Tadalafil Aristo 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafilo Aristo 5 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, consult 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, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafilo Aristo is used for the treatment of adult men with:

• erectile dysfunction. This occurs when a man cannot achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafilo Aristo has demonstrated significant improvement in the ability to obtain a durable penile erection suitable for sexual activity.

Following sexual stimulation, Tadalafilo Aristo works by helping to relax the blood vessels in the penis, allowing increased blood flow into the penis. The result is improved erectile function.

Tadalafilo Aristo will not help if you do not have erectile dysfunction. It is important to warn you that Tadalafilo Aristo is not effective without sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland enlarges over time. Symptoms include difficulty starting to urinate, sensation that the bladder has not emptied completely, and increased need to urinate, even during the 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 been shown to improve these urinary symptoms within as little as 1-2 weeks after starting treatment.

2. What you need to know before starting to take Tadalafil Aristo

Do not take Tadalafil Aristo if:

• you are allergic to tadalafil or to 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 pectoris (“chest pain”). Tadalafil 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 disease 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 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 Tadalafil 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 Tadalafil 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.

Since benign prostatic hyperplasia and prostate cancer may have similar symptoms, your doctor will perform a prostate cancer evaluation before starting treatment with Tadalafil Aristo for benign prostatic hyperplasia. Tadalafil Aristo does not treat prostate cancer.

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 deformity of the penis;
• a severe liver problem;
• a severe kidney problem.

It is not known whether Tadalafil 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 cut (radical prostatectomy without neurovascular bundle preservation).

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

Tadalafil Aristo is not intended for use in women.

Children and adolescents

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

Taking Tadalafil 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 Tadalafil Aristo if you are already using nitrates.

Some medicines may be affected by Tadalafil Aristo or may affect how well Tadalafil 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 treating 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 Tadalafil Aristo with food and alcohol

Information about the effect of alcohol is provided in section 3 “How to take Tadalafil Aristo”. Grapefruit juice may affect the effectiveness of Tadalafil Aristo and should be consumed with caution. Consult your doctor for further information.

Fertility

In dogs treated with tadalafil, a reduction in sperm production by the testes was observed. In some men, a reduction in sperm count has been observed. These effects are unlikely to result in infertility.

Driving and using machines

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

Tadalafil 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 medicine.

Tadalafil 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 given 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 with some water. The tablets can be taken with or without food.

The tablet may be divided into equal doses.

Alcohol consumption 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 dose is one 5 mg tablet once daily, taken at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafilo Aristo. This will be achieved by taking half a 5 mg tablet.

Do not take Tadalafilo Aristo more than once a day.

Tadalafilo Aristo taken daily allows you to achieve an erection at any time during the 24-hour day, provided sexual stimulation is present. Tadalafilo Aristo taken daily may be beneficial for men who expect to have sexual activity two or more times per week.

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

Alcohol consumption may affect your ability to obtain an erection.

For the treatment of benign prostatic hyperplasia

The recommended dose is one 5 mg tablet once daily, taken at approximately the same time each day.

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

You must not take Tadalafilo Aristo more than once a day.

If you take more Tadalafilo Aristo than you should

Contact your doctor. You may experience adverse effects described in section 4, “Possible side effects.”

If you forget to take Tadalafilo Aristo

Take your dose as soon as you remember, but do not take a double dose to make up for missed 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 may 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, swelling of the eyelids, 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 heart attack and stroke have also been reported in men taking Tadalafilo Aristo. Most of these men had pre-existing heart problems before taking this medicine.

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

Some additional rare adverse effects have been reported in men taking Tadalafilo Aristo that were not reported 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 pectoris, 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 diarrhea.

Reporting of adverse effects

If you experience any adverse effect, consult 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 the sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafilo Aristo 5 mg

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other components are:

Tablet core:

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

Film coating:

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

Appearance of the product and contents of the pack

Tadalafilo Aristo 5 mg are yellow, oblong, biconvex film-coated tablets, scored on one side and engraved with “T 5” on the other side, measuring 8.60 x 4.40 mm.

Tadalafilo Aristo 5 mg is available in blister packs containing 10, 14, 20, 28, 30, 50, 60, 84, 90 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

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

Austria: Tadalafil Aristo 5 mg Filmtabletten
Czech Republic: 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

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

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