Tadalafil aristo

Package leaflet: Information for the user

Tadalafil Aristo, 10 mg, film-coated tablets
Tadalafil Aristo, 20 mg, film-coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 personally. 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 any not listed in this leaflet, tell 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 you take 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 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 satisfactory sexual intercourse. Tadalafil Aristo has been shown to significantly improve 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.
Following sexual stimulation, Tadalafil Aristo helps widen the blood vessels in the penis, allowing increased blood flow into the penis. This results in improved erection. Tadalafil Aristo does not benefit patients who do not have erectile dysfunction.
It is important to be aware that Tadalafil Aristo 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.

2. Important information before using 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, e.g. amyl nitrite. This is a group of medicines ("nitrates") used to treat angina (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). It has been shown that PDE5 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 Tadalafil Aristo, consult a doctor.
Please remember that sexual activity involves some risk for patients with heart conditions, as it places additional strain on the heart. If there are any heart problems, inform the doctor.
Before taking the medicine, the patient should inform the doctor if any of the following apply:

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

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

• after pelvic surgery
• after total or partial removal of the prostate gland with nerve-sparing techniques (nerve-sparing radical prostatectomy). If sudden worsening of vision or sudden vision loss occurs, or if vision becomes distorted or blurred while taking 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 hearing worsens 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 the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Do not take Tadalafil Aristo if taking nitrates.
Tadalafil Aristo may affect the action of certain medicines or other medicines may affect the action of Tadalafil Aristo. Tell the doctor or pharmacist if taking any of the following medicines:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or urinary symptoms caused by 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 with 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 more information, consult a 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
In clinical trials, some men taking Tadalafil Aristo reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive a car or operate machinery.
Tadalafil Aristo 10 mg and 20 mg film-coated tablets contain lactose
Each Tadalafil Aristo 10 mg film-coated tablet contains 126 mg of lactose (in monohydrate form).
Each Tadalafil Aristo 20 mg film-coated tablet contains 252 mg of lactose (in monohydrate form).
If the patient has an intolerance to certain sugars, they should consult a doctor before starting treatment with this 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, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Aristo

This medicine should always be taken as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Tadalafil Aristo tablets are intended for oral use only in men. Swallow the tablet with a small amount of water. The tablets may be taken with or without food.
The tablet may be divided into two equal doses.
The recommended dose is one 10 mg tablet taken prior to planned sexual activity. If the effect is too weak, the physician may increase the dose to 20 mg.
Tadalafil Aristo may be taken at least 30 minutes before planned sexual activity. 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 mg and 20 mg is intended for use prior to planned sexual activity. Regular, daily use of the medicine is not recommended.
It is important to be aware that Tadalafil Aristo does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as when the patient is not taking erectile dysfunction medicines.
Alcohol consumption may affect the patient's ability to achieve an erection and may cause transient lowering of blood pressure. If the patient has taken or plans to take Tadalafil Aristo, he should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Use of a higher than recommended dose of Tadalafil Aristo
Inform your doctor. Adverse effects described in section 4, "Possible adverse effects", may occur.
Missed dose of Tadalafil Aristo
Take the missed dose as soon as the patient remembers. 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 doubts regarding 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 everybody will get 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 rash (not common).
• chest pain – do not take nitrates, but seek immediate medical help (not common).
• 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 not known).

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.

Not common (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, and 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 conditions 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 swelling of the face and throat, severe skin rashes, disorders manifesting as blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, or dim central vision or sudden worsening of vision (frequency not known). The adverse reaction dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea was 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, tell 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 required. This will help protect the environment.

6. Contents of the pack 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 ingredients are: Tablet core: monohydrate lactose, spray-dried lactose monohydrate (see section 2 "Important information before taking Tadalafil Aristo"), sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose (101), sodium lauryl sulfate, magnesium stearate. Coating Opadry II Yellow 32K220019, composition: hypromellose, monohydrate lactose, 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, biconvex, with a division line on one side and marked "T 10" on the other side, measuring 11.5 mm x 5.9 mm.
The tablet can be divided into 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, biconvex, with a division line on one side and marked "T 20" on the other side, measuring 13.9 mm x 7.2 mm.
The tablet can be divided into equal doses.
Tadalafil Aristo 20 mg is available in blisters containing 4 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 in the European Economic Area countries 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 película 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 película
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