Package Leaflet: Information for the User

Tadalafilo Aristo 10 mg Film-Coated Tablets

Tadalafilo Aristo 20 mg Film-Coated Tablets

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 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, suitable for a satisfactory sexual activity. Tadalafilo Aristo has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis suitable for sexual activity.

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

Do not take Tadalafilo Aristo if:

• You are allergic to tadalafil 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 ("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, within the last 90 days;

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

• You have low or uncontrolled high blood pressure;

• 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 hypertension (i.e., high blood pressure in the lungs) and chronic pulmonary thromboembolic 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 puts on the heart. If you have a heart problem, consult your doctor.

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 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 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 tadalafil. Although it is not known if the event is directly related to tadalafil, 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;
• 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/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". Grapefruit juice may affect the proper functioning of Tadalafilo Aristo 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. A decrease in sperm count 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 Tadalafilo Aristo 10 mg film-coated tablet contains 126 mg of lactose (as monohydrate).

Each Tadalafilo Aristo 20 mg film-coated tablet contains 252 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.

The recommended initial doseis one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg.

You can initiate sexual activity at least 30 minutes after taking Tadalafilo Aristo.

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

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

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 achieve an erection and 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.

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 may 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 (frequency unknown).

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 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), bleeding in the penis, blood in semen and increased sweating.

Infarction and stroke have also been reported in men taking tadalafilo. 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 tadalafilo 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 decreased vision (frequency unknown).

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 prospectus. You can also report them directly through the Spanish System of 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 containers and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tadalafil

Theactive ingredientis tadalafil.

• Tadalafil Aristo 10 mg film-coated.
• Each tablet contains 10 mg of tadalafil

• Tadalafil Aristo 20 mg film-coated.
• Each tablet contains 20 mg of tadalafil

Theother componentsare:

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

Coating film Opadry II yellow 32K220019:hydroxypropylmethylcellulose, lactose monohydrate, titanium dioxide (E171), triacetin, yellow iron oxide (E172), talc.

Appearance of the product and contents of the pack

Tadalafil Aristo 10 mg film-coated tablets

Tadalafil Aristo 10 mg is a yellow, oval-shaped, biconvex, scored on one side, and engraved with “T 10” on the other side.

Film-coated tablet of 11.50 x 5.90 mm.

Tadalafil Aristo 10 mg is available in aluminum/PVC/PVDC blisters in packs with 4, 8, 10, 12, 20, 30, 56, or 84 film-coated tablets.

Only some pack sizes may be marketed.

Tadalafil Aristo 20 mg film-coated tablets

Tadalafil Aristo 20 mg is a yellow, oval-shaped, biconvex, scored on one side, and engraved with “T 20” on the other side.

Film-coated tablet of 13.90 x 7.20 mm.

Tadalafil Aristo 20 mg is available in aluminum/PVC/PVDC blisters in packs with 2, 4, 8, 10, 12, 20, 24, 30, 48, 56, 70, 84, or 100 film-coated tablets.

Only some pack 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 10 mg Filmtabletten

Tadalafil Aristo 20 mg Filmtabletten

Czech Republic:Tadalafil Aristo

Germany:Tadalafil Aristo 10 mg Filmtabletten

Tadalafil Aristo 20 mg Filmtabletten

Italy:Tadalafil Aristo 10 mg compresse rivestite con film

Tadalafil Aristo 20 mg compresse rivestite con film

Malta:Tadalafil Aristo 10 mg film-coated tablets

Tadalafil Aristo 20 mg film-coated tablets

Netherlands:Tadalafil Aristo 10 mg filmomhulde tabletten

Tadalafil Aristo 20 mg filmomhulde tabletten

Poland:Tadalafil Aristo

Portugal:Tadalafil Aristo 10 mg Comprimido revestido por pelicula

Tadalafil Aristo 20 mg Comprimido revestido por pelicula

Spain:Tadalafilo Aristo 10 mg comprimidos recubiertos con película EFG

Tadalafilo Aristo 20 mg comprimidos recubiertos con película EFG

Romania:Tadalafil Aristo Pharma 10 mg comprimate filmate

Tadalafil Aristo Pharma 20 mg comprimate filmate

Slovakia:Tadalafil Aristo 10 mg filmom obalené tablety

Tadalafil Aristo 20 mg filmom obalené tablety

United Kingdom (Northern Ireland):Tadalafil Aristo 10 mg film-coated tablets

Tadalafil Aristo 20 mg film-coated tablets

Last update of this leaflet: October 2023

The detailed information about this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.