TADALAFIL 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Tadalafil Aristo, 10 mg, Film-Coated Tablets
3. Tadalafil Aristo, 20 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents:
4. What Tadalafil Aristo is and what it is used for
5. Important information before taking Tadalafil Aristo
   1. When not to take Tadalafil Aristo
   2. Warnings and precautions
   3. Children and adolescents
   4. Other medicines and Tadalafil Aristo
   5. Tadalafil Aristo with food and alcohol
   6. Fertility
   7. Driving and using machines
   8. Tadalafil Aristo, 10 mg and 20 mg, film-coated tablets contain lactose
   9. Tadalafil Aristo, 10 mg and 20 mg, film-coated tablets contain sodium
6. How to take Tadalafil Aristo
   1. Take a higher dose of Tadalafil Aristo than prescribed
   2. Miss a dose of Tadalafil Aristo
7. Possible side effects
   1. If the patient experiences any of the following side effects, they should stop taking the medicine and consult their doctor immediately:
   2. Other reported side effects:
8. How to store Tadalafil Aristo
9. Package contents and other information
   1. What Tadalafil Aristo, 10 mg and 20 mg, film-coated tablets contain
   2. What Tadalafil Aristo looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Package Leaflet: Information for the User

Tadalafil Aristo, 10 mg, Film-Coated Tablets

Tadalafil Aristo, 20 mg, Film-Coated Tablets

Tadalafil

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

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What Tadalafil Aristo is and what it is 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. Package contents and other information

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

Tadalafil Aristo is used to treat adult men with:

• erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual performance. It has been shown that Tadalafil Aristo significantly improves the ability to achieve an erection sufficient for satisfactory sexual performance.

Tadalafil Aristo contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
After sexual stimulation, Tadalafil Aristo helps to widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection is improved. Tadalafil Aristo does not help patients who do not have erectile dysfunction.
It is important to note that Tadalafil Aristo does not work without sexual stimulation.
The patient and their partner should engage in foreplay, just as they would if the patient were not taking erectile dysfunction medication.

2. Important information before taking Tadalafil Aristo

When not to take 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, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat 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 in the last 90 days
• if the patient has had a stroke in the last 6 months
• if the patient has low blood pressure or uncontrolled high blood pressure
• if the patient has ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known 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). It has been shown that phosphodiesterase type 5 inhibitors, such as Tadalafil Aristo, 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 taking Tadalafil Aristo, the patient should consult a doctor.
It should be remembered that sexual activity is associated with a risk for patients with heart disease, as it puts an extra strain on the heart. If the patient has heart problems, they should inform their doctor.
Before taking the medicine, the patient should inform their doctor if they have any of the following:

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

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

• had pelvic surgery
• had their prostate removed (radical prostatectomy without nerve sparing). If the patient experiences sudden vision loss or sudden hearing loss, or distorted vision, they should stop taking Tadalafil Aristo and consult their doctor immediately.

In some patients taking tadalafil, a decrease in hearing or sudden hearing loss has been observed.
Although it is not known if this event is directly related to the use of tadalafil, if the patient experiences a decrease in hearing or sudden hearing loss, they should stop taking Tadalafil Aristo and consult their 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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should not take Tadalafil Aristo if they are taking nitrates.
Tadalafil Aristo may affect the way some medicines work, or other medicines may affect the way Tadalafil Aristo works. The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or symptoms of an enlarged prostate)
• other medicines used to treat high blood pressure
• riociguat
• 5-alpha-reductase inhibitors (used to treat an enlarged prostate)
• 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 alcohol

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 it. For more information, the patient should consult their doctor.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes was observed.
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, so the patient should be aware of their reaction to the tablets before driving or operating machinery.

Tadalafil Aristo, 10 mg and 20 mg, film-coated tablets contain lactose

Each 10 mg film-coated tablet contains 126 mg of lactose (as monohydrate).
Each 20 mg film-coated tablet contains 252 mg of lactose (as monohydrate).
If the patient has an intolerance to some sugars, they should consult their doctor before taking the medicine.

Tadalafil Aristo, 10 mg and 20 mg, film-coated tablets contain sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is considered to be essentially "sodium-free".

