Tadalafil Aristo

Package Leaflet: Information for the User

Tadalafil Aristo, 5 mg, Film-Coated Tablets

Tadalafil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, 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, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

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

Tadalafil Aristo contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Tadalafil Aristo, 5 mg is used to treat adult men with:

• erectile dysfunction. 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. After sexual stimulation, Tadalafil Aristo works by helping the blood vessels in your penis to relax and widen, allowing blood to flow into your penis. The result is improved erectile function. Tadalafil Aristo does not work if there is no sexual stimulation.
• symptoms of benign prostatic hyperplasia (an enlarged prostate). Symptoms include difficulty starting to pass urine, a feeling of not completely emptying the bladder, and needing to pass urine more often, even at night. Tadalafil Aristo improves blood flow and relaxes the muscles in the prostate and bladder, which can help to alleviate the symptoms of benign prostatic hyperplasia. It has been shown that Tadalafil Aristo can alleviate these symptoms after 1-2 weeks of treatment.

2. Important information before taking Tadalafil Aristo

When not to take Tadalafil Aristo

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

(see section 6)

• if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris ("chest pain"). It has been shown that Tadalafil Aristo increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• if you have had a heart attack in the last 90 days
• if you have had a stroke in the last 6 months
• if you have low blood pressure or uncontrolled high blood pressure
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "stroke of the eye".
• if you are taking riociguat. This is a medicine used to treat pulmonary 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). It has been shown that phosphodiesterase type 5 inhibitors, such as Tadalafil Aristo, increase the effects of this medicine. If you are taking riociguat, or are unsure, tell your doctor.

Warnings and precautions

Before taking Tadalafil Aristo, tell your doctor. You should be aware that sexual activity carries a risk for patients with heart disease, because it puts extra strain on your heart. If you have a heart condition, tell your doctor.

• sickle cell anemia (abnormal shape of red blood cells)
• multiple myeloma (cancer of the bone marrow)
• leukemia (cancer of the blood cells)
• any deformation of the penis
• severe liver disease
• severe kidney disease

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

• undergone pelvic surgery
• had their prostate removed (radical prostatectomy without nerve-sparing). If you experience sudden loss of vision or sudden loss of hearing, or distorted vision during treatment with Tadalafil Aristo, stop taking Tadalafil Aristo and contact your doctor immediately.

In some patients taking tadalafil, a sudden decrease or loss of hearing has been observed. Although it is not known if this event is directly related to tadalafil, if you experience a sudden 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 is not intended for use by children and adolescents under 18 years.

Other medicines and Tadalafil Aristo

Tell your doctor about all the medicines you are taking, or have recently taken, and those you plan to take. Do not take Tadalafil Aristo if you are taking nitrates. Tadalafil Aristo may affect the way some medicines work, or some medicines may affect the way Tadalafil Aristo works. Tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or symptoms of benign prostatic hyperplasia)
• other medicines used to treat high blood pressure
• riociguat
• 5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia)
• medicines such as ketoconazole (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines)
• rifampicin, erythromycin, clarithromycin, or itraconazole
• other treatments for erectile dysfunction.

Tadalafil Aristo with food and drink

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Aristo, and therefore, caution should be exercised when consuming grapefruit juice. For more information, ask your doctor.

Fertility

When tadalafil was administered to rats, a decrease in sperm production was observed in the testes. A decrease in sperm concentration was observed in some men. It is unlikely to lead to infertility.

Driving and using machines

Some men taking Tadalafil Aristo during clinical trials reported dizziness. Therefore, you should be aware of how you react to the tablets before driving or operating machinery.

