Tadalafil aristo

Package leaflet: Information for the user

Tadalafil Aristo, 5 mg, coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Tadalafil Aristo is and what it is used for
2. What you need to know 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 Tadalafil Aristo is and what it is 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 in the treatment of adult men:

• with erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Aristo has been shown to significantly improve the ability to achieve an erection sufficient for sexual intercourse. Following sexual stimulation, Tadalafil Aristo helps widen the blood vessels in the penis, allowing blood to flow into the penis. This results in improved erection. Tadalafil Aristo does not help patients who do not have erectile dysfunction. It is important to be aware that Tadalafil Aristo, when used to treat erectile dysfunction, does not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.
• with lower urinary tract symptoms caused by a common condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, a sensation of incomplete bladder emptying, and the need to urinate more frequently, even during the night. Tadalafil Aristo improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. Tadalafil Aristo has been shown to relieve these lower urinary tract symptoms within 1–2 weeks of starting treatment.

2. Important information before using Tadalafil Aristo

When not to use Tadalafil Aristo

• if the patient is allergic to tadalafil or any of the other ingredients of this medicine

(listed in section 6)

• if the patient is taking organic nitrates in any form or other nitric oxide donors, e.g. 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 enhances the effects of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor
• if the patient has severe heart disease or has had a heart attack within the last 90 days
• if the patient has had a stroke within the last 6 months
• if the patient has low blood pressure or uncontrolled high blood pressure
• if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to as "eye stroke"
• if the patient is 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). PDE5 inhibitors such as Tadalafil Aristo have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting treatment with Tadalafil Aristo, consult a doctor.
Please remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms, therefore the doctor will perform an examination to rule out prostate cancer before starting treatment with Tadalafil Aristo for symptoms of benign prostatic hyperplasia. Tadalafil Aristo is not used to treat prostate cancer.
Before taking the medicine, the patient should inform their doctor if any of the following apply:

• sickle cell anemia (abnormal shape of red blood cells)
• multiple myeloma (a bone marrow tumor)
• leukemia (a blood cell cancer)
• any penile deformity
• severe liver disease
• severe kidney disease

It is not known whether Tadalafil Aristo is effective in patients:

• after pelvic surgery
• after complete or partial removal of the prostate gland with nerve damage (nerve-sparing radical prostatectomy). If sudden worsening of vision or sudden vision loss occurs, or if vision becomes distorted, blurred, or dim during treatment with Tadalafil Aristo, the patient should stop taking Tadalafil Aristo and contact a doctor immediately.

In some patients taking tadalafil, worsening or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if worsening or sudden hearing loss occurs, the patient should stop taking Tadalafil Aristo and contact a doctor immediately.
Tadalafil Aristo is not intended for use in women.
Children and adolescents
Tadalafil Aristo is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Aristo
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Tadalafil Aristo if you are using nitrates.
Tadalafil Aristo may affect the action of certain medicines or other medicines may affect the action of Tadalafil Aristo. Tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or urinary symptoms due to 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 tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines)
• rifampicin, erythromycin, clarithromycin, or itraconazole
• other treatments for erectile dysfunction.

Tadalafil Aristo, alcohol, and grapefruit juice
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Aristo, and therefore caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When Tadalafil Aristo was administered to dogs, a reduction in sperm production in the testes was observed. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
During clinical trials, some men taking Tadalafil Aristo reported dizziness. Therefore, patients should be aware of their individual response to the tablets before deciding to drive or operate machinery.
Tadalafil Aristo 5 mg, coated tablets contain lactose
Each coated tablet contains 63 mg of lactose (in the form of monohydrate).
If the patient has an intolerance to certain sugars, they should consult their doctor before starting treatment.
Tadalafil Aristo 5 mg, coated tablets contain sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Aristo

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Tadalafil Aristo tablets are intended for oral use in men only. Swallow the tablet whole with a glass of water. The tablets may be taken with or without food.
The tablet may be divided into two equal doses.
Alcohol consumption may cause a temporary decrease in blood pressure. If you have taken or plan to take Tadalafil Aristo, you should avoid consuming large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.

Treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Aristo. In this case, half of a 5 mg tablet should be taken.
Do not take Tadalafil Aristo more frequently than once a day.
Taking Tadalafil Aristo once daily allows you to achieve an erection following sexual stimulation at any time within 24 hours. Daily administration of Tadalafil Aristo may be beneficial for men who plan to engage in sexual activity twice a week or more.
It is important to understand that Tadalafil Aristo does not work in the absence of sexual stimulation. You and your partner should engage in foreplay, just as you would if you were not taking medication for erectile dysfunction.
Alcohol consumption may affect your ability to achieve an erection.

Treatment of symptoms of benign prostatic hyperplasia (BPH)
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. If a patient has both benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once daily.
Do not take Tadalafil Aristo more than once a day.

Taking more Tadalafil Aristo than prescribed
Inform your doctor immediately. Adverse effects described in section 4, "Possible side effects," may occur.

If you forget to take Tadalafil Aristo
Take the missed dose as soon as you remember. 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 about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the
medicine and seek immediate medical advice:

• 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 Tadalafil Aristo (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
• sudden vision loss (rare), distorted, blurred, or dim central vision, or sudden worsening of vision (frequency unknown).

Other reported adverse reactions:
Common (affects 1 to 10 users in 100)

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

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

• dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling tired.
  Rare (affects 1 to 10 users in 10,000)
• fainting, seizures, transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), rectal bleeding, presence of blood in semen, and increased sweating. Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these patients had pre-existing heart problems before starting treatment with this medicine.

There have been reports of rare cases of partial, transient, or permanent
visual impairment or vision loss in one or both eyes.
In men taking tadalafil, several additional rare adverse reactions
have been reported which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, disorders characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown). The adverse reaction: dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store 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 after EXP. The expiry date refers to the last day of the specified month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Tadalafil Aristo 5 mg film-coated tablets contain

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• Other ingredients:
  Tablet core: monohydrate lactose, spray-dried, monohydrate lactose (see section 2 "Important information before taking Tadalafil Aristo"), sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose (101), sodium lauryl sulfate, magnesium stearate.
  Coating: Opadry II Yellow 32K220031, composed of: hypromellose, monohydrate lactose, titanium dioxide, triacetin, yellow iron oxide (E 172), talc.

What Tadalafil Aristo looks like and contents of the packaging
Tadalafil Aristo 5 mg: yellow, oval film-coated tablets, convex on both sides, with a division line on one side and the imprint “T 5” on the other, measuring 8.7 mm x 4.5 mm.
The tablet can be divided into equal doses.
Tadalafil Aristo 5 mg is available in blisters containing 28 film-coated tablets.

Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw
Poland

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 for sale in the European Economic Area and 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 pelicula 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 pelicula
Romania Tadalafil Aristo Pharma 5 mg comprimate filmate
Slovakia Tadalafil Aristo 5 mg filmom obalen*é* tablety
United Kingdom (Northern Ireland) Tadalafil Aristo 5 mg film-coated tablets
Italy Tadalafil Aristo
September 2025