TADALAFIL ARISTO 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Aristo 10 mg film-coated tablets EFG

Tadalafil Aristo 20 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Tadalafil Aristo is indicated for the treatment of erectile dysfunction in adult men. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil Aristo has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

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

It is important to note that Tadalafil Aristo is not effective if there is no sexual stimulation. You and your partner will still need to use sex stimulation to get an erection.

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

Do not take Tadalafil Aristo if:

• you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6);

• you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used for the treatment of angina pectoris (“chest pain”). Tadalafil Aristo has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor;

• you have a severe heart or liver problem;

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

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

• you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”;

• 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 shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before taking Tadalafil Aristo.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, tell your doctor.

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

• sickle cell anemia (a disorder of the red blood cells);

• multiple myeloma (cancer of the bone marrow);
• leukemia (cancer of the blood cells);
• any deformation of the penis;
• a severe liver problem;
• a severe kidney problem.

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

• had surgery in the pelvic area;
• had an operation to remove the prostate gland (prostatectomy).

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 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 loss of hearing, stop taking Tadalafil Aristo and contact your doctor immediately.

Tadalafil Aristo is not intended for use by women.

Children and adolescents

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

Using Tadalafil Aristo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or symptoms of an enlarged prostate);

• other medicines for high blood pressure;

• riociguat;

• a 5-alpha reductase inhibitor (used to treat an enlarged prostate);

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

• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines);

• rifampicin, erythromycin, clarithromycin, or itraconazole;

• other treatments for erectile dysfunction.

Taking Tadalafil Aristo with drinks and alcohol

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

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will lead to infertility.

Driving and using machines

Some men taking Tadalafil Aristo during clinical trials experienced dizziness. Check carefully how you react to 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 medicine.

Tadalafil Aristo contains sodium

This medicine 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 exactly the administration instructions given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

The tablet can be split 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 start sexual activity from 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 anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that Tadalafil Aristo is not effective if there is no sexual stimulation. You and your partner will still need to use sex stimulation to get an erection.

Consuming large amounts of alcohol may affect your ability to get 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 side effects as described in section 4 “Possible side 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are usually mild to moderate.

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

• allergic reactions including skin rash (uncommon);

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

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

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

Other side effects that have been reported:

Common(seen in 1 to 10 in every 100 patients)

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

Uncommon(seen in 1 to 10 in every 1,000 patients)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears,

swelling of hands, feet, or ankles, and feeling tired.

Rare(seen in 1 to 10 in every 10,000 patients)

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

Additionally, the following rare side effects have been reported in men taking tadalafil:

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

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines Vigilance System for Human Use: www.notificaRAM.es. By reporting side 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 which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil

The active substanceis 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 ingredientsare:

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

Opadry II yellow 32K220019 film coating: hypromellose, 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 EFG

Tadalafil Aristo 10 mg is a yellow, oval, biconvex, 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, biconvex, 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, 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 medicine from 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 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: 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 last revision of this package leaflet: October 2023

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