Tadalafil Aristo 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafilo Aristo 10 mg film-coated tablets EFG

Tadalafilo Aristo 20 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Tadalafilo Aristo is and what it is used for
2. What you need to know before taking Tadalafilo Aristo
3. How to take Tadalafilo Aristo
4. Possible side effects
5. How to store Tadalafilo Aristo
6. Contents of the pack and other information

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

Tadalafilo Aristo is indicated for the treatment of erectile dysfunction in adult men. Erectile dysfunction occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafilo Aristo has demonstrated significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

Tadalafilo Aristo contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafilo Aristo works by helping to relax the blood vessels in your penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafilo Aristo will not help you if you do not have erectile dysfunction.

It is important to warn you that Tadalafilo Aristo is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in sexual stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Tadalafilo Aristo

Do not take Tadalafilo Aristo if:

• you are allergic to tadalafil or any of the other ingredients of this medicine (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 medicines ("nitrates") used to treat angina (chest pain). Tadalafilo Aristo has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor;

• you have a severe heart condition or have recently had a heart attack (within the last 90 days);

• you have recently had a stroke (within the last 6 months);

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

• you have ever experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye";

• you are taking riociguat. This medicine 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). PDE5 inhibitors, such as Tadalafilo Aristo, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to take Tadalafilo Aristo.

Be aware that sexual activity involves a possible risk for patients with heart problems due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

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

• sickle cell anemia (an abnormality of red blood cells);

• multiple myeloma (a cancer of the bone marrow);

• leukemia (a cancer of blood cells);

• any penile deformity;

• severe liver problems;

• severe kidney problems.

It is not known whether Tadalafilo Aristo is effective in patients who have undergone:

• pelvic surgery;

• a surgical procedure in which the prostate has been partially or completely removed and the nerves to the prostate have been severed (radical prostatectomy without preservation of neurovascular bundles).

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

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

Tadalafilo Aristo is not intended for use in women.

Children and adolescents

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

Taking Tadalafilo Aristo with other medicines

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

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

Some medicines may interact with Tadalafilo Aristo or affect how well Tadalafilo Aristo works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia);

• other medicines for high blood pressure;

• riociguat;

• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia);

• medicines such as ketoconazole tablets (for treatment of fungal infections) and protease inhibitors for treatment of AIDS or HIV infection;

• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);

• rifampicin, erythromycin, clarithromycin, or itraconazole;

• other treatments for erectile dysfunction.

Taking Tadalafilo Aristo with food and alcohol

Information about the effect of alcohol is provided in section 3, "How to take Tadalafilo Aristo". Grapefruit juice may affect how well Tadalafilo Aristo works and should be taken with caution. Consult your doctor for further information.

Fertility

In treated dogs, a reduction in sperm production by the testes was observed. Some men have shown reduced sperm count. It is unlikely that these effects would lead to infertility.

Driving and use of machines

Some men who took Tadalafilo Aristo during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafilo Aristo contains lactose

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

Each 20 mg film-coated tablet of Tadalafilo Aristo contains 252 mg of lactose (as monohydrate).

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

Tadalafilo Aristo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially sodium-free.

3. How to take Tadalafilo Aristo

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The tablet may be divided into equal doses.

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

After taking Tadalafilo Aristo, you may initiate sexual activity at least 30 minutes after taking the tablet.

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

You must not take Tadalafilo Aristo more than once a day. Tadalafilo Aristo 10 and 20 mg should be taken prior to anticipated sexual activity and is not recommended for continuous daily use.

It is important to inform you that Tadalafilo Aristo is not effective in the absence of sexual stimulation. Therefore, you and your partner must engage in sexual stimulation as you normally would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to obtain 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 upon standing.

If you take more Tadalafilo Aristo than you should

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

If you forget to take Tadalafilo Aristo

Take the missed dose as soon as you remember, but do not take a double dose to make up for forgotten doses. You must not take Tadalafilo Aristo more than once a day.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. These effects are generally mild to moderate in intensity.

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

• allergic reactions including rashes (uncommon);

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

• priapism, a prolonged and possibly painful erection after taking Tadalafilo Aristo (rare frequency). If you experience this type of erection, which may last continuously for more than 4 hours, you must contact a doctor immediately;

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

Other adverse effects that have been reported:

Common (observed in 1 to 10 out of every 100 patients)

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

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

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (ringing in the ears), swelling of the hands, feet or ankles, and feeling tired.

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

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

Rare cases of myocardial infarction (heart attack) and stroke have also been reported in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medicine.

Rare cases of decreased or sudden, partial, transient or permanent vision loss in one or both eyes have also been reported.

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

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeats, angina, and sudden cardiac death.
• Distorted, dimmed, blurred central vision or sudden decrease in vision (frequency not known).

In men over 75 years of age receiving tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse effect was diarrhoea.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Aristo

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafilo Aristo

The active substance is tadalafil.

• Tadalafilo Aristo 10 mg film-coated tablet.

• Each tablet contains 10 mg of tadalafil.

• Tadalafilo Aristo 20 mg film-coated tablet.

• Each tablet contains 20 mg of tadalafil.

The other components are:

Tablet core: lactose monohydrate (see end of section 2 “What you need to know before taking Tadalafilo Aristo”), croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

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

Appearance of the medicinal product and contents of the container

Tadalafilo Aristo 10 mg film-coated tablets EFG

Tadalafilo Aristo 10 mg is a yellow, oval-shaped, biconvex film-coated tablet, scored on one side and marked with “T 10” on the other side.

Film-coated tablet of 11.50 x 5.90 mm.

Tadalafilo Aristo 10 mg is available in aluminum/PVC/PVDC blisters packed in containers containing 4, 8, 10, 12, 20, 30, 56 or 84 film-coated tablets.

Only certain pack sizes may be marketed.

Tadalafilo Aristo 20 mg film-coated tablets EFG

Tadalafilo Aristo 20 mg is a yellow, oval-shaped, biconvex film-coated tablet, scored on one side and marked with “T 20” on the other side.

Film-coated tablet of 13.90 x 7.20 mm.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin

Germany

Manufacturer Responsible

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid, Spain

This medicinal product is authorised in the European Economic Area (EEA) Member States and the United Kingdom (Northern Ireland) under 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

Date of the most recent review of this leaflet: October 2023

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