3. How to take Tadalafil Aristo

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
Tadalafil Aristo tablets are intended for oral use only in men. The tablet 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.
The recommended dose is one 10 mg tablet, taken before planned sexual activity. If the effect is too weak, the doctor may increase the dose to 20 mg.
Tadalafil Aristo can be taken at least 30 minutes before planned sexual activity. Tadalafil Aristo may still be effective up to 36 hours after taking the tablet.
The patient should not take Tadalafil Aristo more than once a day.
Tadalafil Aristo 10 mg and 20 mg is intended for use before planned sexual activity. It is not recommended to take the medicine on a continuous, daily basis.
It is important to note that Tadalafil Aristo does not work without sexual stimulation.
The patient and their partner should engage in foreplay, just as they would if the patient were not taking erectile dysfunction medication.
Consuming alcohol may affect the patient's ability to achieve an erection and may cause a temporary decrease in blood pressure. If the patient has taken Tadalafil Aristo or plans to take it, they should not consume large amounts of alcohol (blood alcohol level 0.08% or higher), as this may increase the risk of dizziness when standing up.

Take a higher dose of Tadalafil Aristo than prescribed

The patient should inform their doctor. Side effects (see section 4 "Possible side effects") may occur.

Miss a dose of Tadalafil Aristo

The patient should take the dose as soon as they remember. They should not take a double dose to make up for a forgotten tablet. The patient should not take Tadalafil Aristo more than once a day.
In case of further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tadalafil Aristo can cause side effects, although not everybody gets them.
These effects are usually mild or moderate.

If the patient experiences any of the following side effects, they should stop taking the medicine and consult their doctor immediately:

• allergic reactions, including skin rash (not very common).
• chest pain - the patient should not take nitrates, but should seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erections after taking Tadalafil Aristo (rare). If the patient experiences such an erection, they should seek medical help immediately.
• sudden vision loss (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 pain, pain in arms and legs, flushing, nasal congestion, and indigestion.

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

• dizziness, stomach upset, 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(affects 1 to 10 users in 10,000)
• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden hearing loss, hives (itchy, red bumps on the skin), penile bleeding, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these patients had heart problems before taking the medicine.
There have been reports of rare cases of partial, transient, or permanent vision loss or blindness in one or both eyes.
Men taking tadalafil have reported several additional rare side effects that were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• distorted vision, blurred vision, or sudden loss of vision (frequency not known). The side effect dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhea was reported more frequently in men over 65 years of age taking tadalafil.

Reporting side effects
If the patient experiences any side effects, including any side effects not listed in the package leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: 22 49-21-301,
fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, the patient can help provide more information on the safety of the medicine.

5. How to store Tadalafil Aristo

The medicine should be stored out of sight and reach of children.
The patient should not use the medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
The medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Aristo, 10 mg and 20 mg, film-coated tablets contain

• The active substance is tadalafil.

Tadalafil Aristo 10 mg, film-coated tablets:
Each film-coated tablet contains 10 mg of tadalafil.
Tadalafil Aristo 20 mg, film-coated tablets
Each film-coated tablet contains 20 mg of tadalafil.

• Other ingredientsare: Core:lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate. Opadry II Yellow 32K220019coating, which contains: hypromellose, lactose monohydrate, titanium dioxide, triacetin, yellow iron oxide (E 172), talc.

What Tadalafil Aristo looks like and contents of the pack

Tadalafil Aristo, 10 mg, film-coated tablets
Tadalafil Aristo, 10 mg: yellow, oval, film-coated tablets with a score line on one side and "T 10" on the other side, 11.5 mm x 5.9 mm in size.
The tablet can be divided into two equal doses.
Tadalafil Aristo 10 mg is available in blisters containing 4 film-coated tablets.
Tadalafil Aristo, 20 mg, film-coated tablets
Tadalafil Aristo, 20 mg: yellow, oval, film-coated tablets with a score line on one side and "T 20" on the other side, 13.9 mm x 7.2 mm in size.
The tablet can be divided into two equal doses.
Tadalafil Aristo 20 mg is available in blisters containing 4 film-coated tablets.

Marketing authorization holder

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

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 authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Tadalafil Aristo 10/ 20 mg Filmtabletten
Czech Republic
Tadalafil Aristo
Spain
Tadalafil Aristo 10/ 20 mg comprimidos recubiertos con pelicula EFG
Netherlands
Tadalafil Aristo 10/ 20 mg filmomhulde tabletten
Malta
Tadalafil Aristo 10/ 20 mg film-coated tablets
Germany
Tadalafil Aristo 10/ 20 mg Filmtabletten
Poland
Tadalafil Aristo
Portugal
Tadalafil Aristo 10/ 20 mg Comprimido revestido por pelicula
Romania
Tadalafil Aristo Pharma 5 mg comprimate filmate
Slovakia
Tadalafil Aristo 10/ 20 mg filmom obalené tablety
United Kingdom (Northern Ireland)
Tadalafil Aristo 10/ 20 mg film-coated tablets
Italy
Tadalafil Aristo
Date of last revision of the package leaflet:October 2023