Tadalafil Aristo, 5 mg, film-coated tablets contain lactose

Each film-coated tablet contains 63 mg of lactose (as monohydrate). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tadalafil Aristo, 5 mg, film-coated tablets contain sodium

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

3. How to take Tadalafil Aristo

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Tadalafil Aristo tablets are for oral use only in men. The tablets should be swallowed with a small amount of water. The tablets can be taken with or without food. The tablet can be divided into two equal doses. Drinking alcohol may cause a temporary drop in blood pressure. If you have taken Tadalafil Aristo or plan to take it, do not drink large amounts of alcohol (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

Treatment of erectile dysfunction

The recommended dose is one 5 mg tablet taken once a day, at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg, depending on your response to Tadalafil Aristo. You should take half of the 5 mg tablet. Do not take Tadalafil Aristo more than once a day. Taking Tadalafil Aristo once a day may be useful for men who anticipate having sexual activity twice a week or more. It is important to note that Tadalafil Aristo does not work without sexual stimulation. You and your partner should engage in foreplay, just as you would if you were not taking erectile dysfunction treatment. Drinking alcohol may affect your ability to get an erection.

Treatment of benign prostatic hyperplasia symptoms

The recommended dose is one 5 mg tablet taken once a day, at approximately the same time of the day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose of one 5 mg tablet once a day remains the same. Do not take Tadalafil Aristo more than once a day.

What to do if you take more Tadalafil Aristo than you should

Inform your doctor. You may experience side effects described in section 4 "Possible side effects".

What to do if you forget to take Tadalafil Aristo

Take the dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet. 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 taking Tadalafil Aristo and contact your doctor immediately:

• allergic reactions, including skin rash (uncommon)
• chest pain - do not take nitrates, but seek medical help immediately (uncommon)
• priapism, a prolonged and possibly painful erection after taking Tadalafil Aristo (rare). If you have an erection that lasts more than 4 hours, contact your doctor immediately.
• sudden loss of vision (rare), distorted vision, blurred vision, or sudden loss of vision (frequency not known)

Other reported side effects:

Common(affects 1 to 10 users in 100)

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

Uncommon(affects 1 to 10 users in 1,000)

• dizziness, stomach pain, nausea, vomiting, acid reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired. Rare(affects 1 to 10 users in 10,000)
• fainting, seizures, and transient memory loss, swelling of the eyelids, redness of the eyes, sudden loss of hearing, hives (itchy, red welts on the skin), bleeding from the penis, blood in semen, and increased sweating

There have been reports of rare cases of partial, temporary, or permanent decrease in vision or loss of vision in one or both eyes. In men taking tadalafil, several additional rare side effects have been reported, which were not observed in clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac deaths
• distorted vision, blurred vision, or sudden loss of vision (frequency not known)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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

What Tadalafil Aristo, 5 mg, film-coated tablets contain

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate, magnesium stearate. Coating: Opadry II Yellow 32K220031, containing hypromellose, lactose monohydrate, titanium dioxide, triacetin, yellow iron oxide (E 172), talc.

What Tadalafil Aristo looks like and contents of the pack

Tadalafil Aristo 5 mg: yellow, oval, film-coated tablets, with a score line on one side and "T 5" on the other side, 8.7 mm x 4.5 mm in size. The tablet can be divided into two equal doses. Tadalafil Aristo 5 mg is available in blisters of 28 film-coated tablets.

Marketing Authorisation Holder

Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warszawa

Manufacturer/Importer

Laboratorios Medicamentos Internacionales S.A.
Calle de la Solana, 26
28850 Torrejón de Ardoz, Madrid
Spain
Aristo Pharma GmbH
Wallenroder Straße 8–10
13435 Berlin
Germany

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

Austria
Tadalafil Aristo 5 mg Filmtabletten
Czech Republic
Tadalafil Aristo
Spain
Tadalafil Aristo 5 mg comprimidos recubiertos con película EFG
Netherlands
Tadalafil Aristo 5 mg filmomhulde tabletten
Malta
Tadalafil Aristo 5 mg film-coated tablets
Germany
Tadalafil Aristo 5 mg Filmtabletten
Poland
Tadalafil Aristo
Portugal
Tadalafil Aristo 5 mg Comprimido revestido por película
Romania
Tadalafil Aristo Pharma 5 mg comprimate filmate
Slovakia
Tadalafil Aristo 5 mg filmom obalené tablety
United Kingdom (Northern Ireland) Tadalafil Aristo 5 mg film-coated tablets
Italy
Tadalafil Aristo
Date of last revision of the leaflet:October 2023