TADALAFIL 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Tadalafil Aristo, 10 mg, coated tablets
3. Tadalafil Aristo, 20 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Tadalafil Aristo and what is it 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, coated tablets contain lactose
   9. Tadalafil Aristo, 10 mg and 20 mg, coated tablets contain sodium
6. How to take Tadalafil Aristo
   1. Taking a higher dose of Tadalafil Aristo than recommended
   2. Missing a dose of Tadalafil Aristo
7. Possible side effects
   1. If any of the following side effects occur, the patient should stop taking the medicine and consult their doctor immediately:
   2. Other reported side effects:
8. How to store Tadalafil Aristo
9. Contents of the pack and other information
   1. What Tadalafil Aristo, 10 mg and 20 mg, 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 the United Kingdom (Northern Ireland) under the following names:

Leaflet attached to the packaging: information for the user

Tadalafil Aristo, 10 mg, coated tablets

Tadalafil Aristo, 20 mg, coated tablets

Tadalafil

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

• Keep this 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 leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 is used to treat adult men:

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

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 of the penis, allowing blood to flow into the penis. As a result, the erection improves. Tadalafil Aristo does not help patients who do not have erectile dysfunction.
It is important to be aware that Tadalafil Aristo does not work without sexual stimulation.
The patient and his partner should arrange foreplay, just like when the patient is 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 effect 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), 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). 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 starting treatment with Tadalafil Aristo, the patient should consult a doctor.
It should be remembered that sexual activity is associated with a certain risk for patients with heart disease, as it puts an additional 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 conditions:

• 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:

• after pelvic surgery
• after total or partial removal of the prostate gland, during which the prostate nerves are cut (radical prostatectomy without nerve sparing). If sudden vision loss or sudden vision disturbance occurs during treatment with Tadalafil Aristo, the patient should stop taking the medicine and consult a doctor immediately.

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

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.
Tadalafil Aristo should not be taken if the patient is taking nitrates.
Tadalafil Aristo may affect the action of some medicines or other medicines may affect the action of Tadalafil Aristo. The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or symptoms of an enlarged prostate gland)
• other medicines used to treat high blood pressure
• riociguat
• 5-alpha-reductase inhibitors (used to treat an enlarged prostate gland)
• medicines such as ketoconazole in tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection
• phenobarbital, phenytoin, and carbamazepine (antiepileptic 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 should be consumed with caution. 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, coated tablets contain lactose

Each 10 mg Tadalafil Aristo coated tablet contains 126 mg of lactose (in the form of monohydrate).
Each 20 mg Tadalafil Aristo coated tablet contains 252 mg of lactose (in the form of 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, coated tablets contain sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered ``sodium-free''.

3. How to take Tadalafil Aristo

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they 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 continuously, on a daily basis.
It is important to be aware that Tadalafil Aristo does not work without sexual stimulation.
The patient and his partner should arrange foreplay, just like when the patient is 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 concentration 0.08% or higher), as this may increase the risk of dizziness when standing up.

Taking a higher dose of Tadalafil Aristo than recommended

The patient should inform their doctor. Side effects described in section 4 ``Possible side effects'' may occur.

Missing 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 the missed tablet. The patient should not take Tadalafil Aristo more than once a day.
If the patient has any further doubts about taking the medicine, they should consult their 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 or moderate.

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

• allergic reactions, including rashes (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 such an erection occurs and lasts continuously for more than 4 hours, the patient should seek medical help immediately.
• sudden vision loss (rare), distorted, blurred, or decreased vision (frequency not known).

Other reported side effects:

Common(affects 1 to 10 in 100 patients)

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

Uncommon(affects 1 to 10 in 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(affects 1 to 10 in 10,000 patients)
• 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 starting treatment with this 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 a few additional rare side effectsthat 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, blurred, or decreased vision or sudden vision loss (frequency not known). The side effect of 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 leaflet, they should tell 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, more information can be gathered 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 this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
This 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

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

• The active substanceis tadalafil.

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

• Other ingredientsare: Core:lactose monohydrate, spray-dried, lactose monohydrate (see section 2 ``Important information before taking Tadalafil Aristo''), croscarmellose sodium, hypromellose (LH 11), microcrystalline cellulose (101), sodium lauryl sulfate, magnesium stearate. Opadry II Yellow 32K220019 coating, consisting of :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, coated tablets
Tadalafil Aristo, 10 mg: yellow, oval, coated tablets with a dividing line on one side and ``T 10'' on the other side, biconvex, 11.5 mm x 5.9 mm in size.
The tablet can be divided into equal doses.
Tadalafil Aristo 10 mg is available in blisters containing 4 coated tablets.
Tadalafil Aristo, 20 mg, coated tablets
Tadalafil Aristo, 20 mg: yellow, oval, coated tablets with a dividing line on one side and ``T 20'' on the other side, biconvex, 13.9 mm x 7.2 mm in size.
The tablet can be divided into equal doses.
Tadalafil Aristo 20 mg is available in blisters containing 4 coated tablets.

Marketing authorization holder

Aristo Pharma Sp. z o.o.
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 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 leaflet:October 2023