TADALAFIL ARISTO 20 mg FILM-COATED TABLETS

2. What you need to know before taking Tadalafil Aristo

Do not take Tadalafil 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 pectoris ("chest pain"). It has been seen that Tadalafil Aristo increases the effects of these medications. If you are taking any type of nitrate or are unsure, tell your doctor;

• you have a severe heart disease or have recently suffered a heart attack, in the last 90 days;

• you have recently suffered a stroke, in the last 6 months;

• you have low blood pressure or uncontrolled high blood pressure;

• you have ever experienced 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 blood clots). Phosphodiesterase type 5 inhibitors, such as Tadalafil Aristo, have shown that they increase 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 Tadalafil Aristo.

Be aware that sexual activity carries a possible risk in patients with heart problems, due to the additional effort it requires for 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 deformation;
• a severe liver problem;
• a severe kidney problem.

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

• surgery in the pelvic area;
• a surgical intervention in which the prostate was totally or partially removed and the prostate nerves were cut (radical prostatectomy without preservation of neurovascular bundles).

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

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 Tadalafil Aristo and contact your doctor immediately.

Tadalafil Aristo is not intended for use in women.

Children and adolescents

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

Use of Tadalafil Aristo with other medications

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

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

Some medications may be affected by Tadalafil Aristo or may affect the proper functioning of Tadalafil Aristo. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or symptoms associated with benign prostatic hyperplasia);
• other medications for treating 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 AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications);
• rifampicin, erythromycin, clarithromycin, or itraconazole;
• other treatments for erectile dysfunction.

Taking Tadalafil Aristo with drinks and alcohol

Information about the effect of alcohol can be found in section 3 "How to take Tadalafil Aristo". Grapefruit juice may affect the proper functioning of Tadalafil Aristo and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

Some men who took Tadalafil Aristo during clinical trials experienced dizziness. Carefully check how you react when taking the tablets before driving or using machines.

Tadalafil Aristo contains lactose

Each Tadalafil Aristo 10 mg film-coated tablet contains 126 mg of lactose (as monohydrate).

Each Tadalafil 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.

Tadalafil Aristo contains sodium

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

3. How to take Tadalafil Aristo

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

Tadalafil Aristo 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.

The tablet can be divided into equal doses

The recommended initial dose is 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.

When taking Tadalafil Aristo, you can initiate sexual activity at least 30 minutes after taking it.

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

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

It is essential to warn you that Tadalafil Aristo is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medication for erectile dysfunction.

Alcohol consumption may affect your ability to have an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil 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 Tadalafil Aristo than you should

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

If you forget to take Tadalafil Aristo

Take your dose as soon as you remember, but do not take a double dose to make up for forgotten doses. Do not take Tadalafil Aristo more than once a day.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them. These effects are generally mild to moderate.

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

• allergic reactions, including rash (uncommon);

• chest pain - do not use nitrates, but seek medical help immediately (uncommon);

• priapism, a prolonged and potentially painful erection after taking Tadalafil Aristo (rare). If you experience this type of erection, which can last continuously for more than 4 hours, you should contact a doctor immediately;

• sudden loss of vision (rare), distorted, blurred, or sudden decrease in vision (frequency not known).

Other adverse effects that have been reported:

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

• headache, back pain, muscle pain, pain in the arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon(observed in 1 to 10 out of 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, nosebleeds, ringing in the ears, swelling of the hands, feet, or ankles, and feeling tired.

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

• fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden or temporary loss of hearing, hives (red itchy patches on the skin), bleeding in the penis, blood in the semen, and increased sweating.

Myocardial infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medication.

Rarely, cases of decreased or lost vision, partial, transient, or permanent in one or both eyes have been reported.

Some additional rare adverse effectshave been reported in men taking Tadalafil Aristo that were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.
• Distorted, blurred, or sudden decrease in vision (frequency not known).

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

Reporting adverse effects

If you experience any adverse effects, consult your doctor, even if they are not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tadalafil Aristo

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

Do not use this medication after the expiration date shown on the box and blister after "EXP". 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tadalafil Aristo

The active ingredientis tadalafil.

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

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

The other componentsare:

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

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

Appearance of the product and package contents

Tadalafil Aristo 10 mg film-coated tablets EFG

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

Film-coated tablet 11.50 x 5.90 mm.

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

Not all pack sizes may be marketed.

Tadalafil Aristo 20 mg film-coated tablets EFG

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

Film-coated tablet 13.90 x 7.20 mm.

Tadalafil Aristo 20 mg is available in aluminum/PVC/PVDC blisters in packs of 2, 4, 8, 10, 12, 20, 24, 30, 48, 50, 56, 70, 84, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin

Germany

Manufacturer

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 medication 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 medication 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 película

Tadalafil Aristo 20 mg Comprimido revestido por película

Spain: Tadalafil Aristo 10 mg comprimidos recubiertos con película EFG

Tadalafil 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

Date of the last revision of this prospectus: October 2023

Detailed information about this medication is available on the European Medicines Agency website http://www.ema.europa.eu.