabletten

Italy:Tadalafil Aristo 5 mg compresse rivestite con film

Malta:Tadalafil Aristo 5 mg film-coated tablets

Netherlands:Tadalafil Aristo 5 mg filmomhulde tabletten

Poland:Tadalafil Aristo

Portugal:Tadalafil Aristo 5 mg Comprimido revestido por pelicula

Romania:Tadalafil Aristo Pharma 5 mg comprimate filmate

Slovakia:Tadalafil Aristo 5 mg filmom obalené tablety

Spain:Tadalafilo Aristo 5 mg comprimidos recubiertos con película EFG

United Kingdom (Northern Ireland):Tadalafil Aristo 5 mg film-coated tablets

Last review date of this leaflet: October 2023

More detailed information about this medicine is available on the European Medicines Agency websitehttp://www.ema.europa.eu.